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Clinical Trials/NCT01200576
NCT01200576
Completed
N/A

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

FHI 3601 site in 1 country621 target enrollmentOctober 2010

Overview

Phase
N/A
Intervention
Not specified
Conditions
Long-term and Permanent Contraceptive Methods
Sponsor
FHI 360
Enrollment
621
Locations
1
Primary Endpoint
Reasons for discontinuation
Status
Completed
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2010
End Date
March 2012
Last Updated
13 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
FHI 360
Responsible Party
Sponsor

Eligibility Criteria

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

  • Not provided

Outcomes

Primary Outcomes

Reasons for discontinuation

Time Frame: 1 year

Prevalence and incidence rates of immediate and delayed complications associated with insertion or removal

Time Frame: 1 year

The cumulative probability of pregnancy through one year

Time Frame: 1 year

Prevalence and incidence rate of adverse events

Time Frame: 1 year

The cumulative probability of early discontinuation through one year

Time Frame: 1 year

Study Sites (1)

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