NCT03285672

FP-101 for the Treatment of Hot Flashes in Postmenopausal Women

A Phase 2, Randomized, Double-blind, Placebo Controlled, Single Dose-level, Proof-of-concept Study Evaluating FP-101 for the Treatment of Vasomotor Symptoms in Postmenopausal Women

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 109 (actual)
• Sponsor: Fervent Pharmaceuticals · Industry
• Sex: Female
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine the efficacy of FP-101 versus placebo for the treatment of hot flashes in postmenopausal women.

Detailed description

Vasomotor symptoms, commonly known as hot flashes or hot flushes, are the most common symptoms experienced by women who are perimenopausal or postmenopausal. FP-101 is postulated to mediate one of the mechanisms thought to drive hot flashes in post-menopausal women. This study will evaluate the efficacy and safety of FP-101 for the treatment of hot flashes in post-menopausal women.

Conditions

• Hot Flashes

Interventions

Type	Name	Description
DRUG	FP-101	Dose 1
DRUG	Placebo Comparator	Dose 1

Timeline

• Start date: 2018-03-26
• Primary completion: 2018-10-29
• Completion: 2018-10-29
• First posted: 2017-09-18
• Last updated: 2018-11-01

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study