Contraceptive Effectiveness of Sino-implant (II) in China

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

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

Study Overview

• Status: Completed
• Conditions: Contraception

Detailed Description

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:

1. To evaluate the contraceptive effectiveness of Sino-implant (II) during the fifth year of use.
2. To characterize the total and free levonorgestrel (LNG) plasma concentration-time profiles over five years following Sino-implant (II) insertion
3. 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

• Study Type: Observational
• Enrollment (Actual): 538

Contacts and Locations

Study Locations

• China
  • Anyang, China
    • An Yang Population and Family Planning Service Station
  • Lingbao, China
    • Lingbao Population and Family Planning Service
  • Lushi, China
    • Lushi Family Planning Technical Service Station
  • Shanghai, China
    • Shanghai Institute of Planned Parenthood
  • Tongxiang, China
    • Tongxiang Population and Family Planning Service Station

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 44 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Study Population: Women who have received contraceptive implants from the Tongxiang, An Yang, Lingbao, and Lushi Family Planning Service Stations.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: FHI 360
• Collaborators: Bill and Melinda Gates Foundation
• Investigators: Principal Investigator: Markus Steiner, Ph.D., FHI 360

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: September 3, 2013
• First Submitted That Met QC Criteria: September 3, 2013
• First Posted (Estimate): September 6, 2013

Study Record Updates

• Last Update Posted (Estimate): February 17, 2016
• Last Update Submitted That Met QC Criteria: February 16, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 458241-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED