A PHASE IIA, RANDOMIZED, DOUBLE-BLIND, PLACEBO- AND ACTIVE-CONTROLLED STUDY TO EXAMINE MK6913 FOR THE TREATMENT OF VASOMOTOR SYMPTOMS IN POSTMENOPAUSAL WOME

MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 0 人开始时间: 2010年6月16日最近更新: 2023年9月4日

试验速览

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•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)

•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
•5. Patient has human immunodeficiency virus (HIV) infection and/or is being treated
•6. Patient is currently a regular user or a recent past abuser of alcohol or illicit drugs
•7. Patient has any contraindication for taking 17β-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
•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

发起方

MERCK SHARP & DOHME PERU S.R.L.,