Acceptability of the NuvaRing Among Students

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

273 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2009-07-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Birth Control Compliance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Contraceptive vaginal ring

Contraceptive vaginal ring (NuvaRing)

Group Type ACTIVE_COMPARATOR

NuvaRing

Intervention Type DEVICE

Contraceptive vaginal ring

Oral contraceptive pill

Oral contraceptive pill (Ortho Tri-cyclen Lo)

Group Type ACTIVE_COMPARATOR

Ortho Tri-cyclen Lo

Intervention Type DRUG

Low dose oral contraceptive

Interventions

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Ortho Tri-cyclen Lo

Low dose oral contraceptive

Intervention Type DRUG

NuvaRing

Contraceptive vaginal ring

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes