Improving Contraceptive Effectiveness in Obese Women
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- LNG Steady State at Baseline and Then Post-randomization
研究概览
简要总结
The main hypothesis for this study is that increased Body Mass Index (BMI) alters oral contraceptive metabolism in a manner which results in decreased effectiveness in obese women.
详细描述
This study is being conducted to understand how effective oral hormonal birth control (the pill) is for women with high body mass index ("BMI" - the ratio of your height and weight BMI"). Previous studies of birth control traditionally do not include women above a certain BMI number, so safety and efficacy is not clearly understood in this population, yet the pill is still widely used in women with high BMI.
Reproductive-aged, ovulatory women of obese (BMI >30 kg/m2), will be placed on oral contraceptives for 2 months, then randomized into two intervention arms for an additional 2 months. At several key time points, synthetic steroid pharmacokinetics, gonadotropins (LH, FSH) and ovarian hormone levels (estradiol, progesterone), ovarian follicular activity by ultrasound monitoring, and cervical mucus testing will be monitored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 18-35
- •BMI > 30kg/m2
- •Proof of a normal breast and pelvic exam within last 9 months
- •Self reported normal menstrual periods (24-35 days)
- •Good general health
- •In the investigator's opinion, are subject's veins suitable the repeat blood draws dictated by study protocol
- •Single progesterone level during screening visit ≥ 3ng/mL
- •Hematocrit ≥ 36%
排除标准
- •Contradictions to COCs (history of deep vein thrombosis,myocardial infection, uncontrolled hypertension, pulmonary embolus, diabetes with vascular changes, stroke, migraines with neurologic changes, breast cancer, impaired liver function, uncontrolled thyroid disease, hypersensitivity or allergy to birth control)
- •Smoker (must smoke 0 cigarettes)
- •Actively seeking/involved in a weight loss program
- •Currently pregnant/seeking pregnancy in the next 6 months
- •Currently breast-feeding
- •Past or current diagnosis of polycystic ovarian disease
- •Recent use of birth control (Depot medroxyprogesterone: 6 months, Progestin implants: 6 months, Oral contraceptives, patch or ring: 2 months, Hormone impregnated IUD: 6 months)
- •Currently taking medication that interferes with COC's (Rifampin, Carbamazepine, St. John's Wort)
研究组 & 干预措施
All participants
A low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days).
干预措施: All participants (Aviane) (Drug)
Aviane and Portia
A low dose oral contraceptive given cyclically (30mcg EE component, 21 days of active pills/cycle with a 7 day hormonal-free interval) for two cycles
干预措施: Portia (Drug)
Aviane & Aviane
A very-low dose oral contraceptive given continuously for 56 days (20mcg EE component, 28 days of active pills/cycle with no hormone free interval)
干预措施: Aviane (Drug)
结局指标
主要结局
LNG Steady State at Baseline and Then Post-randomization
时间窗: baseline (2 months) and post-randomization (4 months)
The main goal is to test whether key pharmacokinetic parameters of levonordestrel (LNG) differ between obese women taking traditionally dosed OCs versus the interventional arms (i.e. using each obese subject as their own control).
次要结局
- LNG AUC(baseline (2 months))
- EE Steady State Baseline(Baseline (2 months))
- EE Steady State After Randomization(Post-randomiziation 4 months)
研究者
Alison Edelman
Associate Professor
Oregon Health and Science University