A Multinational, Multicenter, Randomized, Open-Label Study to Evaluate the Impact of DR-102 Compared to a 28-day Standard Oral Contraceptive Regimen, on Hemosatic Parameters in Healthy Women
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 293
- 试验地点
- 27
- 主要终点
- Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Prothrombin Fragment 1 + 2 Levels
研究概览
简要总结
This study is being conducted to evaluate the impact of DR-102, a 28-day oral contraceptive compared to a standard 28-day oral contraceptive regimen 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
- •Thrombophlebitis or thromboembolic disorders; known or suspected clotting disorders; thrombogenetic valvulopathies or rhythm disorders
- •Others as dictated by FDA-approved protocol
研究组 & 干预措施
Treatment I: (DR-102)
21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
干预措施: desogestrel/ethinyl estradiol and ethinyl estradiol (Drug)
Treatment II
21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
干预措施: desogestrel/ethinyl estradiol (Drug)
结局指标
主要结局
Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Prothrombin Fragment 1 + 2 Levels
时间窗: Baseline through Month 6
Normal range for this hemostatic parameter was 41 to 372 pmol/L. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.
次要结局
- Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Protein C Activity(Baseline through Month 6)
- Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Corticosteroid-Binding Globulin(Baseline through Month 6)
- Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Serum Random Total Cortisol(Baseline through Month 6)
- Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in D-Dimer(Baseline through Month 6)
- Least Squares Mean Change From Baseline Over the 6-Month Period in Protein S Total Antigen(Baseline through Month 6)
- Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Antithrombin(Baseline through Month 6)
- Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Factor VII(Baseline through Month 6)
- Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Thyroid-Stimulating Hormone (TSH)(Baseline through Month 6)
- Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Factor II Activity(Baseline through Month 6)
- Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Factor VIII(Baseline through Month 6)
- Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Sex Hormone Binding Globulin(Baseline through Month 6)
- Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Activated Partial Thromboplastin Time (APTT)-Based Activated Protein-C (APC) Resistance(Baseline through Month 6)
- Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Endogenous Thrombin Potential (EPT)-Based Activated Protein-C (APC) Resistance(Baseline through Month 6)