NCT01334190

Brief Summary

This will be a non-comparative prospective observational study of women using Zarin as a primary method of contraception in Kenya. It will be conducted in close collaboration with the Kenya MoH in several MoH-affiliated clinics that have experience with implants and sufficient expected flow of implant users per month. The investigators will enroll a total of 600 women divided into two cohorts in this one-year prospective study:

  • a prospective cohort consisting of 300 women who will be followed-up 3 and 12 months after enrollment; and
  • a surveillance cohort of 300 women who will report back to the clinic during 12 months after enrollment only if they have complications, medical problems, pregnancy, or want to remove the implant The main study outcomes are pregnancy, immediate and delayed complications associated with insertion or removal, adverse events, early discontinuation and reasons for discontinuation, and level of women's satisfaction with Zarin services.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
602

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2011

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

April 11, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 13, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

July 2, 2013

Status Verified

July 1, 2013

Enrollment Period

1.7 years

First QC Date

April 11, 2011

Last Update Submit

July 1, 2013

Conditions

Contraceptive Usage

Keywords

AE adverse eventAIDS acquired immunodeficiency syndromeALT (SGPT) alanine aminotransferaseART antiretroviral therapyAST (SGOT) aspartate aminotransferaseDCF data collection formsDMC Data Monitoring CommitteeFDA (U.S.) Food and Drug AdministrationGCP Good Clinical Practice guidelinesHB sAg Hepatitis B surface antigenICH International Conference of HarmonisationIND Investigational New Drug ApplicationIRB Institutional Review BoardIU international unitsmg milligram(s)mm3 cubic millimeter(s)PCR polymerase chain reactionSAE serious adverse eventµg microgramULN upper limit of the normal rangeWB Western Blotpost-marketing monitoringsafetyefficacyacceptability

Outcome Measures

Primary Outcomes (1)

  • The cumulative probability of pregnancy

    1 year

Secondary Outcomes (5)

  • Prevalence and incidence rates of immediate and delayed complications associated with insertion or removal

    1 year

  • Prevalence and incidence rate of adverse events

    1 year

  • The cumulative probability of early discontinuation of Zarin through one year

    1 year

  • Reasons for discontinuation

    1 year

  • Level of women's satisfaction with Zarin services

    1 year

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

healthy women aged 18-44

You may qualify if:

  • be aged 18-44 years, inclusive
  • be willing to sign an informed consent document
  • be willing to give contact information for follow up
  • agree to return for follow-up visits
  • have decided to receive Zarin as a method of contraception and met the clinic criteria for eligibility of this method of contraception

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FHI

Nairobi, Nairobi County, Kenya

Location

MeSH Terms

Conditions

Contraception BehaviorAcquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Reproductive BehaviorBehaviorHIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Vera Halpern, MD

    FHI 360

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2011

First Posted

April 13, 2011

Study Start

June 1, 2011

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

July 2, 2013

Record last verified: 2013-07

Locations

KE(1)