The state of menopause clinical trials, Q4 2026
A snapshot of every menopause, perimenopause, hot-flush and genitourinary-syndrome trial that is open or about to open, from the US registry (ClinicalTrials.gov) and the EU registry (CTIS).
Headline findings
- 281 menopause trials are open or about to open across the two registries (273 on ClinicalTrials.gov, 8 in the EU's CTIS). 61 of them are observational studies that test no treatment.
- Late-stage drug trials are rare. Only 14 open trials are at Phase 3 or Phase 2/3, against 167 interventional trials with no drug phase (behavioural, supplement, device and similar studies).
- Most menopause research is academic. Industry is the lead sponsor of 39 open trials (14%), spread across 34 companies. Only 7 of those 39 industry trials carry a drug-development phase; the rest test supplements, consumer products, devices or apps, or are observational.
- The new non-hormonal drugs are a small slice so far. 6 open interventional trials test an NK3 or NK1,3 antagonist (fezolinetant or elinzanetant), compared with 36 testing hormonal therapy, 79 behavioural or lifestyle approaches and 53 supplements.
- The US leads, Europe follows, Ireland barely features. Of the 242 open trials that list sites, 86 (36%) recruit in the US and 67 (28%) in the EU; 1 lists an Irish site.
Download: PDF versionThe 281 open trials (CSV)All figures (JSON)
1. Phase: mostly non-drug studies
Of the 220 open interventional trials, 167 have no drug phase. These test behaviour change, exercise, supplements, devices and similar approaches. 53 carry a drug-development phase, and 14 of those are at Phase 3 or Phase 2/3.
2. Country: the US leads, Europe follows, Ireland barely features
242 of the 281 open trials list at least one site. 86 recruit in the United States, 67 in at least one EU country and 13 in the United Kingdom. 76 recruit only outside the US, UK and EU. The most active EU countries are Spain (16), Italy (9), France (8), Denmark (7), Sweden (5), Germany (4).
Ireland. 1 open menopause trial lists a site in Ireland: NCT07417228 (The Impact of Concurrent Training on Women Experiencing Symptoms of Menopause, sponsor: University College Dublin). Across all 1,460 menopause records in both registries (any status, any year), 6 have ever listed an Irish site.
3. Sponsors: academic-led, with a long tail of companies
Universities, hospitals and other non-profits lead most open trials. Industry leads 39 (14%), spread across 34 companies; 29 of those companies have just one open trial. Companies with more than one open trial:
| Company (lead sponsor) | Open trials |
|---|---|
| Bayer | 2 |
| Stratpharma AG | 2 |
| SRI International | 2 |
| Astellas | 2 |
| Mucosa Innovations, S.L. | 2 |
Industry-led open trials with a drug-development phase:
| Trial | Company | Phase | Title |
|---|---|---|---|
| NCT07829653 | Astellas Pharma Inc | Phase 3 | A Study to Confirm if Fezolinetant Helps to Reduce Hot Flashes in Indian Women Going Through Menopause |
| NCT07794150 | Corium Innovations, Inc. | Phase 1 | A Study to Assess the Skin Irritation and Sensitization of Estradiol/Levonorgestrel TDS in Healthy Postmenopausal Subjects |
| NCT07762287 | Bayer | Phase 1 | Evaluation of Possible Ways the Body May Process Two Different Forms of Elinzanetant in Healthy Study Participants |
| NCT06644573 | Nyree Penn | Phase 1 | Evaluating the Efficacy and Safety of PROSOMNIA Sleep Therapy™ in Patients With Sleep Deprivation and Chronic Insomnia |
| NCT07042516 | Tioga Pharmaceuticals | Phase 2 | Safety and Efficacy of Asimadoline (TP0052) in Patients With Vasomotor Symptoms (VMS). |
| NCT07850050 | Boehringer Ingelheim | Phase 3 | SYNCHRONIZE®-HERA: A Study to Test Whether Survodutide Helps Women Who Are Living With Overweight or Obesity and Are Going Through or Have Finished Menopause, to Lose Weight |
| 2024-520234-30-00 | The Pharmaceutical Company LEK-AM Sp. Zoo., Przedsiebiorstwo Farmaceutyczne Lek-Am Sp. z o.o. | Phase 3 | A randomized, double-blind, placebo-controlled, multicenter study evaluating the effect of a 12-week DHEA combination of 20 mg and 2 mg prolonged-release melatonin on sleep quality and mood in postmenopausal women. |
For context, the industry sponsors with the most menopause records of any status on ClinicalTrials.gov are Bayer (34), Novo Nordisk A/S (16), Pfizer (13), Wyeth is now a wholly owned subsidiary of Pfizer (13), Hoffmann-La Roche (9), Warner Chilcott (8), Astellas Pharma Global Development, Inc. (8), Bonafide Health (7). Sponsor names are as registered; we group only obvious variants of one company name (for example two Astellas entities).
4. What is being tested
Each open trial is tagged by the treatments in its registry record, and a trial testing two kinds of treatment counts in both. Behavioural and lifestyle approaches (79) and supplements or herbal products (53) lead. Hormonal therapy appears in 36 open trials, and devices, apps and procedures in 33.
NK3 and NK1,3 antagonists are the first new class of non-hormonal drug for hot flushes. 6 open interventional trials test one:
| Trial | Lead sponsor | Phase | Title |
|---|---|---|---|
| NCT07606664 | Rebecca Thurston | Phase 3 | Fezolinetant and Vascular Health and Brain Health |
| NCT06975111 | University of Colorado, Denver | Phase 2/3 | Focusing on the Menopausal Transition to Improve Mid-Life Women's Health |
| NCT06917313 | Yale University | Phase 2 | FLASH-Breast: Evaluating the Efficacy of Fezolinetant in Reducing Vasomotor Symptoms in Women With Breast Cancer on Endocrine Therapy |
| NCT07077395 | Massachusetts General Hospital | Phase 2 | Finding Links Between Hot flASHes and CardioVascular Disease |
| NCT07829653 | Astellas Pharma Inc | Phase 3 | A Study to Confirm if Fezolinetant Helps to Reduce Hot Flashes in Indian Women Going Through Menopause |
| NCT07762287 | Bayer | Phase 1 | Evaluation of Possible Ways the Body May Process Two Different Forms of Elinzanetant in Healthy Study Participants |
1 further open observational studies follow women already prescribed one of these drugs (NCT07602530, Astellas Pharma Europe Ltd.).
5. Due to finish in the next 12 months
107 ongoing ClinicalTrials.gov studies (85 interventional) give an estimated primary completion date between 2026-10-21 and 2027-10-21; 18 are industry-led. These dates are sponsors' own estimates and often slip: 122 ongoing studies already list a primary completion date that has passed. The industry-led and Phase 2 or Phase 3 trials in that window:
| Trial | Title | Lead sponsor | Phase | Status | Primary completion (est.) |
|---|---|---|---|---|---|
| NCT07342400 | A Clinical Study to Assess Histological Changes From Treatment of Poly L-lactic Acid Biostimulator on Women at Various Menopausal Stages | Galderma R&D industry | N/A (non-drug) | Recruiting | 2026-11 |
| NCT07653620 | Hydration & Female Life Stages | PepsiCo Global R&D industry | N/A (non-drug) | Recruiting | 2026-11 |
| NCT07393672 | Effects of Hemp-Derived Cannabinoids on Menopause Symptoms | Washington State University | Phase 2 | Recruiting | 2026-11-10 |
| NCT07861295 | Satavari and Ashoka for Menopause (SAM) Study | Vidya USA Corporation industry | N/A (non-drug) | Recruiting | 2026-12-01 |
| NCT07611305 | ProGo Menopause Wellbeing Study | Hofseth Biocare ASA industry | N/A (non-drug) | Not yet recruiting | 2026-12 |
| NCT06962345 | Changes in the Impact of Genitourinary Syndrome of Menopause With a Novel Nonhormonal Vulvovaginal Gel Assessed by PROMs. | Mucosa Innovations, S.L. industry | N/A (non-drug) | Recruiting | 2026-12 |
| NCT07413705 | BTL-699-2 and HPM-6000UF Devices for the Improvement of Depressive Symptoms and Sexual Function Among Perimenopausal and Postmenopausal Women | BTL Industries Ltd. industry | N/A (non-drug) | Recruiting | 2026-12-11 |
| NCT06111209 | The Anabolic Effect of Testosterone on Pelvic Floor Muscles | Brigham and Women's Hospital | Phase 2 | Active, not recruiting | 2026-12-31 |
| NCT06611514 | Effect of Intravaginal Prasterone on Symptoms of Genitourinary Syndrome of Menopause (GSM) in Women in Menopause With Previous Breast Cancer | European Institute of Oncology | Phase 3 | Not yet recruiting | 2027-01-01 |
| NCT07880041 | Evaluation of the Effect of a Nutraceutical Supplement on Hair Growth and Hair Quality in Premenopausal and Menopausal Women | LycoRed Ltd. industry | N/A (non-drug) | Recruiting | 2027-01 |
| NCT07538167 | Food Trial Evaluating Fecal Abundance of SBD111 With Once-Daily Versus Twice-Daily Administration in Healthy Adults | Solarea Bio, Inc industry | N/A (non-drug) | Not yet recruiting | 2027-01 |
| NCT03916978 | Autologous PRP Intra Ovarian Infusion to Restore Ovarian Function in Menopausal Women | Genesis Athens Clinic | Phase 2/3 | Recruiting | 2027-01-30 |
| NCT04031456 | Autologous PRP Infusion May Restore Ovarian Function and May Promote Folliculogenesis in POI Patients | Genesis Athens Clinic | Phase 2/3 | Recruiting | 2027-01-30 |
| NCT05664477 | PhytoSERM to Prevent Menopause Associated Decline in Brain Metabolism and Cognition | Roberta Brinton | Phase 2 | Active, not recruiting | 2027-01-31 |
| NCT07118891 | Study Evaluating ABCL635 for Vasomotor Symptoms of Menopause | AbCellera Biologics Inc. industry | Phase 1/2 | Active, not recruiting | 2027-02 |
| NCT07762287 | Evaluation of Possible Ways the Body May Process Two Different Forms of Elinzanetant in Healthy Study Participants | Bayer industry | Phase 1 | Recruiting | 2027-02-22 |
| NCT07386249 | Exploration of the Effect of a Wheat Polar Lipid Complex on Vaginal Dryness in Healthy Postmenopausal Women | Seppic industry | N/A (non-drug) | Recruiting | 2027-03 |
| NCT06530459 | The MUSE Study for Menopausal Arthralgia | National University Hospital, Singapore | Phase 2/3 | Recruiting | 2027-04 |
| NCT07548307 | Radicle Revive™: A Study Assessing the Impact of Health and Wellness Products on Menopausal-Related Health Issues Associated Health Outcomes and Related Health Outcomes | Radicle Science industry | N/A (non-drug) | Active, not recruiting | 2027-04-07 |
| NCT07663305 | Evaluation of a Mobile Menopause Application | Endo Health GmbH industry | N/A (non-drug) | Recruiting | 2027-05 |
| NCT07794150 | A Study to Assess the Skin Irritation and Sensitization of Estradiol/Levonorgestrel TDS in Healthy Postmenopausal Subjects | Corium Innovations, Inc. industry | Phase 1 | Recruiting | 2027-05-31 |
| NCT01530373 | Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients | University of Arkansas | Phase 2 | Recruiting | 2027-07 |
| NCT07834463 | Randomized Evaluation of Natural Extract for Menopausal Wellness (RENEW) | India Glycols Ltd industry | N/A (non-drug) | Recruiting | 2027-08-31 |
| NCT07824648 | Thermoregulatory Physiology of Menopausal Hot Flashes | SRI International industry | N/A (non-drug) | Recruiting | 2027-09-15 |
Methods
Data pulled: 21 October 2026, 13:27 Irish time (UTC+1). This report is a fixed snapshot; the live menopause tracker is refreshed weekly, so its numbers will move.
- ClinicalTrials.gov (API v2,
clinicaltrials.gov/api/v2/studies): condition searchmenopause OR perimenopause OR "vasomotor symptoms" OR "hot flashes" OR "hot flushes". - EU CTIS (public search at
euclinicaltrials.eu): free-text and medical-condition searches for menopause, perimenopause, vasomotor symptoms, hot flushes and hot flashes, de-duplicated by EU CT number. CTIS holds trials under the EU Clinical Trials Regulation; older EU trials in EudraCT are not included. - Relevance filter (the same as the live tracker): a record is kept only if its conditions or title mention menopause or perimenopause, menopausal symptoms, climacteric, vasomotor symptoms, hot flushes or night sweats, or vaginal atrophy / genitourinary syndrome of menopause. Mentions of "postmenopausal" or "premenopausal" alone do not count, and male-only trials are removed (729 records removed). For this report we also removed 7 records the filter wrongly kept (fertility trials of "human menopausal gonadotropin" and one coronary "vasomotor" trial). That leaves 1,442 ClinicalTrials.gov and 18 CTIS records.
- Open means "Recruiting" or "Not yet recruiting" on ClinicalTrials.gov, and "Authorised, recruitment pending", "Authorised, recruiting" or "Ongoing, recruiting" in CTIS. Some trials are registered in both registries and may be counted twice.
- Sponsor type uses each registry's own lead-sponsor class (ClinicalTrials.gov: industry, NIH, other federal or government, network, other; CTIS: sponsor type). "Academic, hospital & non-profit" is ClinicalTrials.gov's "other" class plus CTIS hospitals, universities and patient organisations.
- Treatment types are assigned by keyword rules on the intervention names and types in each record (CTIS: product names and title). Hormonal therapy covers oestrogens, progestogens, testosterone, DHEA/prasterone, tibolone and conjugated oestrogens/bazedoxifene. "Other drugs" includes non-hormonal medicines such as SSRIs/SNRIs, oxybutynin and clonidine, and drugs used as research tools. Placebo, sham and usual-care arms are ignored. The rules are approximate; the CSV lists every trial with its tags so they can be checked.
- Countries are the site countries listed in each record; 39 open trials list no sites yet. EU means the 27 member states.
- Completion dates are the primary completion dates on ClinicalTrials.gov, usually sponsors' estimates. The CTIS public search does not give a completion date, so EU-only trials are not in section 5.
Registry records are written by trial sponsors and may be out of date. This report is information, not medical advice. If you are thinking about joining a trial, talk to your doctor and the study team. Corrections: [email protected].