Kenya Sino-implant (II) PK Study

NCT01930994 | Withdrawn

• 1 other identifier: 475139
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Contraception

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Total and Free LNG concentrations at Four Years of Jadelle and Sino-implant 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

  6 months

• SHBG serum concentration-time profile over 4 years following Sino-implant (II) and over 5 years following Jadelle insertion.

  6 months

Study Arms (6)

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.

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• FHI 360: lead
• Marie Stopes International: collaborator

Study Sites (1)

Marie Stopes Kenya Eastleigh Clinic

Nairobi, Kenya

Location

Study Officials

• Mark Ayallo, MD

  Marie Stopes Kenya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2013
• First Posted: August 29, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 14, 2013

Record last verified: 2013-10

Locations

KE (1)