Acceptability of NuvaRing to College Women

Condition(s) targeted: Contraception

Intervention: vaginal contraceptive ring and birth control pill (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: University of Chicago

Official(s) and/or principal investigator(s):
Melissa Gilliam, MD, Principal Investigator, Affiliation: University of Chicago

Overall contact:
Melissa Gilliam, MD, MPH, Phone: 773-834-0840, Email: mgilliam@babies.bsd.uchicago.edu

The purpose of this study is to compare the use and attitudes of the vaginal contraceptive ring NuvaRing® to the oral contraceptive pill Ortho Tri-Cyclen® Lo among college women. Both NuvaRing® and OrthoTricyclen® Lo are approved for use by the Food and Drug Administration (FDA). The information gathered from this study may help improve contraceptive use among college women.

Official title: Acceptability of NuvaRing to College Women

Study design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment

Primary outcome: The primary outcome is to conduct a randomized controlled-trial comparing acceptability of the NuvaRing® to oral contraceptive pills among college women.

Secondary outcome: The secondary outcome is to compare rates of bleeding and compliance among college women using NuvaRing® with those using oral contraceptive pills.

Detailed description: The objective of this study is to compare the acceptability of NuvaRing® versus oral contraceptive pills among college women. Study participants will undergo an enrollment visit consisting of: history and physical examination, baseline questionnaire, randomization, contraceptive counseling and distribution. Women will be contacted at 6 months following study completion to determine continuation rates of the method to which they were randomized. During the study period, all data collection will be via automatic electronic mail reminders, and participants will complete all study instruments via intranet. All study instruments will be developed and administered in conjunction with the UIC Center for Advanced Distance Education (CADE). Acceptability data will be collected on a daily basis, at baseline and three months via an electronic survey. Descriptive statistics will be used to summarize survey data. This research is relevant, as it will provide important data on whether NuvaRing® is more acceptable to college students than OCs. As college females represent a large population of females at risk for unintended pregnancy, such knowledge could have important public health implications. It will provide unique information on the daily events associated with contraceptive use among women with high amounts of physical activity and irregular daily schedules. It will offer important information on the research methodology via electronic mail and internet. Finally, a campus-based study of a monthly contraceptive will provide an important contribution to the lack of literature on contraceptive compliance and acceptability.

Hypothesis: College students will have greater acceptance and better compliance with the vaginal contraceptive ring compared to oral contraceptives.

Minimum age: 18 Years. Maximum age: 26 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- University of Illinois at Chicago (UIC) and University of Chicago undergraduate

females ages 18-26 who intend to be enrolled at either university for the full study period will be eligible for this study.

- Over 18

- Currently using or interested in using oral contraceptives (OC)

- Interested in using hormonal contraceptives, specifically NuvaRing and OC for next 3

months

- In general good health

- Premenopausal with the ability to menstruate

- Willing to avoid use of intravaginal products such as douches, medications, and

spermicides while participating in study

- Willing and able to sign informed consent

- Willing and able to comply with study protocol and scheduled visits

Exclusion Criteria:

- Known or suspected pregnancy

- Pregnancy within 2 months of trial medication

- Contraindications for combined hormonal contraceptive method

- Hypersensitivity or allergy to NuvaRing or oral contraceptives

- Use of the following within 2 months of start of trial medications:

- Hydantoins

- Barbiturates

- Primidone

- Carbamazepine

- Oxcarbazepine

- Topiramate

- Felbamate

- Rifampin

- Griseofulvin

- Sex steroids (other than pre- and post- trial contraceptive method)

- St. John’s wort

- Use of investigational drug within 2 months of start of trial medication

- Past use of any contraceptive vaginal ring

- Use of any injectable contraception within 6 months of trial medication

- Planning pregnancy in next 6 months

- Any condition determined by investigator to contraindicate participation in study

Melissa Gilliam, MD, MPH, Phone: 773-834-0840, Email: mgilliam@babies.bsd.uchicago.edu

University of Chicago, Chicago, Illinois 60637, United States; Recruiting
Melissa GIlliam, MD, MPH, Phone: 773-702-0840, Email: mgilliam@babies.bsd.uchicago.edu
Peggy Bennett, RN, BSN, Phone: 773-702-9228, Email: pbennett@medicine.bsd.uchicago.edu
Melissa Gilliam, MD, MPH, Principal Investigator

University of Illinois at Chicago, Chicago, Illinois 60607, United States; Not yet recruiting
Allison Cowett, MD, MPH, Phone: 312-996-7430, Email: acowett@uic.edu
Allison Cowett, MD, MPH, Principal Investigator

Starting date: September 2005
Ending date: August 2010
Last updated: March 16, 2007