NCT00185224已完成2 期
A Single-center, Open-label, Controlled, Randomized Study to Investigate the Impact of a Sequential Oral Contraceptive (SH T00658ID) as Compared to a Sequential Oral Contraceptive Containing Ethinylestradiol and Levonorgestrel (SH D00264A) on Plasma Lipids, Hemostatic Variables, and Carbohydrate Metabolism in Healthy Female Volunteers Aged 18-50 Years Over 7 Treatment Cycles, Including the Pharmacokinetics
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Impact on metabolic parameters (e.g. hemostatic parameters) after 6 month treatment
研究概览
简要总结
The purpose of this study is to confirm the safety of SH T00658ID with regard to plasma lipids, hemostatic variables, and carbohydrate metabolism. In addition, the pharmacokinetic parameter following the long term administration of SH T00658ID will be assessed.
详细描述
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy female volunteers between 18 and 50 years requiring contraception
排除标准
- •Pregnancy or lactation
- •Any conditions that might interfere with the outcome as well as all contraindications for OC use
研究组 & 干预措施
Arm 1
Experimental
干预措施: EV/DNG (Qlaira, BAY86-5027, SH T00658K) (Drug)
Arm 2
Active Comparator
干预措施: SH D00264A (Triquilar) (Drug)
结局指标
主要结局
Impact on metabolic parameters (e.g. hemostatic parameters) after 6 month treatment
时间窗: Baseline, Cycle 7
次要结局
- Measurement of PK parameters(Cycle 4, Cycle 7)
研究者
研究点 (1)
Loading locations...
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