Acceptability of the NuvaRing Among Students

University of Chicago273 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

273

Conditions

Birth Control Compliance

Interventions

Ortho Tri-cyclen LoDRUG

Low dose oral contraceptive

NuvaRingDEVICE

Contraceptive vaginal ring

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (3)

University of Chicago, Section of Family Planning

Chicago, Illinois, United States

University of Chicago

Chicago, Illinois, United States

University of Illinois

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Adherence Rate (Rate of Perfect Method Use)

"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

Time frame: For the first 3 months

Secondary Outcomes

Satisfaction Rate

Time frame: at 3 months

Continuation Rate

Rate of intention to continue the contraceptive method at 3 months

Time frame: at 3 months

Data from ClinicalTrials.gov

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