A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Phase 2, Multi-Center, Dose-Finding Study to Evaluate the Effects of RAD1901 in the Treatment of Vasomotor Symptoms in Postmenopausal Women
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Percent Change in Composite Score Over Time
研究概览
简要总结
The purpose of this study is to determine whether RAD1901 is effective in decreasing hot flashes in postmenopausal women.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Have documented evidence of a minimum of 7 moderate to severe hot flashes per day, or 50 per week.
- •Be in good general health as determined by medical history, physical examination, and inclusion procedures and is without evidence of any clinically significant abnormalities.
- •Have a normal pelvic assessment with no clinically significant signs on examination and pelvic ultrasound.
- •Have a normal mammogram at the time of study screening.
排除标准
- •A history of chronic or recurrent renal, hepatic, pulmonary, allergic, cardiovascular, gastrointestinal, endocrine, central nervous system, hematologic, immunologic or metabolic diseases to a degree that would compromise patient safety or interfere with the interpretation of study data. A history of active presence of thrombophlebitis, thrombosis, thromboembolic disorders.
- •A history of active presence of stroke, transient ischemic attack (TIA), heart attack or ischemic heart disease.
- •Unexplained vaginal bleeding within the 3 months prior to study entry.
研究组 & 干预措施
RAD1901 10 mg
Oral once a day for 28 days
干预措施: RAD1901 (Drug)
RAD1901 25 mg
Oral once a day for 28 days
干预措施: RAD1901 (Drug)
RAD1901 50 mg
Oral once a day for 28 days
干预措施: RAD1901 (Drug)
RAD1901 100 mg
Oral once a day for 28 days
干预措施: RAD1901 (Drug)
Placebo
Oral once a day for 28 days
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change in Composite Score Over Time
时间窗: Week 4 minus baseline week
Percent change in composite score (frequency x severity) of hot flashes (Mild=1, Moderate=2, Severe=3) at 4 weeks compared to baseline, in the intent-to-treat population.
Percent Change in Frequency of Hot Flashes Over Time
时间窗: Week 4 minus baseline week
Percent change of moderate and severe hot flash frequency at 4 weeks compared to baseline using weekly Subject diary data, in the intent-to-treat population.
次要结局
- Determine the Effects of RAD1901 on Luteinizing Hormone (LH) Over Time.(Day 29 minus baseline)
- Determine the Effects of RAD1901 on Follicular Stimulating Hormone (FSH) Over Time.(Day 29 minus baseline)