Oral Contraceptive Efficacy and Body Weight: Does Obesity Affect the Risk of Contraceptive Failure?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Concentrations of circulating oral contraceptives dosed in a standard cyclic fashion in obese and normal BMI cohorts
研究概览
简要总结
The purpose of the blood spot validation portion of the study is to test if measuring female hormone levels in the blood is as accurate through a finger stick, as it is by a blood draw from a vein. The purpose of the feasibility study is to evaluate ovulation occurrence in two populations of oral contraceptive users: heavier and lighter women.
详细描述
The blood spot validation portion of the study tests the hypothesis that progesterone assays from self-collected daily blood spots are equivalent to serum samples, and that the values obtained can identify women that ovulate. After validating collection methods, enrollment will begin for the feasibility portion of the study looking at thin and heavy women on birth control pills. All women in this portion of the study will take a very-low dose birth control pill that is normally available through a doctor's office. During each month of the study, women will have their blood pressure and weight recorded, and have their blood drawn twice per week or use a finger stick kit daily at home to check for the natural hormones and brain chemicals that tells if an egg develops. During the last week of each menstrual cycle (period week), women will also have their blood drawn to measure the levels of hormone found in the birth control pill. Women will also need to report in a written diary that they have taken their birth control pill for the day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •age 18 to 35
- •single baseline hematocrit ≥ 36%
- •single progesterone level of 3 ng/mL or greater during the luteal phase (days 18 to 25) in the menstrual cycle prior to treatment with OCs.
排除标准
- •any absolute contraindications to ethinyl estradiol and levonorgestrel
- •actively seeking or involved in a weight loss program (must be weight stable)
- •pregnancy, breastfeeding, or seeking pregnancy
- •diagnosis of Polycystic Ovarian Syndrome
- •recent (8 week) use of OC (patch or ring included), intrauterine, or implantable hormonal contraception
- •DepoProvera use within six months
- •current use of drugs that interfere with metabolism of sex steroids.
研究组 & 干预措施
I
10 normal weight women (BMI < 25 kg/m2)
干预措施: ethinyl estradiol / levonorgestrel (Drug)
II
10 obese women (BMI >30 kg/m2)
干预措施: ethinyl estradiol / levonorgestrel (Drug)
结局指标
主要结局
Concentrations of circulating oral contraceptives dosed in a standard cyclic fashion in obese and normal BMI cohorts
时间窗: Approximately one year
次要结局
未报告次要终点
研究者
Alison Edelman
Principal Investigator
Oregon Health and Science University
