A Multinational, Multicenter, Randomized, Open-Label Study to Evaluate the Impact of a 91-Day Extended Cycle Oral Contraceptive Regimen, Compared to Two 28-day Standard Oral Contraceptive Regimens, on Hemostatic Parameters in Healthy Women.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 265
- 试验地点
- 1
- 主要终点
- Change From Baseline to End of Month 6 in Prothrombin Fragment 1+2 Levels
研究概览
简要总结
This study is being conducted to evaluate the impact of a 91-day extended cycle oral contraceptive compared to two 28-day oral contraceptive regimens on hemostatic parameters in healthy women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Premenopausal, non-pregnant, non-lactating women age 18-40 years old
- •Body Mass Index (BMI) ≥18 kg/m² and <30 kg/m²
- •Regular spontaneous menstrual cycle
- •Others as dictated by FDA-approved protocol
排除标准
- •Any condition which contraindicates the use of combination oral contraceptives
- •Any history of, or active, deep vein thrombosis, pulmonary embolism, or arterial thromboembolic disease within one year of screening
- •Any known genetic component for thrombophilia including Factor V Leiden mutation, prothrombin mutation, protein C deficiency, protein S deficience, or antithrombin III deficiency
- •Others as dictated by FDA-approved protocol
研究组 & 干预措施
91-day Levonorgestrel Oral Contraceptive
Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
干预措施: 91-day Levonorgestrel Oral Contraceptive (Drug)
28-day Levonorgestrel Oral Contraceptive
Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
干预措施: 28-day Levonorgestrel Oral Contraceptive (Drug)
28-day Desogestrel Oral Contraceptive
Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
干预措施: 28-day Desogestrel Oral Contraceptive (Drug)
结局指标
主要结局
Change From Baseline to End of Month 6 in Prothrombin Fragment 1+2 Levels
时间窗: Baseline to Month 6
Prothrombin fragment 1+2 is a coagulation factor, released when prothrombin is cleaved by activated factor X. Elevated plasma levels of prothrombin fragment 1+2 indicate high risk of thrombosis.
次要结局
- Change From Baseline to End of Month 6 in Tissue Plasminogen Activator (t-PA)(Baseline to Month 6)
- Change From Baseline to End of Month 6 in Factor II(Baseline to Month 6)
- Change From Baseline to End of Month 6 in Factor VII(Baseline to Month 6)
- Change From Baseline to End of Month 6 in Factor VIII(Baseline to Month 6)
- Change From Baseline to End of Month 6 in D-dimer(Baseline to Month 6)
- Change From Baseline to End of Month 6 in Plasmin-Antiplasmin (PAP) Complex(Baseline to Month 6)
- Change From Baseline to End of Month 6 in Activated Partial Thromboplastin Time (APTT) Based Activated Protein-C Resistance (APC)(Baseline to Month 6)
- Change From Baseline to End of Month 6 in Endogenous Thrombin Potential (EPT) Based Activated Protein-C Resistance (APC)(Baseline to Month 6)
- Change From Baseline to End of Month 6 in Fibrinogen(Baseline to Month 6)
- Change From Baseline to End of Month 6 in Plasminogen(Baseline to Month 6)
- Change From Baseline to End of Month 6 in Antithrombin(Baseline to Month 6)
- Change From Baseline to End of Month 6 in Protein C Activity(Baseline to Month 6)
- Change From Baseline to End of Month 6 in Protein C Antigen(Baseline to Month 6)
- Change From Baseline to End of Month 6 in Free Protein S(Baseline to Month 6)
- Change From Baseline to End of Month 6 in Total Protein S(Baseline to Month 6)
- Change From Baseline to End of Month 6 in Tissue Factor Pathway Inhibitor (TFPI)(Baseline to Month 6)
- Change From Baseline to End of Month 6 in Thyroid Stimulating Hormone (TSH)(Baseline top Month 6)
- Change From Baseline to End of Month 6 in Total Cortisol(Baseline to Month 6)
- Change From Baseline to End of Month 6 in Corticosteroid Binding Globulin(Baseline to Month 6)
- Change From Baseline to End of Month 6 in Sex Hormone Binding Globulin (SHBG)(Baseline to Month 6)