A Study to Evaluate the Contraceptive Effectiveness During the Third, Fourth and Fifth Year of Sino-implant (II) Use and the Pharmacokinetics Over Five Years of Use in Chinese Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- FHI 360
- 入组人数
- 538
- 试验地点
- 5
- 主要终点
- Pregnancy Pearl Index
研究概览
简要总结
A cohort study to Evaluate the contraceptive effectiveness of Sino-implant (II) during the 3rd and 4th years of use in Chinese women
详细描述
A Study to Evaluate the Contraceptive Effectiveness during the Third, Fourth and Fifth Year of Sino-implant (II)Use and the Pharmacokinetics (PK) over Five Years of use in Chinese Women
Population: A total of 590 Chinese Sino-Implant (II) users between 20and 44 years of age enrolled in one of four prospective cohorts:
Cohort 1: n=20 women with insertion dates 3-5months prior to enrollment and followed for 2-6 months Cohort 2:n=20 women with insertion dates 9-11 months prior to enrollment and followed for 2-6 months Cohort 3: n=250 women with insertion dates 21-24 months prior to enrollment and followed through month 36 Cohort 4:n=300 women with insertion dates 33-36 months prior to enrollment and followed through month 6
Study Duration: 33 total months in the field: 3 months of participant recruitment(all cohorts); up to 27 months of pregnancy monitoring and PK blood sampling in Cohort 4 (up to 15 months in Cohort 3 and 6 months in Cohort 1 and Cohort 2);and 3 months of close-out activities.
For secondary PK outcomes, blood samples will be taken 2 to 6 months apart from each woman in Cohort 1 and Cohort 2; at enrollment, month 30 and month 36 from the first 20 consenting women in Cohort 3; and at enrollment and months 42, 48, 54, and 60 from the first 30 consenting women in Cohort 4.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Have a confirmed Sino-implant (II) set in place;
- •Have a confirmed contraceptive implant insertion date consistent with the criteria for the cohort she is to be enrolled in;
- •Be aged between 20 and 44 years, inclusive;
- •Not wish to become pregnant in the next year;
- •No desire to get implant removal within the next year;
- •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 follow-up visit(s).
排除标准
- •Acute liver disease or cirrhosis by self-report;
- •Benign or malignant tumor of the liver by self-report;
- •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;
- •Known HIV-positive status 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
Pregnancy Pearl Index
时间窗: 27 months
Pregnancy Pearl Index (number of pregnancies per 100 woman-years) during the third and fourth years of use, respectively, in Cohort 3 and Cohort 4
次要结局
- Serum SHBG concentrations measured by a chemiluminescence immunoassay(27 months)
- Pregnancy Pearl Index during the fifth year of Sino implant (II) use(27 months)
- Total and free LNG plasma concentrations measured by a high-performance liquid chromatography with mass spectrometry assay(27 months)