A Study to Find Out How Safe Long-term Treatment With Fezolinetant is in Women With Hot Flashes Going Through Menopause

What this trial studies

This study was for women in menopause with hot flashes. Menopause, a normal part of aging, was the time of a woman's last period. Hot flashes can interrupt a woman's daily life. The purpose of this study was to find out how safe it is for these women to take fezolinetant in long term (up to 52 weeks).

Conditions in scope

• Hot Flashes

Interventions

• fezolinetant (Drug) — administered orally
• placebo (Drug) — administered orally

Who can join

Women only · Ages 40 Years to 65 Years

Inclusion criteria

• Subject has a body mass index ≥ 18 kg/m\^2 and ≤ 38 kg/m\^2.
• 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:
• Spontaneous amenorrhea for ≥ 12 consecutive months
• Spontaneous amenorrhea for ≥ 6 months with biochemical criteria of menopause (follicle stimulating hormone \> 40 IU/L), or
• Having had bilateral oophorectomy ≥ 6 weeks prior to the screening visit.
• 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 mammogram findings (obtained at screening or within the prior 12 months of study enrollment). Appropriate documentation includes a written report or an electronic report indicating normal/negative or no clinically significant mammographic findings.

Exclusion criteria

• Subject uses a prohibited therapy (strong or 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 previous or current history of a malignant tumor, except for basal cell carcinoma.
• Subject's systolic blood pressure is ≥ 130 mmHg or diastolic blood pressure is ≥ 80 mmHg based on the average of 2 to 3 readings, on at least 2 different occasions within the screening period.
• Subjects who do not meet these criteria may be re-assessed after initiation or review of antihypertensive measures.
• Subjects with a medical history of hypertension can be enrolled once they are medically clear (stable and compliant).
• Subject has a history of severe allergy, hypersensitivity or intolerance to drugs in general, including the study drug and any of its excipients.
• 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 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 182 sites. See all sites on ClinicalTrials.gov.

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: PHASE3
• Start date: 2019-07-10
• Primary completion: 2022-01-04
• Last update posted: 2024-11-05
• First posted: 2019-07-01

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

• Number of Participants With Treatment Emergent Adverse Events (TEAEs) (From first dose of study drug until 21 days after last dose of study drug (Up to 55 weeks))
  An AE is any untoward medical occurrence in a participant administered a study drug, \& which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable \& unintended sign, symptom, or disease temporally associated with the use of medicinal product (MP) whether or not considered related to MP. An AE is…
• Number of Participants With Mild, Moderate and Severe TEAE (From first dose of study drug until 21 days after last dose of study drug (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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product…
• Percentage of Participants With Endometrial Hyperplasia (Baseline Up to 52 weeks)
  Endometrial hyperplasia was confirmed from the endometrial biopsy report.
• Percentage of Participants With Endometrial Cancer (Baseline Up to 52 weeks)
  Endometrial cancer was confirmed from the endometrial biopsy report.

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.