A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Chinese Women Going Through Menopause (NCT06812754) | Clinical Trial Compass
CompletedPhase 2
A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Chinese Women Going Through Menopause
China150 participantsStarted 2025-03-10
Plain-language summary
Hot flashes are the most common reason women going through menopause seek medical attention. Hormone replacement therapy, or HRT, is most often prescribed to treat hot flashes. However, HRT can't be used by all women or for as long as may be needed.
The goal of this study is to confirm if fezolinetant helps reduce hot flashes in Chinese women going through menopause. This study will also confirm the safety of fezolinetant and how well the women cope with (tolerate) the treatment. The women will take 1 tablet of the study medicine either fezolinetant or placebo once a day for up to 12 weeks. This is decided by chance alone. The placebo looks like fezolinetant but will not have any medicine in it.
Women that want to take part in the study will be given an electronic handheld device with an app to track their hot flashes and night sweats. The women will record this information before, during and after taking the study treatment. During the study, the women will visit the study clinic several times. At each visit they will be asked if they had any medical problems. The women will have general safety checks. At some visits, a breast ultrasound (mammogram), cervical smear, and ultrasound of the womb (uterus) may be done.
The last clinic visit will be 3 weeks after the women take their final tablet of the study medicine (fezolinetant or placebo).
Who can participate
Age range
40 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participant has a body mass index \>/= 16 kg/m2 and \</= 38 kg/m2 at screening visit.
* Participant must be seeking treatment or relief for vasomotor symptom(s) (VMS) associated with menopause and confirmed as menopausal per 1 of the following criteria at the screening visit:
* Spontaneous amenorrhea for \>/= 12 consecutive months
* Spontaneous amenorrhea for \>/= 6 months with biochemical criteria of menopause (follicle-stimulating hormone (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 randomization, participant must have a minimum average of 7 moderate to severe hot flash(es) (HFs) (VMS) per day (data must be available for at least 7 of the last 10 days prior to randomization).
* 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 electrocardiogram (ECG) within the reference range for the population studied, or showing no clinically relevant deviations.
* Participant has documentation of a normal/negative or no clinically significant findings mammogram (or breast ultrasound) (e.g., \< Breast Imaging-Reporting and Data System (BI-RADS) class 4; obtained at screening or …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean change in the frequency of moderate to severe Vasomotor Symptoms (VMS) from baseline to week 12