MedDataX Logo

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

NCT ID: NCT01200576

Last Updated: 2013-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

621 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Long-term and Permanent Contraceptive Methods

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

healthy volunteers

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

\-
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bill and Melinda Gates Foundation

OTHER

Sponsor Role collaborator

Marie Stopes International

OTHER

Sponsor Role collaborator

FHI 360

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Odile Hanitriniaina, MD

Role: PRINCIPAL_INVESTIGATOR

Marie Stopes International

Kristen Hopkins

Role: STUDY_CHAIR

Marie Stopes International

Tania Boler

Role: PRINCIPAL_INVESTIGATOR

Marie Stopes International

Markus Steiner, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

FHI 360

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Marie Stopes Madagascar Mobile Outreach Sites and Static Clinics

Madagascar, , Madagascar

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Madagascar

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

10225

Identifier Type: -

Identifier Source: org_study_id