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

NCT01015677 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2018-08-31

Study results available
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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

DRUG

MK-6913

DRUG

17-β estradiol

DRUG

Placebo to MK-6913

DRUG

Placebo to 17-β estradiol

DRUG

MK-6913 25 mg

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-17
Primary Completion
2010-07-30
Completion
2010-07-30

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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 NCT01015677 on ClinicalTrials.gov