NCT01291004已完成1 期
A Multicenter, Open-Label Study to Evaluate Ovarian Follicular Activity and Hormone Levels With the Oral Contraceptive Regimen DR-102 Compared to Two 28-day Oral Contraceptive Regimens Containing Different Synthetic Progestins
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 206
- 试验地点
- 2
- 主要终点
- Evaluation of ovarian follicular development by the Hoogland and Skouby grading scale from baseline to week 16.
研究概览
简要总结
This study is being conducted to evaluate the impact of a 28-day oral contraceptive compared to two 28-day oral contraceptive regimens containing different synthetic progestins on ovarian follicular activity and hormone levels 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 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Premenopausal, non-pregnant, non-lactating women age 18-35 years old
- •Body Mass Index (BMI) ≥18 kg/m² and <30 kg/m²
- •Regular spontaneous menstrual cycle
- •Others as dictated by Food and Drug Administration (FDA)-approved protocol
排除标准
- •Any condition which contraindicates the use of combination oral contraceptives
- •Known thrombophlebitis or thromboembolic disorders; known or suspected clotting disorders; thrombogenic valvulopathies or rhythm disorders
- •Migraine headaches with focal, neurological symptoms
- •Others as dictated by FDA-approved protocol
研究组 & 干预措施
28-day Desogestrel Oral Contraceptive
Experimental
干预措施: Desogestrel/ethinyl estradiol and ethinyl estradiol (Drug)
28-day Drospirenone Oral Contraceptive
Active Comparator
干预措施: 28-day drospirenone oral contraceptive (Drug)
28-day Levonorgestrel Oral Contraceptive
Active Comparator
干预措施: 28-day levonorgestrel oral contraceptive (Drug)
结局指标
主要结局
Evaluation of ovarian follicular development by the Hoogland and Skouby grading scale from baseline to week 16.
时间窗: 16 weeks
Change in serum Estradiol level from baseline to week 16.
时间窗: 16 weeks
Change in serum Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) levels from baseline to week 16.
时间窗: 16 weeks
Change in serum Progesterone level from baseline to week 20.
时间窗: 20 weeks
次要结局
- Change from baseline to week 15 in D-dimer.(15 weeks)
- Change from baseline to week 15 in Fibrinogen.(15 weeks)
- Change from baseline to week 15 in Plasminogen, Factor II, Factor VII, Factor VIII, Protein C, and Free and Total Protein S.(15 weeks)
- Change from baseline to week 15 in Thyroid Stimulating Hormone (TSH).(15 weeks)
- Return to ovulation rate at week 20.(Week 20)
- Change from baseline to week 15 in Prothrombin fragment 1 + 2 levels.(15 weeks)
- Change from baseline to end of week 15 in Plasmin-Antiplasmin complex(15 weeks)
- Change from baseline to week 15 in APTT and ETP based activated protein-C resistance (APC).(15 weeks)
- Change from baseline to week 15 in Tissue Plasminogen Activator (t-PA).(15 weeks)
- Change from baseline to week 15 in Antithrombin.(15 weeks)
- Change from baseline to week 15 in Total Cortisol and Corticosteroid Binding Globulin (CBG).(15 weeks)
- Change from baseline to week 15 in Tissue Factor Pathway Inhibitor (TFPI).(15 weeks)
- Change from baseline to week 15 in Sex Hormone Binding Globulin (SHBG).(15 weeks)
研究者
研究点 (2)
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