A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Chinese Women Going Through Menopause

What this trial studies

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.

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/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.

Exclusion criteria

• Participant has known substance abuse or alcohol addiction within 6 months of screening.
• Participant has a current malignancy, with exception of non-metastatic basal cell carcinoma of the skin.
• Participant has a history of malignancy with exceptions of at least 5 years post-treatment and without known recurrence.
• 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.
• Participant has a history within the last 6 months 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 (a response of "yes" to question 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale \[C-SSRS\]), or who is at significant risk to commit suicide at screening \[visit 1\].
• Participant has previously been enrolled in a clinical trial with fezolinetant or other neurokinin (NK) receptor antagonists.

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 26 sites. See all sites on ClinicalTrials.gov.

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: PHASE2
• Start date: 2025-03-10
• Primary completion: 2026-02-11
• Last update posted: 2026-03-19
• First posted: 2025-02-06

Sponsor & contact

Lead sponsor: Astellas Pharma Global Development, 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 in the frequency of moderate to severe Vasomotor Symptoms (VMS) from baseline to week 12 (Baseline to Week 12)
  Frequency of moderate and severe VMS events will be calculated as the sum of moderate and severe VMS events per day.

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.