[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"menopause\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:menopause":26},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,98,0,25,[9,41,73,119,145,176,197,221,246,279,306,331,357,385,414,441,471,489,512,538,567,595,619,653,676],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100630385","endocrine-disruption-menopause-and-poor-sleep-in-women-with-type-2-diabetes-effects-on-cardiovascular-health-100630385",false,"NCT07486986","Endocrine Disruption, Menopause, and Poor Sleep in wOmen With Type 2 Diabetes: Effects on Cardiovascular Health","EMPOWER","Inclusion Criteria:\n\n* Female Sex\n* Age range 48-58 years\n* In menopausal transition phase (pre-menopause or peri-menopause)\n* Diagnosis of Type 2 Diabetes Mellitus\n* Have access to and regularly use a smartphone with internet access\n\nExclusion Criteria:\n\n* Male Sex\n* Currently Pregnant\n* Prior history of total hysterectomy or bilateral oophorectomy\n* Prior diagnosis of any of the following:\n\nCoronary Vascular Disease (CVD) including coronary heart disease, heart failure, congenital heart disease stroke\u002Ftransient ischemic attack, valvular heart disease, peripheral vascular disease, aortapathy, atrial fibrillation or flutter, other CVD.\n\n\\- Untreated serious mental illness (e.g, untreated psychosis).","FEMALE","48 Years","58 Years",{"count":21,"type":22},381,"ESTIMATED","OBSERVATIONAL","EMPOWER aims to determine the overall effect of menopause and sleep disruption on cardiac remodeling in women with type 2 diabetes.",[26,27,28],"Menopause","Sleep Disruption","T2DM","NOT_YET_RECRUITING","2026-06-30",{"date":32,"type":33},"2026-07-01","ACTUAL",{"date":35,"type":22},"2026-09",{"date":37,"type":22},"2032-12",{"name":39,"class":40},"Ottawa Heart Institute Research Corporation","OTHER",{"id":42,"slug":43,"hasResults":12,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":49,"sex":17,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":4},"100644536","cuidar-me-a-web-based-psychological-intervention-for-perimenopausal-women-a-pilot-randomized-controlled-trial-100644536","NCT07672002","Cuidar-ME, a Web-based Psychological Intervention for (Peri)Menopausal Women: A Pilot Randomized Controlled Trial","A Pilot Randomized Controlled Trial to Evaluate the Acceptability, Feasibility and Preliminary Efficacy of a Web-based Psychological Intervention to Promote Well-being and Mental Health During (Peri)Menopause","Cuidar-ME","Inclusion Criteria:\n\n* Being female;\n* Being between 40 and 60 years old;\n* Being in perimenopause or natural post-menopause;\n* Residence in Portugal;\n* Having access to a computer, tablet, or smartphone and internet (a necessary - condition to complete the program);\n* Being able to read and write in Portuguese.\n\nExclusion Criteria:\n\n* Having menopause induced by medical or surgical reasons;\n* Presence of a severe physical medical condition (self-reported);\n* Presence of a severe psychiatric illness (self-reported);\n* Presence of suicidal ideation.",true,"40 Years","60 Years",{"count":53,"type":22},150,"INTERVENTIONAL",[56],"NA","The Cuidar-ME program is a web-based cognitive-behavioral intervention designed to promote well-being and mental health in women during (peri)menopause. The main goal of this research is to evaluate its acceptability, feasibility and preliminary evidence of efficacy of the intervention. This pilot randomized controlled trial uses a two-arm design and serves as a preliminary step before a full-scale RCT.\n\nA sample of at least 150 (peri)menopausal women, aged 40 to 60, will be recruited online. Participants who meet the eligibility criteria will be randomly assigned to either the web-based intervention (Cuidar-ME) or a waitlist control condition (which will receive access to the program after the study concludes).\n\nParticipation in this study will last approximately 3 months. Participants in both conditions will be invited by the researchers via email to complete baseline and post-intervention assessments. These assessments will include self-report questionnaires evaluating several outcomes (e.g., quality of life, menopausal symptoms, depressive and anxiety symptoms, menopause representations, etc.), potential mechanisms of treatment response (emotional regulation and self-compassion), as well as user acceptability and feasibility.",[26,59],"Perimenopause",[26,61,62,63,64],"Cognitive-Behavioral Therapy","Web-Based Intervention","Quality of Life","Mental Health","2026-06-26",{"date":30,"type":33},{"date":68,"type":22},"2026-09-01",{"date":70,"type":22},"2027-02-01",{"name":72,"class":40},"University of Coimbra",{"id":74,"slug":75,"hasResults":12,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":49,"sex":17,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":85,"conditions":86,"keywords":92,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":118},"100645235","crest-samphire-guided-care-program-on-wellbeing-work-productivity-and-quality-of-life-100645235","NCT07679074","CREST: Samphire Guided Care Program on Wellbeing, Work Productivity, and Quality of Life","A 12-Week Prospective Cohort Study Evaluating the Efficacy of the Samphire Guided Care Program on Wellbeing, Work Productivity, and Quality of Life in Individuals With Menstrual and Pelvic Health Conditions","CREST","Inclusion Criteria:\n\n* Self-identified female, aged 18-65 years at the time of enrollment\n* Basic English literacy\n* Able and willing to provide informed consent electronically\n* Residing in the United States\n* Reporting mood or cognitive symptoms associated with menstruation, perimenopause, or menopause (must endorse a minimum of three of the following: irritability, emotional dysregulation, brain fog, fatigue, reduced concentration, sleep disruption, or low mood)\n* Symptoms present for at least 3 months and sufficiently severe to interfere with daily functioning, work performance, quality of life, or interpersonal relationships\n* Currently in full-time employment with medical benefits as part of compensation package\n* Access to a smartphone with internet access compatible with the Samphire mobile application\n* Able to safely operate the study device in the home environment\n* Willing to complete baseline, mid-program, and end-of-program questionnaires and engage with the 12-week guided care program\n\nExclusion Criteria:\n\n* Pregnancy, breastfeeding, or actively planning pregnancy during the study period\n* History of epilepsy or seizure disorder\n* Severe or unstable neurological disease that, in the opinion of the study team, may increase risk or interfere with participation\n* Implanted electronic or metal devices in the head, neck, or brain region contraindicated for tDCS use\n* Active scalp lesions, open wounds, or dermatologic conditions at electrode sites that may interfere with safe device use\n* Current diagnosis of schizophrenia, bipolar disorder, or other severe psychiatric condition that would make participation inappropriate, as determined by screening\n* Active suicidal ideation, recent suicidal behavior, or clinically significant self-injurious behavior, as determined by participant self-report during screening\n* Inability to provide informed consent or safely use the device in the home environment\n* Current participation in another interventional neurotechnology or drug study","18 Years","65 Years",{"count":84,"type":22},50,"This study evaluates the feasibility and efficacy of the Samphire Guided Care (SGC) program\n\n* a 12-week structured digital health program combining clinician-led onboarding, at-home neuromodulation using the Lutea tDCS device, neuromodulation coach support, and app-based symptom tracking - on work productivity, employee wellbeing, and quality of life in individuals experiencing mood and cognitive symptoms associated with menstruation, perimenopause, or menopause.",[87,88,89,90,59,26,91],"Premenstrual Syndrome","Premenstrual Dysphoric Disorder","Dysmenorrhea","Endometriosis","Pelvic Pain",[93,94,95,96,97,98,99,100,101,102,103,104,105,106,107],"tDCS","neuromodulation","hormonal health","menstrual symptoms","perimenopause","menopause","PMDD","PMS","work productivity","brain fog","mood","cognitive function","digital health","decentralized clinical trial","guided care","RECRUITING","2026-06-25",{"date":32,"type":33},{"date":112,"type":33},"2026-06-01",{"date":114,"type":22},"2027-03-01",{"name":116,"class":117},"Samphire Group, Inc.","INDUSTRY",1,{"id":120,"slug":121,"hasResults":12,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":4,"eligibilityCriteria":125,"healthyVolunteers":49,"sex":17,"minAge":50,"maxAge":82,"enrollmentInfo":126,"targetDuration":4,"studyType":54,"phases":128,"briefSummary":129,"conditions":130,"keywords":132,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":138,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":118},"100645147","effect-of-zenrest-lotus-seed--rice-germ-extract-blend-on-sleep-quality-in-menopausal-women-100645147","NCT07678359","Effect of ZenRest™ Lotus Seed & Rice Germ Extract Blend on Sleep Quality in Menopausal Women","A Randomized, Double-Blind, Placebo-Controlled, 6-Week Pilot Study to Evaluate the Effect of ZenRest™ Lotus Seed & Rice Germ Extract Blend on Sleep Quality in Menopausal Women","Inclusion Criteria:\n\n* Female, aged 40-65 years at time of enrollment\n* Confirmed menopausal status: (a) natural menopause (≥12 consecutive months of amenorrhea without other clinical cause), or (b) surgical menopause (bilateral oophorectomy with documented date of procedure)\n* Positive onboarding sleep screener: rates sleep quality as \"Fairly Bad\" or \"Very Bad\" AND reports sleep difficulty at least once per week in the prior month\n* PSQI global score \\>5 at T0 baseline assessment (formal eligibility gate)\n* Owns and actively uses an Oura Ring Generation 4 at time of enrollment\n* Demonstrates ≥80% Oura Ring wear compliance in the 30 days prior to enrollment, confirmed via Alethios platform sync at onboarding\n* Willing to wear Oura Ring Generation 4 continuously for 42 nights throughout the study period\n* Willing to maintain stable diet, sleep habits, medications, and supplement use throughout the 42-day study period\n* No planned major disruptions to sleep schedule, shift work, or travel across ≥3 time zones during the study period\n* Access to a smartphone or computer to complete eConsent and digital questionnaires\n* Able to provide informed consent via the Alethios eConsent platform\n\nExclusion Criteria:\n\n* Current use of prescription sleep medications (benzodiazepines, non-benzodiazepine hypnotics, doxepin, suvorexant) within 30 days of enrollment\n* Current use of melatonin supplements at doses \\>1 mg\u002Fday within 14 days of enrollment\n* Diagnosis of a clinically significant sleep disorder requiring treatment (obstructive sleep apnea unless adequately treated and stable, restless legs syndrome, narcolepsy)\n* Diagnosis of a major psychiatric disorder currently requiring pharmacological treatment\n* Current use of hormone replacement therapy initiated within 90 days of enrollment, or any planned changes to HRT during the study (stable long-term HRT is acceptable)\n* Regular use of GABAergic, serotonergic, or sedating supplements (valerian, passionflower, ashwagandha, kava) within 14 days of enrollment\n* Shift work or schedule regularly requiring sleep between 06:00 and 22:00\n* Planned travel across 3 or more time zones during the 42-day study period\n* Known allergy to lotus, rice, or related botanicals\n* Active cardiovascular, hepatic, renal, or neurological condition that in the PI's judgment would affect sleep or participant safety\n* Participation in another interventional study within 30 days of enrollment\n* In the opinion of the PI, any condition compromising participant safety or data integrity",{"count":127,"type":22},60,[56],"The goal of this clinical trial is to learn if ZenRest™ (Lotus Seed \\& Rice Germ Extract Blend) can help improve sleep quality in menopausal women aged 40-65 with mild-to-moderate sleep complaints.\n\nThe main questions it aims to answer are:\n\n* Does taking ZenRest™ daily improve subjective, participant-reported sleep quality compared to a placebo?\n* Does ZenRest™ improve objective sleep metrics, specifically sleep efficiency, when monitored via an Oura Ring wearable device?\n* Does the extract improve secondary sleep and lifestyle factors, such as insomnia severity, daytime sleepiness, and vitality? Researchers will compare ZenRest™ to a placebo (a look-alike capsule that contains no active ingredients) to see if the botanical blend has a measurable effect on sleep quality.",[131,26],"Sleep Quality",[133,134,135,136,137,26,131],"ZenRest","Lotus Seed Extract","Rice Germ Extract","Spermidine","Neferine",{"date":32,"type":33},{"date":140,"type":22},"2026-07",{"date":142,"type":22},"2026-10",{"name":144,"class":117},"Nutraland USA, Inc.",{"id":146,"slug":147,"hasResults":12,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":151,"eligibilityCriteria":152,"healthyVolunteers":12,"sex":17,"minAge":153,"maxAge":154,"enrollmentInfo":155,"targetDuration":4,"studyType":54,"phases":157,"briefSummary":158,"conditions":159,"keywords":162,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":118},"100641340","effect-of-mandala-coloring-on-menopausal-attitude-perceived-stress-and-mindfulness-100641340","NCT07657429","Effect of Mandala Coloring on Menopausal Attitude, Perceived Stress and Mindfulness","The Effect of Mandala Coloring on Menopausal Attitudes, Perceived Stress, and Mindfulness in Women During Menopause: A Randomized Controlled Trial","MANDALA-MENO","* Inclusion Criteria:\n\n  * Women aged 45-55 years\n  * Being in the menopausal period (absence of menstruation for at least 12 months)\n  * Ability to read and understand Turkish\n  * Voluntary agreement to participate in the study\n* Exclusion Criteria:\n\n  * Diagnosed psychiatric or cognitive disorders\n  * Communication problems preventing participation\n  * Visual impairment or fine motor limitations preventing mandala coloring\n  * Use of hormone replacement therapy\n  * Regular participation in mandala coloring, mindfulness, or similar mind-body practices","45 Years","55 Years",{"count":156,"type":22},140,[56],"Menopause is a natural life stage associated with hormonal changes that may affect women physically and psychologically. During this period, women may experience increased stress levels, negative attitudes toward menopause, and decreased mindfulness. Mandala coloring is a structured art-based intervention that may promote relaxation and improve psychological well-being. This randomized controlled trial aims to evaluate the effect of mandala coloring on attitudes toward menopause, perceived stress, and mindfulness levels among menopausal women.",[26,160,161],"Psychological Stress","Mindfulness",[163,26,164,161,165,166],"Mandala Coloring","Perceived Stress","Women Health","Randomized Controlled Trial","2026-06-24",{"date":169,"type":33},"2026-06-29",{"date":171,"type":22},"2026-05-30",{"date":173,"type":22},"2026-09-30",{"name":175,"class":40},"Ondokuz Mayıs University",{"id":177,"slug":178,"hasResults":12,"nctId":179,"briefTitle":180,"officialTitle":180,"acronym":4,"eligibilityCriteria":181,"healthyVolunteers":49,"sex":17,"minAge":81,"maxAge":182,"enrollmentInfo":183,"targetDuration":4,"studyType":54,"phases":184,"briefSummary":186,"conditions":187,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":192,"completionDateStruct":193,"leadSponsor":195,"locationsCount":118},"100644665","early-phase-1-beta3-adrenergic-receptors-and-cardiovascular-function-in-aging-women-100644665","NCT07674680","Beta3-adrenergic Receptors and Cardiovascular Function in Aging Women","Inclusion Criteria:\n\nHealthy women Assigned female at birth 18-70 years of age Body mass index \\\u003C18 or ≥30 kg\u002Fm2\n\nExclusion Criteria:\n\nAssigned male at birth Pregnancy Breastfeeding History of hormone replacement therapy, chemical menopause, or oophor-ectomy Polycystic ovarian syndrome or Primary ovarian insufficiency Current smoking\u002FNicotine use Blood pressure ≥140\u002F90 mmHg Increased risk of bleeding, pro-coagulant disorders, clotting disorders, anticoagulation therapy Nerve\u002Fneurologic disease Cardiovascular, hepatic, renal, respiratory disease Hypersensitivity to nitroglycerin Diabetes Communication barriers","70 Years",{"count":127,"type":22},[185],"EARLY_PHASE1","We hypothesize vascular beta3 adrenergic receptors are present and functional in aging women and can be targeted to attenuate sympathetic vasoconstriction and enhance vascular function in aging women.",[188,189,26],"Women","Aging","2026-06-23",{"date":169,"type":33},{"date":140,"type":22},{"date":194,"type":22},"2029-05",{"name":196,"class":40},"University of Missouri-Columbia",{"id":198,"slug":199,"hasResults":12,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":49,"sex":17,"minAge":204,"maxAge":205,"enrollmentInfo":206,"targetDuration":4,"studyType":54,"phases":208,"briefSummary":210,"conditions":211,"keywords":212,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":215,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":219,"locationsCount":118},"100577459","phase-4-role-of-menopause-in-thermoregulation-100577459","NCT06798571","Role of Menopause in Thermoregulation","The Influence of Estrogen on the Thermoregulatory Responses to Heat Stress in Pre and Postmenopausal Women","Inclusion Criteria:\n\n* Women ages 42-64\n\nExclusion Criteria:\n\n* Chron's disease, diverticulitis, or similar gastrointestinal disease\n* Abnormal resting exercise electrocardiogram (ECG)\n* Tobacco use\n* High-risk determined by the Atherosclerotic Cardiovascular Disease (CVD) Risk Factor\n* Assessment\n* Using hormone therapy\n* Using hormonal contraceptives","42 Years","64 Years",{"count":207,"type":22},24,[209],"PHASE4","The frequency and severity of heat waves has increased in the last decades. Older adults (over 65 years) have impaired responses to heat stress making them at increased risk for adverse events. Previous heat waves report that women over 65 experience worse health outcomes than any other age group and age matched men.\n\nAging and reproductive hormones, specifically estrogen, independently alter responses to heat stress. However, the combined effects of low estrogen following menopause and aging on the response to heat stress are unknown. In this study, the investigators will identify the role of estrogen in pre and post menopausal women on thermoregulatory responses to heat stress.",[26,189],[213,214],"Thermoregulation","Heat Stress",{"date":167,"type":33},{"date":217,"type":33},"2025-03-01",{"date":68,"type":22},{"name":220,"class":40},"Penn State University",{"id":222,"slug":223,"hasResults":12,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":12,"sex":17,"minAge":50,"maxAge":51,"enrollmentInfo":228,"targetDuration":4,"studyType":54,"phases":230,"briefSummary":231,"conditions":232,"keywords":233,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":118},"100639154","evaluation-of-the-effects-of-lifestyle-medicine-and-mindfulness-based-group-medical-visits-on-stress-microbiome-and-quality-of-life-in-women-experiencing-perimenopause-and-menopause-100639154","NCT07619352","Evaluation of the Effects of Lifestyle Medicine and Mindfulness-based Group Medical Visits on Stress, Microbiome, and Quality of Life in Women Experiencing Perimenopause and Menopause","A Pilot Study to Evaluate the Effects of Lifestyle Medicine and Mindfulness-based Group Medical Visits on Stress, Microbiome, and Quality of Life in Women Experiencing Perimenopause and Menopause","Inclusion Criteria:\n\n1. Biological female.\n2. Age 40 to 60.\n3. Irregular menstruation for 3 months and experiencing perimenopause or menopause as determined by reporting at least one symptom on the Menopause Quality of Life Questionnaire (MENQOL).\n4. Ability to attend group medical visits monthly, in-person for 8 months, at The Ohio State University Center for Integrative Health as well as the baseline and end of study visit.\n5. Ability to participate in the Mindfulness in Motion (MIM) study activities.\n6. Ability and willingness to download MyCap, the smartphone app that securely links participant study responses to the REDCap study project.\n7. WiFi connectivity or LTE to allow use of MyCap when not at OSU study site\n\nExclusion Criteria:\n\n1. Participants with surgically induced menopause, e.g., hysterectomy, oophorectomy.\n2. Currently receiving or planning to receive hormone therapy for perimenopausal or menopausal symptoms.\n3. Currently taking or planning to take hormonal contraceptives.\n4. Currently taking or planning to take hormone altering medications; i.e. Taxol.\n5. Currently taking probiotics, Siberian rhubarb (Rheum rhaponticum), Black cohosh (Actaea racemosa), Chaste tree berry (Vitex agnus-castus).\n6. Inability to read and\u002For understand English (consent and questionnaires in English).\n7. Current severe alcohol or substance abuse disorder.\n8. Participants with documented cognitive disorder that limits the ability to independently read, understand, and\u002For complete the survey or biological; i.e. dementia, Alzheimer's or biological tests.\n9. Participants with major psychiatric disorders not controlled by medication or other psychiatric treatments.",{"count":229,"type":22},40,[56],"While perimenopause and menopause are natural biological transitions, women may experience a wide range of physical, emotional, and cognitive symptoms. Although pharmacological options for symptom relief are available, these options may not be acceptable or suitable for all women. Integrative approaches for symptom relief, offered through group medical visits, may complement traditional therapies by increasing access to providers, allowing more time for focused education, and fostering supportive discussions with other women experiencing similar symptoms of perimenopause or menopause.\n\nThe purpose of this study is to assess the effectiveness of eight monthly group medical visits that incorporate individual physical assessments, focused education on the foundational elements of Lifestyle Medicine relative to health and well-being, mindfulness practices, and community-building discussions with women experiencing perimenopause or menopause. Individual outcomes, obtained before the group medical visits begin, at each monthly group medical visit, and four months after the group medical visits are completed, will include measures of participants' perimenopause or menopause symptoms, stress, inflammation, microbiome (good bacteria in the body), height\u002Fweight, body mass index (BMI), systolic and diastolic blood pressure, and self-reported perceptions of physical, mental, and social health.\n\nEach 120-minute monthly group medical visit, led by a specially trained nurse practitioner and a mindfulness instructor, will include a brief physical assessment, educational discussions related to menopause and lifestyle medicine, experiential mindfulness practices, and the development of individual health and well-being goals.",[59,26],[97,98,234,235,236,237],"stress","microbiome","quality of life","women","2026-06-18",{"date":190,"type":33},{"date":241,"type":22},"2026-08-01",{"date":243,"type":22},"2028-08-30",{"name":245,"class":40},"Ohio State University",{"id":247,"slug":248,"hasResults":12,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":4,"eligibilityCriteria":252,"healthyVolunteers":12,"sex":17,"minAge":153,"maxAge":154,"enrollmentInfo":253,"targetDuration":4,"studyType":54,"phases":255,"briefSummary":256,"conditions":257,"keywords":260,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":118},"100641801","meleis-transition-theory-based-education-and-counseling-program-in-menopausal-women-100641801","NCT07657078","Meleis' Transition Theory-Based Education and Counseling Program in Menopausal Women","The Effect of a Meleis' Transition Theory-Based Education and Counseling Program on Menopausal Symptoms, Perimenopausal Depression, and Menopause-Specific Quality of Life in Menopausal Women: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Female participants aged 45 to 55 years\n* Naturally menopausal women\n* Menopause duration not exceeding 2 years\n* Experiencing menopausal symptoms\n* Sexually active\n* Able to read and write Turkish\n* Willing to participate voluntarily\n* Able to provide written informed consent\n* Not currently receiving hormone replacement therapy\n* No history of psychiatric disorders\n* No previous menopause-related education\n\nExclusion Criteria:\n\n* Failure to continue participation in the study\n* Failure to attend education and counseling sessions\n* Withdrawal from the study at any time\n* Withdrawal of informed consent\n* Loss to follow-up",{"count":254,"type":22},114,[56],"This randomized controlled trial aims to evaluate the effectiveness of a Meleis' Transition Theory-based education and counseling program on menopausal symptoms, perimenopausal depression, and menopause-specific quality of life among naturally menopausal women aged 45 to 55 years.\n\nParticipants will be randomly assigned to either the intervention group or the control group. The intervention group will receive a structured four-week education and counseling program based on Meleis' Transition Theory, supported by a secure online messaging group and follow-up counseling sessions. The control group will receive routine care and standard information during the study period and will be offered a one-day educational session after completion of the final assessment.\n\nThe outcomes will be measured at baseline and Week 16 using the Menopause Rating Scale, the Perimenopausal Depression Scale, and the Menopause-Specific Quality of Life Questionnaire-II.",[26,258,259],"Menopausal Symptoms","Perimenopausal Depression",[26,261,262,263,264,265,266,267,268,269],"Menopausal transition","Meleis' Transition Theory","Education","Counseling","Menopausal symptoms","Perimenopausal depression","Quality of life","Women's health","Nursing","2026-06-17",{"date":272,"type":33},"2026-06-22",{"date":274,"type":22},"2026-06-15",{"date":276,"type":22},"2026-10-15",{"name":278,"class":40},"Ankara Medipol University",{"id":280,"slug":281,"hasResults":12,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":4,"eligibilityCriteria":285,"healthyVolunteers":49,"sex":17,"minAge":50,"maxAge":286,"enrollmentInfo":287,"targetDuration":4,"studyType":54,"phases":289,"briefSummary":290,"conditions":291,"keywords":297,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":300,"startDateStruct":301,"completionDateStruct":302,"leadSponsor":304,"locationsCount":4},"100641575","veda-study-dhea-vs-estradiol-100641575","NCT07574216","VEDA Study (DHEA vs Estradiol)","The Use of Vaginal Estrogen vs DHEA in Perimenopausal and Menopausal Women","Inclusion Criteria:\n\n* Peri- or post-menopausal status\n* Presence of any genitourinary or vaginal symptom (e.g., dryness, itching, discomfort, dyspareunia)\n* Willingness and ability to use vaginal therapy\n* Ability to provide informed consent\n* English speaker\n* Ages 40-90\n\nExclusion Criteria:\n\n* Use of systemic hormone therapy within the last 6 months\n* Gynecologic malignancy\n* Known allergy to study medications\n* Active vaginal infection at enrollment\n* Prior pelvic radiation","90 Years",{"count":288,"type":22},324,[56],"This study is being done to compare two vaginal treatments, vaginal estrogen and vaginal DHEA, that are used to treat vaginal and urinary symptoms related to menopause. These symptoms may include vaginal dryness, discomfort, painful intercourse, or urinary problems and can affect quality of life and sexual health. Women who choose to participate will be randomly assigned to use one of the two treatments for a set period of time. Participants will complete questionnaires about their symptoms and sexual health and have simple vaginal testing at the beginning and end of the study. The goal of this research is to better understand how these treatments affect vaginal health and sexual function so healthcare providers can make informed treatment decisions and improve care for postmenopausal women.",[292,293,294,26,295,296],"Post-menopause","Pre-menopause","Sexual Function","Vaginal Dryness","Painful Intercourse",[298,299],"DHEA","vaginal estrogen",{"date":270,"type":33},{"date":112,"type":22},{"date":303,"type":22},"2031-12-31",{"name":305,"class":40},"University of Arizona",{"id":307,"slug":308,"hasResults":12,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":312,"eligibilityCriteria":313,"healthyVolunteers":49,"sex":17,"minAge":153,"maxAge":82,"enrollmentInfo":314,"targetDuration":4,"studyType":54,"phases":316,"briefSummary":317,"conditions":318,"keywords":324,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":325,"startDateStruct":326,"completionDateStruct":327,"leadSponsor":329,"locationsCount":4},"100623836","fascial-yoga-in-menopausal-women-100623836","NCT07401810","Fascial Yoga in Menopausal Women","The Effect of Fascial Yoga on Perceived Stress, Cognitive Control, and Cognitive Flexibility in Menopausal Women","FascialYogaM","Inclusion Criteria:\n\n* Female participants aged 45-65 years\n* In the menopausal period, defined as at least 12 months since the last menstrual period\n* Able to read and understand Turkish and to complete self-report questionnaires\n\nExclusion Criteria:\n\n* Current or past diagnosis of a psychiatric disorder or ongoing psychiatric treatment\n* Regular use of antidepressant, anxiolytic, or corticosteroid medications\n* History of cancer or currently receiving active oncological treatment\n* Participation in facial yoga or similar yoga-based programs within the past 6 months\n* Any medical condition that may prevent safe participation in mild physical activity\n* Incomplete attendance to intervention sessions or incomplete outcome data during the study period",{"count":315,"type":22},100,[56],"Aim:\n\nThe aim of this study is to evaluate the effects of a structured fascial yoga-based behavioral intervention on perceived stress, cognitive control, and cognitive flexibility in menopausal women. The study aims to determine whether a non-pharmacological and non-invasive behavioral intervention can support psychological and cognitive functioning and reduce perceived stress in menopausal women.\n\nDesign:\n\nThis study is designed as a randomized controlled, pretest-posttest experimental study with a post-intervention follow-up assessment. Eligible participants will be randomly assigned to either the intervention group or the control group receiving usual care. Outcomes will be assessed at baseline, immediately after the intervention, and at follow-up to evaluate both the immediate and sustained effects of the intervention.\n\nMethod:\n\nA total of 100 menopausal women aged 45-65 years will be recruited from the menopause outpatient clinic and randomly assigned to either the intervention group or the control group. The intervention group will participate in a 12-week online fascial yoga program consisting of two 60-minute sessions per week.\n\nIn this study, fascial yoga is defined as a fascia-focused, non-pharmacological, and non-invasive behavioral intervention that includes myofascial release techniques, breath regulation, body awareness, and basic yoga practices to support stress regulation and cognitive functioning. The program will include myofascial release techniques, basic yoga postures suitable for all physical fitness levels, and structured breathing exercises. All sessions will be conducted online in a group format, and no audio or video recordings will be taken.\n\nThe control group will continue to receive routine outpatient care during the study period. After completion of the follow-up assessments, the fascial yoga program will be offered to participants in the control group upon request.\n\nData will be collected at three time points: at baseline before the intervention, immediately after completion of the 12-week intervention, and at the follow-up assessment 8 weeks after the intervention. Perceived stress, cognitive control, and cognitive flexibility will be assessed using validated self-report questionnaires.\n\nHypotheses:\n\nH1: Menopausal women participating in the fascial yoga intervention will show a significant reduction in perceived stress levels compared with the control group at post-intervention and follow-up assessments.\n\nH2: Menopausal women participating in the fascial yoga intervention will show a significant improvement in cognitive control and cognitive flexibility compared with the control group at post-intervention and follow-up assessments.",[26,319,320,321,166,322,164,323],"Stress, Psychological","Cognitive Flexibility","Nonpharmacological Interventions","Cognitive Control","Yoga",[26,164,320,322,323],{"date":270,"type":33},{"date":32,"type":22},{"date":328,"type":22},"2027-06-01",{"name":330,"class":40},"Marmara University",{"id":332,"slug":333,"hasResults":12,"nctId":334,"briefTitle":335,"officialTitle":335,"acronym":4,"eligibilityCriteria":336,"healthyVolunteers":49,"sex":17,"minAge":50,"maxAge":51,"enrollmentInfo":337,"targetDuration":4,"studyType":54,"phases":339,"briefSummary":340,"conditions":341,"keywords":344,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":349,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"locationsCount":118},"100454163","hot-flashes-and-neurovascular-function-in-women-100454163","NCT05193968","Hot Flashes and Neurovascular Function in Women","Inclusion Criteria:\n\n* Non-smokers.\n* Non-obese.\n* Have at least one ovary.\n* Free from cardiovascular disease.\n* Not taking medications influencing cardiovascular function.\n\nExclusion Criteria:\n\n\\- None.",{"count":338,"type":22},120,[56],"Women who experience hot flashes are at greater risk for hypertension and other cardiovascular disease. Neurovascular control mechanisms are likely to play an important role in this relationship. As such, these studies are designed to provide a major step forward in understanding the link between hot flashes and neurovascular dysfunction and, by extension, cardiovascular disease in women.",[342,26,343],"Hot Flashes","Vasomotor System; Labile",[345,346,347],"Neurovascular function","Autonomic function","Microvascular Function","2026-06-10",{"date":350,"type":33},"2026-06-12",{"date":352,"type":33},"2022-02-24",{"date":354,"type":22},"2026-12",{"name":356,"class":40},"Mayo Clinic",{"id":358,"slug":359,"hasResults":12,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":363,"eligibilityCriteria":364,"healthyVolunteers":49,"sex":17,"minAge":365,"maxAge":4,"enrollmentInfo":366,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":368,"conditions":369,"keywords":371,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":376,"lastUpdatePostDateStruct":377,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":118},"100641816","significance-of-estrogen-status-for-muscle-function-physical-fitness-and-physiological-health-parameters---a-comparison-of-age-matched-groups-of-women-before-and-after-menopause-100641816","NCT07649356","Significance of Estrogen Status for Muscle Function, Physical Fitness, and Physiological Health Parameters - a Comparison of Age-matched Groups of Women Before and After Menopause.","Effects of Estrogen on Muscle Gain During 12-weeks of Exercise in Post-menopausal Women","HER-MUSCLEX","Inclusion Criteria:\n\n* Regular menstrual bleeding (21-35 days cycle).\n* At least 9 menstrual cycles the last year\n* Age \\>47 years old\n* BMI 20-30\n\nExclusion Criteria:\n\n* Only premenopausal women: Follicular stimulating hormone \\> 30 mmol\u002FL\n* Systematic strength training during the last year (\\> 1 strength training session per week)\n* Systematic high intensity cardiovascular training during the last year (\\\u003C2 times per week)\n* Injuries to the legs which may prevent participation in the physical training program\n* Magnetizable metals or electrical devices implanted in the body, such as a pacemaker\n* Use of medication that can influence the effect of immobilization and\u002For training\n* Muscular or joint disorders which may affect the results\n* Metabolic diseases (such as diabetes and cardiovascular diseases)\n* Previous or present liver or cancer disease\n* Current or previous thrombosis\n* Porphyria\n* Epilepsia\n* Systemic autoimmune disease\n* Edema\n* Smoking or use of other nicotine containing products\n* Claustrophobia\n* Addictive behavior, defined as abuse of cannabis, opioids, or other intoxicating substances.\n* Lack of ability to cooperate\n* Blood parameters out of normal range at the health check\n* Blood pressure above 140\u002F90 mmHg","47 Years",{"count":367,"type":22},30,"As females age and transition through menopause, the decline in oestrogen level profoundly affects skeletal muscle mass and function. HER-MUSCLE aims to unravel the differences in pre and post menopausal women, in regards to muscle size, strength and function.\n\nFocusing on postmenopausal females, an increasingly at-risk demographic, HER-MUSCLE addresses a critical gap in understanding how oestrogen influences muscle mass and function.\n\nThe project involves:\n\n1. Molecular Analysis: Advanced techniques will study the muscle microenvironment, focusing on muscle stem cells (MuSCs), fibro-adipogenic progenitors (FAPs), and other cells critical for muscle regeneration and maintenance.\n2. Mitochondrial Function assessed in vivo via magnetic resonance spectroscopy: The impact of oestrogen on mitochondrial health will be examined, exploring how it preserves mitochondrial function and ability to recovery and resist fatigue in response to muscle contractions.\n\nOur preliminary data indicate that oestrogen can promote muscle protein synthesis. HER-MUSCLE aims to pave the way for novel therapeutic strategies to manage sarcopenia in postmenopausal women, ultimately leading to better health outcomes and enhanced well-being for this growing population segment.",[370,26],"Muscle Mass and Strength",[372,373,26,374,375],"Muslce Mass","Muscle Strength","Estrogen","Mitochondria function","2026-06-09",{"date":378,"type":33},"2026-06-16",{"date":380,"type":33},"2026-02-01",{"date":382,"type":22},"2027-08-01",{"name":384,"class":40},"Mette Hansen",{"id":386,"slug":387,"hasResults":12,"nctId":388,"briefTitle":389,"officialTitle":389,"acronym":4,"eligibilityCriteria":390,"healthyVolunteers":49,"sex":391,"minAge":81,"maxAge":50,"enrollmentInfo":392,"targetDuration":4,"studyType":54,"phases":393,"briefSummary":394,"conditions":395,"keywords":400,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":407,"lastUpdatePostDateStruct":408,"startDateStruct":409,"completionDateStruct":410,"leadSponsor":412,"locationsCount":118},"100643362","assessing-the-effects-of-hormones-on-noninvasive-transcranial-stimulation-100643362","NCT07635017","Assessing the Effects of Hormones on Noninvasive Transcranial Stimulation","Inclusion Criteria:\n\n* Age between 18 and 40 years old\n* Female subjects must have regular menstrual cycles (defined as a cycle that occurs at predictable intervals, typically between 24 and 38-days length) via self-report\n\nExclusion Criteria:\n\n* Allergies to henna\n* Allergies to gel used for electrodes\n* History of seizures or epilepsy\n* Subjects must not have any serious disease, disorder, infection, or cognitive impairments that could affect their ability to participate in this study.\n* Female subjects of child-bearing potential must not be pregnant\n* Subjects must not have any implanted stimulators or pulse generators\n* Subjects must not have heart disease, including known arrhythmia\n* Subjects must not have any metal implants in their head","ALL",{"count":7,"type":22},[56],"This study is investigating how two types of non-invasive brain stimulation, transcranial electrical stimulation (TES) and transcranial magnetic stimulation (TMS), affect brain activity, and whether combining them produces stronger or more consistent effects than either one used alone. The motivation for this comes from the observation that TMS, which is FDA-approved for treating depression, tends to work less well in postmenopausal women because lower estrogen levels reduce the brain's ability to respond to stimulation. The research team believes that pairing TMS with TES, which targets a different set of brain cells, may be able to overcome this hormonal barrier and make stimulation more effective. Participants will come into the lab for up to 24 visits over 8 months, beginning with an initial visit to establish the right stimulation settings, followed by a series of stimulation sessions in which brain activity is measured before and after receiving either TES, TMS, or both together. For female participants, sessions will be scheduled at specific points in the menstrual cycle to capture the natural monthly rise and fall of estrogen, while male participants will be scheduled on a comparable fixed interval as a comparison group. The insights gained from this study could directly inform the development of better, more reliable brain stimulation treatments for women with depression.",[396,397,398,399,26],"Cortical Excitability","Healthy","TMS","Menstrual Cycle",[401,402,403,59,404,405,396,406],"Transcranial Magnetic Stimulation","Transcranial Electrical Stimulation","Noninvasive Neuromodulation","Electromyography","Hormones","Synaptic Plasticity","2026-06-04",{"date":376,"type":33},{"date":32,"type":22},{"date":411,"type":22},"2028-07-01",{"name":413,"class":40},"Carnegie Mellon University",{"id":415,"slug":416,"hasResults":12,"nctId":417,"briefTitle":418,"officialTitle":419,"acronym":420,"eligibilityCriteria":421,"healthyVolunteers":12,"sex":17,"minAge":81,"maxAge":4,"enrollmentInfo":422,"targetDuration":4,"studyType":54,"phases":424,"briefSummary":425,"conditions":426,"keywords":428,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":407,"lastUpdatePostDateStruct":433,"startDateStruct":435,"completionDateStruct":437,"leadSponsor":439,"locationsCount":118},"100571074","menopausal-hormone-therapy-glp-1-agonists-and-glucose-and-energy-homeostasis-in-postmenopausal-women-with-diabetes-100571074","NCT06715514","Menopausal Hormone Therapy, GLP-1 Agonists, and Glucose and Energy Homeostasis in Postmenopausal Women With Diabetes","Effects of Combined Menopausal Hormone Therapy and GLP-1 Receptor Agonist Therapy on Glucose and Energy Homeostasis in Early Postmenopausal Women With or at Risk of Diabetes","DECLARED-CT","Individuals fulfilling at enrolment all of the following inclusion criteria are eligible for the study:\n\n* Early postmenopausal status (STRAW+10 stage +1b or +1c and FSH\\>25.0mU\u002FL)\n* Presence of menopausal symptoms (total MRS-II score ≥1)\n* BMI ≥ 27.0kg\u002Fm2\n* Pre- or existing type 2 diabetes (HbA1c 5.7%-8.5%)\n* No prior or current use of MHT\n\nThe presence of any of the following exclusion criteria will lead to exclusion of the individuals:\n\n* DPP4-inhibitor, SLGT2-inhibitor or sulfonylurea use within 8 weeks prior to study enrolment\n* GLP-1RA use within 6 months prior to study enrolment\n* Insulin therapy within 8 weeks prior to study enrolment\n* History of bariatric surgery\n* More than 2% change in body weight within three months prior to study enrolment (based on documented or reported weights)\n* Contraindications for the use of the study medication as per prescription labelling: Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2\n* Known or suspected cancer of breast or other sexual organ, abnormal genital bleeding of unknown cause, hepatic neoplasia\n* Arterial or venous thromboembolic events, porphyria\n* Known allergy or hypersensitivity to Wegovy®, Estradot® or Utrogestan® (pharmaceutical agents or any of the excipients)\n* Systemic hormone therapy or hormonal contraceptives (e.g. estrogens, progestogens, androgens) during the study and within 12 months prior to participation\n* Herbal remedies and complimentary medicines for menopausal symptoms during the study\n* Physical or psychological condition or any medical intervention (including medication not specified above) likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator\n* Participation in another clinical trial that interferes with the interpretation of the study results\n* Inability to read German\n* Unwillingness to follow the study procedures",{"count":423,"type":22},96,[56],"The overall aim is to investigate the hypothesis that restoring E2 levels through MHT improves glucose and energy homeostasis and potentiates the beneficial effects of GLP-1RA in early postmenopausal women with pre- or existing type 2 diabetes.\n\nThe primary objective is to assess the efficacy of combined MHT and GLP-1RA in improving glucose control in early postmenopausal women with pre- or existing type 2 diabetes, compared to GLP-1RA alone. Secondary objectives include efficacy analyses on body weight, other measures of cardiometabolic health, lifestyle behaviour, menopausal symptoms, and the exploration of mechanisms underpinning potential glycaemic and weight control benefits, and biomarkers of haemostasis.",[26,427],"Type 2 Diabetes",[429,26,430,431,166,432],"Diabetes","Menopausal Hormone Therapy","Womens Health","GLP-1 receptor agonist",{"date":434,"type":33},"2026-06-05",{"date":436,"type":33},"2025-02-18",{"date":438,"type":22},"2026-12-31",{"name":440,"class":40},"Lia Bally",{"id":442,"slug":443,"hasResults":12,"nctId":444,"briefTitle":445,"officialTitle":446,"acronym":447,"eligibilityCriteria":448,"healthyVolunteers":49,"sex":17,"minAge":153,"maxAge":82,"enrollmentInfo":449,"targetDuration":4,"studyType":54,"phases":451,"briefSummary":452,"conditions":453,"keywords":456,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":463,"lastUpdatePostDateStruct":464,"startDateStruct":465,"completionDateStruct":467,"leadSponsor":469,"locationsCount":118},"100556603","nitrate-exercise-and-vascular-function-in-midlife-women-100556603","NCT06527248","Nitrate, Exercise and Vascular Function in Midlife Women","Effects of Dietary Nitrate From Beetroot Juice on Vascular Function and Adaptations to Exercise Training in Postmenopausal Women: a Randomized, Placebo-controlled Study","Women's-Beet","Inclusion Criteria:\n\n* Postmenopausal women (amenorrhoeic ≥1 year), between the ages of 45 and 65 years, inclusive, who are either normotensive or are medically treated for stage 1 hypertension\n* Written informed consent\n\nExclusion Criteria:\n\n* Current or recent (within previous 3 months) engagement in exercise training (i.e., planned, structured, and regular exercise) with an average net exercise time of \\>2 hours per week\n* Above-average cardiorespiratory fitness levels (i.e., a V̇O2 max max above the 75th percentile of age- and sex-specific normative data: ≥43 mL\u002Fkg\u002Fmin for women aged 45-49 years, ≥38 mL\u002Fkg\u002Fmin for women aged 50-59 years, ≥35 mL\u002Fkg\u002Fmin for women aged 60-65 years)\n* Any evidence of acute or chronic diseases such as symptomatic cardiovascular or peripheral vascular disease, moderate or severe chronic kidney disease (estimated glomerular filtration rate (GFR) \\\u003C50 mL\u002Fmin), pulmonary, neural, or musculoskeletal disease, osteoporotic fractures, cancer, or type 1 or 2 diabetes mellitus\n* Fasting glucose \\>7.0 mmol\u002FL or HbA1c \\> 6.5 rel. %\n* BMI \\\u003C18.5 kg\u002Fm2 or \\>30kg\u002Fm2\n* A mean 24-hour ambulatory systolic\u002Fdiastolic blood pressure of ≥130\u002F80 mm Hg\n* Irregular resting electrocardiography (ECG)\n* Inability to perform physical exercise\n* Abnormal cardiovascular responses during the baseline V ̇O2 max test, including symptoms, ECG abnormalities, arrhythmias, or exaggerated blood pressure responses\n* Current or recent (\\\u003C12 months) oestrogen-based hormone-replacement therapy\n* Chronic use of nitric oxide (NO) donors, organic nitrites\u002Fnitrates, Ticagrelor, sodium-glucose cotransporter 2 (SGLT2) inhibitors, high-dose statins (i.e., Simvastatin \\>40mg\u002Fday, Atorvastatin \\>20mg\u002Fday, Rosuvastatin \\>10mg\u002Fday), acetylsalicylic acid \\>100mg\u002Fday, non-steroidal anti-inflammatory drugs (NSAID)\n* A change in drug therapy likely to influence major outcomes within the previous 2 months, or likelihood that drug therapy would change during the study\n* Use of antibiotics (within previous 2 months)\n* Use of antibacterial mouthwash (volunteers willing to cease using antibacterial mouthwash for a period of 4 weeks before randomization will be included)\n* Being vegan or vegetarian or consumption of \\>5 serves of vegetables per day\n* Current or recent (within previous 6 months) significant (\\>6%) loss or gain of body weight\n* Current or recent (\\\u003C12 months) regular smoking of \\>5 cigarettes per day\n* Alcohol intake of \\>70 g per week and\u002For binge drinking behaviour\n* Inability or unwillingness to follow the study protocol",{"count":450,"type":22},54,[56],"The purpose of this clinical study in women after menopause is to investigate whether the daily intake of nitrate from beetroot juice over 12 weeks enhances the positive effect of exercise training on vascular function, blood pressure and physical performance.\n\nThe risk of cardiovascular diseases (CVD) increases with advancing age and women are particularly affected. In women, the decline in the sex hormone oestrogen in the blood circulation with menopause contributes to impaired vascular function and an increased CVD risk; in part through increased inflammatory processes, oxidative stress, and a reduced body's own production of nitric oxide (NO). NO is a signaling molecule that is important for vascular function. Endurance-based exercise training is a key lifestyle strategy to prevent CVD. However, studies indicate that exercise is less effective in terms of its health-promoting adaptations in women after menopause as compared with men of similar age.\n\nThis study investigates the effect of exercise training in combination with the intake of nitrate-rich beetroot juice on functions of the cardiovascular system. Nitrate is a nitrogen compound that is found naturally in plant foods (e.g. beetroot juice) and is converted to NO in the human body. Results of previous studies indicate vasodilatory, blood pressure-lowering and performance-enhancing effects as well as positive influences on inflammatory processes and oxidative stress following nitrate intake. The hypothesis is that nitrate intake concomitant to training promotes training adaptations and further improves vascular function, blood pressure and physical performance compared to training without nitrate intake.\n\nFor the study, 54 untrained postmenopausal women (with the ages between 45 and 65 years) will be recruited and randomly allocated into two groups. Both groups will undergo 12 weeks of endurance-based exercise training. One group will receive nitrate-rich beetroot juice, and the other nitrate-depleted beetroot juice (as placebo). Vascular function, blood pressure, maximum oxygen uptake, and blood biomarkers for nitrate metabolism, inflammation status and oxidative stress will be examined.\n\nThe anticipated study results will provide new insights into whether nitrate as a 'training adjunct' improves health-promoting training adaptations in women after menopause. The overall aim is to improve the cardiovascular health and performance of middle-aged women and reduce their increased CVD risk.",[397,26,454,455],"Hypertension","Inflammation",[457,458,459,460,461,462],"Women after menopause","Vascular function","Exercise training responsiveness","Cardiovascular health","Dietary nitrate-nitrite-nitric oxide-pathway","Beetroot juice","2026-06-03",{"date":434,"type":33},{"date":466,"type":33},"2025-03-31",{"date":468,"type":22},"2027-03",{"name":470,"class":40},"University of Vienna",{"id":472,"slug":473,"hasResults":12,"nctId":474,"briefTitle":475,"officialTitle":475,"acronym":4,"eligibilityCriteria":476,"healthyVolunteers":12,"sex":17,"minAge":153,"maxAge":51,"enrollmentInfo":477,"targetDuration":4,"studyType":54,"phases":478,"briefSummary":479,"conditions":480,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":481,"lastUpdatePostDateStruct":482,"startDateStruct":484,"completionDateStruct":486,"leadSponsor":488,"locationsCount":118},"100643700","menozen-vr-for-menopause-symptom-management-phase-2-100643700","NCT07633743","MenoZen VR for Menopause Symptom Management: Phase 2","Inclusion Criteria:\n\n* Women currently between 45-60 years of age;\n* Have moderate to severe VMS, defined as 28 or more hot flashes per week (including night sweats) and were sufficient severity to prompt them to seek therapeutic intervention;\n* Are English-speaking;\n* Able to participate fully in all aspects of the study;\n* Have understood and signed study informed consent;\n* Have access to a computer or smartphone and home Wi-Fi;\n* Willing to participate in weekly VR sessions for 8 weeks.\n\nExclusion Criteria:\n\n* Women receiving systemic menopause hormonal therapy (progesterone, testosterone, estrogen). Low-dose topical vaginal estrogen is okay;\n* Women receiving non-hormonal therapy for the management of hot flashes (fezolinetant or elinzanetant, any SSRI\u002FSNRI, oxybytunin, and\u002For gabapentin being prescribed for hot flashes, if for other reasons and still with hot flashes then okay);\n* Women receiving active cognitive behavioral therapy (CBT) for hot flashes. CBT for mood symptoms is okay;\n* Have a known, active, untreated clinically significant psychiatric condition (severe depression, psychosis, bipolar disorder, or severe depression);\n* Have severe visual, auditory, or vestibular impairments that may interfere with VR use;\n* Have a facial\u002Fhead deformity that will prohibit the wearing of a VR head mounted displace (HMD);\n* Self-reported history of acute and\u002For severe motion sickness;\n* Have had a seizure in the past year;\n* Concurrently enrolled in another intervention trial for menopause symptoms;\n* Have a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence.",{"count":229,"type":22},[56],"The purpose of this research is to evaluate the feasibility, acceptability, tolerability, and clinical efficacy of MenoZen VR (virtual reality) for managing menopause symptoms in women.",[26],"2026-06-02",{"date":483,"type":33},"2026-06-08",{"date":485,"type":22},"2026-07-31",{"date":487,"type":22},"2028-07-31",{"name":356,"class":40},{"id":490,"slug":491,"hasResults":12,"nctId":492,"briefTitle":493,"officialTitle":494,"acronym":495,"eligibilityCriteria":496,"healthyVolunteers":49,"sex":17,"minAge":153,"maxAge":51,"enrollmentInfo":497,"targetDuration":4,"studyType":54,"phases":498,"briefSummary":499,"conditions":500,"keywords":501,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":504,"lastUpdatePostDateStruct":505,"startDateStruct":507,"completionDateStruct":508,"leadSponsor":510,"locationsCount":118},"100636437","the-balance-study---improving-glucose-control-through-prebiotic-gut-health-drink-in-postmenopausal-women-100636437","NCT07565675","The BALANCE Study - Improving Glucose Control Through Prebiotic Gut Health Drink in Postmenopausal Women","Improving Glucose Control Through Prebiotic Gut Health Drink in Postmenopausal Women","BALANCE","Inclusion Criteria::\n\n* Female, aged 45-60 years\n* Post-menopausal (no menstrual period for ≥12 months)\n* No serious long-term medical conditions\n* Living in the UK\n* Able to read English and provide electronic informed consent\n* Willing and able to comply with study procedures, including dietary intervention and sample collection\n* Willing to provide stool samples at specified time points\n* BMI ≥25 kg\u002Fm² with one of the following:\n\n  * Impaired glucose tolerance (7.8-11.0 mmol\u002FL at 2-hour OGTT), or\n  * Impaired fasting glucose (5.6-6.9 mmol\u002FL), or\n  * HbA1c 5.7%-6.4%\n* No intentional dieting within the past month\n* No \\>5% body weight loss in the past year\n* No changes in physical activity in the past 2-4 weeks and no intention to change during the study\n\nExclusion Criteria:\n\n* Significant gastrointestinal disease (e.g., inflammatory bowel disease, coeliac disease) or other major medical conditions affecting gut microbiota or study safety\n* Immunocompromised status or other serious chronic illness\n* Use of antibiotics within the past 2-3 months\n* Regular use of probiotics or prebiotics within the past 4 weeks\n* Use of medications or special diets that significantly affect gut microbiota (e.g., chronic laxatives, immunosuppressants)\n* Known allergies or intolerances to components of the prebiotic formulation\n* Participation in another interventional clinical trial within the past 3 months",{"count":367,"type":22},[56],"The menopausal transition is associated with a decline in oestrogen levels, contributing to adverse metabolic changes including increased central adiposity, systemic inflammation, and insulin resistance. These changes are linked to a higher risk of developing type 2 diabetes in postmenopausal women.\n\nRecent evidence suggests that the gut microbiota plays an important role in metabolic regulation and glucose homeostasis. Menopause-related hormonal changes may alter the composition and function of the gut microbiome, with downstream effects on insulin sensitivity. Additionally, certain gut bacteria (i.e., Bifidobacterium species) regulate circulating oestrogen via β-glucuronidase activity, highlighting a potential interaction between microbial composition and hormonal balance. Observational findings support associations between menopausal stage, gut microbiota alterations, and insulin homeostasis.\n\nPrebiotics are non-digestible compounds that selectively stimulate beneficial gut bacteria and may improve metabolic outcomes. Modulation of the gut microbiota through prebiotic supplementation represents a promising non-pharmacological strategy to improve glucose control. Multiple studies have demonstrated that inulin (a common prebiotic) can improve glucose regulation and aid weight loss in individuals with obesity, prediabetes, or type 2 diabetes. However, to date, no randomised controlled trials have specifically investigated prebiotic supplementation in postmenopausal women with prediabetes using dynamic measures such as the Oral Glucose Tolerance Test (OGTT).\n\nThe present study aims to investigate the effect of daily consumption of an inulin-containing prebiotic gut health drink (ió everyday) on glucose control in postmenopausal women with prediabetes. The primary objective is to determine whether the intervention improves glycaemic control. Secondary objectives include exploration of changes in metabolic markers and assessment of the role of the gut microbiota in mediating these effects.\n\nIt is hypothesised that consumption of ió everyday will improve glucose control in prediabetic women who have recently undergone menopause. This hypothesis is supported by evidence demonstrating that inulin and soluble corn fibre can improve glucose regulation and support weight management in individuals with obesity, prediabetes, or type 2 diabetes, as well as findings from a previous study (Ethics Ref ID: LSC 23\u002F383), which demonstrated that one month of ió everyday consumption significantly reduced fasting glucose, with a trend towards weight reduction and no reported adverse effects.",[26],[98,502,503],"diabetes","obesity","2026-05-27",{"date":506,"type":33},"2026-05-28",{"date":348,"type":22},{"date":509,"type":22},"2027-05-15",{"name":511,"class":40},"University of Roehampton",{"id":513,"slug":514,"hasResults":12,"nctId":515,"briefTitle":516,"officialTitle":516,"acronym":517,"eligibilityCriteria":518,"healthyVolunteers":49,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":519,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":521,"conditions":522,"keywords":524,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":531,"lastUpdatePostDateStruct":532,"startDateStruct":533,"completionDateStruct":534,"leadSponsor":536,"locationsCount":4},"100638583","moving-forward-with-menopause-treatment-through-pharmacists-expanded-roles-in-hormone-health-100638583","NCT07618039","MOving Forward With MENopause Treatment Through Pharmacists' Expanded Roles in Hormone Health","MOMENT","Inclusion Criteria:\n\nPharmacist (pharmacies) participants:\n\n* Select community pharmacies with an appointment based system as chosen in consultation with PANS.\n* Pharmacist participants must be licensed to practice direct patient care in Nova Scotia.\n* Pharmacist participants must have completed the MOMENT education and training.\n\nPatient participants:\n\n* Resident of Nova Scotia with a provincial MSI card.\n* People with the anatomical and physiological components (AFAB) that would predispose them to signs and symptoms of menopause that are associated with decreasing hormones (e.g., estrogen).\n* Signs and\u002For symptoms of the menopause and the person is seeking care for the same, regardless of whether they are using treatments.\n\n  * The potential participants will screen using MQ6 questions based on: 1) changes in periods; 2) presence of hot flashes; 3) vaginal dryness, pain, or sexual concerns; 4) bladder issues or incontinence; 5) new sleep difficulties; 6) new or increased anxiety, irritability, depression or low mood.\n\n    * People with symptoms in 2, 3, or 4 indicate symptoms for which MHT may be indicated and are eligible to be included for the study.\n    * People with only number 1 should talk with the pharmacist to determine if these symptoms are related to menopause and what the menstrual changes are (i.e. frequency, volume, regularity, duration, non-menstrual bleeding, bleeding outside of the reproductive age, acute or chronic bleeding). If there is evidence of other signs and symptoms of menopause on assessment, they can be included. If no other signs or symptoms related to menopause are present, people will be referred back to their regular primary care provider, if the person has one. If not, the pharmacist will provide the person with information on care options (e.g., https:\u002F\u002Fwww.nshealth.ca\u002Fwheretogoforhealthcare).\n    * People only with 5 can be considered as part of common ailments prescribing (existing scope within the Standards of Practice for Prescribing Drugs), if appropriate, and will be included in the study only if other signs and symptoms of menopause are present.\n    * People only with number 6 will be assessed regarding their symptoms. If no other signs or symptoms related to menopause are present, people will be referred back to their regular primary care provider, if the person has one. If not, the pharmacist will provide the person with information on care options (e.g., https:\u002F\u002Fwww.nshealth.ca\u002Fwheretogoforhealthcare) and options for mental health care if deemed appropriate (https:\u002F\u002Fmha.nshealth.ca\u002Fen). Additionally, the pharmacist can determine if there are options within their existing scope to provide care to the patient, if appropriate, and also refer the patient to a Bloom Program pharmacy if deemed appropriate.\n* Perimenopausal people who previously had symptoms of menopause and were also receiving hormonal contraceptives but warrant a transition to MHT based on clinical factors (e.g., older age, reached menopause).\n\nExclusion Criteria:\n\nPatient participants:\n\n* People with surgical menopause via oophorectomy.\n\n  o Patients who have had oophorectomy experience early menopause (i.e., surgical menopause). These patients are most likely to have previously received or currently be receiving systemic treatment with MHT. If this was not the case, pharmacists will refer the patient back to their regular primary care provider, if the patient has one. If not, the pharmacist will provide the person with information on care options (e.g., https:\u002F\u002Fwww.nshealth.ca\u002Fwheretogoforhealthcare).\n\n  o If the pharmacist deems that a renewal of previous MHT is appropriate, they will use their clinical discretion and follow their legal and ethical obligations as per usual when engaging in this activity.\n* People with a final menstrual period (FMP) \\\u003C 40 years or \"early menopause\" (FMP \\\u003C45 years).\n\n  o additional investigation is required to explore underlying causes related to their menstrual cessation (e.g., hypothalamic-pituitary-ovarian axis conditions or other possible causes). People in this category will be referred back to their regular primary care provider, if the person has one. If not, the pharmacist will provide the person with information on care options (e.g., https:\u002F\u002Fwww.nshealth.ca\u002Fwheretogoforhealthcare). Typically, people in this situation are typically treated with hormones to around the age of 51 (i.e. typical age of menopause).\n\n  o Note: a person that had premature or early menopause and has progressed beyond the typical age of treatment for replacement of hormones (i.e., 51), and is currently experiencing signs and symptoms via screening, can be considered for inclusion.\n* Perimenopausal people who are seeking contraception prescribing.\n\n  o Pharmacists should engage in prescribing for contraceptive management as per the Nova Scotia College of Pharmacists Standards of Practice for Prescribing Drugs.\n* People who are stable on existing MHT and other therapies to manage menopausal symptoms and no changes are required.\n* People who only require a renewal, adaptation, or therapeutic substitution for a menopausal treatment. These activities fall within pharmacists' existing scope.\n\n  o Exception: people who do not have a doctor or nurse practitioner are eligible for inclusion if the pharmacist has been providing these prescribing services.\n* GSM induced by testosterone therapy for gender affirming care. o Transmasculine or gender diverse individuals using testosterone therapy with GSM induced by testosterone therapy (these people should be managed in collaboration with their gender affirming care providers).\n* The person cannot consent for themselves for the study due to cognitive impairment (e.g., advanced Alzheimer's disease or other dementias).\n\nConsiderations related to inclusion and exclusion criteria:\n\n• Older age: older age is not necessarily an exclusion criteria but will have a role as \"a flag\" in clinical assessment.\n\no People AFAB who are \\> 10 years after their FMP or \\> 60 years of age are not globally initiated on systemic MHT if they have have symptoms and have never had MHT before. However, there must be a benefit-risk discussion with the person regarding the treatment options if treatment is being sought, and therapies must be individualized. Although, \"second-line\", there are other systemic non-MHT options available for symptom management and other treatments (e.g., localized treatments such as intravaginal hormones for GSM). Regardless of the treatment, a benefit-risk discussion is required with the person AFAB.",{"count":520,"type":22},200,"The MOMENT project centres pharmacists as key partners for people assigned female at birth (AFAB) in improving menopause care. Menopause is a major life event, which half of our population will experience. For many, the mental and physical symptoms of menopause can impact quality of life, relationships, and workplace productivity. There are significant inequities in menopause health care and knowledge gaps for health care providers and the public with menopause being poorly understood. Menopausal Hormone Therapy (MHT) and related treatments are under-utilized and symptom control for people AFAB is often suboptimal. Since the publication of the Women's Health Initiative (WHI) study of postmenopausal women in 2002, menopausal care changed and misinformation about the risks versus benefits of MHT continue to create fear in those AFAB and health care providers. Guideline-concordant care includes MHT as first-line therapies for symptoms and there is increasing interest to improve the care of menopausal people. When MHT is not appropriate, there are other non-hormonal options that are available.\n\nWhat do pharmacists already legally do in Nova Scotia for hormone therapies and other treatments commonly used for menopausal management for those assigned female at birth?\n\n* Hormones and non-hormonal therapies: Pharmacists receive prescriptions for and dispense MHT and other therapies related to menopausal symptoms, and as per the Standards of Practice, assess appropriateness of all prescriptions for patients, which includes, but is not limited to, assessing indications, contraindications, dosing and intervals, drug interactions (drug-drug, drug-disease, drug-food, etc.), and providing education on the medication, including but not limited to its proper use and storage, expectations of side effects and benefits, how to monitor progress, and when to follow-up and seek help. Pharmacists have a relationship and responsibility to patients for shared decision making. This requires that they know the benefits (e.g., symptom reduction, health outcome reduction or improvement) and risks (e.g., adverse effects, contraindications, drug interactions) of hormones, and in the specific patient context.\n* Pharmacists can prescribe MHT and other non-hormonal therapies with a diagnosis as set out in collaboration with another health care professional (e.g., physicians, nurse practitioners) as per the existing legal framework in Nova Scotia.\n* Pharmacists provide ongoing care and monitoring throughout a patient's medication journey.\n* Pharmacists engage in prescribing renewals and therapeutic substitutions. They assume the prescribing responsibility when deciding to lengthen the time a patient can receive the prescription after it was initially prescribed by another prescriber, and when changing, adapting, or substituting medications as clinically indicated.\n* Pharmacists prescribe hormones for contraception.\n* Pharmacists can also prescribe non-MHT medications for other conditions related to menopause (e.g., insomnia) and recommend nonpharmacological interventions (e.g., cognitive behavioural therapy for insomnia, CBTi) as this is already part of the scope of practice.\n\nWhat is the project proposing? This project will focus on initiation of treatments for menopausal symptoms (e.g., MHT and other guideline-concordant treatments) for AFAB participants as a part of menopause signs' and symptoms' management and adds initiation to other participant pharmacist prescribing responsibilities as described above.\n\nThe Pharmacy Association of Nova Scotia will facilitate communications to pharmacies and pharmacists, to request participation in the project. This will go to community pharmacies that have a practice setting that includes dedicated time for appointment-based prescribing services. For brevity, the investigators refer to these as appointment-based pharmacies (ABPs). The additional prescribing responsibilities will be facilitated through the existing legal framework in Nova Scotia. This means that it would be considered \"Prescribing in Accordance with an Approved Research or Pilot Protocol\" according to the existing regulatory framework within the Nova Scotia Pharmacy Regulator.\n\nThe project includes mixed methods with quantitative and qualitative approaches. The main sources of data will be anonymized data capture by pharmacist participants, surveys of both pharmacist participants and patient participants, and interviews of both groups of participants (i.e., pharmacist participants and patient participants).\n\nInitiating treatments for menopause based on the current scope of practice is a natural progression of the scope of pharmacists' practice. It provides the opportunity to improve the health of those with menopausal signs and symptoms. The project can explore feasibility of an additional MHT prescriber in the health system and whether scale and spread should be explored further.",[26,523],"Pharmacists",[525,98,526,527,528,529,530],"pharmacists","implementation","access","menopause hormone therapy","genitourinary syndrome of menopause","vasomotor symptoms","2026-05-26",{"date":112,"type":33},{"date":32,"type":22},{"date":535,"type":22},"2027-12-31",{"name":537,"class":40},"Dalhousie University",{"id":539,"slug":540,"hasResults":12,"nctId":541,"briefTitle":542,"officialTitle":543,"acronym":544,"eligibilityCriteria":545,"healthyVolunteers":12,"sex":17,"minAge":546,"maxAge":4,"enrollmentInfo":547,"targetDuration":4,"studyType":54,"phases":549,"briefSummary":550,"conditions":551,"keywords":553,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":558,"lastUpdatePostDateStruct":559,"startDateStruct":560,"completionDateStruct":562,"leadSponsor":564,"locationsCount":566},"100637120","microrna-and-markers-and-therapeutic-response-to-romosozumab-and-abaloparatide-in-postmenopausal-osteoporosis-100637120","NCT07616401","MicroRNA and Markers and Therapeutic Response to Romosozumab and Abaloparatide in Postmenopausal Osteoporosis","MicroRNA and Circulating Markers Predictive of the Therapeutic Response to Romosozumab and Abaloparatide Treatment in Women With Postmenopausal Osteoporosis","ROMIRNA","Inclusion Criteria:\n\n* Female sex\n* Postmenopause\n* Densitometric diagnosis of osteoporosis\n* Normal calcium diet\n* Supplement with cholecalciferol or calcifediol\n\nExclusion Criteria:\n\n* Premenopause\n* Chronic therapy with glucocorticosteroids, or other treatments that may affect bone metabolism\n* Diseases and conditions that may affect bone metabolism","50 Years",{"count":548,"type":22},42,[56],"Osteoporosis is a systemic skeletal disorder affecting approximately 10% of individuals over 50 years of age. It is characterised by an increased risk of fragility fractures, which constitute a major source of morbidity, mortality, and healthcare burden worldwide.\n\nA range of pharmacological therapies has been approved for osteoporosis, with demonstrated efficacy in reducing fracture risk. These include anabolic agents that stimulate osteoblast-mediated bone formation (teriparatide, abaloparatide), antiresorptive agents that inhibit osteoclast-driven bone resorption (bisphosphonates, denosumab), and dual-action agents such as romosozumab, which, through sclerostin inhibition, simultaneously enhances bone formation and suppresses resorption. In clinical practice, these agents are administered sequentially or in combination to optimise therapeutic outcomes.\n\nThe primary goal of anti-osteoporotic therapy is to reduce the risk of incident and subsequent fractures. In postmenopausal osteoporosis, this objective is closely linked to meaningful gains in bone mineral density (BMD), as measured by dual-energy X-ray absorptiometry (DEXA), with attainment of osteopenic ranges associated with low fracture probability (\\\u003C15% for major osteoporotic fractures and \\\u003C3% for hip fractures, according to FRAX). However, selecting the most effective therapeutic strategy remains challenging, as robust predictors of individual treatment response are lacking. Although bone turnover markers are widely used to monitor treatment effects, their value in predicting clinical outcomes is limited.\n\nMicroRNAs (miRNAs) are small (\\~22 nucleotides), single-stranded, non-coding RNAs that regulate gene expression at the post-transcriptional level through binding to complementary sequences in target mRNAs. Circulating miRNAs are stabilised by association with proteins and extracellular vesicles, making them attractive candidates as biomarkers. Increasing evidence indicates that miRNAs play key roles in osteoblast and osteoclast differentiation, proliferation, and apoptosis, and distinct miRNA expression profiles have been associated with osteoporosis and fragility fractures.\n\nAn emerging area of interest is the interaction between osteoactive therapies and circulating miRNA signatures. To date, available data are largely limited to antiresorptive agents and teriparatide. No studies have yet addressed miRNA expression profiles in patients treated with romosozumab or abaloparatide.\n\nBeyond miRNAs, additional molecular pathways implicated in osteoimmunological crosstalk and ageing are gaining attention as potential biomarkers. Nitric oxide (NO) plays a multifaceted role in bone homeostasis, inhibiting osteoclast activity while promoting osteoblast function. Reduced circulating NO levels have been identified as an independent predictor of osteoporotic fractures in postmenopausal women. Autophagy is increasingly recognised as a critical regulator of bone remodelling, influencing both osteoblastic and osteoclastic activity. Dysregulation of autophagic pathways disrupts bone homeostasis and contributes to bone loss. These processes are tightly controlled by complex molecular networks, including miRNAs, and are closely linked to lysosomal function. In this context, cathepsin K has emerged as a promising therapeutic target in osteoporosis.\n\nThe present study primarily aims to identify circulating microRNAs, whose early treatment-induced changes are predictive of the outcome of the therapy in terms of changes in BMD. Secondary, it aims to identify correlations of the changes in microRNAs serum concentrations with variations in biomarkers of bone metabolism as well as of aging.\n\nThe study enrols women with diagnosis of severe postmenopausal osteoporosis addressed to treatment with romosozumab or with abaloparatide. All women will be assessed at baseline and after 2, 6 and 12 months of treatment.",[552,26],"Osteoporosis",[552,554,555,556,557],"Bone markers","MicroRNA","Romosozumab","Abaloparatide","2026-05-23",{"date":112,"type":33},{"date":561,"type":33},"2025-08-31",{"date":563,"type":22},"2029-08-31",{"name":565,"class":40},"Istituto Auxologico Italiano",2,{"id":568,"slug":569,"hasResults":12,"nctId":570,"briefTitle":571,"officialTitle":571,"acronym":4,"eligibilityCriteria":572,"healthyVolunteers":12,"sex":17,"minAge":50,"maxAge":205,"enrollmentInfo":573,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":575,"conditions":576,"keywords":581,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":586,"lastUpdatePostDateStruct":587,"startDateStruct":589,"completionDateStruct":591,"leadSponsor":593,"locationsCount":118},"100638771","agewise-unravelling-the-gut-hormone-axis-in-womens-ageing-100638771","NCT07614542","AGEWISE: Unravelling the Gut-Hormone Axis in Women's Ageing","Inclusion Criteria:\n\n* Female sex\n* Aged 40 to 64 years\n* Resident in mainland Portugal or the islands\n* Able and willing to provide written informed consent\n* Willing to provide stool and blood samples and complete three questionnaires\n\nExclusion Criteria:\n\n* Age below 40 years or 65 years and older\n* Inability to give informed consent\n* Refusal to provide stool or blood samples or complete questionnaires\n* Pregnancy\n* Diagnosed gastrointestinal disorders (including inflammatory bowel disease, Crohn's disease, ulcerative colitis, irritable bowel syndrome, chronic diarrhoea of unknown cause, or recurrent Clostridioides difficile infection)\n* Active oncological disease",{"count":574,"type":22},300,"AGEWISE is an observational study that aims to understand how changes in gut microbiome are related to hormonal changes during women's ageing, particularly across the different stages of menopause. The study will include healthy women aged 40 to 64 years living in Portugal, who will provide stool and blood samples and complete questionnaires about their health, lifestyle, diet, and menopausal symptoms. Researchers will study the gut microbiome together with hormone levels and markers of inflammation to better understand how menopause affects long-term health and to support the development of improved prevention strategies for women.",[26,577,578,579,580],"Gut Microbiome","Hormonal Changes","Chronic Low-Grade Inflammation","Inflammaging",[235,582,583,584,585],"biomarkers","metagenomics","menopausal transition","women's health","2026-05-22",{"date":588,"type":33},"2026-05-29",{"date":590,"type":33},"2025-06-02",{"date":592,"type":22},"2036-12",{"name":594,"class":40},"Gulbenkian Institute for Molecular Medicine",{"id":596,"slug":597,"hasResults":12,"nctId":598,"briefTitle":599,"officialTitle":600,"acronym":601,"eligibilityCriteria":602,"healthyVolunteers":12,"sex":17,"minAge":50,"maxAge":51,"enrollmentInfo":603,"targetDuration":4,"studyType":54,"phases":605,"briefSummary":606,"conditions":607,"keywords":4,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":609,"lastUpdatePostDateStruct":610,"startDateStruct":611,"completionDateStruct":613,"leadSponsor":615,"locationsCount":618},"100581889","phase-4-menopausal-ht-for-women-living-with-hiv-hot-100581889","NCT06856174","Menopausal HT for Women Living With HIV (HoT)","Menopausal Hormone Therapy for Women Living With HIV (HoT)","HoT","* Living with HIV\n* Assigned female sex at birth\n* Between the ages of 40 and 60 years\n* In the late menopausal transition (perimenopause) or early postmenopause\n* Experiencing hot flashes and\u002For night sweats\n* Willing and able to complete a daily diary\n* Does not have medical condition that would contraindicate hormone therapy\n* Not taking medications to treat hot flashes\n* Not taking medications that cannot be combined with hormone therapy\n* Receiving antiretrovirals (HIV medication) for more than 1 year\n* Not pregnant and willing and able to use at least non-hormonal birth control to prevent pregnancy\n* Willing and able to provide informed consent after discussion with the research staff",{"count":604,"type":22},105,[209],"Women living with HIV have been shown to experience more frequent and severe hot flashes and night sweats (collectively known as vasomotor symptoms) as compared to women living without HIV. This correlates with disturbed sleep, increased depressive symptoms, increased anxiety, worse mental function, interference with activities of daily living including work, and worse overall quality of life.\n\nHormone therapy is considered to be the most effective therapy for hot flashes and night sweats and the most appropriate choice to prevent bone loss at the time of menopause for women without HIV. However, the usefulness of hormone therapy has not been specifically studied in women living with HIV.\n\nThis trial is being done to see if:\n\n* There is evidence to support the use of hormone therapy (estradiol with or without progesterone) for the treatment of hot flashes and night sweats in women living with HIV\n* Hormone therapy improves mental function, mood, sleep, quality of life, bone health, heart health, and inflammation in women living with HIV\n* Hormone therapy is safe and tolerable for women living with HIV",[608,26],"HIV Infection","2026-05-20",{"date":586,"type":33},{"date":612,"type":33},"2026-04-09",{"date":614,"type":22},"2027-09-20",{"name":616,"class":617},"Advancing Clinical Therapeutics Globally for HIV\u002FAIDS and Other Infections","NETWORK",23,{"id":620,"slug":621,"hasResults":12,"nctId":622,"briefTitle":623,"officialTitle":623,"acronym":4,"eligibilityCriteria":624,"healthyVolunteers":12,"sex":17,"minAge":81,"maxAge":82,"enrollmentInfo":625,"targetDuration":627,"studyType":23,"phases":4,"briefSummary":628,"conditions":629,"keywords":638,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":645,"lastUpdatePostDateStruct":646,"startDateStruct":647,"completionDateStruct":649,"leadSponsor":651,"locationsCount":4},"100638708","a-retrospective-and-prospective-clinical-registry-for-data-collection-of-perimenopausal-menopausal-and-premature-ovarian-insufficiency-women-100638708","NCT07606326","A Retrospective and Prospective Clinical Registry for Data Collection of Perimenopausal, Menopausal and Premature Ovarian Insufficiency Women","Inclusion Criteria:\n\n* 1\\. Age: women aged 18-60 years at the time of enrollment and in follow up, up to 65 years old\n* 2\\. Women in Perimenopause, defined as the transitional period preceding the final menstrual period, characterized by changes in menstrual cycle regularity and\u002For the onset of menopausal symptoms. Women experience variable cycle length, skipped cycles, or amenorrhea of less than 12 months' duration, often accompanied by vasomotor symptoms, sleep disturbances, and other menopause-related complaints.\n* 3\\. Women in Menopause, defined as the permanent cessation of menstruation resulting from loss of ovarian follicular activity and is diagnosed retrospectively after 12 consecutive months of amenorrhea in the absence of other pathological or physiological causes. Women may present with persistent menopausal symptoms and\u002For long-term consequences of estrogen deficiency, including changes in bone, cardiovascular, metabolic, and genitourinary health.\n\nlt includes women in early Menopause, defined as menopause occurring before the age of 45 years, but after 40 years, in the absence of surgical or iatrogenic causes.\n\n* 4\\. Women in Premature Ovarian lnsufficiency (POI), defined as impaired ovarian function occurring before the age of 40 years, characterized by oligo- or amenorrhea, elevated gonadotropin levels, and hypoestrogenism.\n* 5\\. Women with iatrogenic menopause, caused by:\n* Bilateral oophorectomy\n* Chemotherapy or radiotherapy-induced ovarian failure\n* Other pharmacological treatments resulting in ovarian insuftficiency\n* 6\\. Women evaluated at the specialized Menopause Clinic or the Multidisciplinary Endocrinology\u002FMetabolic Disorders clinic.\n* 7\\. Data availability: for retrospective participants, sufficient medical records must be available; tor prospective participants, patients must be willing to participate in the registry and provide informed consent.\n* 8\\. All women are eligible regardless of concomitant diseases, to reflect real-world clinical practice.\n\nExclusion Criteria:\n\n* 1\\. Women unable to provide informed consent due to cognitive impairment or severe psychiatric conditions.\n* 2\\. Women already participating in interventional clinical trials affecting menopausal or metabolic management in a way that could bias observational data.\n* 3\\. Women with incomplete medical records for retrospective data collection or those refusing informed consent for prospective enrollment.",{"count":626,"type":22},5000,"20 Years","This study is designed as on observational, retrospective, and prospective clinical registry aimed at collecting comprehensive real-world data on women in perimenopause, menopause, and with premature ovarian insufficiency (POI) attending a specialized Menopause Clinic and a Multidisciplinary Outpatient Clinic dedicated to Endocrinology and Metabolic Disorders.\n\nThe registry comprises both retrospective data, extracted from the medical records of eligible patients evaluated from January 2000 onward, and prospective data, which will be continuously collected for all newly referred patients up to 2040. This combined design allows the longitudinal observation of clinical characteristics, management strategies, and health outcomes across different stages of the menopausal transition and premature ovarian insufficiency within routine clinical practice.\n\nClinical management and therapeutic strategies, including hormone replacement therapy and non-hormonal interventions, will be documented. Laboratory data, as well as imaging data routinely used in clinical practice, will be recorded when available.\n\nEnrolled patients will undergo a personalized follow-up schedule based on clinical findings and the conclusions of each visit, in accordance with standard clinical practice. Follow-up visits may be scheduled annually for routine monitoring or at shorter intervals (semi-annual or quarterly) in the presence of conditions requiring closer clinical surveillance.\n\nThe registry is intended to reflect real-world clinical practice and to support the descriptive evaluation of patterns of care, symptom burden, and longitudinal clinical outcomes in women undergoing the menopausal transition or affected by premature ovarian insufficiency. The collected data will provide a structured platform for epidemiological analyses and hypothesis-generating observational research aimed at improving the understanding and management of menopausal health and associated endocrine and metabolic conditions.",[26,430,630,631,632,633,634,635,636,637],"Menopause Surgical","Menopause Related Conditions","Menopausal Complaints","Menopausal Osteoporosis","Menopause-related Hot Flashes","Menopausal and Perimenopausal Disorder, Unspecified","Menopausal and Postmenopausal Women","Premature Ovarian Failure (POF)",[98,97,639,640,641,529,642,643,644],"premature ovarian failure","hormonal replacement teraphy","osteoporosis","hot flashes","menopausal discomfort","menopausal symptoms","2026-05-19",{"date":531,"type":33},{"date":648,"type":22},"2026-06",{"date":650,"type":22},"2040-12",{"name":652,"class":40},"IRCCS San Raffaele",{"id":654,"slug":655,"hasResults":12,"nctId":656,"briefTitle":657,"officialTitle":658,"acronym":4,"eligibilityCriteria":659,"healthyVolunteers":49,"sex":391,"minAge":660,"maxAge":82,"enrollmentInfo":661,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":663,"conditions":664,"keywords":665,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":669,"lastUpdatePostDateStruct":670,"startDateStruct":671,"completionDateStruct":672,"leadSponsor":674,"locationsCount":118},"100593377","brazilian-registry-of-menopausal-health-100593377","NCT07005648","Brazilian Registry of Menopausal Health","Population-based Cross-sectional Observational Study for a Brazilian Registry of Menopausal Women and Associated Factors Related to Clinical Profile, Socioeconomic Aspects, Social Disparities, Access to Healthcare, Quality of Life, and Knowledge About Menopause","Inclusion Criteria:\n\n1. Women aged between 35 and 65 years attending medical consultation at public and private outpatient health services;\n2. Ability to confirm voluntary participation and sign the Informed Consent Form\n\nExclusion Criteria:\n\n1. Inability to respond to the interview for any reason\n2. Suspected or confirmed pregnancy\n3. Lactation\n4. Uncontrolled diabetes\n5. Uncontrolled arterial hypertension\n6. Uncontrolled thyroid disorders\n7. Grade 3 obesity, defined by a BMI equal to or greater than 40.0 kg\u002Fm²\n8. Diagnosis of psychiatric disorders that may compromise participation in the interview\n9. Previous hysterectomy\n10. Previous oophorectomy\n11. Current use of illicit drugs","35 Years",{"count":662,"type":22},1592,"The Brazilian Registry of Menopausal Health is a national study aimed to better understand the health and quality of life of participants aged 35 to 65 who are in the menopausal transition or postmenopausal phase, including cisgender women and transgender men.\n\nThe study's hypothesis is that significant regional and socioeconomic disparities influence individuals' health, knowledge, and perception of menopause.",[26],[26,666,667,668],"Post Menopause","Menopause Transition","Climateric","2026-05-18",{"date":609,"type":33},{"date":30,"type":22},{"date":673,"type":22},"2026-12-30",{"name":675,"class":40},"Science Valley Research Institute",{"id":677,"slug":678,"hasResults":12,"nctId":679,"briefTitle":680,"officialTitle":680,"acronym":4,"eligibilityCriteria":681,"healthyVolunteers":49,"sex":17,"minAge":153,"maxAge":154,"enrollmentInfo":682,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":683,"conditions":684,"keywords":685,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":669,"lastUpdatePostDateStruct":688,"startDateStruct":689,"completionDateStruct":691,"leadSponsor":693,"locationsCount":118},"100553750","menopause-transition-sex-hormone-deficiency-and-autonomic-and-vascular-function-100553750","NCT06490146","Menopause Transition, Sex Hormone Deficiency and Autonomic and Vascular Function","Inclusion Criteria:\n\n* Female\n* age 45-55 years\n* premenopausal\n* not using any medications determined to affect autonomic function\n* eumenorrheic\n* not planning to become pregnant for the duration of participation in the study\n* English-speaking, literate, willing and able to provide informed consent.\n\nExclusion Criteria:\n\n* Diabetes\n* pregnant or breastfeeding\n* cardiac or pulmonary disorders\n* severe obesity (body mass index \\[BMI\\] ≥ 40 kg\u002Fm 2 )\n* hypertension\n* obstructive sleep apnea\n* current use of heart or blood pressure medications, current use of hormonal contraceptives or other forms of exogenous sex hormones\n* report of nicotine\u002Ftobacco use in the last six months, report of current alcohol abuse,\n* history of treatment with chemotherapy\u002Fradiation\n* coagulopathy disorders and\u002For use of anticoagulant medications, and current use of anxiolytics and\u002For antidepressants.",{"count":315,"type":22},"This is a longitudinal study to determine the influence of the menopause transition on autonomic and vascular function. PI Keller-Ross has published data demonstrating that postmenopausal females have greater sympathetic neural reactivity during a stressor compared with age-matched males and younger females and males. A paucity of literature exists, however, on the role of the menopause transition in autonomic function because the majority of experimental studies on menopause physiology are cross-sectional and\u002For focused on older, postmenopausal females .\n\nThe influence of age on HTN is robust, whereas the effects of menopause are still unclear. Preliminary data demonstrate a clear association between age and sympathetic activity in females; how the transition through menopause influences these relations, however, remains unknown. The study will enroll 80 midlife (45-55 years of age) females to measure longitudinally the trajectory of autonomic and vascular function during the transition through menopause. The study hypothesizes that through the menopause transition, an increase in sympathetic activity and an impaired baroreflex sensitivity and endothelial function will emerge.",[26],[686,97,687],"blood pressure","vascular",{"date":609,"type":33},{"date":690,"type":33},"2025-04-01",{"date":692,"type":22},"2030-08-21",{"name":694,"class":40},"University of Minnesota"]