Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Text Size

A Prospective Observational Study of the Performance of Zarin in Kenya

This study has been completed.
Sponsor:
Collaborator:
United States Agency for International Development (USAID)
Information provided by (Responsible Party):
FHI 360
ClinicalTrials.gov Identifier:
NCT01334190
First received: April 11, 2011
Last updated: July 1, 2013
Last verified: July 2013
History of Changes
  Purpose

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.


Condition
Contraceptive Usage

Study Type: Observational
Official Title: A Prospective Observational Study of the Performance of Zarin in Kenya

Further study details as provided by FHI 360:

Primary Outcome Measures:
  • The cumulative probability of pregnancy [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prevalence and incidence rates of immediate and delayed complications associated with insertion or removal [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Prevalence and incidence rate of adverse events [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • The cumulative probability of early discontinuation of Zarin through one year [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Reasons for discontinuation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Level of women's satisfaction with Zarin services [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Enrollment: 602
Study Start Date: June 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
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

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.

  Eligibility
Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
healthy women aged 18-44
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01334190

Locations
Kenya
FHI
Nairobi, Kenya
Sponsors and Collaborators
FHI 360
United States Agency for International Development (USAID)
Investigators
Principal Investigator: Vera Halpern, MD FHI 360
  More Information

Responsible Party: FHI 360
ClinicalTrials.gov Identifier: NCT01334190     History of Changes
Other Study ID Numbers: 10264 
Study First Received: April 11, 2011
Last Updated: July 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by FHI 360:
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

ClinicalTrials.gov processed this record on September 29, 2016