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

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 2

Conditions: Women; Moderate to Severe Vasomotor Symptoms in Postmenopausal

Treatments: Drug: Placebo to MK-6913; Drug: 17-β estradiol; Drug: MK-6913; Drug: MK-6913 25 mg; Drug: Placebo to 17-β estradiol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01015677

MK-6913-004 (Other Identifier)

6913-004

Details and patient eligibility

About

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.

Enrollment: 99 patients

Sex: Female

Ages: 35 to 60 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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99 participants in 4 patient groups, including a placebo group

MK-6913 75 mg

Experimental group

Description:

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

Treatment:

Drug: MK-6913

Drug: Placebo to 17-β estradiol

17-β estradiol 1 mg

Active Comparator group

Description:

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

Treatment:

Drug: Placebo to MK-6913

Drug: 17-β estradiol

Placebo

Placebo Comparator group

Description:

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)

Treatment:

Drug: Placebo to MK-6913

Drug: Placebo to 17-β estradiol

MK-6913 25 mg

Experimental group

Description:

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

Treatment:

Drug: MK-6913 25 mg