Clinical trial NCT01930994: Kenya Sino-implant (II) PK Study
Official title: A Pharmacokinetic Study to Compare Sino-implant (II) During Four Years of Use to Jadelle During Five Years of Use by Kenyan Women
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Contraception
Keywords: LNG: Levonorgestrel
MSI: Marie Stopes International
MSK: Marie Stopes Kenya
PK: Pharmacokinetic
Lead sponsor: FHI 360
Sponsor class: OTHER
Collaborators: name: Marie Stopes International
First posted: 2013-08-29
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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

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: 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.

Primary outcomes:
measure: Total and Free LNG concentrations in Jadelle users at Four Years and Sino-implant users at Five Years
timeFrame: 6 months
Secondary outcomes:
measure: Total and Free LNG concentrations at Four Years of Jadelle and Sino-implant Use
timeFrame: 6 months
measure: Total and free LNG plasma concentration-time profiles at 4 years following Sino-implant (II) and at over 5 years following Jadelle insertion
timeFrame: 6 months
measure: SHBG serum concentration-time profile over 4 years following Sino-implant (II) and over 5 years following Jadelle insertion.
timeFrame: 6 months
Other outcomes:
Locations:
city: Nairobi
country: Kenya
facility: Marie Stopes Kenya Eastleigh Clinic
Study officials:
affiliation: Marie Stopes Kenya
name: Mark Ayallo, MD
role: PRINCIPAL_INVESTIGATOR
References: