Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Bill and Melinda Gates Foundation | OTHER |
| Marie Stopes International | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | healthy volunteers |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| The cumulative probability of pregnancy through one year | 1 year | |
| Prevalence and incidence rate of adverse events | 1 year | |
| Prevalence and incidence rates of immediate and delayed complications associated with insertion or removal | 1 year | |
| The cumulative probability of early discontinuation through one year | 1 year | |
| Reasons for discontinuation | 1 year |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
-
Not provided
Not provided
Not provided
Not provided
healthy women of any age
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Odile Hanitriniaina, MD | Marie Stopes International | Principal Investigator |
| Kristen Hopkins | Marie Stopes International | Study Chair |
| Tania Boler | Marie Stopes International | Principal Investigator |
| Markus Steiner, Ph.D. | FHI 360 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marie Stopes Madagascar Mobile Outreach Sites and Static Clinics | Madagascar | Madagascar |
Not provided