Skip to main content
OpenTrials
Completed

NCT Number: NCT00677742

The Impact of Pack Supply on Birth Control Pill Continuation

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

Up to 35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Medical Center, Family Planning Clinic

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

enhanced initial supply of oral contraception

Other

7 packs of pills, or 1 pack of pills and a prescription for 6 refills

conventional initial supply of oral contraception

Other

3 packs of pills, or 1 pack of pills and a prescription for 2 refills

Primary outcomes

  1. oral contraception continuation

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Official study title

Impact of Pack Supply on Oral Contraception Continuation

Acronym: SixPack

Important dates

Study start
2007
Primary completion
2009
Study completion
2012
First posted
May 14, 2008
Registry last updated
Dec 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.