Oral Contraception and Ovarian Suppression in Women With Different Weights
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 226
- 试验地点
- 1
- 主要终点
- Risk of Oral Contraceptive (OC) Failure Due to Less Contraceptive-mediated Ovarian Suppression.
研究概览
简要总结
This study proposes a double blind randomized clinical trial to include normal weight and obese women who have normal ovulatory function at baseline; the investigators will randomize women to 2 widely used OCs and evaluate ovarian follicle development and circulating progesterone to assess ovarian suppression during OC use.
详细描述
There is a large gap between lowest expected failure rates of about 1.5% and typical use failure rates of about 7% per year. This gap may be due to incorrect use or to decreased oral contraceptive (OC) effectiveness in population subgroups. Recent reports suggest greater OC failure among heavier women, particularly those using the lowest doses. The prevalence of obesity in the US population has recently increased to about 23% in women aged 20-29, peak years for OC use. OC physiology and effectiveness have not been evaluated in obese women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Aged 18-35
- •Body Mass Index (BMI) 19-24.9 or 30-39.9 kg/m^2
- •Willing to take birth control pills for 3-4 months
- •Recent spontaneous pregnancy or cyclic menses
排除标准
- •Contraindications to hormonal contraceptives
- •Oophorectomy/Polycystic ovary syndrome (PCOS)
- •Taken oral contraceptives to regulate menses recently
- •Weight reduction surgery
- •Used Depo-Provera within the last 12 months
- •Pregnant or currently breastfeeding
- •Desiring pregnancy within the next 4 months
- •Unable to make study visit commitment
- •Previous participation in this study
研究组 & 干预措施
Obese group
Participants with a BMI of 30-39.9 kg/m^2
干预措施: Low dose formulation (Drug)
Normal Weight group
Participants with a BMI of 19-24.9 kg/m^2
干预措施: Low dose formulation (Drug)
Normal Weight group
Participants with a BMI of 19-24.9 kg/m^2
干预措施: High dose formulation (Drug)
Obese group
Participants with a BMI of 30-39.9 kg/m^2
干预措施: High dose formulation (Drug)
结局指标
主要结局
Risk of Oral Contraceptive (OC) Failure Due to Less Contraceptive-mediated Ovarian Suppression.
时间窗: Up to 8 biweekly visits from start of OCP therapy
Perpendicular diameter, ethinyl estradiol, and progesterone values were used to create Hoogland Scores. Hoogland Scores were used to assess ovarian suppression during OC use. The Hoogland Score comprises 6 grades (Because of small numbers, grades 5 and 6 were combined): 1. no activity 2. potential activity 3. nonactive follicle-like structure 4. active follicle-like structure 5. luteinized unruptured follicle 6. ovulation Each participant received a score from 1-6 to indicate the level of ovarian suppression; total number of participants were tallied for each Hoogland score.
次要结局
- Pharmacokinetics of 15 Obese Weight and 15 Normal Weight Women on Combined Oral Contraceptives.(24 hours during week 3 of follow-up cycle)
- Lipid or Carbohydrate Metabolism in Obese Versus Normal Weight Oral Contraceptive (OC) Users at Baseline and Exit Visit (12-16 Weeks OC Exposure).(Screening (baseline) and follow-up 1 (exit))
研究者
Carolyn L. Westhoff
Professor of Obstetrics and Gynecology, Population and Family Health and Epidemiology at the New York-Presbyterian Hospital at the Columbia University Medical Center
Columbia University