Kenya Sino-implant (II) PK Study

NCT ID: NCT01930994

Last Updated: 2013-10-14

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2013-12-31

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

Conditions

Contraception

Keywords

LNG: Levonorgestrel; MSI: Marie Stopes International; MSK: Marie Stopes Kenya; PK: Pharmacokinetic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Cohort 1

Twenty Sino-implant (II) and twenty Jadelle users enrolled 1-3 months before their 6-month insertion anniversary.

No interventions assigned to this group

Cohort 2

TwentySino-implant (II) and twenty Jadelle users enrolled 1-3 months before their 12-month insertion anniversary;

No interventions assigned to this group

Cohort 3

Twenty Sino-implant (II) and twenty Jadelle) users enrolled 1-3 months before their 24-month insertion anniversary

No interventions assigned to this group

Cohort 4

Twenty Sino-implant(II) and twenty Jadelle users enrolled 1-3 months before their 36-month insertion anniversary;

No interventions assigned to this group

Cohort 5

Forty Sino-implant (II) and forty Jadelle users enrolled 1-3 months before their 48-month insertion anniversary;

No interventions assigned to this group

Cohort 6

Forty Jadelle users enrolled 2-6 months before their 60-month insertion anniversary.

No interventions assigned to this group

Eligibility Criteria

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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Marie Stopes International

OTHER

Sponsor Role: collaborator

FHI 360

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Ayallo, MD

Role: PRINCIPAL_INVESTIGATOR

Marie Stopes Kenya

Locations

Marie Stopes Kenya Eastleigh Clinic

Nairobi, , Kenya

Countries

Kenya

Other Identifiers

475139

Identifier Type: -

Identifier Source: org_study_id