A Study to Assess Long-term Safety of Fezolinetant Given to Japanese 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. Researchers want to find other ways to treat hot flashes.

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 confirmed as menopausal per one of the following criteria at the screening visit (visit 1):
• For a post-menopausal participant: Spontaneous amenorrhea for \>/=12 consecutive months; Spontaneous amenorrhea for \>/=6 months with biochemical criteria of menopause (follicle-stimulating hormone (FSH) \> 40 IU/L); Having had bilateral oophorectomy \>/=6 weeks prior to the screening visit (visit 1) (with or without hysterectomy); Having had hysterectomy without bilateral oophorectomy with the biochemical criteria of menopause (FSH \> 40 IU/L); or Having been confirmed to be post-menopausal in the 2693-CL-0310 study.
• For a peri-menopausal participant: Spontaneous amenorrhea for \>/=60 days but \< 6 consecutive months 2 times in the 2 most recent menstrual cycles with biochemical criteria of peri-menopause (FSH \> 25 IU/L); or Spontaneous amenorrhea for \>/=6 months but \< 12 consecutive months with biochemical criteria of peri-menopause (FSH \> 25 IU/L and ≤ 40 IU/L); Having had hysterectomy without bilateral oophorectomy with the biochemical criteria of peri-menopause (FSH \> 25 IU/L and ≤ 40 IU/L).
• Participant is seeking treatment for relief of vasomotor symptoms (VMS) associated with menopause.
• Female participant:
• Is not pregnant and at least 1 of the following conditions apply: Not a women of childbearing potential (WOCBP); WOCBP who has a negative urine pregnancy test day 1 (visit 2) and agrees to follow the contraceptive guidance from the time of informed consent through at least 21 days after final study intervention administration.
• Must not be breastfeeding or lactating starting at screening and throughout the investigational period and for 21 days after final study intervention administration.
• Must not donate ova starting at first administration of study intervention and throughout the investigational period and for 21 days after final study intervention administration

Exclusion criteria

• Participant has a history of an undiagnosed uterine bleeding within the 6 months prior to the screening visit (visit 1).
• Participant has a current malignant tumor or history (except for a participant who has not received treatment for malignant tumors for at least 5 years before informed consent acquisition and was not considered to have recurrence) of a malignant tumor except for non-metastatic basal cell carcinoma of the skin.
• 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) that could confound interpretation of the study outcome.
• Participant uses a prohibited therapy (hormone therapy, hormone replacement therapy (HRT), hormonal contraceptive, any treatment for VMS \[prescription medications, over-the-counter, or herbal/Kampo medicines\] or strong or moderate cytochrome P450 1A2 (CYP1A2) inhibitors and is not willing to wash out or discontinue use of such drugs from screening visit (visit 1) through the follow-up visit (visit 16) or it is not medically appropriate to discontinue such drugs for the duration of the study.
• Participant has been randomized/registered in a clinical trial with fezolinetant previously or had previous exposure to marketed fezolinetant elsewhere.
• Participant has a present or previous history of participation in this study.
• Participant has received any investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening visit (visit 1).
• Participant has an unacceptable result from the transvaginal ultrasound (TVU) assessment at screening (i.e., full length of endometrial cavity cannot be visualized or presence of clinically significant abnormal findings).

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 24 sites. See all sites on ClinicalTrials.gov.

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: PHASE3
• Start date: 2024-02-22
• Primary completion: 2026-03-19
• Last update posted: 2026-04-08
• First posted: 2024-01-16

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

• Number of participants with Adverse Events (AEs) (Up to Week 55)
  An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. 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 study intervention.…

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.