Single Center, Double Blind, Randomized, Crossover Study to Investigate the Impact of the Oral Contraceptive Yasmin (30 µg EE / 3 mg DRSP) Compared to Microgynon (30 µg / 150 LNG) on Hemostasis Parameters in 40 Female Volunteers
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 43
- 主要终点
- Pro-coagulatory parameters: Factor VIII (activity), Fibrinogen
研究概览
简要总结
The objective of this study was to investigate the impact of the oral contraceptive YASMIN (containing: drospirenone 3 mg/ethinyl estradiol 30 mcg) in comparison with the oral contraceptive MICROGYNON (containing: levonorgestrel 150 mcg/ethinyl estradiol 30mcg) on factors of blood coagulation and fibrinolysis in female subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Clinically normal safety laboratory results
排除标准
- •Standard contraindications for use of combined oral contraceptives (class label). Including:
- •Presence or history of thromboembolic process in veins (such as deep venous thrombosis, pulmonary embolism) or arteries (e.g., stroke, myocardial infarction) or a known genetic component (homozygous), venous thromboembolic event in a close relative (parents or siblings) at younger age (</= 40 years)
- •Acute and chronic severe liver dysfunction or disease. There should be an interval of at least 6 months between the subsidence of a viral hepatitis (normalization of the liver parameters) and the start of the study medication.
- •Use of preparations where experience shows affect on the activity of hepatic enzymes.
研究组 & 干预措施
Arm 1
干预措施: Yasmin (DRSP 3mg/EE 0.03 mg) (Drug)
Arm 2
干预措施: Microgynon (LNG 0.15 mg/EE 0.03 mg) (Drug)
结局指标
主要结局
Pro-coagulatory parameters: Factor VIII (activity), Fibrinogen
时间窗: At baseline and after wash out (period 2); after 7 cycles of treatment in each of the two study periods
Anti-coagulatory parameters: Protein C (activity), Antithrombin III(activity), APC resistance (factor V mutation)
时间窗: At baseline and after wash out (period 2); after 7 cycles of treatment in each of the two study periods
次要结局
- Rosing test: APC sensitivity ratio(At baseline and after wash out (period 2); after 7 cycles of treatment in each of the two study periods)
- Pro-coagulatory parameters: Factor VIII (activity), Activation markers: D-dimer, Prothrombin fragment 1+2(At baseline and after wash out (period 2); after 7 cycles of treatment in each of the two study periods)