NCT01200576

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
621

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 13, 2010

Completed
18 days until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

March 29, 2013

Status Verified

March 1, 2013

Enrollment Period

1.3 years

First QC Date

September 10, 2010

Last Update Submit

March 28, 2013

Conditions

Long-term and Permanent Contraceptive Methods

Keywords

CRF: Case Report FormDM: Data ManagementFHI: FHI (formerly known as Family Health International)IRB: Institutional Review BoardIUD: Intra-uterine DeviceLTPM: Long-term and Permanent Contraceptive MethodsMSI: Marie Stopes InternationalMSM: Marie Stopes MadagascarPHSC: Protection of Human Subjects CommitteePI: Principal InvestigatorSAE: Serious Adverse EventSino-Implant (II)SOP: Standard Operating ProcedureZarin

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (1)

1

healthy volunteers

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

healthy women of any age

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marie Stopes Madagascar Mobile Outreach Sites and Static Clinics

Madagascar, Madagascar

Location

Study Officials

  • 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

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2010

First Posted

September 13, 2010

Study Start

October 1, 2010

Primary Completion

February 1, 2012

Study Completion

March 1, 2012

Last Updated

March 29, 2013

Record last verified: 2013-03

Locations

MA(1)