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

This study has been completed.
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
Marie Stopes International
Information provided by (Responsible Party):
FHI 360
ClinicalTrials.gov Identifier:
NCT01200576
First received: September 10, 2010
Last updated: March 28, 2013
Last verified: March 2013
  Purpose

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
Long-term and Permanent Contraceptive Methods

Study Type: Observational
Official Title: A Prospective Observational Study of the Clinical Performance of Zarin in Madagascar

Resource links provided by NLM:


Further study details as provided by FHI 360:

Primary Outcome Measures:
  • The cumulative probability of pregnancy through one year [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Prevalence and incidence rate of adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Prevalence and incidence rates of immediate and delayed complications associated with insertion or removal [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • The cumulative probability of early discontinuation through one year [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Reasons for discontinuation [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 621
Study Start Date: October 2010
Study Completion Date: March 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
healthy volunteers

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.

  Eligibility

Genders 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:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01200576

Locations
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
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
  More Information

No publications provided

Responsible Party: FHI 360
ClinicalTrials.gov Identifier: NCT01200576     History of Changes
Other Study ID Numbers: 10225
Study First Received: September 10, 2010
Last Updated: March 28, 2013
Health Authority: United States: Institutional Review Board
Madagascar: Ministry of Health

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

ClinicalTrials.gov processed this record on November 20, 2014