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Selective Estrogen Receptor Modulator

fezolinetant for Hot Flashes (Daylight Trial)

Phase 3
Waitlist Available
Research Sponsored by Astellas Pharma Global Development, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, weeks 1, 4, 8, 12, 16, 20 and 24
Awards & highlights
Pivotal Trial

Summary

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.

Eligible Conditions
  • Hot Flashes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, weeks 1, 4, 8, 12, 16, 20 and 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, weeks 1, 4, 8, 12, 16, 20 and 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean change in the frequency of moderate to severe VMS from baseline at week 24
Secondary study objectives
Mean change in severity of moderate to severe VMS from baseline at weeks 1, 4, 8, 12, 16 and 20
Mean change in the frequency of moderate to severe VMS from baseline at weeks 1, 4, 8, 12, 16 and 20
Mean change in the patient-reported sleep disturbance by the Patient-reported Outcomes Measurement Information System Sleep Disturbance - Short Form 8b (PROMIS SD SF 8b total score) from baseline at week 24
+6 more

Side effects data

From 2022 Phase 3 trial • 1831 Patients • NCT04003389
9%
Headache
5%
COVID-19
100%
80%
60%
40%
20%
0%
Study treatment Arm
Fezolinetant 45 mg
Placebo
Fezolinetant 30 mg

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: fezolinetantExperimental Treatment1 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: placeboPlacebo Group1 Intervention
Participants receive placebo matched to fezolinetant tablets orally once daily for 24 weeks of treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
fezolinetant
2020
Completed Phase 3
~2880

Find a Location

Who is running the clinical trial?

Astellas Pharma Global Development, Inc.Lead Sponsor
199 Previous Clinical Trials
121,901 Total Patients Enrolled
6 Trials studying Hot Flashes
4,755 Patients Enrolled for Hot Flashes
Executive Medical DirectorStudy DirectorAstellas Pharma Global Development, Inc.
25 Previous Clinical Trials
7,799 Total Patients Enrolled
3 Trials studying Hot Flashes
2,859 Patients Enrolled for Hot Flashes
~116 spots leftby Oct 2025
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