A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women in Asia Going Through Menopause

What this trial studies

This study is for women in menopause with moderate to severe 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 study treatments are fezolinetant (1 tablet) once a day or placebo (1 tablet) once a day.

Conditions in scope

• Hot Flashes

Interventions

• Fezolinetant (Drug) — Oral
• Placebo (Drug) — Oral

Who can join

Women only · Ages 40 Years to 65 Years

Inclusion criteria

• Participant has a body mass index ≥16 kg/m\^2 and ≤38 kg/m\^2 (extremes included) at screening visit.
• Participant must be seeking treatment or relief for vasomotor symptoms (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 ovary
• Within the 10 days prior to randomization, participant must have a minimum average of 7 to 8 moderate to severe HFs (VMS) per day, or 50 to 60 per week.
• Participant 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 electrocardiogram (ECG) within the reference range for the population studied, or showing no clinically relevant deviations.

Exclusion criteria

• Participant uses a prohibited therapy (strong and moderate cytochrome P450 1A2 \[CYP1A2\] inhibitors, hormone replacement therapy \[HRT\], hormonal contraceptive or any treatment for VMS \[prescription, over the counter, or herbal\]) or is not willing to wash out and discontinue use of such drugs for the full duration of study conduct.
• Participant has known substance abuse or alcohol addiction within 6 months of screening.
• Participant has a history of a malignant tumor, except for non-metastatic basal cell carcinoma of the skin.
• 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, at the discretion of the investigator, be re-assessed after initiation or review of antihypertensive measures.
• Participant has a history of severe allergy, hypersensitivity, or intolerance to drugs in general, including the study drug and any of its excipients.
• For Participants with a uterus: Participant has an unacceptable result from the TVU assessment at screening, i.e. full length of endometrial cavity cannot be visualized or presence of a clinically significant finding.
• For Participants with a uterus and endometrial thickness \>4mm indicated by TVU: Participant has an endometrial biopsy confirming presence of disordered proliferative endometrium, endometrial hyperplasia, endometrial cancer, or other clinically significant at screening. A biopsy with insufficient material for evaluation, or unevaluable material is acceptable provided the endometrial thickness is no greater than 8 mm.
• Participant has a history within the last 6 months of undiagnosed uterine bleeding.

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Showing the first 10 of 48 sites. See all sites on ClinicalTrials.gov.

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: PHASE3
• Start date: 2020-03-17
• Primary completion: 2022-04-20
• Last update posted: 2025-01-31
• First posted: 2020-01-21

Sponsor & contact

Lead sponsor: Astellas Pharma China, Inc. (Industry)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Mean change from baseline in the frequency of moderate to severe vasomotor symptoms (VMS) (Baseline to Week 4)
  Frequency of moderate or severe VMS events will be calculated as the sum of moderate or severe VMS events per day.
• Mean change from baseline in the frequency of moderate to severe VMS (Baseline to Week 12)
  Frequency of moderate or severe VMS events will be calculated as the sum of moderate or severe VMS events per day.
• Mean change from baseline in the severity of moderate to severe VMS (Baseline to Week 4)
  The severity of VMS will be calculated using a weighted average of VMS events.
• Mean change from baseline in the severity of moderate to severe VMS (Baseline to Week 12)
  The severity of VMS will be calculated using a weighted average of VMS events.

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.