Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Columbia University Centers for Disease Control and Prevention |
---|---|
Information provided by: | Columbia University |
ClinicalTrials.gov Identifier: | NCT00677742 |
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 | Intervention |
---|---|
Healthy Volunteers |
Other: enhanced initial supply of oral contraception Other: conventional initial supply of oral contraception |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Impact of Pack Supply on Oral Contraception Continuation |
Estimated Enrollment: | 750 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
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
|
2: Active Comparator
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
|
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.
Ages Eligible for Study: | up to 35 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
Columbia University Medical Center, Family Planning Clinic | |
New York, New York, United States, 10032 |
Principal Investigator: | Katharine O'Connell, MD, MPH | Columbia University |
Responsible Party: | Columbia University ( Katharine O'Connell, MD (Principal Investigator) ) |
Study ID Numbers: | AAAC1723, 1 FPRPA0060250100 |
Study First Received: | May 12, 2008 |
Last Updated: | July 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00677742 |
Health Authority: | United States: Institutional Review Board |
oral contraception hormonal contraception contraceptive behavior patient compliance Contraceptive behavior |
Healthy |