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

Phase 2TerminatedNCT01015677

Merck Sharp & Dohme LLC99 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Moderate to Severe Vasomotor Symptoms in Postmenopausal Women

Interventions

MK-6913DRUG

17-β estradiolDRUG

Placebo to MK-6913DRUG

Placebo to 17-β estradiolDRUG

Eligibility

Sex: FEMALEMin age: 35 YearsMax age: 60 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Percent Change From Baseline in the Number of Weekly Moderate to Very Severe Hot Flashes (Excluding Outliers) at Week 4

Hot flashes were recorded in real time and hot flashes recorded retrospectively in the morning and evening reports in a diary day via the Hot Flash e-diary were summed to determine the total number of hot flashes over a diary day. The total number of weekly moderate or worse hot flashes were calculated as the sum of the total number of hot flashes that occur over a diary week (non-missing diary day), divided by the number of days of diary completion, and multiplied by 7 (standardized week). At least 4 non-missing diary days were required to define the total number of weekly moderate or worse hot flashes. Hot flash data was excluded for participants whose number of moderate to severe hot flashes per week were in the top 1% of number of hot flashes reported to exclude any outlier effect.

Time frame: Baseline and Week 4

Number of Participants Who Experienced at Least One or More Adverse Events (AE)

An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

Time frame: Up to 6 weeks

Number of Participants Who Discontinued Study Drug Due to an AE

An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

Time frame: Up to 4 weeks

Secondary Outcomes

Percent Change From Baseline in the Weekly Hot Flash Severity Score (Combining Severe and Very Severe Score) at Week 4

Hot flash severity score is calculated by the sum of: the number of mild hot flashes, 2 times number of moderate hot flashes, 3 times the number of severe hot flashes, and 4 times the number of very severe hot flashes. This sum was standardized to a 7-day week if there were any missing days in the e-diary. The severity of each hot flash was recorded by the Hot Flash e-diary.

Data from ClinicalTrials.gov

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