NCT00161681已完成3 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Levonorgestrel 90 Mcg and Ethinyl Estradiol 20 Mcg in a Continuous Daily Regimen on Menstrual Cycle-Related Symptoms
Wyeth is now a wholly owned subsidiary of Pfizer48 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2005年7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
- 200
- 试验地点
- 48
- 主要终点
- To evaluate the efficacy of a continuous-use OC regimen containing a combination of LNG/EE in preventing moderate to severe cycle-related symptoms compared with placebo
研究概览
简要总结
The purpose of this study is to determine whether LNG/EE is effective in the treatment of menstrual cycle related symptoms.
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
- •Healthy women aged 18 to 49 years
- •Regular 21 to 35 day menstrual cycles for 3 months prior to study visit 1
- •History of menstrual cycle related symptoms as determined by the investigator.
排除标准
- •Contraindication to combination oral contraceptives
- •Depression requiring hospitalization or associated with suicidal ideation within the last 3 years
- •Use of antidepressants/anxiolytics within 10 days of screening and for the duration of the study.
结局指标
主要结局
To evaluate the efficacy of a continuous-use OC regimen containing a combination of LNG/EE in preventing moderate to severe cycle-related symptoms compared with placebo
次要结局
- To evaluate the effects of this LNG/EE regimen on work productivity and subject satisfaction in subjects with moderate to severe cycle-related symptoms at baseline compared with placebo
研究者
研究点 (48)
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