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A Study of MK-6913 for the Treatment of Hot Flashes in Postmenopausal Women (6913-004) | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

NCT01015677•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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.

Eligibility

Age

35 - 60 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Woman with at least 50 moderate to very severe hot flash episodes per week
•Postmenopausal
•Between 45 and 60 years of age if naturally menopausal, or between 35 and 60 if she underwent a bilateral oophorectomy
•Not receiving hormone therapy
•Has had both a normal mammogram and a normal Pap test in the past 6 months
•Generally healthy

Exclusion Criteria

•A history of cancer, except for certain skin cancers
•Undiagnosed vaginal bleeding or any uterine endometrial disorder
•Currently uses tobacco products, or has used them in the last 6 months
•Has human immunodeficiency virus (HIV)

Key Dates

Start Date

December 17, 2009

Primary Completion Date

July 30, 2010

Completion Date

July 30, 2010

Last Updated

August 31, 2018

Enrollment

ACTUAL participants

Conditions

Moderate to Severe Vasomotor Symptoms in PostmenopausalWomen

Interventions

MK-6913

DRUG

17-β estradiol

DRUG

Placebo to MK-6913

DRUG

Placebo to 17-β estradiol

DRUG

MK-6913 25 mg

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 31, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Effect of Helfer Skin Tap and Cold Application on Pain and Hemodynamics During Vaccination

Ultra-early Identification of Fetal Chromosomal Characteristics From Extravillous-trophoblast Cells

Prevention of Stretch Marks in Expectant Mothers

Evaluation of the Absence of Intraoperative Bladder Catheterization in Case of Planned Cesarean Section

Role of Saline Infusion Sonohysterography in Detection of Pelvic Adhesions in Infertile Women

Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KSHN001034 in Healthy Postmenopausal Female Volunteers