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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01200576
Recruitment Status : Completed
First Posted : September 13, 2010
Last Update Posted : March 29, 2013
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
Marie Stopes International
Information provided by (Responsible Party):
FHI 360

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.

Condition or disease
Long-term and Permanent Contraceptive Methods

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.

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Study Type : Observational
Actual Enrollment : 621 participants
Official Title: A Prospective Observational Study of the Clinical Performance of Zarin in Madagascar
Study Start Date : October 2010
Actual Primary Completion Date : February 2012
Actual Study Completion Date : March 2012

Group/Cohort
1
healthy volunteers



Primary Outcome Measures :
  1. The cumulative probability of pregnancy through one year [ Time Frame: 1 year ]
  2. Prevalence and incidence rate of adverse events [ Time Frame: 1 year ]
  3. Prevalence and incidence rates of immediate and delayed complications associated with insertion or removal [ Time Frame: 1 year ]
  4. The cumulative probability of early discontinuation through one year [ Time Frame: 1 year ]
  5. Reasons for discontinuation [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
healthy women of any age
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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01200576


Locations
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Madagascar
Marie Stopes Madagascar Mobile Outreach Sites and Static Clinics
Madagascar, Madagascar
Sponsors and Collaborators
FHI 360
Bill and Melinda Gates Foundation
Marie Stopes International
Investigators
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Principal Investigator: Odile Hanitriniaina, MD Marie Stopes International
Study Chair: Kristen Hopkins Marie Stopes International
Principal Investigator: Tania Boler Marie Stopes International
Principal Investigator: Markus Steiner, Ph.D. FHI 360
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Responsible Party: FHI 360
ClinicalTrials.gov Identifier: NCT01200576    
Other Study ID Numbers: 10225
First Posted: September 13, 2010    Key Record Dates
Last Update Posted: March 29, 2013
Last Verified: March 2013
Keywords provided by FHI 360:
CRF: Case Report Form
DM: Data Management
FHI: FHI (formerly known as Family Health International)
IRB: Institutional Review Board
IUD: Intra-uterine Device
LTPM: Long-term and Permanent Contraceptive Methods
MSI: Marie Stopes International
MSM: Marie Stopes Madagascar
PHSC: Protection of Human Subjects Committee
PI: Principal Investigator
SAE: Serious Adverse Event
Sino-Implant (II)
SOP: Standard Operating Procedure
Zarin