A Study to Find the Best Dose of Fezolinetant to Treat Hot Flashes in Women Going Through Menopause

What this trial studies

This study is for menopausal women who have hot flashes. Menopause, a normal part of life, is the time after a woman's last period. Hot flashes often occur during menopause. They can disrupt a woman's daily life.

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

• Subject has a body mass index ≥ 16 kg/m\^2 and ≤ 38 kg/m\^2 at screening visit.
• Subject 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:
• For post-menopausal subjects:
• 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)
• For peri-menopausal subjects:
• Skipped menstrual period with amenorrhea for ≥ 60 days but \< 6 consecutive months with biochemical criteria of peri-menopause (FSH \> 25 IU/L); or

Exclusion criteria

• Subject uses a prohibited therapy (strong or moderate cytochrome P450 1A2 \[CYP1A2\] inhibitors, hormone replacement therapy \[HRT\], hormonal contraceptive or any treatment for VMS \[prescription, over the counter, or herbal/Chinese medicine\]) or is not willing to wash out and discontinue use of such drugs for the full duration of study conduct or it is not medically appropriate to discontinue such drugs for the duration of the study.
• Subject has known substance abuse or alcohol addiction within 6 months of screening.
• Subject has a history of a malignant tumor except for non-metastatic basal cell carcinoma of the skin.
• Subject has uncontrolled hypertension.
• Subject has a history of severe allergy, hypersensitivity, or intolerance to drugs in general, including the IP and any of its excipients.
• For subjects with a uterus: Subject 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 abnormal finding).
• Subject has a history of an undiagnosed uterine bleeding within the previous 6 months of screening.
• Subject has a history of seizures or other convulsive disorders.

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 40 sites. See all sites on ClinicalTrials.gov.

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: PHASE2
• Start date: 2021-11-17
• Primary completion: 2022-11-11
• Last update posted: 2024-10-26
• First posted: 2021-09-05

Sponsor & contact

Lead sponsor: Astellas Pharma 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 mild, moderate and severe vasomotor symptom (VMS) (Baseline and Week 8)
  Frequency of mild, moderate or severe VMS events will be calculated as the sum of mild, moderate or 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.