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 Wome
- Conditions
- MedDRA version: 12.1Level: LLTClassification code 10060800Term: Hot flushvasomotor symptoms (hot flashes)
- Registration Number
- EUCTR2009-016070-33-DK
- Lead Sponsor
- Merck Sharp & Dohme Corp.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 300
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
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
- Primary Outcome Measures
Name Time Method Main Objective: To assess the effect of 4 weeks of treatment with MK-6913 on percent<br>change from baseline in weekly frequency of hot flashes of moderate or greater<br>severity.<br>;Primary end point(s): At the end of the 4-week treatment period, the change in weekly hot flash frequency and severity will be compared to the baseline for each individual patient and for each study group.;Secondary Objective: To assess the effect of 4 weeks of treatment with MK-6913 on percent change from baseline in weekly hot flash severity score.<br>To assess the effect of 4 weeks of treatment with MK-6913 on reduction in FSH.<br>To assess the effect of 4 weeks of treatment with 17 ß -estradiol 1 mg versus placebo on weekly hot flash frequency and severity score.<br>To compare the effect of 4 weeks of treatment with MK-6913 versus 1 mg 17ß-estradiol on weekly hot flash frequency and severity score.<br>To assess the effect of 4 weeks of treatment with MK-6913 on serum lipid parameters.<br>
- Secondary Outcome Measures
Name Time Method