A Prospective, Single-Center, Open-Label, Randomized Study to Evaluate Suppression of the Pituitary-Ovarian Axis With Three Different Regimens of Oral Contraceptive Pills
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Compare differences in hormone patterns (follicle stimulating hormone [FSH], luteinizing hormone [LH], inhibin-B, and estradiol)
研究概览
简要总结
This is a randomized, open-label study to evaluate pituitary ovarian suppression in healthy, reproductive-aged women using three different regimens of oral contraceptives (OCs). Two extended regimen OCs, Seasonale (levonorgestrel/ethinyl estradiol 0.15/0.03 mg for 84 days followed by 7 days of placebo), and Seasonique (levonorgestrel/ethinyl estradiol 0.15/0.03 mg for 84 days followed by 7 days of ethinyl estradiol 0.01 mg), and a 28-day regimen OC, Portia (levonorgestrel/ethinyl estradiol 0.15/0.03 mg for 21 days followed by 7 days of placebo).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Not pregnant or breastfeeding
- •Weight <200 lbs
- •Currently taking oral contraceptives in the standard 28-day regimen for at least two months
排除标准
- •Any contraindication to the use of oral contraceptives
- •Pregnancy within the last 3 months
- •Smoking > 10 cigarettes per day
研究组 & 干预措施
1
干预措施: Seasonique (LNG/EE and EE) (Drug)
2
干预措施: Seasonale [levonorgestrel (LNG)/ethinyl estradiol (EE)] (Drug)
3
干预措施: Portia (LNG/EE) (Drug)
结局指标
主要结局
Compare differences in hormone patterns (follicle stimulating hormone [FSH], luteinizing hormone [LH], inhibin-B, and estradiol)
时间窗: Before, during and after the 7-day hormone free interval or EE-supplemented interval
次要结局
- Compare differences in ovarian follicular development(Before, during and after the 7-day hormone free interval or EE-supplemented intervals)
- Compare the differences in hormone withdrawal symptoms(Before, during and after the 7-day hormone free interval or EE-supplemented interval)