Overview

This trial is active, not recruiting.

Condition contraception
Treatments jadelle, sino-implant (ii)
Sponsor FHI 360
Collaborator Bill and Melinda Gates Foundation
Start date January 2011
End date July 2017
Trial size 500 participants
Trial identifier NCT01594632, 10242

Summary

A study to assess the contraceptive effectiveness of Sino-implant (II).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose prevention
Arm
(Experimental)
Contraception using Jadelle implant
jadelle
LNG containing subdermal contraceptive implant
(Active Comparator)
levonorgestrel containing subdermal contraceptive implant [Zarin, Femplant, Trust or Simplant]
sino-implant (ii) Zarin, Femplant, Trust, Simplant
LNG containing subdermal contraceptive implant

Primary Outcomes

Measure
Pearl Index over 4 years of use of Sino-implant (II)
time frame: 4 years

Secondary Outcomes

Measure
Pearl Index over 5 years of use of Sino-implant (II)
time frame: 5 years
Pearl Index over 5 years of use of Sino-implant (II)
time frame: 5 years
Pearl Index over 5 years of use of Sino-implant (II)
time frame: 5 years
Pearl Index over 5 years of use of Sino-implant (II)
time frame: 5 years

Eligibility Criteria

Female participants from 18 years up to 44 years old.

Inclusion Criteria:• In good general health - Aged between 18 and 44 years, inclusive - Not pregnant - Not lactating - Not wishing to become pregnant in the next five years - Request long-acting reversible contraception - If previously used injectable contraceptives for pregnancy prevention, be more than 9 months since last injection of Depo-Provera and more than 3 months after the last injection of a combined injectable contraceptive - If previously used LNG-containing oral pills or implants, be more than 1 week after last hormone intake or implant removal - Be able to understand the information provided and to make personal decisions on participation - Consent to participation and sign a consent form - Agree and be able to return to the clinic for follow-up visits over five years

Additional Information

Official title A Study to Evaluate the Contraceptive Effectiveness, Safety and Acceptability of Sino-implant II
Principal investigator Vivian Brache, LIC
Description Randomized trial to assess the contraceptive effectiveness of Sino-implant (II) and to compare levonorgestrel concentrations, safety and acceptability of Sino-implant (II) and Jadelle.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by FHI 360.