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.
- Conditions
- Vasomotor symptoms, specifically hot flushes, that are classic symptoms of estrogen withdrawal associated with menopause.MedDRA version: 12.1 Level: LLT Classification code 10020411 Term: Hot flushes menopausalMedDRA version: 12.1 Level: LLT Classification code 10020417 Term: Hot flushes, menopausalMedDRA version: 12.1 Level: LLT Classification code 10027301 Term: Menopausal hot flushes
- Registration Number
- EUCTR2009-016070-33-SE
- Lead Sponsor
- Merck Sharp & Dohme (Sweden) AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
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 (if surgically menopausal)
3. Patient had at least 6 months of spontaneous amenorrhea AND a serum FSH level
>40 mIU/mL at the time of Visit 1 OR has undergone a bilateral oophorectomy at
least 6 weeks prior to Visit 1, and a serum FSH level of >40 mIU/mL
4. Patient is not receiving hormone therapy (estrogen alone or estrogen/progestin)
5. Patient has a body mass index (BMI) of =18 and =40 kg/m2
6. Patient is generally healthy
7. Patient has had a recent normal mammogram and a normal Papanicoloau (Pap)
smear test (within 6 months of the Screening)
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
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
5. Patient has human immunodeficiency virus (HIV) infection and/or is being treated
for HIV
6. Patient is currently a regular user or a recent past abuser of alcohol or illicit drugs
7. Patient has any contraindication for taking 17ß-estradiol.
8. Patient has uncontrolled hypertension
9. Patient is currently taking medications which may reduce hot flashes (including
OTC products and herbal remedies), as well as agents listed in protocol Appendix
6.7
10. Patient is taking a statin or other lipid lowering agent, unless the patient has
been on a stable dose of the lipid lowering agent for at least 6 months
11. Patient has donated blood products within 4 weeks of signing informed consent
12. Patient was <80% compliant with e-diary completion during the 14-day placebo
run-in period
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method