[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"menopause-related-conditions\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:menopause-related-conditions":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,47,81,120,146,178,217,250,277,301,329,404,431,455,475],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100637272","progo-menopause-wellbeing-study-100637272",false,"NCT07611305","ProGo Menopause Wellbeing Study","A Decentralized, Randomized, Placebo-Controlled Trial Evaluating ProGo® Salmon Protein Hydrolysate Versus Placebo to Improve Body Profile Metrics and Support Overall Wellbeing in Menopausal Women","Inclusion Criteria:\n\nFemale Age 40-65 years (inclusive). Body Mass Index (BMI) between 25.0 and 32.5 kg\u002Fm².\n\nMenopausal Status: participants need to be in the menopausal transition or post-menopause; these are defined as:\n\n1. Menopausal transition: defined by persistent menstrual cycle length variability, without a history of ≥12 consecutive months of amenorrhea (i.e., post-menopause not yet reached). Any menstrual bleeding must be spontaneous and not induced by exogenous hormones.\n2. Post-menopause: defined as amenorrhea ≥12 consecutive months not attributable to pregnancy, lactation, exogenous hormones, surgery, or other medical causes.\n\nLiterate in English. Able to understand study instructions and required assessments. Treatment Stability\n\n1. Participants must be on stable medical, hormonal, and supplement-based regimens prior to screening and throughout the study period.\n2. Initiation, discontinuation, or dose change within the past 8 weeks of any of the following will be exclusionary:\n\ni. Psychotropic medications known to materially affect fatigue, sleep, or mood, including antidepressants, anxiolytics, sedative-hypnotics, mood stabilizers, or antipsychotic medications.\n\nii. Therapies specifically intended to treat menopausal symptoms (other than those explicitly permitted), including non-systemic hormonal agents, compounded hormone preparations, or pharmacologic agents prescribed for menopausal symptom relief.\n\niii. Supplement-based interventions initiated or modified for the purpose of improving sleep, or energy (e.g., adaptogens, sleep aids, energy-enhancing formulations).\n\nc. Participants must agree to maintain stable use of all permitted medications and supplements and not initiate new treatments likely to affect sleep, mood, or energy during the study period.\n\nInformed Consent and Study Readiness\n\n1. Able and willing to provide written informed consent prior to participation.\n2. Willing to comply with all study procedures and protocol requirements.\n3. Able to swallow tablets. General Health In good general health (no active or uncontrolled diseases or conditions) and able to consume the study product.\n\nExclusion Criteria:\n\nReproductive Stage Cannot Be Reliably Classified:\n\n1. Use, within the preceding 3 months of systemic hormonal therapies that alter menstrual bleeding patterns, including systemic hormonal contraception, hormone replacement therapy (HRT), or GnRH analogs.\n2. History of hysterectomy, as menstrual bleeding-based staging cannot be applied.\n3. Pregnancy, \\\u003C6 months postpartum, or lactational amenorrhea, or known medical causes of amenorrhea.\n4. History of bilateral oophorectomy (surgical menopause)\n\nAllergy\u002FHypersensitivity:\n\na. Participants with known fish allergy\n\nMajor Psychiatric Conditions likely to be significant factor in weight gain:\n\na. Recent antidepressant or anti-psychotic initiation or dose change. Current or recent use (last 3-6 months) of systemic hormone replacement therapy (HRT), selective estrogen receptor modulators (SERMs), or other pharmacologic therapies intended to treat menopausal symptoms.\n\nLocal low-dose vaginal estrogen preparations used for urogenital symptoms (e.g., creams, tablets, or rings) are permitted.\n\nHigh-dose iron supplements or IV iron. Sleep medications Strong herbal or phytoestrogen supplements (soy, red clover, etc.). Use of protein hydrolysate supplements. Vegan or vegetarian\n\nCurrent participation in:\n\n1. Structured weight-loss programs.\n2. New vigorous exercise programs (initiated in last 3 months). Medical Conditions Affecting Menstrual Function\n\na. Clinically diagnosed endocrine disorders known to affect menstruation (e.g., uncontrolled thyroid disease, hyperprolactinemia, polycystic ovary syndrome, unless stable and investigator-approved).\n\nHistory of cancer (except localized skin cancer without metastases) within 1 year prior to screening.\n\nSignificant Comorbid Medical Conditions\n\n1. History or presence of clinically significant or uncontrolled cardiovascular, renal, or hepatic disease.\n2. Active systemic infection (e.g., Lyme disease, tuberculosis, HIV).\n3. Sleep apnea that is untreated or inadequately controlled.\n4. Uncontrolled hypothyroidism or hyperthyroidism.\n5. Active systemic inflammatory or autoimmune disease likely to materially contribute to weight gain through impaired mobility or via treatment with corticosteroid therapy.\n6. Clinically significant anemia or iron deficiency requiring active treatment Impaired Gastrointestinal Absorption\n\nHistory or presence of gastrointestinal disease, surgery, or functional disorder known to impair digestion or absorption of orally administered compounds, including:\n\ni. Celiac disease ii. Short bowel syndrome or malabsorption syndromes iii. Chronic pancreatitis or exocrine pancreatic insufficiency iv. Prior bariatric or gastric surgery b. Inflammatory bowel disease (Crohn's disease or ulcerative colitis) requiring ongoing systemic therapy (including steroid, immunomodulatory, or monoclonal antibody therapy).\n\nSurgery: major surgery within 3 months prior to screening or planned during the study period.\n\nSubstance Use History History of clinically significant alcohol or substance use disorder within the past three years, or alcohol intake significantly above accepted public health thresholds.",true,"FEMALE","40 Years","65 Years",{"count":21,"type":22},100,"ESTIMATED","INTERVENTIONAL",[25],"NA","This study will evaluate whether ProGo®, a salmon protein hydrolysate (SPH), helps to moderate body mass index (BMI) and improve quality of life (QoL) in menopausal women. Healthy, overweight (BMI 25-32.5) menopausal women aged 40-65 years with will be enrolled and participants will be randomized to receive ProGo® (2.0 g), ProGo® (4.0 g), or placebo (in a 2:2:1 ratio) once daily for 18 weeks.\n\nProGo® peptides have demonstrated moderate weight loss of 6%-7% in prior human studies likely a result of improved energy levels and reduced inflammation with improved metabolic health.\n\nThis study will assess the efficacy of ProGo® with change in BMI and menopause-specific quality of life (MENQoL total score) as co-primary endpoints. Secondary outcomes will explore anthropometric measures, skin health, appetite, sleep, physical activity, vasomotor symptoms, and selected blood biomarkers.\n\nThe trial employs a fully decentralized design to enhance accessibility and support real-world relevance.",[28],"Menopause Related Conditions",[30,31,32,33],"Menopause weight gain","Quality of life","Skin health","Sleep quality","NOT_YET_RECRUITING","2026-05-29",{"date":37,"type":38},"2026-06-02","ACTUAL",{"date":40,"type":22},"2026-06",{"date":42,"type":22},"2027-01",{"name":44,"class":45},"Hofseth Biocare ASA","INDUSTRY",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":46},"100639209","effects-of-estrogen-on-muscle-gain-during-12-weeks-of-exercise-in-post-menopausal-women-100639209","NCT07617454","Effects of Estrogen on Muscle Gain During 12-weeks of Exercise in Post-menopausal Women","HER-MUSCLE","Inclusion Criteria:\n\n* 1-10 years since last menstrual bleeding\n* Age \\> 40 years old\n* BMI 20-30\n\nExclusion Criteria:\n\n* Follicular stimulating hormone \\\u003C 30 mmol\u002FL\n* Systematic strength training during the last year (\\> 1 strength training session 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",{"count":55,"type":22},30,[25],"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 mechanisms by which oestrogen enhances muscle growth, providing insights for targeted therapies to improve the health and physical function of postmenopausal females.\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 during anabolic (exercise) conditions.\n\nThe project involves:\n\n1. Clinical Trial: Postmenopausal females will receive either oestrogen or placebo, twelve weeks of exercise training to detect oestrogen regulatory role on muscle mass and function.\n2. 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.\n3. 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.",[28,59],"Exercise Training",[61,62,63,64,65,66,67,68,69],"Physical exercise","Strength training","Cardiovascular training","Muscle hypertrophy","Estrogen","Mitochondria function","Muscle strength","Menopause","Muscle mass","RECRUITING","2026-05-23",{"date":73,"type":38},"2026-06-01",{"date":75,"type":38},"2026-02-01",{"date":77,"type":22},"2027-08-01",{"name":79,"class":80},"Mette Hansen","OTHER",{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":17,"minAge":87,"maxAge":19,"enrollmentInfo":88,"targetDuration":90,"studyType":91,"phases":4,"briefSummary":92,"conditions":93,"keywords":102,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":116,"leadSponsor":118,"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.","18 Years",{"count":89,"type":22},5000,"20 Years","OBSERVATIONAL","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.",[68,94,95,28,96,97,98,99,100,101],"Menopausal Hormone Therapy","Menopause Surgical","Menopausal Complaints","Menopausal Osteoporosis","Menopause-related Hot Flashes","Menopausal and Perimenopausal Disorder, Unspecified","Menopausal and Postmenopausal Women","Premature Ovarian Failure (POF)",[103,104,105,106,107,108,109,110,111],"menopause","perimenopause","premature ovarian failure","hormonal replacement teraphy","osteoporosis","genitourinary syndrome of menopause","hot flashes","menopausal discomfort","menopausal symptoms","2026-05-19",{"date":114,"type":38},"2026-05-26",{"date":40,"type":22},{"date":117,"type":22},"2040-12",{"name":119,"class":80},"IRCCS San Raffaele",{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":124,"acronym":4,"eligibilityCriteria":125,"healthyVolunteers":16,"sex":17,"minAge":126,"maxAge":127,"enrollmentInfo":128,"targetDuration":4,"studyType":23,"phases":130,"briefSummary":133,"conditions":134,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":46},"100591029","phase-2-focusing-on-the-menopausal-transition-to-improve-mid-life-womens-health-100591029","NCT06975111","Focusing on the Menopausal Transition to Improve Mid-Life Women's Health","Inclusion Criteria:\n\n* aged 45-55\n* In the late menopausal transition, defined as 60 days of amenorrhea but less than 365 days of amenorrhea18\n* No current use of hormone therapy or hormonal contraception\n* Presence of a uterus and at least one ovary in order to track menstrual patterns\n* Have a smartphone and broadband access adequate to accept telehealth appointments\n\nExclusion Criteria:\n\n* Lack of broadband access (activity and survey data will be collected electronically whenever possible and some visits will be via telehealth)\n* Lack of regular menstrual periods in mid-reproductive life (ages 25-38) when not on hormones or not pregnant.\n* Pregnancy or actively trying to get pregnant\n* Inability to adhere to study protocol schedule\n* Untreated alcoholism\n* Un- Diagnosed abnormal uterine bleeding\n* Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia (MEN 2) for participants with a BMI\\> 30 kg\u002Fm2.","45 Years","55 Years",{"count":129,"type":22},200,[131,132],"PHASE2","PHASE3","What if midlife women, who are inherently at an increased risk for future cardiometabolic disease due to transitioning into menopause, had access to a suite of evidence-based health interventions? Could these interventions reduce menopause-related inflammation, restore a healthier cardiometabolic profile, reverse epigenetic aging, and reduce bothersome menopausal symptoms? The ultimate goal of this work is to attenuate future disease and enhance women's quality of life, extend healthspan and increase productivity.",[68,135,28,136],"Menopause Hot Flashes","Cardiovascular","2026-04-24",{"date":139,"type":38},"2026-04-30",{"date":141,"type":38},"2026-03-01",{"date":143,"type":22},"2030-10-01",{"name":145,"class":80},"University of Colorado, Denver",{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":16,"sex":153,"minAge":154,"maxAge":4,"enrollmentInfo":155,"targetDuration":4,"studyType":23,"phases":157,"briefSummary":158,"conditions":159,"keywords":164,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":4},"100634321","food-trial-evaluating-fecal-abundance-of-sbd111-with-once-daily-versus-twice-daily-administration-in-healthy-adults-100634321","NCT07538167","Food Trial Evaluating Fecal Abundance of SBD111 With Once-Daily Versus Twice-Daily Administration in Healthy Adults","An Open-Label, Randomized, Parallel-Arm Food Trial Evaluating Fecal Abundance of SBD111 With Once-Daily Versus Twice-Daily Administration in Healthy Adults","Inclusion Criteria:• Provide written informed consent.\n\n* Stated availability throughout entire study period and willingness to fulfill all details of the protocol.\n* Age 35 years or older.\n* Be in general good health as determined by a screening evaluation within 30 days of the first administration of SBD111 medical foods.\n* Willing to comply with protocol and report on compliance and side effects during study period.\n* Body Mass Index between 18.5 and 40kg\u002Fm2.\n\nExclusion Criteria:\n\n* • Are currently taking probiotic or prebiotic supplements or have taken them in the past 30 days. If participant is willing to stop taking probiotic or prebiotic supplement for 30-days, they can be re-screened for eligibility and enrollment after consent.\n\n  * Unwilling to avoid probiotics\u002Fprebiotics supplements for the duration of the study.\n  * Known or suspected allergies to probiotics, maltodextrin, or berries.\n  * Received oral or parenteral antibiotics within 30 days of enrollment or prescribed antibiotics on the day of enrollment.\n  * Major surgery on the intestines or endoscopy within last 3 months.\n  * History of drug and\u002For alcohol abuse at the time of enrollment.\n  * Presence of any of the following based on participant reported health history:\n  * Clinically significant systems abnormalities based on screening questionnaire.\n  * Indwelling catheter or feeding tube.\n  * Febrile illness (oral temperature \\>37 degrees Celsius) or one or more episodes of diarrhea within 72 hours of baseline (first administration of study article).\n  * Active bowel leak, acute abdomen, colitis, or active GI disease or history of gastric or intestinal dysmotility, slowed transit time, variable small intestinal permeability, pancreatitis, or inflammatory bowel disease.\n  * History of Hepatitis B or Hepatitis C infections, cirrhosis, or chronic liver disease.\n  * Underlying structural heart disease or previous history of endocarditis or valve replacement.\n  * Immunosuppression including HIV positive, solid organ or stem cell transplant recipient, receiving any oral or parenteral immunosuppressive therapy.\n  * History of Celiac disease.\n  * History of cancer.\n\n    a. Excluding non-melanoma skin cancers or cancer more than 10 years ago.\n  * History of autoimmune disease and taking any immunosuppressant drugs.\n  * Active tuberculosis.\n  * Pregnant, planning on becoming pregnant within the next 2 months, breastfeeding, positive urine pregnancy test within 24 hours of first administration of DMA.\n  * Participants may be excluded if, in the investigator's opinion, there is evidence of cognitive impairment or dementia which is sufficient to interfere with informed consent or adherence to the study protocol. Four questions will be asked during the informed consent process to confirm participant's understanding and ability to comply. (See section 8.3)\n  * Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the volunteer participating in the study or would make it unlikely the volunteer could complete the study.\n  * Bowel movement frequency less than one per 36-hour period.\n  * If the subject has been in a recent experimental trial, these must have been completed not less than 30 days prior to this study.","ALL","35 Years",{"count":156,"type":22},80,[25],"The purpose of this study is to determine whether a modified formulation and daily intake schedule of SBD111 results in similar levels of probiotic microbes in the gut compared with the currently used formulation. SBD111 is a food made of probiotic microbes (bacteria and yeast) and prebiotic dietary fibers (a form of fiber obtained from diet). SBD111 is a medical food used for the dietary management of postmenopausal bone loss.SBD111 was previously found to be safe and well tolerated in a human clinical safety study and a clinical efficacy study. Study participation will include a screening virtual visit, periodic remote questionnaires and check-in calls, and three at-home stool swab sample collections.\n\nEligible participants will be assigned to one of two SBD111 study groups evaluating different formulations and dosing schedules. Each day for a 28-day period, they will take (i) two capsules once daily or (ii) two capsules twice daily (morning and evening), depending on the study group assigned. Investigators will collect demographic information and will ask questions related to dietary intake, bowel habits, and health history. Upon enrollment into the study, participants will receive six at-home stool sample collection kits, two each for baseline, Week 1, and Week 4 analysis. Samples will be collected at home and mailed to a Sōlaria Biō for analysis of the bacterial community that lives in the intestine (the gut microbiome). During the study, participants will also be asked to complete brief questionnaires related to gastrointestinal symptoms, cognitive function, well-being, and sleep. On days 7 and 28 of the study, they will be asked to complete a brief adherence questionnaire and discuss any adverse (negative) events.\n\nAll participants will receive compensation in the form of gift cards for completing study procedures and returning stool samples. Participants will receive a $50.00 gift card after completing the Week 1 study procedures and after receipt of the mailed baseline and Day 7 stool swab samples. Participants will receive a $150.00 gift card after completing the Week 4 study procedures and after receipt of the mailed Week 4 stool swab sample.",[160,161,28,162,163],"Osteopenia","Osteoporosis","Probiotic Intervention","Synbiotics",[165,166,167,160,161,168],"Probiotic","Synbiotic","Bone Loss","Fully Remote","2026-04-15",{"date":171,"type":38},"2026-04-20",{"date":173,"type":22},"2026-04",{"date":175,"type":22},"2027-02",{"name":177,"class":45},"Solarea Bio, Inc",{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":185,"enrollmentInfo":186,"targetDuration":4,"studyType":23,"phases":188,"briefSummary":190,"conditions":191,"keywords":197,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":213,"leadSponsor":215,"locationsCount":46},"100633458","phase-4-vaginal-estradiol-vs-moisturizer-to-improve-postmenopausal-vaginal-aging-symptoms-and-the-microbiome-in-women-living-with-hiv-100633458","NCT07526948","Vaginal Estradiol vs Moisturizer to Improve Postmenopausal Vaginal Aging Symptoms and the Microbiome in Women Living With HIV","Vaginal Estradiol Versus Moisturizer to Improve Postmenopausal Vaginal Aging Symptoms, Dysbiosis and Markers of Latency Reversal in Menopausal Women Living With HIV","Inclusion Criteria:\n\n* female\n* at least 40 years old\n* menopausal (no menses in 12 months) within 2 years of last menstrual period or perimenopausal in the late menopausal transition, defined as an interval of amenorrhea greater than or equal to 60 days\n* have symptoms of the genitourinary syndrome of menopause (GSM) which developed within the prior 2 years. Symptoms of GSM include vaginal symptoms including dryness, soreness, itching, irritation and dyspareunia and\u002For urinary symptoms including urgency, frequency and recurrent urinary tract infections (UTIs)\n\nExclusion Criteria:\n\n* Unexplained or unevaluated abnormal genital bleeding\n* Current or suspected pregnancy\n* Desired pregnancy\n* If less than 55 years old, have had a hysterectomy and have at least one ovary (as menopause cannot be determined in this case by amenorrhea alone)\n* Pelvic or vaginal surgery in the prior 60 days\n* Used systemic reproductive hormones in the last 2 months\n* Used antibiotics in the last 30 days\n* Used immunosuppressive medications in the prior 60 days including biologics, chemotherapeutics or post transplant immunosuppressive medications\n* Used any vaginal or vulvar preparations in the last month\n* Current active vaginal infection diagnosed at study entry\n* Any serious disease or condition that may interfere with study compliance\n* Current or previous history of breast cancer or estrogen dependent cancer (e.g., ovarian, endometrial)\n* Current or previous history of deep vein thrombosis or pulmonary embolism\n* Current or previous history of myocardial infarction or stroke\n* Known clotting disorder including Protein C, Protein S and antithrombin deficiency, Factor V Leiden or prothrombin mutations\n* Known severe liver disease including cirrhosis or active Hepatitis B\n* Known allergic reaction to Vagifem (estradiol vaginal tablet) or Replens","70 Years",{"count":187,"type":22},62,[189],"PHASE4","This is a research study about the effects of vaginal estradiol compared to moisturizer on vaginal symptoms of menopause and the microbiome in women with HIV. This research study aims to understand how vaginal products affect the aging of the female genital tract in women living with HIV who are menopausal or perimenopausal and have vaginal or urinary symptoms. There is a comparison group of women who are living without HIV. Participants with HIV and vaginal or urinary menopausal symptoms (e.g., dryness, irritation, soreness, itching, pain with sex, dysuria, urgency, or frequent urinary tract infections) will be asked to apply vaginal estradiol or a vaginal moisturizer (Replens). Participants who have vaginal or urinary menopausal symptoms and do not have HIV will receive vaginal estradiol.",[96,192,193,194,28,195,196],"Vaginal Atrophy","Genitourinary Symptoms","HIV (Human Immunodeficiency Virus)","Vaginitis","Perimenopause",[198,199,200,201,68,202,203,204,205,206,207,208],"Pain with sex","Vaginal dryness","Symptoms of menopause","HIV Infection","Vaginal microbiome","Dysbiosis","Aging","Premature aging","Atrophic vaginitis","Genitourinary syndrome of menopause (GSM)","Symptoms of perimenopause","2026-04-08",{"date":211,"type":38},"2026-04-14",{"date":73,"type":22},{"date":214,"type":22},"2031-06-30",{"name":216,"class":80},"Albert Einstein College of Medicine",{"id":218,"slug":219,"hasResults":11,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":223,"eligibilityCriteria":224,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":185,"enrollmentInfo":225,"targetDuration":4,"studyType":23,"phases":226,"briefSummary":227,"conditions":228,"keywords":238,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":242,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":46},"100590048","changes-in-the-impact-of-genitourinary-syndrome-of-menopause-with-a-novel-nonhormonal-vulvovaginal-gel-assessed-by-proms-100590048","NCT06962345","Changes in the Impact of Genitourinary Syndrome of Menopause With a Novel Nonhormonal Vulvovaginal Gel Assessed by PROMs.","Changes in the Impact of Genitourinary Syndrome of Menopause With a Novel Nonhormonal Vulvovaginal Gel Assessed by PROMs. Phase 2, Single Arm, Interventional, Longitudinal, Clinical Trial. Part of STOP GSM PROJECT.","STOPGSMP","Inclusion Criteria:\n\n* Patient has to have at least one symptom of GSM or suffer from symptoms related to vulvovaginal atrophy (as evidenced by gynecological examination with a Vaginal Health Index ≤15).\n* Patient must be postmenopausal with at least 1 year without a menstrual period.\n* Patient must consider that her quality of life is affected by GSM symptoms\n* Patient not followed due to any gynecological disease.\n* All participants must be able to understand and to fill in the self-reported questionnaires.\n\nExclusion Criteria:\n\n* Patients that do not want to fill the questionnaire, especially the questions that address sexual functioning.\n* Participants that use any oral products containing hormones or estrogen receptor modulators for the past 8 weeks, nor vaginal topical hormone products within 4 weeks, neither prescription nor non-prescription therapies for GSM, including topical vaginal non-hormonal lubricants or moisturizers for the last week.\n* Patients with history of vulvar, vaginal and\u002For cervical malignancy.\n* Patients having received radiotherapy treatment in the pelvic and\u002For genital region.\n* Patients with any type of disease that causes alteration of collagenogenesis.\n* Patients that use cytotoxic drugs leading to mucositis and alterations of tissue regeneration in the last 6 months.\n* Patients having received laser and\u002For radiofrequency treatment for handling genital atrophy or other pelvic floor dysfunctions.\n* Patients with active urinary and\u002For genital tract infection.\n* Patients with history of malignant neoplasm of the urinary system.\n* Patients with severe stress urinary incontinence (Sandvik test score equal to or greater than 8).\n* Patients with diagnosis of pelvic organ prolapse grade III or higher according to the POP-Q classification.\n* Patients with medical or surgery history that, at the investigator's discretion, does not allow participation in the study.\n* Patients with any other condition that, at the investigator's discretion, implies that the patient is unable to understand the implication of participating in the study and\u002For following the established procedures.",{"count":156,"type":22},[25],"The goal of this clinical trial is to improve the management of Genitourinary syndrome of menopause (GSM) to preliminary assess safety and effectivity of a novel hormone-free mucosa composition (XCMIM20m) applied topically to the vulvovaginal area. Symptoms of vaginal atrophy will be compared before and after 8 weeks of use of the tested gel with the Day-to-Day Impact of Vaginal Aging (DIVA) PROMs questionnaire to assess changes impact of GSM symptoms.",[229,230,231,232,28,233,234,235,236,237],"Vulvar Atrophy","Vulvovaginal Signs and Symptoms","Genitourinary Syndrome of Menopause","Quality of Life","Dyspareunia","Urinary Incontinence, Urgency-frequency","Sexual Function","Women´s Health","Vaginal Dryness",[231,230,239,232,240,236],"Patient Reported Outcome Measures","Day-to-Day Impact of Vaginal Ageing","2026-03-25",{"date":243,"type":38},"2026-03-30",{"date":245,"type":38},"2024-01-08",{"date":247,"type":22},"2026-12",{"name":249,"class":45},"Mucosa Innovations, S.L.",{"id":251,"slug":252,"hasResults":11,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":256,"eligibilityCriteria":257,"healthyVolunteers":11,"sex":17,"minAge":258,"maxAge":259,"enrollmentInfo":260,"targetDuration":4,"studyType":23,"phases":262,"briefSummary":263,"conditions":264,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":4},"100540558","phase-2-estradiol-supplementation-and-rotator-cuff-repair-100540558","NCT06318403","Estradiol Supplementation and Rotator Cuff Repair","Estradiol Supplementation and Rotator Cuff Repair: A Preliminary Randomized Trial","ESTRCR","Inclusion Criteria\n\n1. A plan for a primary rotator cuff repair\n2. Female sex (assigned sex at birth)\n3. \\>1 cm tear width, full thickness supraspinatus\u002Finfraspinatus tear\n4. Post-menopausal, as defined by at least twelve months since last menses\n5. Age 50-80\n\nExclusion Criteria\n\n1. Active infection\n2. Baseline serum estradiol \\>20 pg\u002FmL\n3. Infraspinatus or supraspinatus muscle atrophy of greater than or equal to Goutallier grade 3\n4. Pre-operative systemic estradiol supplementation\n5. Medically unfit for operative intervention\n6. Revision surgery\n7. Unwillingness to participate in the study, including post-operative imaging\n8. Inability to read or comprehend written instructions\n9. Prisoner\n10. Concomitant patch augmentation or tendon-transfer\n11. Breast cancer or a history of breast cancer or other estradiol-dependent neoplasia\n12. Liver disease as documented in the medical record\n13. Active venous thromboembolic disease, such as deep venous thrombosis, pulmonary embolism, a history of these conditions, or a known predisposition to these disorders (such as Protein C, protein S, or antithrombin deficiency)\n14. Active arterial thromboembolic disease, such as stroke, myocardiac infarction, a history of these conditions, or a known predisposition to these disorders\n15. Isolated subscapularis tears\n16. Known anaphylactic reaction or hypersensitivity to estradiol, adhesive, or transdermal patches","50 Years","80 Years",{"count":261,"type":22},58,[131],"Rotator cuff tears in the shoulder are common causes of pain and disability, often fail to heal with surgery, and tears, worse outcomes after surgery, and failure of healing are associated with estradiol deficiency. In this study, post-menopausal women will be randomized to either estradiol patches or placebo patches after repair of the rotator cuff. The purpose of this study is to determine whether estradiol patches show promise in improving shoulder pain, strength, muscle volumes, and function when given with rotator cuff repair.",[265,266,267,28,68],"Rotator Cuff Tears","Rotator Cuff Injuries","Rotator Cuff Syndrome","2026-03-17",{"date":270,"type":38},"2026-03-19",{"date":272,"type":22},"2028-03",{"date":274,"type":22},"2030-12",{"name":276,"class":80},"University of Utah",{"id":278,"slug":279,"hasResults":11,"nctId":280,"briefTitle":281,"officialTitle":281,"acronym":4,"eligibilityCriteria":282,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":283,"targetDuration":4,"studyType":23,"phases":285,"briefSummary":286,"conditions":287,"keywords":289,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":4},"100627054","targeting-insomnia-to-prevent-depression-in-the-menopause-transition-100627054","NCT07443644","Targeting Insomnia to Prevent Depression in the Menopause Transition","Inclusion Criteria:\n\n1. At least 40 years old and in the perimenopause,\n2. Willingness to participate in a digital research protocol,\n3. Current moderate to severe insomnia symptoms that started or worsened in association with perimenopause,\n4. English fluency.\n\nExclusion Criteria:\n\n1. Current major depressive disorder\n2. Existing diagnosis of a sleep disorder other than insomnia\n3. Experiencing excessive daytime sleepiness\n4. Having received CBT-I in the preceding 6 months\n5. Severe psychiatric or medical conditions or medications that could compromise safe participation in the study or interfere with the scientific aims\n6. Hysterectomy and\u002For bilateral ovariectomy or current hormonal therapy,\n7. Night shift worker",{"count":284,"type":22},230,[25],"This randomized clinical trial is focused on perimenopausal women who have difficulty sleeping. It will randomize digital cognitive behavioral therapy for insomnia (dCBT-I) or a sleep hygiene intervention (SHI). After treatment, participants will be assessed every 3-months over a 2-year period.\n\nThe two main questions the study aims to answer are:\n\n1. Do participants receiving dCBT-I experience less severe depressive symptoms compared with sleep hygiene (SH) over 2 years of study participation?\n2. Are the effects of dCBT-I on depressive symptom severity mediated by an improvement in insomnia symptoms?",[288,28],"Insomnia",[103,109,290,291],"cognitive behavioral therapy for insomnia","insomnia","2026-02-23",{"date":294,"type":38},"2026-03-02",{"date":296,"type":22},"2026-09",{"date":298,"type":22},"2031-02",{"name":300,"class":45},"SRI International",{"id":302,"slug":303,"hasResults":11,"nctId":304,"briefTitle":305,"officialTitle":305,"acronym":4,"eligibilityCriteria":306,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":307,"enrollmentInfo":308,"targetDuration":4,"studyType":23,"phases":310,"briefSummary":311,"conditions":312,"keywords":314,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":321,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":327,"locationsCount":4},"100621831","transcranial-electrical-stimulation-for-noninvasive-study-of-menopausalperimenopausal-symptoms-100621831","NCT07375732","Transcranial Electrical Stimulation for Noninvasive Study of Menopausal\u002FPerimenopausal Symptoms","Inclusion Criteria:\n\n* Age between 40 and 60 years\n* Participants falling under stages -2 to +2 in the Stages of Reproductive Aging Workshop (STRAW +10) as defined below:\n* Early menopause transition (Stage -2): Increased variability in menstrual cycle defined as persistent difference of 7 days or more in the length of consecutive cycles. Persistence is defined as recurrence within 10 cycles of the first variable cycle.\n* Late menopause transition (Stage -1): Occurrence of amenorrhea of 60 days or longer.\n* Final Menstrual Period (Stage 0): Have undergone 12 consecutive months without a menstrual period, not due to other medical causes.\n* Early Postmenopause (Stage +1): 5-8 years after final menstrual period.\n* Late Postmenopause (Stage +2): \\>8 years after final menstrual period.\n* Participants having frequent hot flashes (at least once a day).\n\nExclusion Criteria:\n\n* Disorders that may mask or coincide with menopause and peri-menopause, such as: Primary Ovarian Insufficiency, Thyroid disease (Hyper\u002Fhypothyroidism), Hyperprolactinemia, Cushing's syndrome, Endometrial\u002FOvarian Cancer, Polycystic Ovary Syndrome (PCOS), Functional hypothalamic amenorrhea\n* Concurrent drugs:\n* GnRH agonist\u002Fantagonist\n* Tamoxifen\u002Faromatase inhibitors\n* Other conditions: Recent hematoma (\\\u003C48 hours), History of hemorrhagic disorders (any platelet disorder (ITP, TTP, HUS, Glanzmann thrombasthenia), Hemophilia A\u002FB, history of arterial insufficiency, any prior history of malignancy, current pregnancy, a lifetime history of severe, uncontrolled mood disorders (anxiety, depression, bipolar), psychotic disorders, other neural disorders, or heart disease, any condition that makes them unable to perform tasks outlined in experiment, tattoos on sensory testing sites.","60 Years",{"count":309,"type":22},50,[25],"Participants are being invited to a research study. This research aims to assess the tolerability of transcranial electrical stimulation of the brain, and explore the response of TES on menopausal\u002Fperimenopausal symptoms including hot flashes effects, depression\u002Fanxiety, memory-problems, and muscular problems. This study will assess what types of electrical brain stimulation affect different menopausal related symptoms. This study will help guide the development of electrical stimulation to be used for improving women's health during menopause transition.",[313,135,68,28],"Menopausal Depression",[315,316,317,318,319],"Noninvasive Neuromodulation","Transcranial Electrical Stimulation","Depression","Vasomotor Symptoms","Hot Flashes","2026-01-26",{"date":322,"type":38},"2026-01-29",{"date":324,"type":22},"2026-02",{"date":326,"type":22},"2027-04",{"name":328,"class":80},"Carnegie Mellon University",{"id":330,"slug":331,"hasResults":11,"nctId":332,"briefTitle":333,"officialTitle":333,"acronym":334,"eligibilityCriteria":335,"healthyVolunteers":16,"sex":153,"minAge":87,"maxAge":19,"enrollmentInfo":336,"targetDuration":4,"studyType":23,"phases":337,"briefSummary":339,"conditions":340,"keywords":375,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":397,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":403,"locationsCount":46},"100565622","phase-1-evaluating-the-efficacy-and-safety-of-prosomnia-sleep-therapy-in-patients-with-sleep-deprivation-and-chronic-insomnia-100565622","NCT06644573","Evaluating the Efficacy and Safety of PROSOMNIA Sleep Therapy™ in Patients With Sleep Deprivation and Chronic Insomnia","PSHW","By adhering to the following criteria, the study aims to select a population that can safely undergo the PROSOMNIA Sleep therapy and for whom the therapy is most likely to be beneficial, ensuring the reliability and validity of the study outcomes.\n\nINCLUSION CRITERIA:\n\n1. Age Range: 18-65 years of age Reason: This age range includes adults who are most likely to benefit from the PROSOMNIA Sleep therapy and who can provide informed consent. It also excludes children and older adults who may have different physiological responses or additional health risks.\n2. Diagnosed or Undiagnosed Chronic Insomnia:\n\n   Reason: Included subjects have a consistent pattern of sleep disturbances that PROSOMNIA Sleep Therapy aims to treat.\n3. Diagnosed or Undiagnosed Sleep Deprivation:\n\n   Reason: Includes individuals who are not getting enough sleep quantity, which is a key condition that the PROSOMNIA Sleep Therapy aims to address.\n4. Diagnosed or Undiagnosed REM Sleep Inconsistencies:\n\n   Reason: Includes individuals who are not getting enough sleep quality and those with specific REM sleep phase issues that the PROSOMNIA Sleep Therapy is designed to improve.\n5. Failure to Respond to Conventional Sleep Treatments:\n\n   Reason: Focuses on subjects who have not found relief from existing sleep therapies, ensuring that the study population represents those in need of alternative solutions.\n6. Ability to Provide Informed Consent:\n\nReason: Ensures that participants understand the study and agree to participate voluntarily.\n\nEXCLUSION CRITERIA:\n\n1. Severe Obesity (BMI \\> 40):\n\n   Reason: Severe obesity can increase the risk of complications with anesthesia and may affect sleep patterns in ways that could confound study results.\n2. Cardiovascular Conditions:\n\n   Reason: Patients with significant heart conditions are at higher risk for complications during anesthesia.\n3. Neurological Disorders:\n\n   Reason: These diagnosed conditions and medications such as epilepsy could interfere with sleep patterns and responses to sleep therapy.\n4. Other Health Conditions Contraindicating Anesthesia:\n\n   Reason: Includes any condition that would make the use of anesthesia unsafe.\n5. Greater than ASA II Status:\n\n   Reason: The American Society of Anesthesiologists (ASA) physical status classification system classifies patients based on their pre-anesthesia medical conditions. Excluding those above ASA II ensures that only patients with mild systemic disease are included, to minimize risks.\n6. Current Use of Prohibited Medications:\n\n   Reason: Medications that could interfere with the combined use of anesthesia including, but not limited to sedatives and hypnotics; such as benzodiazepines, Z-drugs and barbiturates.\n7. Pregnancy or Breastfeeding:\n\nReason: Ensures the safety of the fetus or infant, as the effects of the PROSOMNIA Sleep therapy on pregnancy or lactation are unknown.",{"count":21,"type":22},[338],"PHASE1","This clinical trial aims to evaluate the safety and efficacy of PROSOMNIA Sleep Therapy (PSTx) for individuals suffering from chronic insomnia, sleep deprivation, and REM sleep disorders. Chronic insomnia, characterized by difficulty falling or staying asleep, significantly affects patients and quality of life, mood, and cognitive function. REM sleep disorders, in which the body struggles to enter or maintain restful REM sleep, can worsen these issues. The trial introduces a novel therapy using anesthesia-induced sleep, targeting sleep homeostasis and improving sleep architecture.\n\nObjectives: The primary goals of the trial are to determine:\n\n1. Whether PROSOMNIA Sleep Therapy increases the quality of REM sleep.\n2. Whether PSTx increases the duration of REM and\u002For NREM sleep.\n3. Whether PSTx decreases the time it takes participants to fall asleep (sleep onset latency).\n\nParticipants will receive ONE (1) PROSOMNIA Sleep Therapy session lasting between 60-120 minutes. Each session uses Diprivan\u002FPropofol to induce sleep, and is monitored via an EEG to ensure proper sleep stages, particularly REM sleep.\n\nParticipant Criteria:\n\nInclusion: Adults aged 18-65 with diagnosed or undiagnosed chronic insomnia or sleep deprivation.\n\nExclusion: Patients with severe obesity, significant cardiovascular, neurological, or psychiatric conditions, or those with an ASA status above II.\n\nStudy Design: This trial is non-randomized, single-arm and open-label, with all participants receiving the PSTx. The trial does not include a comparison group, as the focus is on evaluating the immediate, direct effects of the therapy.\n\nParticipants will undergo continuous EEG monitoring during therapy sessions, allowing researchers to track brain activity and sleep stages in real-time. This method ensures that sleep cycles, particularly REM sleep, are optimized for therapeutic benefit.\n\nTherapy Methodology:\n\nPROSOMNIA Sleep Therapy leverages anesthesia to mimic natural sleep patterns and enhance the efficiency of REM sleep. Diprivan\u002FPropofol is used to induce REM sleep, while EEG monitoring tracks and maintains proper sleep architecture throughout the session. The therapy promotes the clearance of adenosine, a compound that builds up during wakefulness and drives the need for sleep. Adenosine is cleared during REM sleep, reducing sleep pressure and improving cognitive function.\n\nOutcome Measures:\n\nPrimary Outcomes: Researchers will measure the increase in REM sleep duration, improvement in sleep quality (via self-reported questionnaires), and a reduction in sleep onset latency.\n\nSecondary Outcomes: These include changes in mood, cognitive function, and blood serum uric acid levels. Patient-reported outcomes will also be tracked through tools like the PROSOMNIA Sleep Quiz, which is specifically designed for PSTx.\n\nSignificance: Chronic insomnia and REM sleep disorders affect millions globally, leading to cognitive impairment, mood disturbances, and poor overall health. Traditional treatments, including pharmacological approaches and Cognitive Behavioral Therapy for Insomnia (CBT-I), often provide suboptimal results for many individuals. PSTx offers a novel, therapeutic approach to restoring sleep balance and enhancing the overall quality of sleep, particularly for those who have not responded to conventional treatments.\n\nStudy Process:\n\nRecruitment and Baseline Assessments: Participants undergo a comprehensive sleep assessment, including sleep questionnaires and polysomnography, to establish a baseline for sleep quality and duration. Blood serum uric acid levels will also be measured to track any biochemical changes due to therapy.\n\nTherapy Sessions: Only one (1) PROSOMNIA Sleep Therapy session will be administered, with the session lasting between 60-120 minutes. Diprivan\u002FPropofol is used to induce sleep, and EEG will monitor brain activity to ensure the proper balance of sleep stages.\n\nPost-Therapy Follow-up: Follow-up assessments will occur at 24 hours, 7 days, and 30 days post-treatment. Researchers will analyze the therapy effects on REM sleep, mood, cognitive function, and other health indicators.\n\nPotential Implications: If successful, this trial could revolutionize how we treat sleep disorders by targeting the underlying mechanisms of sleep pressure and REM sleep disruption. PROSOMNIA Sleep Therapy may offer a safe, effective, and immediate alternative for patients who have exhausted other treatment options.\n\nKey Concepts:\n\nHomeostatic sleep drive, (Process S), caused by adenosine buildup during wakefulness, is disrupted by chronic insomnia. This impacts cognitive function health and recovery. Anesthesia-induced REM sleep via PSTx helps regulate this homeostatic sleep stage, offering deeper and more restorative sleep compared to other sleep therapies. The study uses statistical methods like ANOVA and Chi-square to measure outcomes.",[341,342,343,344,345,288,346,347,348,349,350,351,352,353,354,355,356,357,358,317,359,360,361,362,363,364,365,366,367,368,369,370,371,28,372,373,374],"Chronic Insomnia","Sleep Deprivation","REM Behavior Disorder","REM Sleep Behavior Disorder","REM Sleep Measurement","Insomnia Related to Specified Disorder","Insomnia Due to Other Mental Disorder","Insomnia Comorbid to Psychiatric Disorder","Insomnia Due to Anxiety and Fear","Insomnia Related to Another Mental Condition","Insomnia Disorders","Idiopathic Hypersomnia","Sleep Disorders, Circadian Rhythm","Post Trauma Nightmares","PTSD - Post Traumatic Stress Disorder","Sleep Quality","Anesthesia","Anxiety","Mental Health","Alzheimer Disease or Associated Disorder","Parkinsons","Circadian Rhythm","Circadian Dysregulation","PTSD","Post-Traumatic","Post-Traumatic Stress Disorder Complex","Military Combat Stress Reaction","Sleep","Military Activity","Veterans","Shift Work Sleep Disorder","Pain","Cancer Pain","Athletes",[376,377,378,379,380,381,382,383,384,385,386,387,388,389,390,391,392,393,288,342,394,352,395,364,359,358,317],"SLEEP","PROSOMNIA Sleep","PROSOMNIA Sleep Therapy","PSTx","PROSOMNIA","Anesthesia Sleep","REM Sleep","REM Sleep Therapy","PROSOMNIA Sleep Health","PROSOMNIA Sleep Wellness","PROSOMNIA Sleep Treatment","Nyree","Nyree Penn","Propofol","Propofol Sleep","Diprivan","Diprivan Sleep","PROSOMNIA Sleep Health and Wellness","IH","Sleep Debt","2025-05-27",{"date":398,"type":38},"2025-05-28",{"date":400,"type":22},"2025-11-01",{"date":402,"type":22},"2026-05-01",{"name":388,"class":45},{"id":405,"slug":406,"hasResults":11,"nctId":407,"briefTitle":408,"officialTitle":409,"acronym":410,"eligibilityCriteria":411,"healthyVolunteers":16,"sex":17,"minAge":412,"maxAge":413,"enrollmentInfo":414,"targetDuration":4,"studyType":23,"phases":415,"briefSummary":416,"conditions":417,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":422,"lastUpdatePostDateStruct":423,"startDateStruct":425,"completionDateStruct":427,"leadSponsor":429,"locationsCount":46},"100364916","phase-2-autologous-prp-infusion-may-restore-ovarian-function-and-may-promote-folliculogenesis-in-poi-patients-100364916","NCT04031456","Autologous PRP Infusion May Restore Ovarian Function and May Promote Folliculogenesis in POI Patients","Investigating Reactivation of Ovarian Function Following Autologous PRP Intra-ovarian Infusion in POI Patients","PRP","Inclusion Criteria:\n\n* Age \\\u003C 40 years, presenting with amenorrhea or menstrual cycle irregularities for at least four months, and elevated FSH levels \\>25 IU\u002FL recorded on two occasions \\>4 weeks apart\n* Normal Karyotype: 46, XX\n* Discontinuation of any complementary\u002Fadjuvant treatment including hormone replacement, acupuncture, and botanotherapy, for at least three months prior to recruitment.\n* Willing to comply with study requirements\n\nExclusion Criteria:\n\n* Any pathological disorder related to reproductive system anatomy\n* AMH \\> 8 pmol\u002FL\n* Endometriosis\n* Adenomyosis\n* Fibroids and adhesions\n* Infections in reproductive system\n* Current or previous diagnosis of cancer in reproductive system\n* History of familiar cancer in reproductive system\n* Severe male factor infertility\n* Prior referral for PGT\n* Ovarian inaccessibility\n* Endocrinological disorders (Hypothalamus-Pituitary disorders, thyroid dysfunction, diabetes mellitus, metabolic syndrome)\n* BMI\\>30 kg\u002Fm2 or BMI\\\u003C18.5 kg\u002Fm2\n* Systematic autoimmune disorders","25 Years","39 Years",{"count":21,"type":22},[131,132],"Autologous PRP intra ovarian infusion may restore ovarian function, may promote folliculogenesis and may improve patients' hormonal profile in patients presenting with POI.",[418,28,419,420,421],"Menopause, Premature","Menopausal Syndrome","Premature Ovarian Failure","Ovarian Failure, Premature","2024-12-20",{"date":424,"type":38},"2024-12-24",{"date":426,"type":38},"2019-07-30",{"date":428,"type":22},"2026-07-30",{"name":430,"class":80},"Genesis Athens Clinic",{"id":432,"slug":433,"hasResults":11,"nctId":434,"briefTitle":435,"officialTitle":436,"acronym":437,"eligibilityCriteria":438,"healthyVolunteers":11,"sex":17,"minAge":126,"maxAge":307,"enrollmentInfo":439,"targetDuration":4,"studyType":23,"phases":440,"briefSummary":441,"conditions":442,"keywords":444,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":446,"lastUpdatePostDateStruct":447,"startDateStruct":449,"completionDateStruct":451,"leadSponsor":453,"locationsCount":46},"100399217","phase-1-affect-of-duavive-on-mood--anxiety-symptoms-100399217","NCT04478305","Affect of Duavive on Mood & Anxiety Symptoms","The Effect of Conjugated Estrogens\u002F Bazedoxifene (CE\u002F BZA) on Peri- and Postmenopausal Mood and Anxiety Symptoms: A Pilot Study","DOMA","Inclusion Criteria:\n\n* Females between 45-60 years of age\n* Able to communicate in English\n* In perimenopause as defined by World Health Organization (WHO) Stages of Reproductive Aging Workshop (STRAW) criteria, OR in early menopause (within 10 years of final menstrual period)\n* Suffering from Depressive symptoms (10+ on CES-D-10) AND\u002FOR anxiety symptoms (10+ on GAD-7)\n\nExclusion Criteria:\n\n* Personal history of breast\u002F ovarian\u002F endometrial cancer\u002F endometrial hyperplasia.\n* Abnormal uterine bleeding that has not been adequately investigated.\n* Active or past venous or arterial thromboembolic disease (deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction, coronary heart disease).\n* Active liver disease.\n* Known protein C, protein S, or antithrombin deficiency or other known thrombophilic disorders.\n* Known or suspected pregnancy, women who may become pregnant, and nursing mothers\n* Partial or complete loss of vision due to ophthalmic vascular disease.\n* Uncontrolled hypertension (Systolic blood pressure \\>160mm Hg and\u002F or diastolic blood pressure \\>95 mm Hg)\n* Endocrine disease (other than thyroid disease) that may adversely affect mood (i.e., Cushing's disease, Addison's disease). For women with abnormal TSH, it will be corrected in advance of trial initiation.\n* Active serious suicidal ideation with intent.\n* Symptoms of active psychosis.\n* Daily use of antidepressive medication.\n* Use of other psychoactive or centrally acting medications within 2 weeks before study screening.\n* Known hypersensitivity to either CE or BZA.",{"count":55,"type":22},[338],"This study evaluates the impact of conjugated estrogens\u002F bazedoxifene (CE\u002F BZA) on the mood (depression and anxiety) in peri- and early menopausal women.",[68,443,368,28],"Depression, Anxiety",[445],"hormone replacement therapy","2024-11-28",{"date":448,"type":38},"2024-12-03",{"date":450,"type":38},"2024-07-03",{"date":452,"type":22},"2025-12",{"name":454,"class":80},"St. Joseph's Healthcare Hamilton",{"id":456,"slug":457,"hasResults":11,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":4,"eligibilityCriteria":461,"healthyVolunteers":16,"sex":17,"minAge":126,"maxAge":462,"enrollmentInfo":463,"targetDuration":4,"studyType":23,"phases":464,"briefSummary":465,"conditions":466,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":467,"lastUpdatePostDateStruct":468,"startDateStruct":470,"completionDateStruct":471,"leadSponsor":473,"locationsCount":4},"100560558","emotional-freedom-technique-eft-applied-to-postmenopausal-women-on-sleep-and-quality-of-life-100560558","NCT06578715","Emotional Freedom Technique (EFT) Applied to Postmenopausal Women on Sleep and Quality of Life","The Effect of Emotional Freedom Technique (EFT) Applied to Postmenopausal Women on Sleep and Quality of Life: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Volunteering to participate in the study,\n* Being able to read and write in Turkish,\n* Women between the ages of 45-64 who have not had menstrual bleeding for at least one year (women under the age of 65 who have entered natural menopause),\n* Not being diagnosed with a psychiatric disease,\n* Not using Hormone Replacement Therapy (HRT),\n* Not using antidepressants, antihistamines, benzodiazepines, hypnotics and narcotics, etc.,\n* Not using any complementary and alternative medicine (such as Reiki, phytoestrogens, acupressure).\n* Scoring '5 and above' on the Pittsburgh Sleep Quality Scale\n\nExclusion Criteria:\n\n* Starting to use Hormone Replacement Therapy after starting the study,\n* Starting to use antidepressants, antihistamines, benzodiazepines, hypnotics and narcotics, etc.,\n* Starting to use any complementary and alternative medicine method,\n* Voluntarily leaving the study.","64 Years",{"count":156,"type":22},[25],"The study will be conducted as a randomized controlled experimental study to determine the effects of the Emotional Freedom Technique (EFT) applied to women in menopause on sleep quality and quality of life.\n\nIt will be conducted with 80 women between the ages of 45-64, registered in a family health center in a city in the east of Turkey, who have been in menopause for at least one year and volunteer to participate in the study.\n\nEFT will be applied to the women to be included in the experimental group in the study once a week, a total of four times in a month.\n\nThe \"Participant Information Form\", \"Utian Quality of Life Scale\" and \"Pittsburgh Sleep Quality Scale\" prepared by the researchers in line with the literature information will be used in the collection of research data.",[28],"2024-10-01",{"date":469,"type":38},"2024-10-02",{"date":467,"type":22},{"date":472,"type":22},"2024-11-01",{"name":474,"class":80},"Ataturk University",{"id":476,"slug":477,"hasResults":11,"nctId":478,"briefTitle":479,"officialTitle":479,"acronym":480,"eligibilityCriteria":481,"healthyVolunteers":16,"sex":153,"minAge":87,"maxAge":4,"enrollmentInfo":482,"targetDuration":258,"studyType":91,"phases":4,"briefSummary":484,"conditions":485,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":503,"lastUpdatePostDateStruct":504,"startDateStruct":506,"completionDateStruct":508,"leadSponsor":510,"locationsCount":46},"100553518","virtual-peri-menopause-registry-of-australia-100553518","NCT06487130","Virtual perI-\u002FMenopause Registry of AusTrALia","VITAL","Inclusion Criteria:\n\n* Any Australian over 18 years of age.\n\nExclusion Criteria:\n\n* None.",{"count":483,"type":22},10000,"13 million (50.7%) Australians are born with ovaries, 14% (\\~3 million) are currently aged 40-59 yrs, \\& all such who live to midlife will experience menopause, defined as \\>12 months without a period. Peri-menopause (peri), typically occurs 5 yrs before menopause as hormone levels decrease. As with oestrogen, peri symptoms can affect every bodily system; e.g. depression\u002Fanxiety, diminished mental function, irregular periods, hot flushes, sleep problems, vaginal atrophy \\& urinary urgency. These symptoms are linked with lower quality of life \\& significantly higher work impairment; a third experiencing symptoms so severe as to impede daily life \\& increase risk of suicide. Lifetime increased risks of diabetes, heart disease, osteoporosis \\& dementia are also associated with menopause, yet it remains disconcertingly poorly studied.\n\nThe investigators propose to create a world-first, cutting-edge, consumer-driven, Virtual peri-\u002Fmenopause registry of AusTrALia (VITAL). The unique design will enable consumers to determine VITAL's questions, encourage secure revelation of private data e.g. vaginal \\& mental health symptoms, \\& to direct priorities for research, education, \\& health service improvements. VITAL will thus deliver optimal assessments of incidence, prevalence \\& impact.\n\nThe participating consumers, researchers, clinical specialists, policy makers, \\& modern virtual data infrastructure enable this unique \\& innovative registry design, future translation to improved community health, \\& promote awareness \\& collaborative synergies. Leveraging the investigators' critical range of expertise \\& ongoing feedback opportunities for both participants \\& stakeholder partnerships, the investigators will create a ground-breaking platform that:\n\n* empowers the consumer voice and priorities,\n* enables peri-\u002Fmenopause research to extend beyond existing niche focuses,\n* evidences the true impact of peri-\u002Fmenopause across the nation,\n* evolves healthcare services and outcomes, \\&\n* educates community, clinicians, \\& policy-makers. After Australian registry establishment, the investigators will expand VITAL to mirror it in other nations while still protecting individual's data the right way, but so all can learn \\& apply the best aspects of care from across the world.",[68,486,487,488,489,490,491,492,493,494,495,496,497,498,499,28,319,500,501,502],"Perimenopausal Disorder","Postmenopausal Symptoms","Health Knowledge, Attitudes, Practice","Healthy Aging","Health Care Utilization","Health Care Seeking Behavior","Mental Health Impairment","Mental Deterioration","Mental Health Issue","Osteoporosis, Postmenopausal","Diabetes Mellitus Risk","Diabetes Mellitus, Type 2","Dementia","Cardiovascular Diseases","Hot Flushes Aggravated","Economic Burden","Social Stigma","2024-07-02",{"date":505,"type":38},"2024-07-05",{"date":507,"type":38},"2023-08-03",{"date":509,"type":22},"2073-08",{"name":511,"class":45},"Bespoke Clinical Research"]