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

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: May 7, 2014
Last verified: May 2014
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 500
Study Start Date: January 2011
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Jadelle
Contraception using Jadelle implant
Drug: Jadelle
LNG containing subdermal contraceptive implant
Other Name: Jadelle
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.

  Eligibility

Ages Eligible for Study:   18 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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 ClinicalTrials.gov identifier: NCT01594632

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

No publications provided

Responsible Party: FHI 360
ClinicalTrials.gov Identifier: NCT01594632     History of Changes
Other Study ID Numbers: 10242
Study First Received: October 13, 2011
Last Updated: May 7, 2014
Health Authority: Dominican Republic: Secretaría del Estado de Salud Pública y Asistencia Social (SESPAS)

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
Levonorgestrel
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral

ClinicalTrials.gov processed this record on August 18, 2014