NL-OMON33166已完成3 期
Multi-center, open-label, randomized, parallel-group comparison of cycle control, bleeding pattern, lipid and carbohydrate metabolism of the transdermal contraceptive patch containing 0.55 mg ethinylestradiol and 2.1 mg gestodene (material no. 80876395) in a 21-day regimen vs. a comparator patch EVRA® (0.6 mg ethinylestradiol and 6 mg norelgestromin) in a 21-day regimen for 7 cycles in 400 women - Evaluation cyclecontrol FC Patch Low vs EVRA
Bayer Health Care AG0 个研究点目标入组 140 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Signed and dated informed consent
- •2. Healthy woman requesting contraception
- •3. Age: 18 - 35 years (inclusive); smokers must not be older than 30 years at the time of informed consent
- •4. Normal cervical smear not requiring further follow-up
- •5. History of regular cyclic menstrual periods
排除标准
- •Pregnancy or lactation, obesity (BMI> 30.0 kg/m2), hypersensitivity to any ingredient of the study drug, significant skin reaction to transdermal preparations, any diseases/conditions that can compromise the functions of the body system (resulting in altered absorption/ accumulation/ metabolism/ excretion of the study drug), any diseases/ conditions that may worsen under hormonal treatment.
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