Marie Stopes Madagascar Mobile Outreach Sites and Static Clinics
Madagascar
Completed
NCT Number: NCT01200576
A Prospective Observational Study of the Clinical Performance of Zarin in Madagascar
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.
Completed
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Notify MeKey information
Sex eligibility
Female
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
-
Treatment and study plan
Primary outcomes
-
The cumulative probability of pregnancy through one year
Time frame: 1 year
-
Prevalence and incidence rate of adverse events
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 early discontinuation through one year
Time frame: 1 year
-
Reasons for discontinuation
Time frame: 1 year
Sponsors and collaborators
Lead sponsor
FHI 360
Other
Collaborators
- Bill and Melinda Gates Foundation
- Marie Stopes International
Registry information
Important dates
- Study start
- 2010
- Primary completion
- 2012
- Study completion
- 2012
- First posted
- Sep 13, 2010
- Registry last updated
- Mar 29, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.