NCT01015677

A Study of MK-6913 for the Treatment of Hot Flashes in Postmenopausal Women (6913-004)

A Phase IIa, Randomized, Double-Blind, Placebo- and Active-Controlled Study to Examine MK-6913 for the Treatment of Vasomotor Symptoms in Postmenopausal Women

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: Female
• Age: 35 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the safety, tolerability, and efficacy of MK-6913 for the treatment of moderate-to-very-severe vasomotor symptoms (hot flashes or hot flushes) in postmenopausal women. The primary study hypothesis is that one or more doses of MK-6913 will result in a significantly greater reduction from baseline, compared to placebo, in the number of moderate to very severe hot flashes after 4 weeks of treatment.

Conditions

• Moderate to Severe Vasomotor Symptoms in Postmenopausal
• Women

Interventions

Type	Name	Description
DRUG	MK-6913
DRUG	17-β estradiol
DRUG	Placebo to MK-6913
DRUG	Placebo to 17-β estradiol
DRUG	MK-6913 25 mg

Timeline

• Start date: 2009-12-17
• Primary completion: 2010-07-30
• Completion: 2010-07-30
• First posted: 2009-11-18
• Last updated: 2018-08-31
• Results posted: 2016-05-04