Acceptablity of the NuvaRing Among Students

Condition(s) targeted: Birth Control Compliance

Intervention: Ortho Tri-cyclen Lo (Drug); NuvaRing (Device)

Phase: Phase 4

Status: Recruiting

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

Overall contact:
Amy B Neustadt, MPH, Phone: 773-834-3890, Email: aneustadt@babies.bsd.uchicago.edu

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.

Official title: Acceptablity of the NuvaRing Among College and Graduate Students

Study design: Other, Randomized, Open Label, Uncontrolled, Parallel Assignment

Primary outcome: Satisfaction/Acceptablity

Secondary outcome:

Compliance

Side effects

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.

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 OC 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

Amy B Neustadt, MPH, Phone: 773-834-3890, Email: aneustadt@babies.bsd.uchicago.edu

University of Chicago, Section of Family Planning, Chicago, Illinois 60637, United States; Recruiting
Melissa L Gilliam, MD, MPH, Principal Investigator

University of Chicago, Chicago, Illinois 60637, United States; Recruiting
Melissa Gilliam, MD MPH, Principal Investigator
Sabrina Holmquist, MD MPH, Sub-Investigator
Lisa Memmel, MD, Sub-Investigator
Sara Mornar, MD, Sub-Investigator
Mishka Terplan, MD MPH, Sub-Investigator
Amy Whitaker, MD, Sub-Investigator

University of Illinois, Chicago, Illinois, United States; Active, not recruiting

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
Ending date: July 2009
Last updated: July 2, 2008