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

NCT05312567 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2023-10-26

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

FP-101

daily oral tablet administration (b.i.d.)

Sponsors & Collaborators

  • ICON plc

    collaborator INDUSTRY

  • Fervent Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Helmut H Albrecht, MD · Lumanity

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
46 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-24
Primary Completion
2023-04-05
Completion
2023-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05312567 on ClinicalTrials.gov