Pharmacokinetics of Implanon in Obese Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- To describe the pharmacokinetic profile of Implanon (etonogestrel) among obese women.
研究概览
简要总结
Prior studies examining the pharmacokinetics, safety, and efficacy of the new etonogestrel-containing single rod implantable contraceptive device, Implanon, did not include women who exceeded 130% of ideal body weight. Yet, as these women comprise a significant portion of the U.S. population, studies of Implanon in obese women are essential. The proposed study represents an important first step in addressing the lack of data on Implanon in obese women. We aim to examine the pharmacokinetics of Implanon in obese women during the first 6 months of use and to provide data on the acceptability, side effect profile, and ease of insertion, palpation, and removal in these women. We also aim to collect samples for future validation studies of the use of the blood spot (finger-stick blood sample on filter paper) as a method of determining plasma etonogestrel.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •premenopausal with a uterus and at least one ovary
- •willing and able to sign the informed consent
- •willing to comply with the study protocol and visit schedule
- •have a body mass index of less than 25, or greater than or equal to 30
- •weight stable
排除标准
- •known or suspected pregnancy
- •delivery (vaginal or cesarean) within 4 months of device insertion
- •abortion (first or second trimester) within 4 months of device insertion
- •contraindications to Implanon use
- •hemophilia
- •undiagnosed abnormal genital bleeding
- •hypersensitivity or allergy to any components of Implanon
- •personal or family history of thrombosis or thromboembolic disorders
- •hepatic tumors or active liver disease
- •known or suspected carcinoma of the breast or history of breast cancer
- •more that one cardiovascular risk factor such as hypertension or diabetes
- •known history of PCOS, diabetes, or glucose abnormality
- •present use or use within 2 months of device insertion of a CYP3A4 inducer
- •breastfeeding women
- •use of an investigational drug within 2 months of device insertion
- •use of injectable contraception within 6 months of device insertion
- •planning a pregnancy in the next 12 months
- •known HIV infection
- •smoking over the age of 35
结局指标
主要结局
To describe the pharmacokinetic profile of Implanon (etonogestrel) among obese women.
时间窗: 6 months
次要结局
- To describe bleeding patterns among obese users of Implanon(6 months)
- To describe ease of insertion and palpation of Implanon among obese women(6 months)
- To describe the acceptability of Implanon among obese women(6 months)
- To describe the discontinuation rates, reason for discontinuation, and ease of removal in obese women who discontinue the device before or at the end of the 6 month study period(6 months)
- To determine whether etonogestrel levels can be obtained from finger-stick blood spots(6 months)