[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"menopausal-women\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:menopausal-women":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,49,85,120,145,176,203,230,253],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100603430","phase-4-comparing-digital-therapy-trazodone-and-daridorexant-for-menopause-related-insomnia-symptoms-100603430",false,"NCT07136415","Comparing Digital Therapy, Trazodone, and Daridorexant for Menopause-Related Insomnia Symptoms","CELESTE: Comparative Effectiveness Study of behavioraL and Drug-rElated inSomnia Therapies for pEri- and Post-menopausal People","CELESTE","Inclusion Criteria:\n\n* Age 40-62 years\n* Assigned female sex at birth\n* In peri- or early menopause, following the STRAW criteria of self-report of irregular menstrual cycle or within 5 years from the last menstrual period. When menstrual markers are absent or unreliable (e.g., hysterectomy; endometrial ablation), participants must be older than 45 years old and report hot flashes\n* Insomnia severity index score \\> 10 at screening\n* Insomnia started or worsened during peri- or early menopause\n* English or Spanish speaking (Spanish-only speaking individuals will be recruited after full development of Spanish-facing materials, which may lag initial study start)\n\nExclusion Criteria:\n\n* Untreated, previously diagnosed severe sleep apnea (self-report; chart review; clinician assessment)\n* Untreated, previously diagnosed moderate-severe restless legs syndrome (self-report; chart review)\n* Severe daytime sleepiness (Epworth Sleepiness Scale \\> 15) at screening\n* Sleep schedule issues that would impact effectiveness of the interventions (e.g., night shift workers with \\>1 night shift\u002Fweek; main sleep period outside of 8pm - 11am)\n* Regular use of hypnotics \\> 2 nights\u002Fweek\n* Limited internet access\n* Pregnant or lactating or positive urine pregnancy test at baseline visit\n* Prolonged QTc interval (\\>460 ms) (by study baseline electrocardiogram (EKG) or EKG report in medical record)\n* History of the following health conditions: Uncontrolled hypertension; clinically significant heart disease such as arrhythmias requiring medication, cardiomyopathies, heart failure, clinically significant valvular heart disease, or severe coronary artery disease (unstable angina, myocardial infarction in the prior 6 months); hypersomnia or narcolepsy; bipolar disorder, severe depression, or psychosis ; seizure within the past year; use of opioids or substance use disorder; known allergy or contraindication to trazodone or daridorexant (self-report and chart review); known severe chronic liver disease (e.g. cirrhosis); end-stage renal disease on hemodialysis; other severe medical comorbidity (e.g. likely hospitalization within next 6 months or medical conditions that increase risk of participation at a study clinician's discretion)\n* Use of medications such as those that: Have known potential for significantly prolonging the QT interval (i.e. antiarrhythmics such as amiodarone, sotalol, quinidine, procainamide, dofetilide, and ibutilide), are strong CYP3A4 inhibitors, or are moderate or strong CYP3A4 inducers\n* Use of one of the interventions in the past 6 months\n* Other conditions determined by the PI or study clinician to preclude study participation","FEMALE","40 Years","62 Years",{"count":21,"type":22},1000,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","The goal of this clinical trial is to learn how three current insomnia therapies (trazodone, daridorexant, cognitive behavioral therapy for insomnia) compare with each other in peri- and post-menopausal women. It will also learn about the safety of the treatments. The main questions it aims to answer are:\n\nWhich commonly used insomnia therapies are most effective and safe for improving insomnia symptoms in peri- and post-menopausal people?\n\nHow well do the treatments work for people from different backgrounds, who are at different stages of menopause, and who have different conditions common during menopause (e.g., sleep apnea, mood disturbance, etc.)?\n\nWhat medical problems do participants have when using these treatments?\n\nParticipants will:\n\nBe asked to take trazodone every night, take daridorexant every night, or participate in an online behavioral program for insomnia, for a total of 12 months.\n\nParticipate in a total of one in-person visit and 7 virtual visits (phone calls) over the 12 months.\n\nWear (and keep) a Fitbit and fill out a daily sleep diary for at least 4 weeks over the 12 months.\n\nFill out online surveys 4 times over the 12 months.",[28,29],"Menopausal Women","Insomnia",[31,32,33,34,35],"menopause","insomnia","cognitive behavioral therapy","trazodone","daridorexant","RECRUITING","2026-06-05",{"date":39,"type":40},"2026-06-08","ACTUAL",{"date":42,"type":40},"2026-02-13",{"date":44,"type":22},"2031-02",{"name":46,"class":47},"Brigham and Women's Hospital","OTHER",5,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":55,"sex":17,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":62,"conditions":63,"keywords":64,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":84},"100637396","the-effect-of-value-clarification-based-on-meleiss-transition-theory-on-menopausal-symptoms-depression-anxiety-stress-and-quality-of-life-in-perimenopausal-women-100637396","NCT07584109","The Effect of Value Clarification Based on Meleis's Transition Theory on Menopausal Symptoms, Depression, Anxiety, Stress, and Quality of Life in Perimenopausal Women","Inclusion Criteria:\n\n* Women who agree to participate in the study,\n* Have at least a primary school education,\n* Understand, read, and write Turkish,\n* Have no communication barriers,\n* Are between 45-55 years of age,\n* Have started experiencing menstrual cycle irregularities or have not menstruated,\n* Have experienced at least one menopausal symptom in the last 6 months (hot flashes, irritability, sleep problems, urogenital complaints, etc.),\n* Are in the perimenopausal period according to the Straw Classification of Reproductive Aging in Women criteria,\n* Women who have entered menopause naturally will be included in the study.\n\nExclusion Criteria:\n\n* Women who:\n* Use any complementary or alternative treatment methods (such as Reiki, phytoestrogens, acupressure),\n* Use hypnotic or sedative medications,\n* Have a diagnosed psychiatric illness,\n* Have a gynecological problem causing menstrual irregularities,\n* Have entered menopause as a result of any surgical operation such as a hysterectomy,\n* Are receiving hormone replacement therapy will be excluded from the study.",true,"45 Years","55 Years",{"count":59,"type":22},88,[61],"NA","Menopause is a life stage influenced not only by hormonal factors but also by psychological, social, and cultural factors. Symptoms such as hot flashes, sleep problems, and mood changes may occur, and their severity depends on how a woman perceives and copes with this period.\n\nThe study aims to examine the effects of the \"Value Clarification\" method based on Meleis Transition Theory on menopausal symptoms, depression, anxiety, stress, and quality of life in women during menopause.",[28],[65,66,67,68,69,70,71,72,73],"Menopause","Meleis Transition Theory","Value Clarification","depression","stress","anxiety","menopausal symptoms","quality of life","nursing","NOT_YET_RECRUITING","2026-05-06",{"date":77,"type":40},"2026-05-13",{"date":79,"type":22},"2026-05-04",{"date":81,"type":22},"2026-11-04",{"name":83,"class":47},"Ordu University",1,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":93,"enrollmentInfo":94,"targetDuration":4,"studyType":23,"phases":96,"briefSummary":97,"conditions":98,"keywords":102,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":84},"100631101","comparison-of-oral-dydrogesterone-and-vaginal-progesterone-in-menopausal-hormone-therapy-100631101","NCT07496294","Comparison of Oral Dydrogesterone and Vaginal Progesterone in Menopausal Hormone Therapy","Comparison of Oral Dydrogesterone and Vaginal Micronized Progesterone Regimens Combined With Transdermal Estradiol in Menopausal Hormone Therapy: A Prospective Randomized Controlled Trial","PRO-MHT","Inclusion Criteria:\n\n* Women aged 45-60 years\n* Postmenopausal status (absence of menstruation for ≥12 months)\n* Intact uterus\n* Presence of menopausal symptoms requiring menopausal hormone therapy\n* Willingness to participate and provide written informed consent\n\nExclusion Criteria:\n\n* Unexplained vaginal bleeding\n* History of breast cancer or endometrial cancer\n* Known hypersensitivity to study medications\n* History of thromboembolic disease (e.g., deep vein thrombosis or pulmonary embolism)\n* Severe liver disease\n* Uncontrolled hypertension\n* Any condition that, in the opinion of the investigator, makes participation inappropriate","60 Years",{"count":95,"type":22},200,[61],"Menopause is a natural stage in a woman's life that can be associated with symptoms such as hot flashes, night sweats, sleep problems, and vaginal dryness. Menopausal hormone therapy is commonly used to relieve these symptoms. In women with an intact uterus, progesterone must be used together with estrogen to protect the lining of the uterus.\n\nThe purpose of this study is to compare two commonly used progesterone treatment methods in women receiving menopausal hormone therapy. All participants will use transdermal estradiol gel, and they will be randomly assigned to receive either oral dydrogesterone or vaginal micronized progesterone.\n\nThis prospective randomized controlled study will evaluate the effects of these treatments on endometrial thickness, menopausal symptoms, vaginal health parameters, bleeding patterns, and quality of life over a 12-month follow-up period.\n\nThe results of this study may help determine the most appropriate progesterone regimen for women undergoing menopausal hormone therapy.",[28,99,100,101],"Menopausal Symptom Relief","Hormone Therapy","Menopausal Hormone Therapy",[103,104,105,106,107,108,109,110],"Menopausal hormone therapy","Dydrogesterone","Micronized progesterone","Transdermal estradiol","Progesterone route of administration","Endometrial thickness","Postmenopausal women","Randomized controlled trial","2026-03-23",{"date":113,"type":40},"2026-03-27",{"date":115,"type":22},"2026-04",{"date":117,"type":22},"2027-10",{"name":119,"class":47},"Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital",{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":17,"minAge":127,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":23,"phases":130,"briefSummary":131,"conditions":132,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":144},"100619267","a-clinical-study-to-assess-histological-changes-from-treatment-of-poly-l-lactic-acid-biostimulator-on-women-at-various-menopausal-stages-100619267","NCT07342400","A Clinical Study to Assess Histological Changes From Treatment of Poly L-lactic Acid Biostimulator on Women at Various Menopausal Stages","A Multi-center, Prospective Clinical Study to Assess Histological Changes From Treatment of Poly L-lactic Acid Biostimulator on Women at Various Menopausal Stages","Inclusion Criteria:\n\n* Subjects diagnosed with symmetrical, moderate-to-severe cheek wrinkles on each side of the face as assessed via the Galderma Cheek Wrinkles Scale.\n* Subject with intent to undergo correction of cheek augmentation or contour deficiencies\n* Subjects willing to have a 3-mm punch biopsy on each preauricular side\n* Subjects willing to maintain the current lifestyle, daily routine (e.g., diet, exercise, sleep, etc.), and a stable Body Mass Index (BMI, ± 5 kg\u002Fm2) throughout the study\n* Ability of giving consent for participation in the study.\n* Agreement to adhere to the procedures and requirements of the study and to report to the institute on the day(s) and at the time(s) scheduled for the assessments.\n\nExclusion Criteria:\n\n* Subjects with asymmetrical severity or unidentical cheek wrinkle score between 2 sides of the cheek.\n* Subjects with a history of allergy or hypersensitivity to any ingredient of the treatment products.\n* Previous tissue-augmenting therapy, contouring, or revitalization treatment in the face, except lips.\n* Previous treatment\u002Fprocedure in the face in the previous 6 months that, in the Investigator's opinion, would interfere with the study injections and\u002For study assessments or exposed the study subject to undue risk by study participation, or planning to undergo any of these procedures affecting the treatment area at any time during the study.\n* Subjects with any medical condition that, in the opinion of the Investigator, would make the subject unsuitable for inclusion.","22 Years",{"count":129,"type":22},40,[61],"To assess protein expression stimulated by poly L-lactic acid (PLLA) via punch biopsy at each follow-up visits compared to Baseline.",[133,28],"Cheek Wrinkles","2026-01-13",{"date":136,"type":40},"2026-01-15",{"date":138,"type":40},"2025-08-12",{"date":140,"type":22},"2026-11",{"name":142,"class":143},"Galderma R&D","INDUSTRY",2,{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":149,"acronym":150,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":93,"enrollmentInfo":152,"targetDuration":4,"studyType":154,"phases":4,"briefSummary":155,"conditions":156,"keywords":160,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":169,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":4},"100592890","caramel-retrospective-study-for-personalized-risk-assessment-of-cardiovascular-disease-in-menopausal-and-perimenopausal-women-using-real-world-data-100592890","NCT06999317","CARAMEL: Retrospective Study for Personalized Risk Assessment of Cardiovascular Disease in Menopausal and Perimenopausal Women Using Real World Data","CARAMEL RS","Inclusion Criteria:\n\nSelf-identified as female in the electronic health record (EHR). Age between 40 and 60 years at the time of data collection\u002Findex date. Availability of at least 5-6 years of retrospective data in the EHR, depending on the research objective.\n\nAt least one healthcare encounter (visit, imaging, lab test, diagnosis, etc.) within the defined age range.\n\nFor imaging substudies (e.g., RO3-RO5): availability of at least one relevant imaging test (e.g., DXA, digital mammography, cMRI, CCTA, US) during the age range.\n\nFor signal-based analysis (RO6): presence of ECG monitoring data from implanted devices and at least 2 years of follow-up.\n\nExclusion Criteria:\n\nPrior diagnosis of cardiovascular disease before the observation window (only applicable to specific ROs, e.g., RO2, RO4).\n\nInsufficient data quality or missing key variables needed for modeling (e.g., absence of blood pressure or lipid profile).\n\nPatients with incomplete or inconsistent records (e.g., duplicate IDs, mismatched time frames).\n\nFor signal-based RO6: hospitalizations or diagnoses unrelated to cardiovascular health that may bias AI model training.",{"count":153,"type":22},1500000,"OBSERVATIONAL","This retrospective observational study, part of the EU-funded CARAMEL project, aims to develop and validate personalized cardiovascular disease (CVD) risk assessment models specifically designed for menopausal and perimenopausal women (ages 40-60). The study leverages Real World Data (RWD) collected from multiple international clinical partners, including electronic health records (EHR), diagnostic imaging data, and signal data.\n\nThe main objective is to improve the prediction of CVD precursors such as hypertension and dyslipidemia, as well as mid- and long-term risk of CVD events, through advanced artificial intelligence (AI) models. These models will be trained on multimodal data to capture complex, individualized risk trajectories that current risk calculators fail to address, particularly in women. Special focus is placed on under-researched, women-specific risk factors and their interactions with traditional predictors.\n\nThe study includes several research objectives: (1) predicting the onset of hypertension and dyslipidemia using EHR data; (2) modeling the long-term risk of fatal and non-fatal cardiovascular events and disease trajectories; (3) identifying novel imaging biomarkers from routine screening tests such as mammography, DXA, ultrasound, and cardiac MRI; (4) developing multimodal prediction models combining imaging and clinical data; (5) creating automated AI tools for imaging biomarker extraction; and (6) using signal data from cardiac devices to predict disease progression and events.\n\nThe study population consists of middle-aged women with retrospective data available across different health systems. The expected outcome is a validated set of stratified, personalized CVD risk models that can support targeted prevention strategies and enable more equitable, sex-specific care. This will contribute to reducing the burden of CVD in women and addressing critical gaps in early detection, clinical decision-making, and health policy.\n\nThis project has received funding from the European Union's Horizon Europe Research and Innovation Programme under Grant Agreement No 101156210.",[157,28,158,159],"Cardiovascular Risk Factors","Perimenopausal Women","Real World Data",[161,162,163,164,165,166,167,168],"Cardiovascular Disease","Cardiovascular risk factors","Menopausal women","Perimenopausal women","real world data","personalised prevention","computational modelling","women-specific risks",{"date":136,"type":40},{"date":171,"type":22},"2026-03-01",{"date":173,"type":22},"2028-04-30",{"name":175,"class":47},"Hospital Universitario Virgen Macarena",{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":182,"eligibilityCriteria":183,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":93,"enrollmentInfo":184,"targetDuration":4,"studyType":154,"phases":4,"briefSummary":186,"conditions":187,"keywords":189,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":84},"100615457","comparing-and-predicting-the-risk-of-respiratory-tract-infection-rti-among-post-menopausal-women-on-or-without-hormone-replacement-therapy-hrt-an-observational-cohort-study-100615457","NCT07292857","Comparing and Predicting the Risk of Respiratory Tract Infection (RTI) Among Post-menopausal Women on or Without Hormone Replacement Therapy (HRT): an Observational Cohort Study","Comparing and Predicting the Risk of Respiratory Tract Infection (RTI) Among Post-menopausal Women on or Without Hormone Replacement Therapy (HRT): an Observational Cohort Study (Meno_Flu)","Meno_Flu","Inclusion Criteria:\n\n* Biological sex: female\n* Age: 40-60 years\n* Self-determined decision to participate, confirmed by signing the informed consent form (ICF)\n* Fluent in German\n* Agreement to wear a smartwatch (Garmin Vivosmart 5) for most of the time over six months\n* Ownership of a smartphone compatible with the Fitrockr application\n* Confirmed post-menopausal status: Spontaneous amenorrhea for ≥12 consecutive months without other causes OR ≥6 months of spontaneous amenorrhea with biochemical confirmation (FSH \\> 40 IU\u002FL OR FSH \\> 30 IU\u002FL for women aged ≥50 using hormonal contraception) OR bilateral oophorectomy ≥6 weeks before enrollment\n\nExclusion Criteria:\n\n* Inability to provide informed consent\n* Known allergic reaction to polycarbonate (smartwatch wristband material)\n* Asthma not well-controlled (ACT score \\\u003C20 despite medication)\n* Use of injectable asthma drugs with broad immunomodulatory activity\n* Coronary artery disease\n* Diagnosis of diabetes mellitus\n* Cancer diagnosis\n* Diagnosis of chronic kidney disease\n* Confirmed diagnosis of familial hypercholesterolemia (genetic)\n* Sleep apnea managed with bi-level positive airway pressure (PAP)\n* Chronic rhinosinusitis\n* Severe (stage 3 or 4) chronic obstructive pulmonary disease (COPD) or interstitial lung disease with hospitalization within the prior 12 months for respiratory symptoms\n* Any other condition\u002Ftreatment deemed incompatible with the study objectives by the PI or delegated co-investigators\n* Current employment in the Section of Gynecological Endocrinology and Reproductive Medicine (Inselspital Bern) or any other relation to the principal investigator\n* Concurrent participation in a clinical interventional study\n* Technical inability to pair the participant's smartphone with the smartwatch\n* Inability to comply with study procedures (e.g., due to language, psychiatric illness, or inability to attend study site)",{"count":185,"type":22},400,"Background: Respiratory tract infections (RTIs) are a major public health concern. Global studies published in Lancet Infect. Dis. highlight the persistent morbidity and mortality from RTIs, with upper- and lower-RTIs collectively accounting for more than 100 million disability-adjusted-life-years per year.\n\nDuring menopause, hormonal changes alongside other factors increase the risk for illnesses, such as RTIs, COPD, cardiovascular disease, and diabetes. However, it remains unknown how hormone-replacement therapy during menopause might impact the frequency or severity of RTIs. While hormone replacement therapy (HRT) is often prescribed for menopausal symptom relief, its potential impact on RTI risk and severity has not been examined.\n\nObjective: This observational cohort study aims to compare and predict the risk of RTI among postmenopausal women, with a particular focus on the influence of HRT. The principal aim is to compare the rates and severity of respiratory tract infections in postmenopausal women taking or not taking HRT. The secondary aims are to characterize risk factors for RTI in postmenopausal women and identify signals in wearable data that predict the onset of an RTI before symptoms become apparent.\n\nMethods: 400 women aged 40-60 will be studied, stratified into two groups: postmenopausal women taking HRT, and postmenopausal women not taking HRT. Participants will each be followed for six months, with RTI episodes recorded through self-reporting and confirmed by laboratory tests. Wearable devices will continuously monitor physiological parameters (e.g., heart rate, sleep patterns), and questionnaires will assess lifestyle factors, medical history, and environmental exposure. Statistical modeling and machine learning approaches will be used to analyze infection predictors and develop a model that predicts the risk of onset of an RTI.\n\nImpact: Half of the world's population inevitably undergoes menopause, and this important life transition has wide-ranging impacts on women's health and quality of life for decades. Studies show that women spend more of their lives in poor health than men, with far-reaching impacts on a woman's participation in society, career performance, and ability to care for other family members. A better understanding of risk factors for respiratory infections in menopausal women and whether hormone-replacement therapy influences RTIs will contribute much-needed knowledge to enable better health management strategies for women. Furthermore, an \"early-warning\" system based on wearable signals will provide a valuable tool for quick intervention and to reduce the spread of infectious illnesses. Such an \"early-warning\" system will subsequently be tested for applicability across a broader representation of society as a preventive health measure and tool for pandemic preparedness.\n\nConclusion: Findings will enhance understanding of RTI risk and management in menopausal women and contribute to the development of personalized prevention strategies. Future applications include a wearable-based medical device for real-time RTI risk assessment, potentially reducing antibiotic overuse and improving healthcare efficiency. By enabling early detection and risk stratification, this study paves the way for a proactive and personalized approach to respiratory health in postmenopausal women, ultimately shifting the focus to prevention.",[28,188],"Respiratory Tract Infections (RTI)",[190,65,191,192,193],"Hormone Replacement Therapy","Health monitoring","Wearables","Infection risk","2025-12-05",{"date":196,"type":40},"2025-12-18",{"date":198,"type":40},"2024-09-18",{"date":200,"type":22},"2026-03",{"name":202,"class":47},"Insel Gruppe AG, University Hospital Bern",{"id":204,"slug":205,"hasResults":11,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":4,"eligibilityCriteria":209,"healthyVolunteers":55,"sex":17,"minAge":56,"maxAge":210,"enrollmentInfo":211,"targetDuration":4,"studyType":23,"phases":213,"briefSummary":215,"conditions":216,"keywords":217,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":84},"100584470","phase-2-a-clinical-trial-to-investigate-the-effect-of-pollen-extracts-on-menopausal-symptoms-in-healthy-women-100584470","NCT06889753","A Clinical Trial to Investigate the Effect of Pollen Extracts on Menopausal Symptoms in Healthy Women.","A Randomized, Triple-blind, Placebo Controlled, Parallel Clinical Trial to Investigate the Effect of Pollen Extracts on Menopausal Symptoms in Healthy Women.","Inclusion Criteria:\n\n1. Females between 45-60 years of age, inclusive\n2. BMI 18.5 kg\u002Fm2 - 34.9 kg\u002Fm2 inclusive\n3. Self-reported menopausal women who have not had a menstrual period for \\>12 months prior to screening and are experiencing at least moderate menopausal symptoms as assessed by the total MRS score of ≥9 at screening\n4. Presence of menopausal symptoms for at least six months prior to screening including, vasomotor symptoms (hot flushes, sweating) AND at least two of the following symptoms: sleep disturbance, joint pain, mood changes, fatigue and lack of energy, vaginal dryness, urinary changes, and changes in sexual function\n5. Agrees to maintain current lifestyle as much as possible throughout the study, including diet, exercise, medications, dietary supplements, and sleep\n6. Able and willing to complete all study assessments\n7. Provided voluntary, written, informed consent to participate in the study\n8. Healthy as determined by medical history with no unstable, diagnosed medical conditions as assessed by the Qualified Investigator (QI)\n\nExclusion Criteria:\n\n1. Females who have had unilateral oophorectomy or hysterectomy or uterine ablation\n2. Allergy (including bee products or pollen, sensitivity, or intolerance to investigational products or placebo ingredients\n3. Ongoing diagnosis with anxiety disorder, sleep disorder, or major depression as assessed by the QI\n4. Ongoing unstable diagnosis of musculoskeletal disorders as assessed by the QI\n5. Current untreated urogenital diagnosis as assessed by the QI\n6. Unstable metabolic disease or chronic diseases as assessed by the QI\n7. Current or history of any significant diseases of the gastrointestinal tract as assessed by the QI\n8. Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI\n9. Current unstable Type I or Type II diabetes\n10. Significant cardiovascular event in the past six months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis\n11. History of or current diagnosis with kidney and\u002For liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones in participants who are symptom free for 6 months\n12. Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least three months will be considered by the QI\n13. Major surgery in the past three months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI\n14. Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years\n15. after diagnosis are acceptable\n16. Individuals with unstable autoimmune disease or are immune compromised as assessed by the QI\n17. Use of medical cannabinoid products\n18. Chronic use of cannabinoid products (\\>2 times\u002Fweek) as assessed by the QI\n19. Alcohol intake average of \\>2 standard drinks per day as assessed by the QI\n20. Alcohol or drug abuse within the last 12 months\n21. Current use of prescribed and\u002For over-the-counter (OTC) medications, supplements, and\u002For consumption of food\u002Fdrinks that may impact the efficacy of the investigational product (Sections 7.3.1 and 7.3.2)\n22. Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI\n23. Individuals who are unable to give informed consent\n24. Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant\n25. Asthmatic, as assessed by the QI","65 Years",{"count":212,"type":22},120,[214],"PHASE2","The goal of this study is to investigate the effect of pollen extracts on menopausal symptoms in healthy women The main question it aims to answer is:\n\nWhat is the difference in change in severity of menopausal symptoms as assessed by the total Menopause Rating Scale (MRS) score from baseline at Week 36 between Graminex Water Soluble Pollen Extract (WSPE), Lipid Soluble Pollen Extract (LSPE), and Placebo?\n\nParticipants will be asked to complete the MRS assessment tool to rate their menopausal symptoms while receiving either WSPE, LSPE, or Placebo.",[28],[65,218,219,220],"Flower Pollen Extracts","Water Soluble Pollen Extract","Lipid Soluble Pollen Extract","2025-11-18",{"date":223,"type":40},"2025-11-19",{"date":225,"type":40},"2025-10-29",{"date":227,"type":22},"2026-08",{"name":229,"class":47},"Graminex LLC",{"id":231,"slug":232,"hasResults":11,"nctId":233,"briefTitle":234,"officialTitle":234,"acronym":4,"eligibilityCriteria":235,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":57,"enrollmentInfo":236,"targetDuration":4,"studyType":23,"phases":238,"briefSummary":239,"conditions":240,"keywords":242,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":84},"100609105","the-effectiveness-of-a-proprietary-ashwagandha-extract-on-menopausal-symptoms-a-three-arm-randomized-double-blinded-placebo-controlled-clinical-trial-100609105","NCT07210229","The Effectiveness of a Proprietary Ashwagandha Extract on Menopausal Symptoms: A Three-Arm Randomized, Double-Blinded, Placebo Controlled Clinical Trial","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Stated willingness and demonstrated ability to comply with all study procedures, as well as availability for the duration of the study\n* Baseline score of above-average menopause symptom levels on each of the patient reported scales: NRI-MSS (defined as 22+), the MRS scale (defined as 9+), AND 4+ on the MENQoL.\n* Confirmation of presence of hot flashes\n* Estridiol levels within the bottom 35% of normal ranges for their menstrual cycle phase (follicular\u002Fovulation\u002Fluteal) as established by laboratory reference range\n* Biological sex of female; gender identification of woman\n* Aged 40 to 55, inclusive\n* Good general health as evidenced by medical history and screening\n* For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional month after the end of the study\n* Still menstruating regularly (defined at least one period every 60 days)\n* Agreement to adhere to Lifestyle Considerations throughout study duration\n\nExclusion Criteria:\n\n* Pregnant, trying to conceive, or breastfeeding\n* Hysterectomy, uterine ablation, or related procedure\n* Amenorrhea\n* Consumes \\> 8 alcoholic beverages in an average week\n* Currently consumes an ashwagandha supplement or has consumed one regularly (defined as 1x week or more often) within the past 24 months\n* Consumes any hormonal therapies or menopause-related supplements intended to improve symptoms in any way\n* Current or recent (within 60 days) history of taking thyroid medications, hypertensive drugs, CNS depressants, diabetic medications, benzodiazepines, or immunosuppressants\n* Any liver, kidney, hormonal, or cardiovascular disorder\n* Known allergic reactions to any components of the intervention\n* Recent dramatic weight changes (10% change in body weight in the last 6 months)\n* Introducing a new investigational drug or other intervention within 60 days before the start of the study\n* Any change to diet or lifestyle within 60 days before the start of the study (defined as introducing any new exercise activity, joining a gym, starting a new routine, moving to a new home, adjusting dietary habits (e.g. vegetarian, paleo, etc) or discontinuing any habits or diets.\n* Any health or medical condition which, in the primary investigators opinion, may interfere with the conduct of the study",{"count":237,"type":22},90,[61],"The purpose of this study is to evaluate the efficacy of two proprietary ashwagandha extracts on symptoms of menopause and hormone levels, as compared to a placebo.",[241,28],"Menopausal Hot Flashes",[243],"ashwagandha","2025-09-29",{"date":246,"type":40},"2025-10-07",{"date":248,"type":22},"2025-10-01",{"date":250,"type":22},"2026-03-30",{"name":252,"class":47},"Nutraceuticals Research Institute",{"id":254,"slug":255,"hasResults":11,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":65,"eligibilityCriteria":259,"healthyVolunteers":55,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":260,"targetDuration":4,"studyType":23,"phases":262,"briefSummary":263,"conditions":264,"keywords":269,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":277,"completionDateStruct":278,"leadSponsor":280,"locationsCount":84},"100596229","the-effect-of-animation-based-education-on-menopausal-womens-attitudes-behaviors-and-screening-test-participation-regarding-breast-cancer-100596229","NCT07042737","The Effect of Animation-Based Education on Menopausal Women's Attitudes, Behaviors, and Screening Test Participation Regarding Breast Cancer","The Effect of Education Provided to Women in Menopause Through Animation on Breast Cancer Attitudes, Behaviors, and Screening Test Participation","Inclusion Criteria:\n\n* Not having been diagnosed with breast cancer,\n* not performing regular self-examinations (those who performed self-examinations at least once a month were excluded),\n* not having had a mammogram (those who had a mammogram within the first six months after training were excluded),\n* not having undergone a clinical breast examination (those who underwent a clinical breast examination within the first 6 months after the training were excluded),\n* not breastfeeding or being pregnant, being literate, owning a smartphone,\n* having internet access,\n* not having uterine abnormalities,\n* having ovaries,\n* not having used sex hormones.\n\nExclusion Criteria:\n\n* never experiencing menopausal symptoms,\n* undergoing surgical menopause,\n* currently or previously using hormonal therapy,\n* having a psychiatric disorder,\n* having menstruated in the past year,\n* incomplete forms,\n* not fully participating in video-based education programs.",{"count":261,"type":22},136,[61],"The aim of this study was to determine the effect of education provided to women in menopause through animation on their attitudes toward breast cancer, behaviors, and screening test participation. The study will include a total of 136 women in the menopausal period, comprising 68 experimental group participants and 68 control group participants who have applied to the Orduyeri and Kırtepe Family Health Centers affiliated with the Bartın Public Health Institution. Women who agree to participate in the project, which will run from January to August 2025, will receive 40-45 minute training sessions in a suitable room at the ASM. The training sessions will be conducted in groups of 8-12 people. The training content will include information about the purpose, duration, and rules of the training. After providing information about the project, a pre-test will be administered. Through face-to-face interviews, researchers assigned to the project will show animated videos enriched with sound and images via an online program they have prepared. These videos will be 10-12 minutes long, and an interim test will be conducted. Three months after the pre-test, the women participating in the study will be contacted, and a final test will be administered in their own homes. Project data will be collected using the Personal Information Form, Champion Health Belief Scale, and Breast Cancer Awareness Scale. Descriptive statistics, independent sample t-tests, chi-square tests, and repeated measures analysis of variance (ANOVA) tests will be used in the statistical analysis of the project.",[28,265,266,267,268],"Education Nursing","Breast Cancer Females","Motivation","Screening Strategy",[270,31,271,272,273],"education through animation","breast cancer","screening test","motivation","2025-06-20",{"date":276,"type":40},"2025-06-29",{"date":274,"type":22},{"date":279,"type":22},"2026-10-20",{"name":281,"class":47},"Inonu University"]