Comparison of Serum Contraceptive Hormone Levels Between Normal Weight and Obese Users of the NuvaRing®
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Mean Serum Concentrations of Etonogestrel and Ethinyl Estradiol
研究概览
简要总结
There are over 60 million women of reproductive age in the U.S. and a majority of these women qualify as overweight or obese. Evidence suggests that there is an association between increased body weight and decreased contraceptive efficacy. Studies with the combined hormonal contraceptive patch (Evra®) and the subdermal contraceptive implant (Norplant®) demonstrate higher failure rates in heavier versus lighter women.
Weight related differences in the effectiveness of NuvaRing® need further study. A single secondary analysis of pooled data from Phase III clinical trials of NuvaRing® noted no difference in pregnancy rates among women in the highest weight decile (>166#) versus the rest of the study population using the ring. (Westhoff, 2005) The finding of no difference, however, was influenced by too few obese subjects in the analysis which contributed to wide confidence limits. Additional studies are needed to explore how well the contraceptive ring functions to maintain effective serum steroid concentrations to suppress ovarian activity in obese women.
This investigation focused on evaluating mean serum concentrations of hormones released in obese and normal weight women using the NuvaRing® . This study was a prospective clinical trial. Normal weight women are defined as women with a BMI 19-24.9 and obese women are those with a BMI 30-39.9. We recruited forty adult women interested in initiating the combined hormonal contraceptive ring to two months of use to complete analysis of at least 34 subjects (17 normal weight, 17 obese). We compared mean serum concentrations of ethinyl estradiol (E2) and etonogestrel (ENG) along with additional markers for ovarian suppression. These markers included sonographic evidence of follicular development and ovulation as well as circulating E2 levels which strongly correlate with follicular development and endometrial proliferation during the second month of NuvaRing® use. Assessment of these parameters will translated to understanding contraceptive-mediated suppression of ovarian function in these two groups. Subjects also logged patterns of ring use and bleeding patterns during the study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Meet BMI requirements
- •Weight stable
- •English speaking
- •Desire contraception
- •History of regular menses with normal uterus and ovaries
- •Medically eligible for combined hormonal contraception
- •Tolerates phlebotomy/TVS
排除标准
- •Exclusion:
- •Heavy smokers
- •Users of medications that alter hormone levels
研究组 & 干预措施
1- Obese Women /Nuvaring
Obese subjects (BMI 30-39.9)received two contraceptive hormonal rings. During the second cycle of ring use, subjects returned to the study site for serial serum hormone measurements and transvaginal ultrasound twice weekly during four weeks of continuous use.
干预措施: NuvaRing (Drug)
2- Normal Weight / Nuvaring
Normal weight subjects (BMI 19-24.9) received two contraceptive hormonal rings. During the second cycle of ring use, subjects returned to the study site for serial serum hormone measurements and transvaginal ultrasound twice weekly during four weeks of continuous use.
干预措施: NuvaRing (Drug)
结局指标
主要结局
Mean Serum Concentrations of Etonogestrel and Ethinyl Estradiol
时间窗: Measurements at Week 3 and Week 6 continuous ring use
Serum concentrations were obtained from thirty-seven women completed follow-up.
次要结局
- Number of Participants Achieving a Maximum Follicle Diameter > 13mm During the 3 Weeks of Follow-up(continuous ring use, an average of 3 weeks)
- Mean Endometrial Proliferation(Transvaginal ultrasound measurements of endometrial proliferation will be completed over continuous ring use, an average of 3 weeks)
研究者
Carolyn L. Westhoff
Director of Family Planning and Preventive Services Division
Columbia University
