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Completed

NCT Number: NCT00635570

Acceptability of the NuvaRing Among Students

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of Chicago, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ortho Tri-cyclen Lo

Drug

Low dose oral contraceptive

Nuvaring

Device

Contraceptive vaginal ring

Primary outcomes

  1. Adherence Rate (Rate of Perfect Method Use)

    Time frame: 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

  1. Satisfaction Rate

    Time frame: at 3 months

  2. Continuation Rate

    Time frame: at 3 months

    Rate of intention to continue the contraceptive method at 3 months

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • Organon

Registry information

Official study title

Acceptability of the NuvaRing Among College and Graduate Students

Acronym: ACCEPT

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Mar 13, 2008
Registry last updated
Feb 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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