NCT00447863撤回1 期
An Open-Label, Single-Dose, Randomized, 2-Period, Crossover, Bioequivalence Study to Compare Levonorgestrel 90 mg/Ethinyl Estradiol 20 mg in 2 Dosage Forms With Different Dissolution Characteristics in Healthy, Cycling Women
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点开始时间: 2007年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 主要终点
- To assess the bioequivalence of 2 batches of LNG/EE tablets with different dissolution characteristics
研究概览
简要总结
Levonorgestrel/ethinyl estradiol (LNG/EE) is an investigational drug that is being developed as an oral contraceptive (birth control pill). The purpose of this trial is to compare different preparations of LNG/EE by assessing the way they are absorbed into the blood.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 18 to 35 years.
- •Healthy as determined by the investigator on the basis of medical history and screening evaluations.
- •Must have a history of normal menstrual cycles (24 to 34 days) for the 3-month period preceding entry into the study.
排除标准
- •Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the test article.
- •Presence, history, or family history of thrombophlebitis, thrombosis, or thromboembolitic disorders, deep vein thrombosis, pulmonary embolism, or known coagulopathy.
- •Bethesda system report of low-grade squamous intraepithelial lesion or greater for a cervical cytologic smear obtained within the last 3 months.
结局指标
主要结局
To assess the bioequivalence of 2 batches of LNG/EE tablets with different dissolution characteristics
次要结局
- To obtain additional safety and tolerability data concerning LNG/EE in healthy, cycling women
研究者
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