A Phase 3, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of Levonorgestrel 90 mg and Ethinyl Estradiol 20 mg in a Continuous Daily Regimen for Oral Contraception

Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 2,000 人开始时间: 2003年2月1日最近更新: 2013年2月8日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方
入组人数: 2,000
主要终点: To evaluate safety and contraceptive efficacy

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

To evaluate the safety and contraceptive efficacy of an oral contraceptive containing a combination of LNG 90 mg/EE 20 mg in a continuous-use regimen.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Single Group
盲法: None

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 the 3-month period preceding visit 1
•Must be sexually active and at risk for becoming pregnant.

排除标准

•Planned use of any other form of birth control other than the test article.
•Depression requiring hospitalization or associated with suicidal ideation within the last 3 years.
•High blood pressure (defined as elevated sitting blood pressure: > 140/90 mm Hg).

结局指标

主要结局

To evaluate safety and contraceptive efficacy

次要结局

To evaluate the effects of this LNG/EE combination on bleeding profile, endometrial histology, hemostasis measures, hemoglobin levels, discontinuation rates, subject satisfaction, and cycle-related symptoms and work productivity at baseline.

研究者

发起方

Wyeth is now a wholly owned subsidiary of Pfizer

申办方类型

Industry

责任方

Sponsor

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