The Impact of Pack Supply on Birth Control Pill Continuation

Oral Contraception Clinical Trial

— SixPack  

Official title:

Impact of Pack Supply on Oral Contraception Continuation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00677742
• Other study ID #: AAAC1723
• Secondary ID: 1 FPRPA006025010
• Status: Completed
• Phase: N/A
• First received: May 12, 2008
• Last updated: December 11, 2012
• Start date: June 2007
• Est. completion date: November 2012

Study information

• Verified date: December 2012
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: November 2012
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Oral Contraception

Intervention

Other:
• enhanced initial supply of oral contraception
7 packs of pills, or 1 pack of pills and a prescription for 6 refills
• conventional initial supply of oral contraception
3 packs of pills, or 1 pack of pills and a prescription for 2 refills

Locations

Country	Name	City	State
United States	Columbia University Medical Center, Family Planning Clinic	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	oral contraception continuation		6 months	No