Non-Hormonal pill targets hot flashes in menopause
NCT ID NCT07829653
First seen Sep 21, 2026 · Last updated Sep 21, 2026
Summary
This phase 3 trial tests whether fezolinetant 45 mg, a non-hormonal daily tablet, reduces the frequency and severity of hot flashes and night sweats in Indian women going through menopause. About 100 women will take one tablet daily for up to 12 weeks and track their symptoms with an electronic device or smartphone app. Researchers will compare symptom changes from before treatment to during treatment and check for side effects. The drug is already approved in more than 40 countries, and this study aims to confirm its effects in Indian women.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- fezolinetant, an oral non-hormonal medicine for menopausal hot flashes
- What this could lead to
- If it works, fezolinetant could offer Indian women a non-hormonal daily pill to reduce hot flashes and night sweats, adding to options already available in other countries.
- What could go wrong
- The trial is small and single-arm, so every participant receives the drug and there is no comparison group. Results in Indian women may differ from other populations, and the 12-week treatment period cannot show long-term safety or benefit.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Participant has a body mass index ≥ 17 kg/m\^2 and ≤ 38 kg/m\^2 at screening visit. * Participant must be seeking treatment or relief for VMS associated with menopause and confirmed as menopausal, defined as meeting 1 of the following criteria for natural or surgical menopause at the screening visit: * Spontaneous amenorrhea for ≥ 12 consecutive months * Spontaneous amenorrhea for ≥ 6 months with biochemical criteria of menopause (FSH \> 40 IU/L); or * Having had bilateral oophorectomy ≥ 6 weeks prior to the screening visit (with or without hysterectomy). * FSH \> 40 IU/L if participants received hysterectomy but still have an ovary/ovaries. * Within the 10 days prior to start of active treatment, participant must have a minimum average of 7 moderate to severe hot flashs (VMS) per day (data must be available for at least 7 of the last 10 days prior to treatment). * Participant is in good general health as determined on the basis of medical history and general physical examination, performed at the screening visit; hematology and biochemistry parameters, pulse rate and/or blood pressure, and ECG within the reference range for the population studied, or showing no clinically relevant deviations. * Participant has a negative urine pregnancy test at screening; this is not required for participants who have had a total hysterectomy. * Participant has a negative serology panel (i.e., negative hepatitis B surface antigen \[HBsAg\], negative hepatitis C virus antibody \[HCVAb\] and negative human immunodeficiency virus antibody \[HIVAb\] screens) at screening. * Participant agrees not to participate in another interventional study while participating in the present study. Exclusion Criteria: * Participant has known substance abuse or alcohol addiction within 6 months of screening. * Participant has a history of malignancy with the exception of at least 5 years post treatment and without known recurrence. * Participant has a current malignancy, with the exception of non-metastatic basal cell carcinoma of the skin. * Participant has a history within the last 6 months prior to screening of undiagnosed uterine bleeding. * Participant has a medical condition or chronic disease (including history of neurological \[including cognitive\], hepatic, renal, cardiovascular, gastrointestinal, pulmonary \[e.g., moderate asthma\], endocrine, or gynecological disease) or malignancy that could confound interpretation of the study outcome. * Participant has a history of suicide attempt or suicidal behavior within the last 12 months or has suicidal ideation within the last 12 months, or who is at significant risk to commit suicide. * Participant has previously been enrolled in a clinical trial with fezolinetant or other neurokinin (NK) receptor antagonists. * Participant uses a prohibited therapy (strong and moderate CYP \[cytochrome P450\] 1A2 inhibitors, systemic hormone replacement therapy \[HRT\], or hormonal contraceptive, or any treatment for VMS \[prescription, over the counter, off-label or herbal\]) or is not willing to wash-out and discontinue use of such drugs for the full duration of study conduct. * Participant has received any investigational therapy within 35 days or 5 half-lives, whichever is longer, prior to screening. * Participant has uncontrolled hypertension defined as systolic blood pressure ≥ 140 mmHg or diastolic blood pressure as ≥ 90 mmHg based on an average of 2 to 3 readings within the screening period. * Participants with a medical history of hypertension who are well controlled may be enrolled. * Participants who do not meet these criteria may be re-assessed after initiation or review of antihypertensive measures. * Participant has active liver disease, jaundice, elevated liver aminotransferases (alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\]), elevated total bilirubin (TBL) or direct bilirubin (DBL), elevated international normalized ratio (INR) or elevated alkaline phosphatase (ALP). Patients with mildly elevated ALT or AST up to 1.5 x upper limit of normal (ULN) can be enrolled if TBL are normal. Patients with mildly elevated ALP (up to 1.5 x ULN) can be enrolled if cholestatic liver disease is excluded and no cause other than fatty liver is diagnosed. Patients with Gilbert's syndrome with elevated TBL may be enrolled as long as hemolysis is ruled-out (i.e., DBL, hemoglobin and reticulocytes are normal). * Participant has creatinine \> 1.5 × ULN; or estimated glomerular filtration rate using the Modification of Diet in Renal Disease formula ≤ 30 mL/min per 1.73 m\^2 at screening. * Participant has any condition which makes the participant unsuitable for study participation. * Participant has known or suspected hypersensitivity to fezolinetant or any components of the formulation used. * Participant is unable or unwilling to complete the study procedures.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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