ContraceptionNCT00253019
A Comparison of Continuation Rates for Three Hormonal Contraceptive Methods
An observational study of Contraception, run by Emory University at 1 site in United States.
Trial summary
This study will assess the continuation rates among women using oral contraceptive pills, Depo-Provera and Ortho Evra following a first trimester abortion. Read more about this study
- Who is it for?
- Ages 13 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- How many people
- 321 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Nov 2005
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 13 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Participants were recruited from a indigent, urban, African American population.
Who may be able to join
- Age 13-45 women presenting at the ambulatory surgery at Grady Memorial Hospital who want to use either oral contraceptive pills, ortho evra or depo provera?
Who cannot join
- Leaving the Atlanta area within 6 months?
- Desires pregnancy within the next 6 months?
- Unable to provide contact information?
- Contraindications to hormonal contraceptive?
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Continuation Rates for Three Hormonal Contraceptive Methods (Oral Contraceptive Pills, Depo Provera and Ortho Evra) Among Women Seeking First Trimester Abortion.
This study will assess the continuation rates among women using oral contraceptive pills, Depo-Provera and Ortho Evra following a first trimester abortion.
Read the detailed description
Unintended pregnancy rates among women in the United States continue to surpass that of the rest of the developed world at great cost to society. Contraceptive failure has been attributed to poor compliance with contraceptive methods and results in unintended pregnancies. This study will evaluate the 3-month continuation rates among women using the oral contraceptive pill and Depo-Provera. It will also assess the continuation rates of Ortho Evra®, which has not previously been studied in the adolescent population. This study will provide information with regard to pregnancy rates and 3-month patterns of use of contraception among women seeking first-trimester abortion. It will also assess other factors contributing to successful contraception such as the use of emergency contraception and concomitant condom use. The results of this study will be used to inform the practice of providers who provide reproductive health care to women and add to the sparse body of literature available comparing the success of different contraceptive methods used by women.
- Conditions
- Contraception
- Keywords
- birth control, continuation, abortion, contraception
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuation Rates
We followed subjects to evaluate the continuation rates for subjects receiving oral contraceptive pills, Depo Provera and Ortho Evra.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2005 (estimated)
- Study startOct 2004
- Primary completionNov 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by Emory 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 321 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carrie Cwiak, Emory University
- Investigators
- Carrie Cwiak, MD, MPH, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00253019
- Sponsor's protocol ID
- 518-2003
- Status last verified
- Aug 2013
- First submitted
- 14 Nov 2005
- Last updated
- 21 Aug 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Continuation Rates for Three Hormonal Contraceptive Methods (Oral Contraceptive Pills, Depo Provera and Ortho Evra) Among Women Seeking First Trimester Abortion.
- ClinicalTrials.gov ID
- NCT00253019
- Acronym / sponsor ID
- 518-2003
- Conditions
- Contraception
- Keywords
- birth control, continuation, abortion, contraception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 321 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Oct 2004
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 15 Nov 2005 (estimated)
- Results
- Posted 9 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the continuation rates among women using oral contraceptive pills, Depo-Provera and Ortho Evra following a first trimester abortion.
Detailed description
Unintended pregnancy rates among women in the United States continue to surpass that of the rest of the developed world at great cost to society. Contraceptive failure has been attributed to poor compliance with contraceptive methods and results in unintended pregnancies. This study will evaluate the 3-month continuation rates among women using the oral contraceptive pill and Depo-Provera. It will also assess the continuation rates of Ortho Evra®, which has not previously been studied in the adolescent population. This study will provide information with regard to pregnancy rates and 3-month patterns of use of contraception among women seeking first-trimester abortion. It will also assess other factors contributing to successful contraception such as the use of emergency contraception and concomitant condom use. The results of this study will be used to inform the practice of providers who provide reproductive health care to women and add to the sparse body of literature available comparing the success of different contraceptive methods used by women.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 13 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Participants were recruited from a indigent, urban, African American population.
Key inclusion criteria (1 listed)
- Age 13-45 women presenting at the ambulatory surgery at Grady Memorial Hospital who want to use either oral contraceptive pills, ortho evra or depo provera?
Key exclusion criteria (4 listed)
- Leaving the Atlanta area within 6 months?
- Desires pregnancy within the next 6 months?
- Unable to provide contact information?
- Contraindications to hormonal contraceptive?
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Continuation Rates
Time frame: 3 months
We followed subjects to evaluate the continuation rates for subjects receiving oral contraceptive pills, Depo Provera and Ortho Evra.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Carrie Cwiak, MD, MPH principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contraception, run by Emory 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 1 inclusion and 4 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 21 Aug 2013. 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?
Yes. Results are posted in the registry (first posted 9 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Continuation Rates (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2013.