Oral ContraceptionSixPackNCT00677742
The Impact of Pack Supply on Birth Control Pill Continuation
A study testing enhanced initial supply of oral contraception and conventional initial supply of oral contraception in people with Oral Contraception, run by Columbia University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 35 years, women only
- Conditions the study is for
- Oral Contraception
- What is being tested?
- enhanced initial supply of oral contraception and conventional initial supply of oral contraception
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 35 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center, Family Planning Clinic
New York, New York, 10032
About this study
Official title: Impact of Pack Supply on Oral Contraception 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.
Read the 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.
- Conditions
- Oral Contraception
- Being tested
- enhanced initial supply of oral contraception, conventional initial supply of oral contraception
- Keywords
- oral contraception, hormonal contraception, contraceptive behavior, patient compliance
- Medical subject headings
- Contraception Behavior, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enhanced initial supply of oral contraceptionOther
7 packs of pills, or 1 pack of pills and a prescription for 6 refills
conventional initial supply of oral contraceptionOther
3 packs of pills, or 1 pack of pills and a prescription for 2 refills
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | enhanced initial supply of oral contraception Receives: Other: enhanced initial supply of oral contraception |
| 2 | Active comparator | conventional initial supply of oral contraception Receives: Other: conventional initial supply of oral contraception |
What is being measured
The primary outcome is the main question the study is designed to answer.
oral contraception continuation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2008 (estimated)
- Study startJun 2007
- Primary completionApr 2009
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral ContraceptionStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Carolyn L. Westhoff, Columbia University
- Investigators
- Katharine O'Connell, MD, MPH, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00677742
- Sponsor's protocol ID
- AAAC1723
- Other IDs
- 1 FPRPA0060250100
- Acronym
- SixPack
- Status last verified
- Dec 2012
- First submitted
- 12 May 2008
- Last updated
- 12 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21860291
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pack Supply on Oral Contraception Continuation
- ClinicalTrials.gov ID
- NCT00677742
- Acronym / sponsor ID
- SixPack / AAAC1723
- Conditions
- Oral Contraception
- Keywords
- oral contraception, hormonal contraception, contraceptive behavior, patient compliance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Jun 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 14 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: enhanced initial supply of oral contraceptionenhanced initial supply of oral contraception |
| 2 | Active comparator | Other: conventional initial supply of oral contraceptionconventional initial supply of oral contraception |
Who may qualify
- Ages
- Up to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| enhanced initial supply of oral contraception7 packs of pills, or 1 pack of pills and a prescription for 6 refills | Other | 1 |
| conventional initial supply of oral contraception3 packs of pills, or 1 pack of pills and a prescription for 2 refills | Other | 2 |
Primary outcome
oral contraception continuation
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2012.
- Derived from this study: PubMed 21860291White 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katharine O'Connell, MD, MPH principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing enhanced initial supply of oral contraception and conventional initial supply of oral contraception in people with Oral Contraception, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oral contraception continuation (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00677742, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2012.