NL-OMON34789已完成3 期
A randomized, open-label, comparative, multicenter trial to compare the effects on metabolic parameters of two NOMAC-E2 batches (pivotal phase III and commercial batch) and a monophasic COC containing 150 µg LNG and 30 µg EE (Phase III, Protocol No. P06447) - P06447
Schering-Plough0 个研究点目标入组 200 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
- 200
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. Each subject must be female and in good physical and mental health;
- •2. Each subject must be between 18 and 50 years (extremes included) of age at screening;
- •3. Each subject must have a body mass index between 17and 29 kg/m2 (extremes included)
排除标准
- •1. Any contraindication for contraceptive steroids;
- •2. An abnormal cervical smear (i.e. dysplasia, cervical intraepithelial neoplasia (CIN), squamous intraepithelial lesion (SIL), carcinoma in situ, invasive carcinoma) at screening;
- •3. Present use or use within 2 months prior to screening of any hormonal treatment including sex hormones (other than contraceptives), insulin, thyroid and corticosteroid hormones (with the exception of local dermatological use)
- •4. Present use or use within 2 months prior to starting trial medication of hepatic-enzyme inducing medications that may affect the bioavailability of sex steroids, lipid-lowering drugs, or anticoagulants.
研究者
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