A Study of Fezolinetant to Treat Hot Flashes in Women Going Through Menopause

What this trial studies

This study is for women in menopause who have moderate to severe hot flashes. It is for women who are unable to use hormone replacement therapy (HRT). Menopause, a normal part of life, is the time after a woman's last period. Hot flashes often occur during menopause.

Conditions in scope

• Vasomotor Symptoms

Interventions

• fezolinetant (Drug) — oral
• placebo (Drug) — oral

Who can join

Women only · Ages 40 Years to 65 Years

Inclusion criteria

• Participant must be seeking treatment or relief for vasomotor symptoms (VMS) associated with menopause and confirmed as menopausal per one of the following criteria at the screening visit:
• Spontaneous amenorrhea for \>= 12 consecutive months
• Spontaneous amenorrhea for \>= 6 months with biochemical criterion of menopause (follicle-stimulating hormone \[FSH\] \> 40 IU/L)
• Had bilateral oophorectomy \>= 6 weeks prior to the screening visit (with or without hysterectomy)
• Participant has VMS and is unsuitable to receive hormone replacement therapy (HRT) (HRT contraindicated, HRT caution, HRT stoppers and HRT averse participants).
• Participant has a minimum average of 7 moderate to severe hot flash's (HFs) (VMS) per day as recorded in the electronic diary during the last 10 days prior to randomization.
• Participant is in good general health as determined on the basis of medical history, general physical examination, laboratory and other medical assessments.
• Participant has a negative serology panel (including hepatitis B surface antigen, hepatitis C virus antibody and human immunodeficiency virus antibody screens).

Exclusion criteria

• Participant uses a prohibited therapy for VMS (e.g., prescription, over-the-counter or herbal) prior to screening and for the duration of treatment with investigational product (IP).
• Participant has known documented substance abuse or alcohol addiction within 6 months of screening.
• Participant has history of a malignant tumor within the last 5 years, except for basal cell carcinoma.
• Participant has endometrial thickness \> 8 mm on the locally read screening transvaginal ultrasound (TVU) or any clinically significant findings that that would make the participant ineligible.
• Participant has history of severe allergy, hypersensitivity or intolerance to the IP and/or any of its excipients.
• Participant has a history of seizures or other convulsive disorders unless well controlled.
• Participant has a medical condition or chronic disease (including history of neurological \[including cognitive\], renal, cardiovascular, gastrointestinal, pulmonary \[e.g., moderate asthma\], endocrine or gynecological disease) or malignancy that could confound interpretation of the study outcome.
• Participant has any of the following: active liver disease, jaundice, elevated liver aminotransferases at screening (alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\]), elevated total bilirubin (TBL) or direct bilirubin (DBL) \> 1.5 × upper limit of normal (ULN), elevated International Normalized Ratio (INR) \> 1.5 (unless participant is receiving anticoagulant therapy) or elevated alkaline phosphatase (ALP). Participants with mildly elevated ALT or AST up to 1.5 × ULN can be enrolled if TBL and DBL are normal. Participants with mildly elevated ALP (up to 1.5 × ULN) can be enrolled if cholestatic liver disease is excluded and no cause other than fatty liver is diagnosed. Participants with Gilbert's syndrome with elevated TBL may be enrolled as long as DBL, hemoglobin and reticulocytes are normal.

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 69 sites. See all sites on ClinicalTrials.gov.

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: PHASE3
• Start date: 2021-11-08
• Primary completion: 2023-03-27
• Last update posted: 2024-10-26
• First posted: 2021-09-05

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 VMS from baseline at week 24 (Baseline, week 24)
  The frequency of moderate to severe VMS is the number of moderate to severe VMS per 24 hours. A daily frequency per week is derived by taking the mean of the data over 7 days. Moderate VMS is defined as sensation of heat with sweating/dampness but is able to continue activity. Severe VMS is defined as sensation of intense heat…

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.