CompletedPhase 3

A Study to Assess the Safety and Tolerability of Fezolinetant in Women Seeking Treatment for Relief of Vasomotor Symptoms (VMS) Associated With Menopause

China150 participantsStarted 2020-07-30

Plain-language summary

This study is for women in menopause with hot flashes. Menopause, a normal part of aging, is the time of a woman's last period. Hot flashes can interrupt a woman's daily life. The purpose of this study is to find out how safe it is for these women to take fezolinetant long term (up to 52 weeks). To do that, the study will look at the number and severity of the "adverse events." Those are the side effects that study participants have while they are in the study. The study treatment is fezolinetant (1 tablet of fezolinetant) once a day. The study participants will take study treatment for 52 weeks. At weeks 2 and 4 and then once a month, the study participants will go the hospital or clinic for a check-up. They will be asked about medications, side effects and how they feel. Other checks will include physical exam and vital signs (heart rate, temperature and blood pressure). Blood and urine will be collected for laboratory tests. At some study visits, study participants will complete questionnaires that are about their quality of life. Study participants who still have their uterus will have 2 more tests done at the first and last study visits. One of the 2 tests is endometrial biopsy. This test involves removing a small amount of tissue from the inside lining of the uterus. The tissue is then checked under a microscope. The other test is transvaginal ultrasound. It uses sound waves to create pictures of the organs in the pelvis. The sound waves are transmitted by a probe (transducer), which is placed inside the vagina. Study participants may have a screening mammogram done at the first and/or last study visit. A mammogram is an x-ray picture of the breasts used to screen for breast cancer. Study participants who did not have this test done in the last 12 months will have it done at the first study visit. They will have it done at the last study visit if they are due for their screening mammogram and their own doctor agrees. The last check-up at the hospital or clinic will be 3 weeks after the last dose of study treatment.

Who can participate

Age range40 Years – 65 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subject has a body mass index ≥ 16 kg/m\^2 and ≤ 38 kg/m\^2 at the screening visit. * Subject confirmed as menopausal per 1 of the following criteria at the screening visit: O Subject has spontaneous amenorrhea for \>= 12 consecutive months O Spontaneous amenorrhea for ≥ 6 months with biochemical criteria of menopause (follicle-stimulating hormone \[FSH\] \> 40 International Units per Liter \[IU/L\], or O Having had bilateral oophorectomy ≥ 6 weeks prior to the screening visit (with or without hysterectomy). O FSH \> 40 IU/L if subjects received hysterectomy but still have ovary * Subject is seeking treatment for relief for VMS associated with menopause. * Subject is in good general health as determined on the basis of medical history and general physical examination, including a bimanual clinical pelvic examination and clinical breast examination devoid of relevant clinical findings, 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. * Subject has documentation of a normal/negative or no clinically significant abnormal findings on mammogram (or echo) (e.g., \<BI-RADS class 4; obtained at screening or within the prior 12 months of screening). Appropriate documentation includes a written report or an electronic report indicating normal/negative or no clinically significant abnormal findin…

What they're measuring

Number of Participants With Adverse Events

Timeframe: Up to 55 weeks

Number of Participants With Adverse Events Based on Severity

Timeframe: Up to 55 weeks

Trial details

NCT IDNCT04451226

SponsorAstellas Pharma China, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-06-13