A Phase IIa, Randomized, Double-Blind, Placebo- and Active- Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of MK-6913 for the Treatment of Vasomotor Symptoms in Postmenopausal Women. - Efficacy, Safety, and Tolerability of MK-6913

Phase 1

• Conditions: Vasomotor symptoms (hot flashes); MedDRA version: 12.1 Level: LLT Classification code 10060800 Term: Hot flush

• Registration Number: EUCTR2009-016070-33-BE
• Lead Sponsor: Merck Sharp & Dohme (Europe) Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-12-08
• Study Completion: 2010-07-30
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 300

Inclusion Criteria

1. Patient is a woman with >=50 moderate-to-very severe hot flash episodes per week.
2. Patient is postmenopausal and: is >=45 and <=60 years of age, if naturally menopausal; or >=35 and <=60 years of age, having undergone a bilateral oophorectomy, with or without hysterectomy
had at least 6 months of spontaneous amenorrhea AND a serum FSH level
>40 mIU/mL at the time of Visit 1, OR undergone a bilateral oophorectomy, with or without hysterectomy, at least 6 weeks prior to Visit 1, and a serum FSH level of 40 mIU/mL.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patient has a history of malignancy ??5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer. Patients with a
remote (> 5 year) history of malignancy should have had no evidence of disease for at least 5 years.
2. Patient has any history of breast cancer.
3. Patient has history of deep vein thrombosis (DVT), myocardial infarction (MI),
stroke, chronic liver disease, gallbladder disorder, chronic renal, cardiac and
endocrine diseases.
4. Patient has undiagnosed vaginal bleeding, or has any type of uterine endometrial
disorders.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified