A Prospective Observational Study of the Clinical Performance of Zarin in Madagascar

Completed

• Conditions: Long-term and Permanent Contraceptive Methods

• Registration Number: NCT01200576
• Lead Sponsor: FHI 360

Brief Summary

This one-year observational study will monitor the contraceptive effectiveness, safety and acceptability of Zarin during the first year of use after the method has been approved for public use in Madagascar. It will be implemented by Marie Stopes Madagascar with technical support from Marie Stopes International and FHI. 300 women of reproductive age who selected Zarin as their primary method of contraception will be enrolled in the study at the MSM outreach sites and static clinics.

Detailed Description

This one-year observational study will monitor the contraceptive effectiveness, safety and acceptability of Zarin during the first year of use after the method has been approved for public use in Madagascar. It will be implemented by Marie Stopes Madagascar with technical support from Marie Stopes International and FHI. 300 women of reproductive age who selected Zarin as their primary method of contraception will be enrolled in the study at the MSM outreach sites and static clinics.

Study Timeline

• Study First Submitted: 2010-09-10
• Study First Submitted QC: 2010-09-10
• Study First Posted: 2010-09-13
• Study Start: 2010-10
• Primary Completion: 2012-02
• Study Completion: 2012-03
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-28
• Last Update Posted: 2013-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 621

Inclusion Criteria

• be a participant of the MSM service evaluation and continue using Zarin at 3 months
• agree at the time of Zarin insertion to be contacted regarding an opportunity to participate in more research related to the implant

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reasons for discontinuation	1 year
The cumulative probability of pregnancy through one year	1 year
Prevalence and incidence rates of immediate and delayed complications associated with insertion or removal	1 year
Prevalence and incidence rate of adverse events	1 year
The cumulative probability of early discontinuation through one year	1 year

Trial Locations

Locations (1)

Marie Stopes Madagascar Mobile Outreach Sites and Static Clinics; 🇲🇬 Madagascar, Madagascar