A Prospective Observational Study of the Performance of Zarin in Kenya (NCT01334190)

Study 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.

Read the detailed description

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

Conditions studied

Contraceptive Usage

Keywords

AE adverse event
AIDS acquired immunodeficiency syndrome
ALT (SGPT) alanine aminotransferase
ART antiretroviral therapy
AST (SGOT) aspartate aminotransferase
DCF data collection forms
DMC Data Monitoring Committee
FDA (U.S.) Food and Drug Administration
GCP Good Clinical Practice guidelines
HB sAg Hepatitis B surface antigen
ICH International Conference of Harmonisation
IND Investigational New Drug Application
IRB Institutional Review Board
IU international units
mg milligram(s)
mm3 cubic millimeter(s)
PCR polymerase chain reaction
SAE serious adverse event
µg microgram
ULN upper limit of the normal range
WB Western Blot
post-marketing monitoring
safety
efficacy
acceptability

In context

Lead sponsor

FHI 360 is the lead sponsor of 56 studies on the registry; none are open to participants now.

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

Who can participate

Ages eligible: 18 Years to 44 Years
Sexes eligible: Female
Accepts healthy volunteers: Yes
Sampling method: Non-probability sample

Study population

healthy women aged 18-44

Eligibility criteria

Inclusion Criteria:

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

Study design

Enrollment: 602 participants (actual)

What researchers measure

Primary outcomes

The cumulative probability of pregnancy
Time frame: 1 year

Secondary outcomes

Prevalence and incidence rates of immediate and delayed complications associated with insertion or removal
Time frame: 1 year
Prevalence and incidence rate of adverse events
Time frame: 1 year
The cumulative probability of early discontinuation of Zarin through one year
Time frame: 1 year
Reasons for discontinuation
Time frame: 1 year
Level of women's satisfaction with Zarin services
Time frame: 1 year

Study locations

1 site

FHI
Nairobi, Kenya

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 2, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01334190
Lead sponsor: FHI 360
Collaborators: United States Agency for International Development (USAID)
Responsible party: Sponsor
First posted: Apr 13, 2011
Start date: Jun 2011
Primary completion: Feb 2013
Completion: Feb 2013
Last update: Jul 2, 2013

Study contacts

Vera Halpern, MD

principal investigator · FHI 360

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

A Prospective Observational Study of the Performance of Zarin in Kenya