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CompletedNCT01200576Updated Mar 29, 2013

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

An observational study in Long-term and Permanent Contraceptive Methods, sponsored by FHI 360. Completed at 1 site in Madagascar. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-03-29.

Sponsored by FHI 360 · Observational

Study type
Observational
Enrollment
621
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Long-term and Permanent Contraceptive Methods

Keywords

  • 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
03

In context

Lead sponsor

FHI 360 is the lead sponsor of 59 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

healthy women of any age

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

Exclusion Criteria:

-

05

Study design

Enrollment
621 participants (actual)
Patient registry
No

Groups and cohorts

  • 1

    healthy volunteers

06

What researchers measure

Primary outcomes

  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

07

Study locations

1 site
  • Marie Stopes Madagascar Mobile Outreach Sites and Static Clinics
    Madagascar, Madagascar
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01200576
Lead sponsor
FHI 360
Collaborators
Bill and Melinda Gates Foundation, Marie Stopes International
Responsible party
Sponsor
First posted
Sep 13, 2010
Start date
Oct 2010
Primary completion
Feb 2012
Completion
Mar 2012
Last update
Mar 29, 2013

Study contacts

Odile Hanitriniaina, MD
principal investigator · Marie Stopes International
Kristen Hopkins
study chair · Marie Stopes International
Tania Boler
principal investigator · Marie Stopes International
Markus Steiner, Ph.D.
principal investigator · FHI 360

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.

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