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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01200576
Other study ID # 10225
Secondary ID
Status Completed
Phase N/A
First received September 10, 2010
Last updated March 28, 2013
Start date October 2010
Est. completion date March 2012

Study information

Verified date March 2013
Source FHI 360
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardMadagascar: Ministry of Health
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 621
Est. completion date March 2012
Est. primary completion date February 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility 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

N/A


Related Conditions & MeSH terms

  • Long-term and Permanent Contraceptive Methods

Locations

Country Name City State
Madagascar Marie Stopes Madagascar Mobile Outreach Sites and Static Clinics Madagascar

Sponsors (3)

Lead Sponsor Collaborator
FHI 360 Bill and Melinda Gates Foundation, Marie Stopes International

Country where clinical trial is conducted

Madagascar, 

Outcome

Type Measure Description Time frame Safety issue
Primary The cumulative probability of pregnancy through one year 1 year Yes
Primary Prevalence and incidence rate of adverse events 1 year Yes
Primary Prevalence and incidence rates of immediate and delayed complications associated with insertion or removal 1 year Yes
Primary The cumulative probability of early discontinuation through one year 1 year Yes
Primary Reasons for discontinuation 1 year Yes