LH, FHS, Estradiol and Progesterone Activity During the 7-Day Hormone-Free Interval of Various Combined Oral Contraceptive Regimens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Follicle-stimulating Hormone
研究概览
简要总结
The degree of suppression and subsequent activation of the hypothalamic-pituitary-ovarian axis during the hormone-free interval in combined oral contraceptive (COC) hormone users varies depending on the dose of ethinyl estradiol in the formulation. This variation in activation may be associated with different side effects during the hormone free interval. Progesterone (P) remained suppressed during all 6 COC regimens (<1.8 ng/mL), which indicates continuous contraceptive efficacy during the 7-day hormone free interval of all formulations studied.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy, reproductive age women
- •18 to 35 years old,
- •seeking contraception from the general gynecology clinics of the LAC and USC Medical Center w
- •taking one of 6 possible monophasic COC formulations for at least 3 cycles prior to enrollment
- •regular menstrual cycles prior to COCs
排除标准
- •Irregular bleeding
- •bilateral oophorectomy
- •amenorrhea
- •hormone-sensitive cancer
- •concurrent medications known to interfere with steroid metabolism (i.e., barbiturates, phenytoin, carbamazepine, ethosuximide, primidone, rifampin, tetracycline)
研究组 & 干预措施
Healthy reproductive age women
These volunteers were previously taking the oral contraceptives of interest for a minimum of 3 months
干预措施: combined oral contraceptives (Drug)
结局指标
主要结局
Follicle-stimulating Hormone
时间窗: Serum blood samples were collected for hormone measurements at the same time daily during the 7 day hormone free interval.
mean FSH on day 7 of the pill free interval
次要结局
未报告次要终点
研究者
Frank Stanczyk
Professor
University of Southern California