Long-term and Permanent Contraceptive Methods Clinical Trial
Official title:
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.
| 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: |
N/A
| Country | Name | City | State |
|---|---|---|---|
| Madagascar | Marie Stopes Madagascar Mobile Outreach Sites and Static Clinics | Madagascar |
| Lead Sponsor | Collaborator |
|---|---|
| FHI 360 | Bill and Melinda Gates Foundation, Marie Stopes International |
Madagascar,
| 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 |