Acceptability of the NuvaRing Among Students

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.

• Ortho Tri-cyclen Lo (Drug): Low dose oral contraceptive
• NuvaRing (Device): Contraceptive vaginal ring

Primary outcomes

• Adherence Rate (Rate of Perfect Method Use) [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

Secondary outcomes

• Satisfaction Rate [at 3 months]
• Continuation Rate [at 3 months]: Rate of intention to continue the contraceptive method at 3 months

Sex: Female, ages: 18 Years to any, accepts healthy volunteers

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

Participant flow

Outcome results

• Adherence Rate (Rate of Perfect Method Use) (Primary), Number, Percentage of Participants: Contraceptive Vaginal Ring 57; Oral Contraceptive Pill 45 (p 0.05)
• Satisfaction Rate (Secondary), Number, Percentage of Participants: Contraceptive Vaginal Ring 68; Oral Contraceptive Pill 71 (p >0.05)
• Continuation Rate (Secondary), Number, Percentage of Participants: Contraceptive Vaginal Ring 43; Oral Contraceptive Pill 52 (p >0.05)
• Continuation Rate (Post hoc), Number, Percentage of Participants: Contraceptive Vaginal Ring 26; Oral Contraceptive Pill 29 (p >0.05)

Adverse events

Time frame: 6 months

Other adverse events by term

Limitations and caveats: This study is an randomized controlled trial offering internal but not necessarily external validity. Thus, we do not know whether these findings would be replicable in other populations.

• 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. PMID 17586133
• Results publication: 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. PMID 20177280

• Melissa L Gilliam, MD, MPH, Principal investigator, University of Chicago, Section of Family Planning