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Selective Estrogen Receptor Modulator

FP-101 for Hot Flashes

Phase 2
Waitlist Available
Research Sponsored by Fervent Pharmaceuticals
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 recorded every 12 hrs over a 1-week treatment period.

Summary

This trial tests a slow-release pill called FP-101 to help women over 45 who suffer from severe hot flashes during menopause. The pill aims to reduce the frequency and severity of these hot flashes by releasing its medicine gradually.

Eligible Conditions
  • Hot Flashes
  • Menopause

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~recorded every 12 hrs over a 1-week treatment period.
This trial's timeline: 3 weeks for screening, Varies for treatment, and recorded every 12 hrs over a 1-week treatment period. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in the frequency (average daily number) of moderate-to-severe hot flashes.
Secondary study objectives
Change in nighttime awakenings (average daily number) with or without night sweats.
Hot flushes
Therapeutic procedure
Other study objectives
Any Adverse Events and Concomitant Medications

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active Treatment (FP-101)Experimental Treatment1 Intervention
White to off-white extended-release, round tablets containing FP-101.
Group II: Matching placeboPlacebo Group1 Intervention
White to off-white round tablets without the active ingredient but otherwise matching in size and appearance.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FP-101
2018
Completed Phase 2
~220

Find a Location

Who is running the clinical trial?

Fervent PharmaceuticalsLead Sponsor
1 Previous Clinical Trials
109 Total Patients Enrolled
1 Trials studying Hot Flashes
109 Patients Enrolled for Hot Flashes
ICON plcIndustry Sponsor
85 Previous Clinical Trials
28,371 Total Patients Enrolled
Helmut H Albrecht, MDStudy DirectorLumanity

Media Library

FP-101 (Selective Estrogen Receptor Modulator) Clinical Trial Eligibility Overview. Trial Name: NCT05312567 — Phase 2
Hot Flashes Research Study Groups: Active Treatment (FP-101), Matching placebo
Hot Flashes Clinical Trial 2023: FP-101 Highlights & Side Effects. Trial Name: NCT05312567 — Phase 2
FP-101 (Selective Estrogen Receptor Modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05312567 — Phase 2
~23 spots leftby Nov 2025
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