NL-OMON36952已完成3 期
Multi-center, open-label, randomized study to assess the safety and contraceptive efficacy of two doses (in vitro 12 µg/24 h and 16 µg/24 h) of the ultra low dose levonorgestrel contraceptive intrauterine systems (LCS) for a maximum of 3 years in women 18 to 35 years of age with an extension of the LCS16 treatment arm up to five years - LCS
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 180
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
- •has signed informed consent.;is of age between 18 and 35 years (inclusive), in good general health and requesting contraception.;has, in the opinion of the investigator, suitable general and uterine conditions for inserting the LCS.;has clinically normal safety laboratory results (i.e., inside the specified range for inclusion). ;is willing and able to attend the scheduled visits and to comply with the study procedures.;has regular menstrual cycles (length of cycle 21-35 days) (i.e., endogenous cyclicity without hormonal contraceptive use).
排除标准
- •see also section 4.1.2 e.g.:;Known or suspected pregnancy or is lactating;History of ectopic pregnancies
研究者
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