Clinical trial NCT00635570: Acceptability of the NuvaRing Among Students
Official title: Acceptability of the NuvaRing Among College and Graduate Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Birth Control Compliance
Keywords: Contraception, Compliance, Acceptability
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Organon
First posted: 2008-03-13
Enrollment: 273
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

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 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

Primary outcomes:
measure: Adherence Rate (Rate of Perfect Method Use)
timeFrame: For the first 3 months
Secondary outcomes:
measure: Satisfaction Rate
timeFrame: at 3 months
measure: Continuation Rate
timeFrame: at 3 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago, Section of Family Planning
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Chicago
country: United States
facility: University of Illinois
state: Illinois
Study officials:
affiliation: University of Chicago, Section of Family Planning
name: Melissa L Gilliam, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Gilliam 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.