Acceptability of the NuvaRing Among Students (ACCEPT)

The University of Chicago

Status and phase: Completed; Phase 4

Conditions: Birth Control Compliance

Treatments: Drug: Ortho Tri-cyclen Lo; Device: NuvaRing

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00635570

14067B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 273 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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273 participants in 2 patient groups

Contraceptive vaginal ring

Active Comparator group

Description:

Contraceptive vaginal ring (NuvaRing)

Treatment:

Device: NuvaRing

Oral contraceptive pill

Active Comparator group

Description:

Oral contraceptive pill (Ortho Tri-cyclen Lo)

Treatment:

Drug: Ortho Tri-cyclen Lo