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.

Condition	Intervention
Contraception	Drug: vaginal contraceptive ring and birth control pill

Further Study Details: 

Primary Outcomes: The primary outcome is to conduct a randomized controlled-trial comparing acceptability of the NuvaRing® to oral contraceptive pills among college women.
Secondary Outcomes: The secondary outcome is to compare rates of bleeding and compliance among college women using NuvaRing® with those using oral contraceptive pills.
Expected Total Enrollment:  300

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.

Ages Eligible for Study:  18 Years   -   26 Years,  Genders Eligible for Study:  Female

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

• 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
• 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00145899

Melissa Gilliam, MD, MPH      773-834-0840    mgilliam@babies.bsd.uchicago.edu
Peggy Bennett, RN, BSN      773-702-9228    pbennett@medicine.bsd.uchicago.edu

Illinois
      University of Chicago, Chicago,  Illinois,  60637,  United States
      University of Illinois at Chicago, Chicago,  Illinois,  60607,  United States

Study chairs or principal investigators

Melissa Gilliam, MD,  Principal Investigator,  University of Chicago   

Study ID Numbers:  IRB#14067B
Last Updated:  September 2, 2005
Record first received:  September 1, 2005
ClinicalTrials.gov Identifier:  NCT00145899
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-06