NL-OMON34076已完成2 期
Multicenter, open-label, randomized study to evaluate inhibition of ovulation during treatment with three transdermal patch formulations containing 0.55 mg ethinylestradiol (EE) and 2.10 mg gestodene (GSD) or 0.35 mg EE and 0.67 mg GSD or 0.275 mg EE and 1.05 mg GSD in healthy young female volunteers over a period of 3 treatment cycles - Pharmacodynamic and -kinetic study of 3 transdermal EE and GSD formulations
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 110
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
- •Healthy female volunteers
- •age 18 - 35 years (smoker not older than 30 years, inclusive)
- •ovulatory pre-treatment cycle
排除标准
- •- Contraindications for use of combined (estrogen/gestodene) contraceptive (e.g. history of venous or arterial thromboembolic disease)
- •- Regular intake of medication other than Oral Contraception
- •- Clinically relevant findings (blood pressure, physical and gynecological examination, laboratory examination)
研究者
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