EUCTR2009-016070-33-FR进行中（未招募）1 期
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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 260
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •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
排除标准
- •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
研究者
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