A Pharmacokinetic Study to Compare Sino-implant (II) During Four Years of Use to Jadelle During Five Years of Use by Kenyan Women
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- FHI 360
- 试验地点
- 1
- 主要终点
- Total and Free LNG concentrations in Jadelle users at Four Years and Sino-implant users at Five Years
研究概览
简要总结
A cross-sectional study to compare pharmacokinetics of Sino-implant (II) during four years of used and Jadelle during five years of use by Kenyan women.
详细描述
A cross-sectional study to compare the pharmacokinetics of Sino-implant (II) during four years of use and Jadelle during five years of use by Kenyan women. The active ingredient in both implants is levonorgestrel (LNG) which is a synthetic progestin that has been used in combined oral contraceptives and in progestin-only pills for more than 30 years.
Population: A total of 280 women between the ages of 18 to 44 years who are currently using Sino-implant (II) or Jadelle contraceptive implants will be enrolled in one of six cohorts of women:
Cohort 1: (n=20 Sino-implant (II), n=20 Jadelle) women enrolled 1-3 months before their 6-month insertion anniversary.
Cohort 2: (n=20 Sino-implant (II), n=20 Jadelle) women enrolled 1-3 months before their 12-month insertion anniversary.
Cohort 3: (n=20 Sino-implant (II), n=20 Jadelle) women enrolled 1-3 months before their 24-month insertion anniversary.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Have a Sino-implant (II) or Jadelle implant set in place, confirmed by physical exam;
- •Have a confirmed contraceptive implant insertion date consistent with the criteria for the cohort she is to be enrolled in;
- •Be aged between 18 and 44 years, inclusive;
- •Not wish to become pregnant in the next six months;
- •Not desire implant removal within the next six months.
- •Be able to understand the information given to them and to make personal decisions on whether to participate or not in the study;
- •Consent to participation, and sign an informed consent form;
- •Agree and be able to return to the clinic for the second study visit.
排除标准
- •The following criteria exclude participation in the study:
- •Use of rifampicin, and/or anticonvulsants (barbiturates, phenytoin, phenobarbital, carbamazepine, oxcarbazepine, primidone, topiramate), and/or herbal products containing St. John's wort (Hypericum perforatum), by self-report;7
- •Use of medications containing LNG or other hormones that impact LNG or SHBG disposition, e.g. treatment with LNG or oral contraceptives for bleeding disturbances, by self-report;
- •Use of anti-retroviral drugs, by self-report;
- •Any condition (social or medical) which in the opinion of the Investigator would make study participation unsafe, would interfere with adherence to study requirements or complicate data interpretation.
结局指标
主要结局
Total and Free LNG concentrations in Jadelle users at Four Years and Sino-implant users at Five Years
时间窗: 6 months
Total and free LNG plasma concentrations measured at four years of Sino-implant (II)use and at five years of Jadelle use
次要结局
- Total and Free LNG concentrations at Four Years of Jadelle and Sino-implant Use(6 months)
- Total and free LNG plasma concentration-time profiles at 4 years following Sino-implant (II) and at over 5 years following Jadelle insertion(6 months)
- SHBG serum concentration-time profile over 4 years following Sino-implant (II) and over 5 years following Jadelle insertion.(6 months)