Birth Control CompliancePhase 4ACCEPTNCT00635570
Acceptability of the NuvaRing Among Students
A Phase 4 study testing Ortho Tri-cyclen Lo and NuvaRing in people with Birth Control Compliance, run by University of Chicago at 3 sites in United States.
Trial summary
The ACCEPT study is a Phase IV trial in which women are randomized to either the NuvaRing® vaginal contraceptive ring or a low dose oral contraceptive to assess compliance, side effects, overall acceptability and intent to continue use of the method. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Birth Control Compliance
- What is being tested?
- Ortho Tri-cyclen Lo and NuvaRing
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 273 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2008to Jul 2009
- Phase
- Phase 4
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- over 18
- student enrolled in college or graduate program
- Not have used the contraceptive patch or oral contraceptives within the last month
- Never have used a contraceptive vaginal ring
- Interested in using hormonal contraceptives, specifically NuvaRing and oral contraceptive pills for next 3 months
- In general good health
- Premenopausal with the ability to menstruate
Who cannot join
- Known or suspected pregnancy
- Pregnancy within 2 months of trial medication
- Past use of any contraceptive vaginal ring
- Hypersensitivity or allergy to NuvaRing or Oral Contraceptives
- Use of investigational drug within 2 months of start of trial medication
- Use of the contraceptive patch or oral contraceptives within past month
- Use of any injectable contraception within 6 months of trial medication
- Planning pregnancy in next 6 months
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Chicago, Section of Family Planning
Chicago, Illinois, 60637
University of Chicago
Chicago, Illinois, 60637
University of Illinois
Chicago, Illinois
About this study
Official title: Acceptability of the NuvaRing Among College and Graduate Students
The ACCEPT study is a Phase IV trial in which women are randomized to either the NuvaRing® vaginal contraceptive ring or a low dose oral contraceptive to assess compliance, side effects, overall acceptability and intent to continue use of the method. The study is focused on the acceptability of the vaginal ring among female undergraduate or graduate students.
Read the detailed description
For many women, college is a time of great change that affects one's social and behavioral practices, including sexual behavior. The first part of the NuvaRing ® Acceptability study is an online survey, developed in conjunction with the University of Illinois's Survey Research Laboratory, which examines women's attitudes and beliefs regarding various methods of birth control. The second part of the study is a comparison trial in which the women are randomized to either the NuvaRing ® vaginal contraceptive ring or a low dose oral contraceptive. The women are followed for three months to assess compliance, side effects, overall acceptability and intent to continue use of the method. Ultimately, we would like college women to be well informed about various methods of contraception available to them and to choose the contraceptive method that best suits their lifestyle.
- Conditions
- Birth Control Compliance
- Being tested
- Ortho Tri-cyclen Lo, NuvaRing
- Keywords
- Contraception, Compliance, Acceptability
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ortho Tri-cyclen LoDrug
Low dose oral contraceptive
NuvaRingDevice
Contraceptive vaginal ring
| Study group | Role | What they receive |
|---|---|---|
| Contraceptive vaginal ring | Active comparator | Contraceptive vaginal ring (NuvaRing) Receives: Device: NuvaRing |
| Oral contraceptive pill | Active comparator | Oral contraceptive pill (Ortho Tri-cyclen Lo) Receives: Drug: Ortho Tri-cyclen Lo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence Rate (Rate of Perfect Method Use)
"Perfect use" was defined as reporting never missing a pill or never removing the contraceptive vaginal ring for more than 2 hours during days 1-21 of all three monthly cycles
Measured: For the first 3 months
Secondary outcomes (2)
Satisfaction Rate
Measured: at 3 months
Continuation Rate
Rate of intention to continue the contraceptive method at 3 months
Measured: at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2008 (estimated)
- Study startJul 2008
- Primary completionJan 2009
- Study completionJul 2009
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Birth Control ComplianceStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 273 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Organon
- Responsible party
- Sponsor
- Investigators
- Melissa L Gilliam, MD, MPH, Principal investigator, University of Chicago, Section of Family Planning
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00635570
- Sponsor's protocol ID
- 14067B
- Acronym
- ACCEPT
- Status last verified
- Jun 2013
- First submitted
- 5 Mar 2008
- Last updated
- 3 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Gilliam M, Holmquist S, Berlin A. Factors associated with willingness to use the contraceptive vaginal ring. Contraception. 2007 Jul;76(1):30-4. doi: 10.1016/j.contraception.2007.03.009. Epub 2007 May 24.
PubMed 17586133Gilliam ML, Neustadt A, Kozloski M, Mistretta S, Tilmon S, Godfrey E. Adherence and acceptability of the contraceptive ring compared with the pill among students: a randomized controlled trial. Obstet Gynecol. 2010 Mar;115(3):503-510. doi: 10.1097/AOG.0b013e3181cf45dc.
PubMed 20177280
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability of the NuvaRing Among College and Graduate Students
- ClinicalTrials.gov ID
- NCT00635570
- Acronym / sponsor ID
- ACCEPT / 14067B
- Conditions
- Birth Control Compliance
- Keywords
- Contraception, Compliance, Acceptability
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 273 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Organon
- Study start
- Jul 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 13 Mar 2008 (estimated)
- Results
- Posted 7 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The ACCEPT study is a Phase IV trial in which women are randomized to either the NuvaRing® vaginal contraceptive ring or a low dose oral contraceptive to assess compliance, side effects, overall acceptability and intent to continue use of the method. The study is focused on the acceptability of the vaginal ring among female undergraduate or graduate students.
Detailed description
For many women, college is a time of great change that affects one's social and behavioral practices, including sexual behavior. The first part of the NuvaRing ® Acceptability study is an online survey, developed in conjunction with the University of Illinois's Survey Research Laboratory, which examines women's attitudes and beliefs regarding various methods of birth control. The second part of the study is a comparison trial in which the women are randomized to either the NuvaRing ® vaginal contraceptive ring or a low dose oral contraceptive. The women are followed for three months to assess compliance, side effects, overall acceptability and intent to continue use of the method. Ultimately, we would like college women to be well informed about various methods of contraception available to them and to choose the contraceptive method that best suits their lifestyle.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contraceptive vaginal ring | Active comparator | Device: NuvaRingContraceptive vaginal ring (NuvaRing) |
| Oral contraceptive pill | Active comparator | Drug: Ortho Tri-cyclen LoOral contraceptive pill (Ortho Tri-cyclen Lo) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- over 18
- student enrolled in college or graduate program
- Not have used the contraceptive patch or oral contraceptives within the last month
- Never have used a contraceptive vaginal ring
- Interested in using hormonal contraceptives, specifically NuvaRing and oral contraceptive pills for next 3 months
Key exclusion criteria (8 listed)
- Known or suspected pregnancy
- Pregnancy within 2 months of trial medication
- Past use of any contraceptive vaginal ring
- Hypersensitivity or allergy to NuvaRing or Oral Contraceptives
- Use of investigational drug within 2 months of start of trial medication
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 |
|---|---|---|
| Ortho Tri-cyclen LoLow dose oral contraceptive | Drug | Oral contraceptive pill |
| NuvaRingContraceptive vaginal ring | Device | Contraceptive vaginal ring |
Primary outcome
Adherence Rate (Rate of Perfect Method Use)
Time frame: For the first 3 months
"Perfect use" was defined as reporting never missing a pill or never removing the contraceptive vaginal ring for more than 2 hours during days 1-21 of all three monthly cycles
2 secondary outcomes
Satisfaction Rate
Time frame: at 3 months
Continuation Rate
Time frame: at 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17586133Gilliam M, Holmquist S, Berlin A. Factors associated with willingness to use the contraceptive vaginal ring. Contraception. 2007 Jul;76(1):30-4. doi: 10.1016/j.contraception.2007.03.009. Epub 2007 May 24.
- Derived from this study: PubMed 20177280Gilliam ML, Neustadt A, Kozloski M, Mistretta S, Tilmon S, Godfrey E. Adherence and acceptability of the contraceptive ring compared with the pill among students: a randomized controlled trial. Obstet Gynecol. 2010 Mar;115(3):503-510. doi: 10.1097/AOG.0b013e3181cf45dc.
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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.
Melissa L Gilliam, MD, MPH principal investigator
University of Chicago, Section of Family Planning
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ortho Tri-cyclen Lo and NuvaRing in people with Birth Control Compliance, run by University of Chicago at 3 sites 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 7 inclusion and 8 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 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Nov 2012). 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?
Adherence Rate (Rate of Perfect Method Use) (time frame: For the first 3 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 NCT00635570, which also lists 2 linked publications.
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 3 Feb 2021.