Safety,Effectiveness and Acceptability of Sino-implant II
This study is currently recruiting participants.
Verified March 2013 by FHI 360
Sponsor:
FHI 360
Collaborator:
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
FHI 360
ClinicalTrials.gov Identifier:
NCT01594632
First received: October 13, 2011
Last updated: March 25, 2013
Last verified: March 2013
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Purpose
A study to assess the contraceptive effectiveness of Sino-implant (II).
| Condition | Intervention |
|---|---|
|
Contraception |
Drug: Sino-implant (II) |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group 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: | October 2011 |
| Estimated Study Completion Date: | January 2017 |
| Estimated Primary Completion Date: | January 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Jadelle
Contraception using Jadelle implant
|
Drug: Sino-implant (II)
LNG containing subdermal contraceptive implant
|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01594632
Contacts
| Contact: Vera Halpern, MD | 9195447040 ext 11390 | vhalpern@fhi360.org |
Locations
| Dominican Republic | |
| Profamilia | Recruiting |
| Santo Domingo, Dominican Republic | |
| Contact: Vivian Brache, LIC | |
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: | March 25, 2013 |
| 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 Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013