Safety,Effectiveness and Acceptability of Sino-implant II

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
FHI 360
ClinicalTrials.gov Identifier:
NCT01594632
First received: October 13, 2011
Last updated: October 10, 2013
Last verified: October 2013

October 13, 2011
October 10, 2013
January 2011
July 2018   (final data collection date for primary outcome measure)
Pearl Index over 4 years of use of Sino-implant (II) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01594632 on ClinicalTrials.gov Archive Site
  • Pearl Index over 5 years of use of Sino-implant (II) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Pearl Index over 5 years of use of Sino-implant (II) ; continuation & reasons for discontinuation in both groups.
  • Pearl Index over 5 years of use of Sino-implant (II) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    annual and cumulative probability of pregnancy during 5 years of use of Sino-implant (II)
  • Pearl Index over 5 years of use of Sino-implant (II) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    levonorgestrel concentrations measured by HPLC/MS
  • Pearl Index over 5 years of use of Sino-implant (II) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    LNG concentrations and estimated PK parameters during the first 6 months of use in a sub-group of users; adverse events
Same as current
Not Provided
Not Provided
 
Safety,Effectiveness and Acceptability of Sino-implant II
A Study to Evaluate the Contraceptive Effectiveness, Safety and Acceptability of Sino-implant II

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Contraception
  • Drug: Jadelle
    LNG containing subdermal contraceptive implant
    Other Name: Jadelle
  • Drug: Sino-implant (II)
    LNG containing subdermal contraceptive implant
    Other Name: Zarin, Femplant, Trust, Simplant
  • Experimental: Jadelle
    Contraception using Jadelle implant
    Intervention: Drug: Jadelle
  • Active Comparator: Sino-implant (II)
    levonorgestrel containing subdermal contraceptive implant [Zarin, Femplant, Trust or Simplant]
    Intervention: Drug: Sino-implant (II)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
500
July 2018
July 2018   (final data collection date for primary outcome measure)

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
Female
18 Years to 44 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Dominican Republic
 
NCT01594632
10242
Yes
FHI 360
FHI 360
Bill and Melinda Gates Foundation
Principal Investigator: Vivian Brache, LIC Profamilia
FHI 360
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP