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

(Daylight Trial)

Recruiting at 91 trial locations

Overseen By Astellas Pharma Global Development

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: Astellas Pharma Global Development, Inc.

Must not be taking: VMS therapies

Disqualifiers: Substance abuse, Tumor history, Liver disease, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 24 weeks

453 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is for menopausal women with severe hot flashes who can't use hormone therapy. Participants will take fezolinetant to see if it helps reduce hot flashes. The study will track their symptoms using an app and involve periodic check-ups over several months.

Research Team

Executive Medical Director

Principal Investigator

Astellas Pharma Global Development, Inc.

Eligibility Criteria

Inclusion Criteria

Had bilateral oophorectomy >= 6 weeks prior to the screening visit (with or without hysterectomy)

Had hysterectomy without oophorectomy and who meets the biochemical criterion of menopause (FSH > 40 IU/L).

Participant has a negative serology panel (including hepatitis B surface antigen, hepatitis C virus antibody and human immunodeficiency virus antibody screens).

Exclusion Criteria

You have a history of severe allergic reactions or intolerance to the study drug or any of its components.

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 endometrial thickness > 8 mm on the locally read screening transvaginal ultrasound (TVU) or any clinically significant findings that that would make the participant ineligible.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive fezolinetant or placebo tablets daily for 24 weeks to assess efficacy and safety in reducing hot flashes

24 weeks

Visits at Weeks 2, 4, 8, 12, 16, 20, 24

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a final check-up at Week 27

3 weeks

1 visit (in-person) at Week 27

Treatment Details

Interventions

• Fezolinetant
• Placebo

Participant Groups

Group I: fezolinetant Experimental Treatment 1 Intervention

Participants receive fezolinetant 45 milligrams (mg) (one 30 mg tablet and one 15 mg tablet) orally once daily for 24 weeks of treatment.

Group II: placebo Placebo Group 1 Intervention

Participants receive placebo matched to fezolinetant tablets orally once daily for 24 weeks of treatment.

Fezolinetant is already approved in United States, European Union for the following indications:

Approved in United States as Veozah for:

• Moderate to severe vasomotor symptoms due to menopause

Approved in European Union as Veoza for:

• Hot flushes (vasomotor symptoms) associated with menopause

Who Is Running the Clinical Trial?

Astellas Pharma Global Development, Inc.

Lead Sponsor

Trials

204

Recruited

123,000+

Tadaaki Taniguchi

Astellas Pharma Global Development, Inc.

Chief Medical Officer

M.D., Ph.D.

Naoki Okamura

Astellas Pharma Global Development, Inc.

Chief Executive Officer

Not available