NCT00128934已完成3 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of a Combination of Levonorgestrel and Ethinyl Estradiol in a Continuous Daily Regimen in Subjects With Premenstrual Dysphoric Disorder
Wyeth is now a wholly owned subsidiary of Pfizer83 个研究点 分布在 1 个国家目标入组 744 人开始时间: 2005年8月1日最近更新:
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试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 744
- 试验地点
- 83
- 主要终点
- Mean change in average Daily Record of Severity of Problems (DRSP) 21-item total daily score
研究概览
简要总结
The purpose of this study is to determine whether levonorgestrel (LNG)/ethinyl estradiol (EE) is effective in treating the symptoms of severe premenstrual syndrome (PMS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Generally healthy, women aged 18 to 49 years.
- •History of severe PMS symptoms over the last year, as determined by the investigator.
- •Regular 21 to 35 day menstrual cycle for 2 months prior to first study visit.
排除标准
- •Major depressive disorder requiring antidepressant treatment or hospitalization within the last 3 years.
- •Contraindication to combination oral contraceptives.
- •Use of antidepressants/anxiolytics within 10 days of screening and for the duration of the study.
- •Other exclusions apply.
结局指标
主要结局
Mean change in average Daily Record of Severity of Problems (DRSP) 21-item total daily score
次要结局
- Change from baseline in DRSP 21-item daily score based on the 5 days with the highest DRSP scores in each "estimated" treatment cycle
研究者
研究点 (83)
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