Acceptability of the NuvaRing Among Students
Information source: University of Chicago
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Birth Control Compliance
Intervention: Ortho Tri-cyclen Lo (Drug); NuvaRing (Device)
Phase: Phase 4
Status: Completed
Sponsored by: University of Chicago Official(s) and/or principal investigator(s): Melissa L Gilliam, MD, MPH, Principal Investigator, Affiliation: University of Chicago, Section of Family Planning
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. The study is
focused on the acceptability of the vaginal ring among female undergraduate or graduate
students.
Clinical Details
Official title: Acceptability of the NuvaRing Among College and Graduate Students
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
Primary outcome: Adherence Rate (Rate of Perfect Method Use)
Secondary outcome: Satisfaction RateContinuation Rate
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Locations and Contacts
University of Chicago, Chicago, Illinois 60637, United States
University of Chicago, Section of Family Planning, Chicago, Illinois 60637, United States
University of Illinois, Chicago, Illinois, United States
Additional Information
Section of Family Planning web site
Related publications: Gilliam M, Holmquist S, Berlin A. Factors associated with willingness to use the contraceptive vaginal ring. Contraception. 2007 Jul;76(1):30-4. Epub 2007 May 24.
Starting date: July 2008
Last updated: June 24, 2013
|