Contraceptive Effectiveness of Sino-implant (II) in China

Study Overview
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Brief Summary
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A cohort study to Evaluate the contraceptive effectiveness of Sino-implant (II) during the 3rd and 4th years of use in Chinese women

Detailed Description
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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. Primary Objective: To evaluate the contraceptive effectiveness of Sino-implant (II) during the third and fourth years of use Secondary Objectives: To evaluate the contraceptive effectiveness of Sino-implant (II) during the fifth year of use. To characterize the total and free levonorgestrel (LNG) plasma concentration-time profiles over five years following Sino-implant (II) insertion To characterize the sex hormone binding globulin (SHBG) serum concentration-time profile and its relationship to total LNG levels over five years following Sino-implant (II) insertion

Official Title
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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

Conditions
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Contraception

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>n=20 women with insertion dates 3-5months prior to enrollment and followed for 2-6 months | |
| Cohort 2<br>n=20 women with insertion dates 9-11 months prior to enrollment and followed for 2-6 months | |
| Cohort 3<br>n=250 women with insertion dates 21-24 months prior to enrollment and followed through month 36 | |
| Cohort 4<br>n=300 women with insertion dates 33-36 months prior to enrollment and followed through month 6 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy Pearl Index | 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 | 27 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Serum SHBG concentrations measured by a chemiluminescence immunoassay |  | 27 months |