The Impact of Pack Supply on Birth Control Pill Continuation
SixPack
Impact of Pack Supply on Oral Contraception Continuation
2 other identifiers
interventional
700
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2007
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 12, 2008
CompletedFirst Posted
Study publicly available on registry
May 14, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedDecember 12, 2012
December 1, 2012
1.8 years
May 12, 2008
December 11, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
oral contraception continuation
6 months
Study Arms (2)
1
EXPERIMENTALenhanced initial supply of oral contraception
2
ACTIVE COMPARATORconventional initial supply of oral contraception
Interventions
7 packs of pills, or 1 pack of pills and a prescription for 6 refills
3 packs of pills, or 1 pack of pills and a prescription for 2 refills
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Columbia Universitylead
- Centers for Disease Control and Preventioncollaborator
Study Sites (1)
Columbia University Medical Center, Family Planning Clinic
New York, New York, 10032, United States
Related Publications (1)
White KO, Westhoff C. The effect of pack supply on oral contraceptive pill continuation: a randomized controlled trial. Obstet Gynecol. 2011 Sep;118(3):615-622. doi: 10.1097/AOG.0b013e3182289eab.
PMID: 21860291DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Katharine O'Connell, MD, MPH
Columbia University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Obstetrics and Gynecology, Population and Family Health and Epidemiology at the New York-Presbyterian Hospital at the Columbia University Medical Center
Study Record Dates
First Submitted
May 12, 2008
First Posted
May 14, 2008
Study Start
June 1, 2007
Primary Completion
April 1, 2009
Study Completion
November 1, 2012
Last Updated
December 12, 2012
Record last verified: 2012-12