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Safety,Effectiveness and Acceptability of Sino-implant II in DR

This study is ongoing, but not recruiting participants.
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
FHI 360 Identifier:
First received: October 13, 2011
Last updated: April 14, 2017
Last verified: April 2017
A study to assess the contraceptive effectiveness of Sino-implant (II).

Condition Intervention
Drug: Jadelle
Drug: Sino-implant (II)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Prevention
Official Title: A Study to Evaluate the Contraceptive Effectiveness, Safety and Acceptability of Sino-implant II

Resource links provided by NLM:

Further study details as provided by FHI 360:

Primary Outcome Measures:
  • Pearl Index over 4 years of use of Sino-implant (II) [ Time Frame: 4 years ]

Secondary Outcome Measures:
  • 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) ; continuation & reasons for discontinuation in both groups.

  • Pearl Index over 5 years of use of Sino-implant (II) [ Time Frame: 5 years ]
    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 ]
    levonorgestrel concentrations measured by HPLC/MS

  • Pearl Index over 5 years of use of Sino-implant (II) [ Time Frame: 5 years ]
    LNG concentrations and estimated PK parameters during the first 6 months of use in a sub-group of users; adverse events

Estimated Enrollment: 500
Study Start Date: January 2011
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Jadelle
Contraception using Jadelle implant
Drug: Jadelle
LNG containing subdermal contraceptive implant
Active Comparator: Sino-implant (II)
levonorgestrel containing subdermal contraceptive implant [Zarin, Femplant, Trust or Simplant]
Drug: Sino-implant (II)
LNG containing subdermal contraceptive implant
Other Name: Zarin, Femplant, Trust, Simplant

Detailed 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.

Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01594632

Dominican Republic
Santo Domingo, Dominican Republic
Sponsors and Collaborators
FHI 360
Bill and Melinda Gates Foundation
Principal Investigator: Vivian Brache, LIC Profamilia
  More Information

Responsible Party: FHI 360 Identifier: NCT01594632     History of Changes
Other Study ID Numbers: 10242
Study First Received: October 13, 2011
Last Updated: April 14, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by FHI 360:
AE adverse event
AIDS acquired immunodeficiency syndrome
ALT (SGPT) alanine aminotransferase
ART antiretroviral therapy
AST (SGOT) aspartate aminotransferase
DCF data collection forms
DMC Data Monitoring Committee
FDA (U.S.) Food and Drug Administration
GCP Good Clinical Practice guidelines
HB sAg Hepatitis B surface antigen
ICH International Conference of Harmonization
IND Investigational New Drug Application
IRB Institutional Review Board
IU International units
mg milligram(s)
mm3 cubic millimeter(s)
PCR polymerase chain reaction
SAE serious adverse event
µg microgram
ULN upper limit of the normal range
WB Western Blot

Additional relevant MeSH terms:
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral processed this record on May 24, 2017