Clinical trialNCT05312567CompletedPhase 2Interventional

FP-101 Versus Placebo in the Treatment of Menopausal Vasomotor Symptoms

SponsorFervent PharmaceuticalsEnrollment105MenopauseVasomotor Symptoms

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This Phase II proof of concept study is designed to assess the safety and efficacy of FP-101 (60mg b.i.d.), an extended-release oral tablet product, compared to a matching placebo in the treatment of moderate-to-severe hot flashes in peri- and post-menopausal women over a period of 1-week.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Helmut H Albrecht, MD
Lumanity
Study Director
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

12 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Torrance Clinical Research Institute
Lomita, California, United States
Long Beach Clinical Trial Services
Long Beach, California, United States
Provideré Research Inc.
West Covina, California, United States
Inpatient Research Clinic
Hialeah, Florida, United States
the Angel Medical Research Corporation
Miami Lakes, Florida, United States
Suncoast Clinical Research - Pasco County
New Port Richey, Florida, United States
Cary Medical Group
Cary, North Carolina, United States
Raleigh Medical Group
Raleigh, North Carolina, United States
Clinical Research of Philadelphia
Philadelphia, Pennsylvania, United States
Coastal Carolina Research Center
North Charleston, South Carolina, United States
Discovery Clinical Trials - Stone Oak
San Antonio, Texas, United States
Icon Early Phase Services
San Antonio, Texas, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

FP-101

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 24 Mar 2021
Primary completion: 5 Apr 2023
Completion: 31 Jul 2023
Last update posted: 26 Oct 2023
Registered enrollment: 105
Registry id: NCT05312567

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.