Acceptability of the NuvaRing Among Students (ACCEPT)

January 13, 2021 updated by: University of Chicago

Acceptability of the NuvaRing Among College and Graduate 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

273

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
      • Chicago, Illinois, United States, 60637
        • University of Chicago, Section of Family Planning
      • Chicago, Illinois, United States
        • University Of Illinois

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Contraceptive vaginal ring
Contraceptive vaginal ring (NuvaRing)
Device: NuvaRing
Contraceptive vaginal ring
Active Comparator: Oral contraceptive pill
Oral contraceptive pill (Ortho Tri-cyclen Lo)
Drug: Ortho Tri-cyclen Lo
Low dose oral contraceptive

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
For the first 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction Rate
Time Frame: at 3 months
at 3 months
Continuation Rate
Time Frame: at 3 months
Rate of intention to continue the contraceptive method at 3 months
at 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Collaborators

Organon

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

March 5, 2008

First Submitted That Met QC Criteria

March 12, 2008

First Posted (Estimate)

March 13, 2008

Study Record Updates

Last Update Posted (Actual)

February 3, 2021

Last Update Submitted That Met QC Criteria

January 13, 2021

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14067B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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