Kenya Sino-implant (II) PK Study

A Pharmacokinetic Study to Compare Sino-implant (II) During Four Years of Use to Jadelle During Five Years of Use by Kenyan Women

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.

Study Overview

• Status: Withdrawn
• Conditions: Contraception

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 Type: Observational

Contacts and Locations

Study Locations

• Kenya
  • Nairobi, Kenya
    • Marie Stopes Kenya Eastleigh Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 44 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women between the ages of 18 and 44 who have received contraceptive implants from the Marie Stopes Kenya Eastleigh clinic and MSK mobile clinics in the Nairobi area.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort
Cohort 1; Twenty Sino-implant (II) and twenty Jadelle users enrolled 1-3 months before their 6-month insertion anniversary.
Cohort 2; TwentySino-implant (II) and twenty Jadelle users enrolled 1-3 months before their 12-month insertion anniversary;
Cohort 3; Twenty Sino-implant (II) and twenty Jadelle) users enrolled 1-3 months before their 24-month insertion anniversary
Cohort 4; Twenty Sino-implant(II) and twenty Jadelle users enrolled 1-3 months before their 36-month insertion anniversary;
Cohort 5; Forty Sino-implant (II) and forty Jadelle users enrolled 1-3 months before their 48-month insertion anniversary;
Cohort 6; Forty Jadelle users enrolled 2-6 months before their 60-month insertion anniversary.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: FHI 360
• Collaborators: Marie Stopes International
• Investigators: Principal Investigator: Mark Ayallo, MD, Marie Stopes Kenya

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: August 21, 2013
• First Submitted That Met QC Criteria: August 26, 2013
• First Posted (Estimate): August 29, 2013

Study Record Updates

• Last Update Posted (Estimate): October 14, 2013
• Last Update Submitted That Met QC Criteria: October 11, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: MSI: Marie Stopes International; LNG: Levonorgestrel; MSK: Marie Stopes Kenya; PK: Pharmacokinetic
• Other Study ID Numbers: 475139