Kenya Sino-implant (II) PK Study

Withdrawn

• Conditions: Contraception

• Registration Number: NCT01930994
• Lead Sponsor: FHI 360

Brief Summary

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.

Detailed Description

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.

Cohort 4: (n=20 Sino-implant (II), n=20 Jadelle) women enrolled 1-3 months before their 36-month insertion anniversary.

Cohort 5: (n=40 Sino-implant (II), n=40 Jadelle) women enrolled 1-3 months before their 48-month insertion anniversary.

Cohort 6: (n=40 Jadelle) women enrolled 2-6 months before their 60-month insertion anniversary.

Women in all cohorts will be followed for up to 6 months.

Study Duration: Up to 6 months of participant recruitment and up to 6 months elapsed after the baseline visit for the second study visits. 15 months total in the field including training, study initiation, recruitment, follow-up, and close-out.

Two blood samples spaced 2 to 6 months apart will be drawn from each woman for hormone measurements.

Primary Objective: To compare total and free levonorgestrel (LNG) plasma concentrations at four years of Sino-implant (II) use to total and free LNG plasma concentrations at five years of Jadelle use in Kenyan women

Secondary Objectives:

1. To compare total and free LNG plasma concentrations at four years of Sino-implant (II) use to total and free LNG plasma concentrations at four years of Jadelle use

2. To characterize the total and free LNG plasma concentration-time profiles over four years following Sino-implant (II) and over five years following Jadelle insertion

3. To characterize the sex hormone binding globulin (SHBG) serum concentration-time profile over four years following Sino-implant (II) and over five years following Jadelle insertion

Study Timeline

• Study First Submitted: 2013-08-21
• Study First Submitted QC: 2013-08-26
• Study First Posted: 2013-08-29
• Study Start: 2013-09
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-11
• Last Update Posted: 2013-10-14
• Primary Completion: 2013-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• 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.

Exclusion Criteria

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total and Free LNG concentrations in Jadelle users at Four Years and Sino-implant users at Five Years	6 months	Total and free LNG plasma concentrations measured at four years of Sino-implant (II)use and at five years of Jadelle use

Secondary Outcome Measures

Name	Time	Method
Total and Free LNG concentrations at Four Years of Jadelle and Sino-implant Use	6 months	Total and free LNG plasma concentrations at 4 years of Sino-implant (II) use and total and free LNG plasma concentrations at 4 years of Jadelle use
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	Total and free LNG plasma concentration-time profiles at 4 years of Sino-implant(II)use compared to over 5 years of Jadelle use
SHBG serum concentration-time profile over 4 years following Sino-implant (II) and over 5 years following Jadelle insertion.	6 months	SHBG serum concentration-time profile at at 4 years of Sino-implant(II)use compared to over 5 years of Jadelle use

Trial Locations

Locations (1)

Marie Stopes Kenya Eastleigh Clinic; 🇰🇪 Nairobi, Kenya