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Clinical Trials/NCT00677742
NCT00677742CompletedNot Applicable

Impact of Pack Supply on Oral Contraception Continuation

Columbia University1 site in 1 country700 target enrollmentStarted: June 2007Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
700
Locations
1
Primary Endpoint
oral contraception continuation

Study Overview

Brief Summary

The purpose of this study is to determine whether getting more packs of birth control pills leads to improved continuation, when compared with getting the traditional supply.

Detailed Description

Discontinuation of oral contraceptive use in the initial months is common; successful early continuation is predictive of long term continuation and prevention of unintended pregnancy. The conventional approach to initiation of hormonal contraceptives in publicly funded clinics across the United States is to give the patient a limited supply of OCs, or a prescription with a limited number of refills, and then have her return to the clinic for a refill. This approach requires the patient to make frequent visits to the clinic, a barrier to method continuation.

This randomized trial will evaluate a simple but potentially powerful change in family planning clinic practice, i.e., the effect of dispensing more versus fewer cycles of oral contraception (OC). The study will be carried out in an urban, publicly funded family planning clinic that serves a population that is poor, young and primarily Hispanic or AfricanAmerican. This population was targeted as its members are at increased risk of discontinuing contraception in the first year of use.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
— to 35 Years (Child, Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • English or Spanish speaker
  • age less than or equal to 35 years requesting OC as their primary method of contraception
  • currently sexually active or anticipating sexual activity within the next 30 days

Exclusion Criteria

  • contraindications to oral contraceptives per clinic protocol (e.g., hypertension and pregnancy)
  • currently using OCs (that is, current users requesting a routine refill)
  • desiring pregnancy within the next 6 months
  • leaving the clinic catchment area within 6 months
  • previous participation in this study

Outcomes

Primary Outcomes

oral contraception continuation

Time Frame: 6 months

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Carolyn L. Westhoff

Professor of Obstetrics and Gynecology, Population and Family Health and Epidemiology at the New York-Presbyterian Hospital at the Columbia University Medical Center

Columbia University

Study Sites (1)

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