[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"vasomotor-symptoms\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:vasomotor-symptoms":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,51,75,116,140,163,197],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100641721","goji-berry-and-vasomotor-symptoms-pilot-study-100641721",false,"NCT07660315","Goji Berry and Vasomotor Symptoms Pilot Study","GOJI-VMS Pilot Study: Effects of Two Goji Berry Powder Forms on HDL Function, Vasomotor Symptoms, and Cognitive Performance","GOJI-VMS","Inclusion Criteria:\n\n* Adult women aged 40-65 years\n* Peri- or postmenopausal with vasomotor symptoms (hot flashes) occurring ≥4 days\u002Fweek over the past 2 weeks\n* Willing to consume one mug-cake daily for 30 days\n* Willing to complete daily VMS symptom tracking on a smartphone\n* Hormone therapy (HRT) is allowed if the dose has been stable for ≥8 weeks and hot flashes are still present\n\nExclusion Criteria:\n\n* Combined intake of \\>5 servings of eggs or lutein\u002Fzeaxanthin-rich vegetables per week\n* Current pregnancy or breastfeeding\n* Known allergy or intolerance to goji (Lycium barbarum) or to key mug-cake ingredients (e.g., wheat\u002Fgluten, dairy, and eggs)\n* Current use of warfarin (goji has reported interactions with anticoagulants); other anticoagulants will be reviewed case-by-case\n* Uncontrolled thyroid disease or other medical conditions likely to confound VMS assessment\n* Initiation or planned change of HRT, GLP-1 agonists, or other medications known to affect lipid metabolism or VMS during the 30-day study\n* Current participation in another interventional study\n* Any condition that, in the judgment of investigators, makes participation unsafe or data interpretation unreliable",true,"FEMALE","40 Years","65 Years",{"count":22,"type":23},6,"ESTIMATED","INTERVENTIONAL",[26],"NA","The goal of this clinical trial is to compare two forms of goji berry powder-whole goji berry powder and goji juice powder-in peri- and postmenopausal women aged 40-65 years who experience frequent vasomotor symptoms (hot flashes). The study aims to determine which formulation is more promising for a future larger trial by evaluating effects on HDL cholesterol function, vasomotor symptoms, cognitive performance, and participant acceptability.\n\nThe main questions it aims to answer are:\n\nDoes whole goji berry powder produce a greater improvement in HDL cholesterol efflux capacity (CEC) over 30 days compared with goji juice powder? Are changes in HDL function associated with changes in hot flash burden, cognitive performance, and self-reported cognitive symptoms?\n\nResearchers will compare participants assigned to whole goji berry powder with participants assigned to goji juice powder to evaluate differences in HDL function, vasomotor symptoms, cognitive outcomes, and intervention acceptability.\n\nParticipants will:\n\nConsume one mug cake containing their assigned goji powder daily for 30 days. Record hot flash frequency, duration, and severity using a smartphone-based electronic diary.\n\nAttend study visits at baseline, Day 15, and Day 30. Provide fasting blood samples at baseline and Day 30 for assessment of HDL cholesterol efflux capacity and cardiometabolic biomarkers.\n\nComplete computerized cognitive testing (TabCAT) at baseline and Day 30. Complete questionnaires assessing menopause-related quality of life, brain fog, mental alertness, physical activity, and study acceptability.",[29],"Vasomotor Symptoms",[31,29,32,33,34,35,36,37],"Goji Berry","Hot flush","Lutein","Zeaxanthin","Carotenoids","HDL","Cholesterol Efflux Capacity","NOT_YET_RECRUITING","2026-06-29",{"date":41,"type":42},"2026-07-01","ACTUAL",{"date":44,"type":23},"2026-06-25",{"date":46,"type":23},"2027-10-31",{"name":48,"class":49},"University of California, Davis","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":58,"minAge":59,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":24,"phases":62,"briefSummary":64,"conditions":65,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":71,"leadSponsor":73,"locationsCount":50},"100636634","phase-2-a-trial-on-fezolinetant-for-vasomotor-symptoms-in-men-receiving-androgen-deprivation-therapy-adt-100636634","NCT07568236","A Trial on Fezolinetant for Vasomotor Symptoms in Men Receiving Androgen Deprivation Therapy (ADT)","A Phase II Trial on Fezolinetant for Vasomotor Symptoms in Men Receiving Androgen Deprivation Therapy (ADT) for Prostate Cancer (Fez-Cap)","Inclusion Criteria:\n\n1. Patients aged at least 18 years old on the index date\n2. Histologically confirmed prostatic adenocarcinoma with localised or metastatic disease\n3. Karnofsky index score of 70% or more\n4. Started on androgen deprivation therapy (both medical or surgical), for at least 3 months at baseline\n5. Baseline daily hot flush score ≥4\n\nExclusion Criteria:\n\n1. Patients treated with drugs related to the study medications or with potential effect for vasomotor symptoms, including selective serotonin-re-uptake inhibitors, steroid hormones, clonidine, gabapentin, veralipride, or β-alanine\n2. Concomitant use of CYP1A2 inhibitors, e.g. fluoroquinolone, fluovoxamine, cimetidine, propranolol, verapamil, acyclovir, allopurinol, theophylline, etc.\n3. Active liver disease including:\n\n   \\- cirrhosis - liver failure - jaundice - elevated total or direct bilirubin - abnormal ALT \u002F AST - abnormal INR\n4. Severe (eGFR 15 to less than 30 mL\u002Fmin\u002F1.73 m2) renal impairment or end-stage renal disease (eGFR less than 15 mL\u002Fmin\u002F1.73 m2)","MALE","18 Years",{"count":61,"type":23},54,[63],"PHASE2","This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter clinical study to investigates the efficacy of fezolinetant in men undergoing ADT for prostate cancer in alleviating Vasomotor syndromes.",[29,66],"Prostate Cancer","2026-04-28",{"date":69,"type":42},"2026-05-05",{"date":41,"type":23},{"date":72,"type":23},"2028-03-31",{"name":74,"class":49},"Chinese University of Hong Kong",{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":58,"minAge":19,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":24,"phases":85,"briefSummary":86,"conditions":87,"keywords":105,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":50},"100589690","phase-2-proof-of-concept-trial-to-assess-the-efficacy-and-safety-of-fezolinetant-in-improving-vasomotor-symptoms-in-men-with-prostate-cancer-undergoing-androgen-deprivation-therapy-100589690","NCT06957691","Proof-of-Concept Trial to Assess the Efficacy and Safety of Fezolinetant in Improving Vasomotor Symptoms in Men With Prostate Cancer Undergoing Androgen Deprivation Therapy","Proof-of-Concept Trial to Assess the Efficacy and Safety of Fezolinetant in Improving Vasomotor Symptoms in Men With Prostate Cancer Undergoing Androgen Deprivation Therapy (Fezo-ADT Trial)","Fezo-ADT","Inclusion Criteria:\n\n* Male sex\n* Age 40 years and older\n* Diagnosis of prostate cancer\n* Androgen deprivation therapy\n* Presence of 5 or more moderate-to-severe hot flashes per day or 35 or more moderate-to-severe hot flashes per week\n* Ability to sign the inform consent\n* Willing to use reliable methods of contraception if partner is of childbearing age\n* Ability to record hot flashes electronically\n\nExclusion Criteria:\n\n* Use of abiraterone acetate\n* Use of docetaxel and other chemotherapeutic agents\n* Liver cirrhosis\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above the upper limit of normal\n* Total bilirubin above the upper limit of normal\n* Glomerular filtration rate \\\u003C 30 mL\u002Fmin\n* Use of selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, tricyclic antidepressants, sedatives, or hypnotics\n* Use of over-the-counter hormonal agents or herbal compounds\n* Current use of CYP1A2 inhibitors\n* Ingestion of alcohol within 2 weeks prior to the baseline visit\n* Inability to abstain from alcohol use during the study period.",{"count":84,"type":23},60,[63],"The goal of this clinical trial is to learn if fezolinetant can treat hot flashes (vasomotor symptoms) in men with prostate cancer undergoing androgen deprivation therapy.\n\nThe main questions it aims to answer are:\n\n* Does fezolinetant improve the frequency and severity of hot flashes?\n* Does fezolinetant cause any harm to the liver?\n* Does fezolinetant improve quality of life, sleep quality, fatigue, mood, sexual function, and metabolic parameters?\n\nResearchers will compare how people respond to fezolinetant versus a placebo, which does not contain any active medicine.\n\nParticipants will:\n\n* Take fezolinetant or a placebo every day for 4 weeks\n* Visit the clinic once every 2 weeks for checkups and tests\n* Keep a diary of the number of times and intensity that they experience hot flashes",[66,88,89,90,91,92,93,94,95,29,96,97,98,99,100,101,102,103,104],"Prostate Cancer (Adenocarcinoma)","Prostate Cancer Metastatic Disease","Prostate Cancer Recurrent","Prostate Carcinoma","Prostate Neoplasm","Prostate Adenocarcinoma","Prostate Cancer With Bone Metastasis","Vasomotor Disturbance","Vasomotor Symptoms (VMS)","Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men","Vasomotor Symptoms; Hot Flashes","Androgen Deprivation Therapy","Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma","Androgen-deprivation Therapy","Hot Flashes","Hot Flushes","Hot Flushes and\u002For Sweats",[99,102,103,66,29],"RECRUITING","2026-03-05",{"date":109,"type":42},"2026-03-09",{"date":111,"type":42},"2026-01-14",{"date":113,"type":23},"2028-12-31",{"name":115,"class":49},"Shehzad Basaria, M.D.",{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":58,"minAge":59,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":24,"phases":126,"briefSummary":127,"conditions":128,"keywords":4,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":50},"100618715","men-with-prostate-cancer-optimizing-wellness-by-enhanced-relief-from-hot-flashes-with-acupuncture-100618715","NCT07335224","Men With Prostate Cancer: Optimizing Wellness by Enhanced Relief From Hot Flashes With Acupuncture","MPOWER: A Pilot Trial Among Men With Prostate Cancer: Optimizing Wellness by Enhanced Relief From Hot Flashes With Acupuncture","MPOWER","Inclusion Criteria:\n\n* Male\n* At least 18 years of age\n* Histologically or cytologically confirmed adenocarcinoma of prostate of any stage I-IV\n* Undergoing androgen deprivation therapy (ADT) and\u002For androgen receptor pathway inhibitors\n* Experiencing moderate to severe daily interference from hot flashes, as indicated by the Hot Flash Related Daily Interference Scale (score≥4)\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Able to read, understand, and provide written informed consent\n\nExclusion Criteria:\n\n* Severe or uncontrolled concurrent disease, infection or co-morbidity that, in the opinion of the Investigator, would make the patient inappropriate for enrollment\n* Known hypersensitivity to the acupuncture needles\n* Any condition that in the opinion of the Investigator would impair the patients' ability to comply with the study procedures\n* Unable to comply with study requirements\n* Use of acupuncture for hot flashes within 6 months prior to enrollment",{"count":125,"type":23},24,[26],"Prostate cancer is the most common cancer among men in the United States. Many men with prostate cancer are treated with hormone therapy, also called androgen deprivation therapy (ADT). While this treatment is effective, it often causes bothersome side effects such as hot flashes, poor sleep, fatigue, and other physical and emotional symptoms. There is currently no standard treatment to help manage these side effects in men. Acupuncture is a non-drug treatment that has been shown to help reduce hot flashes and related symptoms in women receiving hormone therapy for breast cancer. However, much less is known about whether acupuncture is helpful for men receiving hormone therapy for prostate cancer. This study will test whether an acupuncture program, combined with usual lifestyle education, is feasible and acceptable for men undergoing ADT. The study will also explore whether acupuncture may help reduce hot flashes and improve related symptoms. A total of 24 men with prostate cancer receiving ADT will be randomly assigned to one of two groups: one group will begin acupuncture right away, and the other group will begin acupuncture after a delay, with regular check-ins during the waiting period. All participants will receive standard lifestyle education. Participants will be followed for about five months and will be asked to complete daily hot flash diaries, questionnaires about their symptoms and quality of life, and wear a Fitbit to track sleep. The results of this pilot study will help determine whether a larger study should be conducted to better understand the role of acupuncture in managing hormone therapy side effects in men with prostate cancer.",[102,129,29,99,130],"Acupuncture Therapy","Prostatic Neoplasms","2026-02-02",{"date":133,"type":42},"2026-02-04",{"date":135,"type":42},"2026-01-08",{"date":137,"type":23},"2027-06-30",{"name":139,"class":49},"Inova Health Care Services",{"id":141,"slug":142,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":4,"eligibilityCriteria":146,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":147,"enrollmentInfo":148,"targetDuration":4,"studyType":24,"phases":150,"briefSummary":151,"conditions":152,"keywords":4,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":50},"100601604","efficacy-of-cl25216-on-vasomotor-symptoms-in-women-during-perimenopause-100601604","NCT07112651","Efficacy of CL25216 on Vasomotor Symptoms in Women During Perimenopause","The Effects of CL25216 on Vasomotor Symptoms in Women During Perimenopause: a Randomised, Double-blind, Placebo-controlled Study","Inclusion Criteria:\n\n* Healthy overweight women (BMI: 25-29 kg\u002Fm2) aged between 40 to 55 years with reports of changes in their menstrual cycle for at least 3 months.\n* Participants needed to have a total score of greater than 16 on the Greene Climacteric Scale (GCS), have an intact uterus and ovaries.\n* Early Perimenopausal Women according \"The Stages of Reproductive Aging Workshop (STRAW) Classification (-2)\" irregular periods without skipping menstrual cycles and more than seven days difference in length of consecutive cycles.\n* Subjects with serum FSH \\>20 U\u002FL on 3-5 days of menstrual cycle.\n* Subjects with normal pelvic TVS and breast mammogram.\n* Subjects with normal fasting blood glucose level (\\\u003C125 mg\u002Fdl).\n* Subject understands the study procedures and provides signed informed consent to participate in the study.\n* Subjects with normal blood thyroid profile.\n* Females of childbearing potential who are sexually active must agree to use adequate contraception and can neither be pregnant nor lactating from screening throughout the duration of the study.\n* Clinical screening including vital signs, electrocardiogram (ECG) and laboratory evaluations (including clinical chemistry, haematology, and complete urinalysis) within the reference range for the testing laboratory or the results are deemed not clinically significant for inclusion into this study by the investigator.\n\nExclusion Criteria:\n\n* History of cerebrovascular disease, thrombo-embolic disorders, heart attack, or angina at any time or thrombophlebitis within the last 5 years, on anti-coagulant or anti-platelet drugs daily for any conditions.\n* Subjects who had received hormonal treatment or any other herbal products in the previous 6 months.\n* Subjects underwent treatment for COVID 19 within last 3 months or tested positive during the study will be excluded.\n* Subjects diagnosed with ovarian cysts ≥ 4 cm or any underlying pathology in pelvic ultrasonography (USG) performed during screening.\n* Chronic or acute life stressors relating to a major life change, experiencing depression and\u002For receiving medication for such illness or disorders, receiving statins or other drugs known to impact on steroid hormone levels.\n* Subjects having active gall bladder disease, gynaecological or breast surgery in the last 6 months.\n* History of breast, endometrial, other gynaecological cancer at any time or other cancer within the last 5 years.\n* Subjects with abnormal ECG.\n* Pregnant and breast feeding female.\n* History of hypersensitivity reactions attributed to investigational product (IP) or its components or related products.\n* Donation\u002Floss of blood 1 unit or 350 mL within 90 days prior to receiving the first dose of study medication.\n* Use of any recreational drugs (cocaine, amphetamine, barbiturates, benzodiazepines, cannabinoids, and morphine).\n* History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment, or compliance with the protocol.\n* Participated in a clinical study with an investigational drug or biologic within the last 30 days.\n* Any condition that in opinion of the investigator, does not justify the subjects\" participation in the study.\n* Subjects with a high blood pressure at screening (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥ 100 mmHg).\n* Subjects with progressive systemic diseases (e.g. tuberculosis, leucosis, collagenosis, multiple sclerosis, AIDS, HIV infections, Hepatitis B surface antigen or Hepatitis C virus (HCV) antibodies or other auto-immune diseases).\n* Evidence or history of clinically significant (in the judgment of the Investigator) haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies, hypothyroidism.\n* High alcohol intake (\\>2 standard drinks per day), smokers (\\>5 cigarettes per day).","55 Years",{"count":149,"type":23},80,[26],"This study is to evaluate the effects of CL25216 on vasomotor symptoms in women during Perimenopause. Enrolled subjects will receive either CL25216 - 250 mg\u002Fday or placebo.",[29],"2025-11-28",{"date":155,"type":42},"2025-12-05",{"date":157,"type":23},"2025-11-24",{"date":159,"type":23},"2026-06-12",{"name":161,"class":162},"ApexCPG LLC","INDUSTRY",{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":4,"eligibilityCriteria":169,"healthyVolunteers":17,"sex":18,"minAge":170,"maxAge":171,"enrollmentInfo":172,"targetDuration":4,"studyType":24,"phases":174,"briefSummary":175,"conditions":176,"keywords":182,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":50},"100611276","jds-hf30-supplementation-on-menopause-related-quality-of-life-outcomes-in-postmenopausal-women-100611276","NCT07238478","JDS-HF3.0 Supplementation on Menopause Related Quality of Life Outcomes in Postmenopausal Women","Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of JDS-HF3.0 in Menopause Related Quality of Life Outcomes in Postmenopausal Women","Inclusion Criteria:\n\n1. Healthy biological females who are 50-70 years of age (inclusive).\n2. Have a body mass index (BMI) between 18.5 to 34.9 kg\u002Fm2 (inclusive).\n3. Self-reported as postmenopause. Defined as 12 months without a menstrual cycle in individuals who undergo \"Natural\" Menopause (Not Surgically or medically induced) and who have self-reported menopausal outcomes for the past 6 months.\n4. Have self-reported menopause related joint outcomes of moderate or severe severity according to a perceived discomfort greater or equal to 5 and less than 10 on a scale of 0-10 (participants rating their discomfort 5-9 will be included).\n5. Have self-reported \\> or equal to 4 hot flashes on average per day.\n6. In good general health (no active or uncontrolled diseases or conditions) and able to consume the study product.\n7. Agree to refrain from treatments listed in Section 6.5 in the defined timeframe.\n8. Have reliable, stable access to Wi-Fi and a smart phone\u002Fdevice.\n9. Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, be able to understand and read questionnaires, and carry out all study-related procedures.\n\nExclusion Criteria:\n\n1. Individuals who are lactating, pregnant, or planning to become pregnant during the study.\n2. Active participation in a clinical trial.\n3. Use of any treatment for menopausal outcomes or other concomitant treatments for menopausal symptoms, joint health or at the discretion of the investigator. (Participants may be deemed ineligible at the discretion of the investigator if the medication may cause adverse interaction.)\n4. Have a known sensitivity, intolerability, or allergy to any of the study product or their excipients.\n5. Use of Glucosamine and\u002For Chondroitin for joint outcomes in the last 3 months prior to screening.\n6. Received a COVID-19 vaccine in the 2 weeks prior to screening or during the study period, current COVID-19 infections or currently have the post-COVID-19 condition as defined by World Health Organization (WHO) (i.e., individuals with a history of probable or confirmed SARS-CoV-2 infection, usually 3 months from the onset of COVID-19 with symptoms that last for at least two months and cannot be explained by an alternative diagnosis).\n7. Have a positive medical history of heart disease, renal disease, hepatic impairment, or active systemic infection (i.e., Lyme disease, TB, HIV).\n8. History of cancer (except localized skin cancer without metastases) within two (2) years prior to screening.\n9. History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the potential subject at risk because of participation in the study or influence the results or the potential subject's ability to participate in the study.\n10. History or presence of gastrointestinal, hepatic, or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs (i.e., Crohn's disease, short bowel, acute or chronic pancreatitis, gastric bypass procedures, or pancreatic insufficiency).\n11. Participant has an abnormality or obstruction of the gastrointestinal tract precluding swallowing (e.g., dysphagia) and digestion (e.g., known intestinal malabsorption, celiac disease, inflammatory bowel disease, chronic pancreatitis, steatorrhea).\n12. Major surgery in three months prior to screening or planned major surgery during the study.\n13. History of alcohol or substance abuse in the last 5 years.\n14. Has evidence of inflammatory rheumatic disease or other diagnosed anti-inflammatory disease.\n15. Has evidence of autoimmune disease(s).\n16. Chronic use of curcumin or curcuminoids in an herbal or dietary supplement. Note: Screened participants that are willing to undergo a washout period of at least 3 months prior to participation in the trial can be enrolled.\n17. Chronic pain medication and use of analgesics specifically for joint-related discomfort (i.e. Opiates, Tramadol) Note: Screened participants that are willing to undergo a washout period of at least 2 weeks during the duration of the trial can be enrolled.\n18. Have severe joint and\u002For severe bone deformities.\n19. Diagnosed bone fractures.\n20. Are a candidate for surgical joint replacement.","50 Years","70 Years",{"count":173,"type":23},250,[26],"The goal of this interventional study is to evaluate whether the study product can help improve quality of life and reduce common menopause symptoms-such as joint discomfort, hot flashes and night sweats-in women aged 50-70. The primary research question is whether taking the study product daily for 12 weeks can reduce the severity and frequency of menopause-related symptoms.",[177,178,179,102,180,181,29],"Joint Discomfort","Joint Pain, Stiffness, Function","Joint Pain","Hot Flash","Night Sweats",[183,184,29,185,102,179,177,186,187],"Postmenopausal","Post menopause","Night sweats","Non-hormonal Treatment","Supplement","2025-11-18",{"date":190,"type":42},"2025-11-20",{"date":192,"type":42},"2025-05-14",{"date":194,"type":23},"2026-10",{"name":196,"class":162},"Bonafide Health",{"id":198,"slug":199,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":204,"enrollmentInfo":205,"targetDuration":4,"studyType":24,"phases":207,"briefSummary":208,"conditions":209,"keywords":210,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":50},"100596212","phase-2-safety-and-efficacy-of-asimadoline-tp0052-in-patients-with-vasomotor-symptoms-vms-100596212","NCT07042516","Safety and Efficacy of Asimadoline (TP0052) in Patients With Vasomotor Symptoms (VMS).","Safety and Efficacy of Asimadoline (TP0052), a Peripherally Restricted Selective Kappa Agonist, for the Treatment of Moderate to Severe Menopausal Symptoms in Midlife Women.","Inclusion Criteria\n\n* Females aged 40-62 years.\n* Untreated patients (either newly diagnosed with VMS or those with a history of VMS but have not been taking drugs that could have an effect on VMS (e.g., SSRIs, SNRIs, gabapentin, pregabalin, clonidine).\n* Menopausal OR late perimenopausal according to the following criteria:\n\nCriteria for Menopause:\n\n* Women who have had a bi-lateral oophorectomy (\\> 6 weeks prior); OR\n* Women with a uterus who have had no vaginal bleeding the past 12 months; OR\n* Women without a uterus (or women with a uterus who have either a levonorgestrel intrauterine device \\[LNG IUD\\] or who have had an endometrial ablation) and who still have one or both ovaries, with follicle stimulating hormone (FSH) level \\> 40 mIU\u002FmL and estradiol ≤ 50 pg\u002FmL (on at least one of two blood draws two weeks apart);\n\nCriteria for Late Perimenopause:\n\n* Women with a uterus who have had consecutive intervals of amenorrhea of at least 60 days for three or more cycles (i.e., three consecutive episodes of vaginal bleeding separated by 60 or more days between vaginal bleeding episodes).\n\n  • At least 40 moderate to severe VMS per week for each of the 2 screening weeks, as reported on daily VMS diaries.\n* Including at least 6 moderate to severe VMS per day on 4 or more days in each of the 2 screening weeks.\n* VMS frequency in week 2 cannot drop by more than 50% from the average weekly level reported during week 1.\n\n  * In general good health as determined by medical history, blood pressure, and heart rate.\n  * Signed informed consent.\n\nExclusion Criteria\n\n* • Use of hormone therapy or hormonal contraceptives (with the exception of the LNG IUD) during the 8 weeks before Screening Visit 1. Use of low-dose vaginal estrogen therapies is allowed, with the exception of vaginal creams used \\>3 times a week.\n* Use of non-hormonal medications that can influence VMS during the 4 weeks before Screening Visit 1, including selective serotonin reuptake inhibitors (SSRIs), selective serotonin-norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin, and clonidine.\n* Use of marijuana or cannabis-derived products (including THC or CBD in any form other than topical, including smoked, vaporized, or edible) that can affect central thermoregulatory processes, mood and perception of VMS, and potentially have pharmacodynamic interactions with the asimadoline during the 4 weeks before Screening Visit 1 as determined by interview and urine drug test.\n* Use of supplements or herbal therapies that can affect VMS including black cohosh, red clover, dong quai, evening primrose oil, maca, ginseng, chasteberry, milk thistle, and phytoestrogens during the 4 weeks before Screening Visit 1.\n* Any current severe or unstable medical illness, including the following:\n\n  * Hypertension of stage 2 or greater (systolic blood pressure ≥ 140 or diastolic blood pressure ≥ 90)\n  * Resting heart rate \\>100.\n  * Current cancer diagnosis, except non-melanoma skin cancer, or any findings suggestive of or indicating breast malignancy.\n  * Current abnormal Pap smear, breast exam, or mammogram.\n  * Coronary artery disease, or cerebrovascular disease.\n  * Moderate to severe substance use disorder in the previous 12 months; suicide attempt in the previous 36 months, any major depressive episode within the previous 12 months, or lifetime diagnosis of psychosis or bipolar disorder.\n* Pregnancy, intending pregnancy, breast feeding.\n* Current participation in another drug trial or intervention study.\n* Inability or unwillingness to complete the study procedures.\n\nTrial-Specific Exclusion Criteria:\n\n* Known hypersensitivity to asimadoline TP0052.\n* Chronic liver or renal disease, or uncontrolled seizure disorder.\n* Use of medications or supplements that act as an inhibitor of P-glycoprotein or as a P-glycoprotein substrate during the 4 weeks prior to Screening Visit 1, including cyclosporine, non-topical ketoconazole, verapamil, digoxin, colchicine, sitagliptin).\n* Blood test results indicating:\n\n  * Liver function tests: AST ≥2 times upper limit of normal; ALT ≥2 times upper limit of normal; total bilirubin ≥ 1.5 times upper limit of normal\n  * Kidney function test: estimated glomerular filtration rate (eGFR) \\\u003C 60 mL\u002Fmin\u002F1.73 m²\n  * Blood count: hematocrit \\\u003C30%.","62 Years",{"count":206,"type":23},120,[63],"This Randomized Clinical Trial entitled Safety and Efficacy of a Peripherally Restricted Selective Kappa Agonist for Moderate to Severe Menopausal Symptoms in Midlife Women is a Phase 2a randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of asimadoline TP0052 for the treatment of moderate to severe menopausal vasomotor symptoms (VMS). The design includes: 2 weeks of daily recording of VMS prior to drug treatment; 8 weeks of double-blind treatment with the peripherally restricted kappa agonist (PRKA), asimadoline TP0052, or placebo; and a safety telephone follow-up post-treatment; after the initial 8-week double-blinded follow-up, all patients undergo treatment with Asimadoline in an open label format for 4 weeks.",[29],[211,212,213,214,215,216],"vasomotor symptoms","VMS","asimadoline","perimenopausal","postmenopausal","hot flashes","2025-09-02",{"date":219,"type":42},"2025-09-09",{"date":221,"type":42},"2025-08-13",{"date":223,"type":23},"2027-02-20",{"name":225,"class":162},"Tioga Pharmaceuticals"]