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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-17

Study Completion Date

2010-07-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Moderate to Severe Vasomotor Symptoms in Postmenopausal Women

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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MK-6913 75 mg

MK-6913 75 mg capsule and matching placebo for 17β-estradiol 1 mg tablet once daily for 4 weeks (Stage 1 and Stage 2)

Group Type EXPERIMENTAL

MK-6913

Intervention Type DRUG

Placebo to 17-β estradiol

Intervention Type DRUG

17-β estradiol 1 mg

17β-estradiol 1 mg tablet and matching placebo for MK-6913 75 mg capsule once daily for 4 weeks (Stage 1 and Stage 2)

Group Type ACTIVE_COMPARATOR

17-β estradiol

Intervention Type DRUG

Placebo to MK-6913

Intervention Type DRUG

Placebo

Matching placebo for MK-6913 75 mg capsule and matching placebo for 17β-estradiol 1 mg tablet once daily for 4 weeks (Stage 1 and State 2)

Group Type PLACEBO_COMPARATOR

Placebo to MK-6913

Intervention Type DRUG

Placebo to 17-β estradiol

Intervention Type DRUG

MK-6913 25 mg

MK-6913 25 mg capsule and matching placebo for 17β-estradiol 1 mg tablet once daily for 4 weeks (Stage 2)

Group Type EXPERIMENTAL

MK-6913 25 mg

Intervention Type DRUG

Interventions

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MK-6913

Intervention Type DRUG

17-β estradiol

Intervention Type DRUG

Placebo to MK-6913

Intervention Type DRUG

Placebo to 17-β estradiol

Intervention Type DRUG

MK-6913 25 mg

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

35 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No