A Study to Assess Long-term Safety of Fezolinetant Given to Japanese Women Going Through Menopause (NCT06206421) | Clinical Trial Compass
CompletedPhase 3
A Study to Assess Long-term Safety of Fezolinetant Given to Japanese Women Going Through Menopause
Japan277 participantsStarted 2024-02-22
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.
Researchers want to find other ways to treat hot flashes. Fezolinetant is a medicine to treat hot flashes in women going through menopause. Fezolinetant is an approved medicine in the US. Further studies are needed before it is available in other regions such as Asia.
In this study fezolinetant will be used to treat hot flashes in Japanese women going through menopause. This study will confirm the safety of fezolinetant and how well the women tolerate the treatment.
Women will either take fezolinetant or a placebo. This is decided by chance alone. The placebo looks like fezolinetant but will not have any medicine in it.
The women will take 1 tablet of the study medicine (fezolinetant or the placebo) once a day for up to 52 weeks.
During the study, the women will visit their study clinic for a check-up about every 4 weeks for up to 52 weeks (1 year). At each visit they will be asked if they had any medical problems. Other checks will include a medical examination and vital signs (temperature, blood pressure and pulse). At some visits, the women will have an ECG to check their heart rhythm and some blood and urine samples will be taken for laboratory tests. During a couple of visits, women who have a womb (uterus) will also have a test called a transvaginal ultrasound. A probe is gently placed inside the vagina. Sound waves will create a picture of the organs in the pelvis. This will allow the study doctor to look more closely at the uterus and surrounding organs.
The last clinic visit will be 3 weeks after the women take their final tablet of the study medicine (fezolinetant or the 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 confirmed as menopausal per one of the following criteria at the screening visit (visit 1):
* For a post-menopausal participant: Spontaneous amenorrhea for \>/=12 consecutive months; Spontaneous amenorrhea for \>/=6 months with biochemical criteria of menopause (follicle-stimulating hormone (FSH) \> 40 IU/L); Having had bilateral oophorectomy \>/=6 weeks prior to the screening visit (visit 1) (with or without hysterectomy); Having had hysterectomy without bilateral oophorectomy with the biochemical criteria of menopause (FSH \> 40 IU/L); or Having been confirmed to be post-menopausal in the 2693-CL-0310 study.
* For a peri-menopausal participant: Spontaneous amenorrhea for \>/=60 days but \< 6 consecutive months 2 times in the 2 most recent menstrual cycles with biochemical criteria of peri-menopause (FSH \> 25 IU/L); or Spontaneous amenorrhea for \>/=6 months but \< 12 consecutive months with biochemical criteria of peri-menopause (FSH \> 25 IU/L and ≤ 40 IU/L); Having had hysterectomy without bilateral oophorectomy with the biochemical criteria of peri-menopause (FSH \> 25 IU/L and ≤ 40 IU/L).
* Participant is seeking treatment for relief of vasomotor symptoms (VMS) associated with menopause.
* Female participant:
* Is not pregnant and at least 1 of the following conditions apply: Not a women of childbearing potential (WOCBP); WOCBP who has a negative urine pregnancy test day 1 (visit 2) and agrees to follow the contraceptive guida…
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.