NCT00314964已完成2 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study Evaluating PD-0299685 for Treatment of Vasomotor Symptoms Associated With Menopause
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 527
- 试验地点
- 81
- 主要终点
- Effectiveness of PD-0299685 in reducing both the frequency and severity of vasomotor symptoms, from baseline to week 4 and week 12.
研究概览
简要总结
The primary purpose of this study is to determine if PD-0299685 is effective and safe in the treatment of vasomotor symptoms (hot flashes / flushes) associated with menopause.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal as defined by 6 months of spontaneous amenorrhea with serum FSH levels >40mlU/ml and estradiol < than = 25 pg/mL or 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy and FSH levels > 40 mlU/ml and estradiol < than = 25 pg/mL
- •Women reporting at least 50 moderate to severe vasomotor symptoms per week, recorded for seven consecutive days
- •Aged 40 to 70 years
排除标准
- •No estrogen monotherapy or estrogen/progesterone containing drug products within applicable wash out period prior to screening
- •Use of SERMs, clonidine within 4 weeks of screening
- •Use of CNS active medication within 1 week of screening
- •Use of medications (SSRI; SNRI), herbal or dietary supplements, including black cohosh, soy, phytoestrogens or over the counter agent known to possibly be effective for the treatment of vasomotor symptoms, within 4 weeks of screening
- •Participation in clinical trial within 30 days
- •Significant medical or psychiatric illness within past 12 months
结局指标
主要结局
Effectiveness of PD-0299685 in reducing both the frequency and severity of vasomotor symptoms, from baseline to week 4 and week 12.
次要结局
- To assess the safety profile of PD-0299685; the benefit of PD-0299685 in quality of life measures and treatment satisfaction of PD-0299685, when compared with placebo.
研究者
研究点 (81)
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