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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
Participant must be seeking treatment or relief for vasomotor symptoms (VMS) associated with menopause and confirmed as menopausal per one of the following criteria at the screening visit:
Participant has VMS and is unsuitable to receive hormone replacement therapy (HRT) (HRT contraindicated, HRT caution, HRT stoppers and HRT averse participants).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to weeks 1, 4, 8, 12, 16, 20 and 24
Awards & highlights

Daylight Trial Summary

This trial is for menopausal women with moderate to severe hot flashes who are unable to use hormone replacement therapy. The study will compare the effects of fezolinetant with placebo to see if fezolinetant reduces the number and severity of hot flashes.

Eligible Conditions
  • Hot Flashes

Daylight Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are experiencing vasomotor symptoms (like hot flashes and night sweats) related to menopause and have been confirmed to be in menopause.
Select...
You have symptoms of menopause (VMS), but cannot take hormone replacement therapy (HRT) for medical reasons, or you prefer not to take HRT.

Daylight Trial Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean change in the frequency of moderate to severe Vasomotor Symptoms (VMS) from baseline to week 24
Secondary outcome measures
Mean change in the frequency of moderate to severe VMS
Mean change in the patient-reported sleep disturbance by the PROMIS SD SF 8b total score from baseline to week 24
Mean change in the severity of moderate to severe VMS
+9 more

Side effects data

From 2022 Phase 3 trial • 1831 Patients • NCT04003389
9%
Headache
6%
COVID-19
100%
80%
60%
40%
20%
0%
Study treatment Arm
Fezolinetant 30 mg
Placebo
Fezolinetant 45 mg

Daylight Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: fezolinetantExperimental Treatment1 Intervention
Participants will receive 2 tablets of fezolinetant once daily for 24 weeks.
Group II: placebo fezolinetantPlacebo Group1 Intervention
Participants will receive 2 tablets of matching placebo once daily for 24 weeks.
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
192 Previous Clinical Trials
120,574 Total Patients Enrolled
5 Trials studying Hot Flashes
4,215 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum number of people who can enroll in this clinical trial?

"That is correct. The information available on clinicaltrials.gov reveals that this trial is searching for patients as we speak. The trial was first advertised on October 25th, 2021 and has since been updated on October 8th, 2020. In total, the study needs 440 individuals from 2 different locations."

Answered by AI

Is this clinical trial available to people who are over the age of 65 years old?

"The minimum age that patients can be to enroll in this clinical trial is 40 and the maximum age is 65."

Answered by AI

Has fezolinetant undergone FDA approval process yet?

"Fezolinetant's safety is well-documented in prior studies, thus it received a score of 3."

Answered by AI

What is the previous research in this field that this study builds off of?

"Development of fezolinetant began in 2021 with the first clinical study being sponsored by Astellas Pharma Global Development, Inc. After the first study, which involved 440 participants, Phase 3 drug approval was granted. As of now, there are 2 active clinical trials involving fezolinetant taking place in 51 cities across 17 countries."

Answered by AI

What does the existing research tell us about fezolinetant?

"The first clinical trials for fezolinetant were completed in 2021 at Site DK45002. As of now, there have been 2693 completed trials. Right now, there are 2 ongoing trials; both are based in Montreal, Quebec."

Answered by AI

Who else is applying?

What state do they live in?
Iowa
Illinois
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
~133 spots leftby Mar 2025