NCT00318799已完成2 期
A Single-centre, Open-label, Crossover, Controlled, Randomized Study to Investigate the Impact of SH T00658ID as Compared to a Monophasic Contraceptive Containing Ethinylestradiol and Levonorgestrel (SH D01155E) on Hemostatic Parameters in 30 Healthy Female Volunteers Over 3 Treatment Cycles
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
- 29
- 试验地点
- 1
- 主要终点
- Intraindividual absolute changes from Baseline in the Parameters of thrombin and fibrin turnover
研究概览
简要总结
The aim of this study is to evaluate the impact of SH T00658ID (EV/DNG tablet) on hemostatic parameters in comparison to a reference oral contraceptive (OC) (SH D01155E) in a crossover design.
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
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy female volunteers
排除标准
- •Pregnancy or lactation
- •Any condition that might interfere with the outcome 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 T00658ID) (Drug)
Arm 2
Active Comparator
干预措施: SH D01155E (Drug)
结局指标
主要结局
Intraindividual absolute changes from Baseline in the Parameters of thrombin and fibrin turnover
时间窗: Baseline, Cycle 3 of each treatment period
次要结局
- Intraindividual absolute changes from Baseline in Pro- and anti-coagulatory parameters and the parameter of thrombin and fibrin turnover (activation marker): Prothrombin (Factor II).(Baseline, Cycle 3 of each treatment period)
- Adverse events(2 treatment periods (3 cycles each), 2 cycles whash out-period and 14 days follow-up period)
研究者
研究点 (1)
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