EUCTR2009-017288-40-NL进行中（未招募）不适用
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 (Protocol No. P06447)
Schering-Plough Research Institute, a Division of Schering Corporation0 个研究点开始时间: 2010年1月13日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1. Each subject must be female and in good physical and mental health;
- •2. Each subject must be >=18 to <=50 years of age at screening;
- •3. Each subject must have a body mass index >=17 and <=29 kg/m2.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Any contraindication for contraceptive steroids;
- •2. An abnormal cervical smear (ie, dysplasia, cervical intraepithelial neoplasia (CIN), squamous intraepithelial lesion (SIL), carcinoma in situ, invasive carcinoma) at screening or documentation of an abnormal smear performed within 6 months prior to screening;
- •3. Present use or use within 2 months prior to screening of any other 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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