Impact of Gastric Bypass Surgery on the Pharmacokinetics of Oral Contraceptive Hormones
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Serum hormone levels of Ethinyl estradiol and levonorgestrel, as assessed by area under the curve (AUC)
研究概览
简要总结
This study will attempt to determine whether having gastric bypass surgery changes the way that the gut absorbs hormones from birth control pills. It is believed that, because gastric bypass surgery causes malabsorption of nutrients and some medications, the levels of birth control hormones after the surgery will be lower than in women before they have the surgery. The investigators will ask several women to take a pack of birth control pills before having bypass surgery, and then another pack several months after surgery. The investigators will measure hormone levels in the blood. The investigators will also measure outcomes that may tell us how well the birth control pills are working, such as ultrasounds of the uterus and ovaries, and examination of the cervix.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Planning to undergo gastric bypass surgery at our institution
- •willing to take 2 monthly cycles of the oral contraceptive: one cycle before and one after surgery
- •use of Depo-provera within 6 months of enrollment
- •Use of implantable or intrauterine contraception
- •able to attend multiple study visits
排除标准
- •Any contraindication to combined hormonal contraceptive use
- •Surgical complications precluding further participation
研究组 & 干预措施
Gastric bypass COC
This is a before-and-after comparison. Women will enroll prior to planned gastric bypass surgery and complete one cycle of oral contraceptive use and evaluation. There will then be no more study procedures/interventions until 3-4 months after surgery. At that time, women will complete the second cycle of OC use and evaluation. Study participation is then complete.
Intervention: Ethinyl estradiol-levonorgestrel(EE 20mcg/LNG 150mcg)
干预措施: ethinyl estradiol-levonorgestrel (Drug)
结局指标
主要结局
Serum hormone levels of Ethinyl estradiol and levonorgestrel, as assessed by area under the curve (AUC)
时间窗: twice weekly x 4 weeks, at 2 separate months: 1 pre-op and one 3-4 months postoperative. Thus, total duration of participation in study will be approximately 7-8 months
次要结局
- Serum levels of FSH, LH, E and P(twice weekly x 4 weeks, at 2 separate months: 1 pre-op and one 3-4 months postoperative. Thus, total duration of participation in study will be approximately 7-8 months)
- Presence of ovarian follicles on transvaginal ultrasound(twice weekly x 4 weeks, at 2 separate months: 1 pre-op and one 3-4 months postoperative. Thus, total duration of participation in study will be approximately 7-8 months)
- Endometrial thickness on transvaginal ultrasound(twice weekly x 4 weeks, at 2 separate months: 1 pre-op and one 3-4 months postoperative. Thus, total duration of participation in study will be approximately 7-8 months)
- Cervical mucus score(twice weekly x 4 weeks, at 2 separate months: 1 pre-op and one 3-4 months postoperative. Thus, total duration of participation in study will be approximately 7-8 months)