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The Impact of Pack Supply on Birth Control Pill Continuation (SixPack)

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ClinicalTrials.gov Identifier: NCT00677742
Recruitment Status : Completed
First Posted : May 14, 2008
Last Update Posted : December 12, 2012
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Oral Contraception Other: enhanced initial supply of oral contraception Other: conventional initial supply of oral contraception

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  (Clinical Trial)
Actual Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of Pack Supply on Oral Contraception Continuation
Study Start Date : June 2007
Primary Completion Date : April 2009
Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
enhanced initial supply of oral contraception
Other: enhanced initial supply of oral contraception
7 packs of pills, or 1 pack of pills and a prescription for 6 refills
Active Comparator: 2
conventional initial supply of oral contraception
Other: conventional initial supply of oral contraception
3 packs of pills, or 1 pack of pills and a prescription for 2 refills

Outcome Measures

Primary Outcome Measures :
  1. oral contraception continuation [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 35 Years   (Child, Adult)
Sexes Eligible for Study:   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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00677742

United States, New York
Columbia University Medical Center, Family Planning Clinic
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Centers for Disease Control and Prevention
Principal Investigator: Katharine O'Connell, MD, MPH Columbia University
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: 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
ClinicalTrials.gov Identifier: NCT00677742     History of Changes
Other Study ID Numbers: AAAC1723
1 FPRPA0060250100
First Posted: May 14, 2008    Key Record Dates
Last Update Posted: December 12, 2012
Last Verified: December 2012

Keywords provided by Carolyn L. Westhoff, Columbia University:
oral contraception
hormonal contraception
contraceptive behavior
patient compliance