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

What this trial studies

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).

Conditions in scope

• Hot Flashes

Interventions

• Fezolinetant (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 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 findings.
• Subject is willing to undergo a transvaginal ultrasound (TVU) to evaluate the uterus and ovaries at screening and at week 52 (end of treatment). For subjects who are withdrawn from the study prior to completion, a TVU should be collected at the early discontinuation (ED) visit. This is not required for subjects who have had a partial (supra-cervical) or full hysterectomy.

Exclusion criteria

• Subject uses a prohibited therapy (strong and moderate cytochrome P450 \[CYP\] 1A2 inhibitors, hormone replacement therapy \[HRT\], hormonal contraceptive, any treatment for VMS \[prescription, over the counter or herbal\]) or is not willing to wash out and discontinue such drugs for the full extent of the study.
• Subject has a 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, defined as systolic blood pressure \>= 140 millimeters of mercury (mmHg) or diastolic blood pressure as \>= 90 mmHg based on an average of 2 to 3 readings within the screening period.
• O Subjects with a medical history of hypertension who are well controlled may be enrolled.
• O Subjects who do not meet the criteria may, be re-assessed after initiation or review of antihypertensive measures.
• Subject has a history of severe allergy, hypersensitivity, or intolerance to drugs in general, including the study drug 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.

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 29 sites. See all sites on ClinicalTrials.gov.

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: PHASE3
• Start date: 2020-07-30
• Primary completion: 2022-06-13
• Last update posted: 2025-01-31
• First posted: 2020-06-30

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

• Number of Participants With Adverse Events (Up to 55 weeks)
  An adverse event (AE) is any untoward medical occurrence in a participant administered a study drug, and which does not necessarily have to have a causal relationship with this treatment.
• Number of Participants With Adverse Events Based on Severity (Up to 55 weeks)
  An AE is any untoward medical occurrence in a participant administered a study drug, and which does not necessarily have to have a causal relationship with this treatment.

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.