Acceptability of the NuvaRing Among Students

Study Overview
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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.

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.

Official Title
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Acceptability of the NuvaRing Among College and Graduate Students

Conditions
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Birth Control Compliance

Intervention / Treatment
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* Drug: Ortho Tri-cyclen Lo
* Device: NuvaRing


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | For the first 3 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contraception, Compliance, Acceptability