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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.
Awards & highlights

Study Summary

This trial is designed to see if FP-101 is a safe and effective treatment for moderate to severe hot flashes in peri- and post-menopausal women.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in the frequency (average daily number) of moderate-to-severe hot flashes.
Secondary outcome measures
Change in nighttime awakenings (average daily number) with or without night sweats.
Hot flushes
Therapeutic procedure
Other outcome measures
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
80 Previous Clinical Trials
25,041 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

Frequently Asked Questions

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

Are recruitment efforts still underway for this investigation?

"Affirmative. The clinical trial's information available on clinicaltrials.gov reveals that recruitment for this medical study, which was initially posted in March 2021, is ongoing and recruiting 100 individuals from 5 different sites."

Answered by AI

What potential risks accompany the administration of FP-101 to individuals?

"The safety profile of FP-101 was judged to be a 2 on the scale of 1 to 3, as this is only a Phase 2 trial. Therefore, while some data has been collected supporting its safety, there are no clinical results demonstrating efficacy."

Answered by AI

How many participants have been accepted into this research experiment?

"To properly conduct this trial, 100 qualified individuals are sought. Potential patients may enroll at either Cary Medical Group in North carolina or Clinical Research of Philadelphia in Pennsylvania."

Answered by AI

Where can individuals access this research investigation?

"Patients are welcome at Cary Medical Group in Cary, North carolina, Clinical Research of Philadelphia in Pennsylvania's largest city, as well as Raleigh Medical Group located in South carolina; additionally 5 other sites are participating."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
California
How old are they?
18 - 65
What site did they apply to?
Torrance Clinical Research Institute
Clinical Research of Philadelphia
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
FP-101 Versus Placebo in the Treatment of Menopausal Vasomotor Symptoms
2021. "FP-101 Versus Placebo in the Treatment of Menopausal Vasomotor Symptoms". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05312567.
~26 spots leftby Apr 2025
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