Acceptability of the NuvaRing Among Students

Phase 4

Completed

• Conditions: Birth Control Compliance
• Interventions: Device: NuvaRing; Drug: Ortho Tri-cyclen Lo

• Registration Number: NCT00635570
• Lead Sponsor: University of Chicago

Brief Summary

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

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 Timeline

• Study First Submitted: 2008-03-05
• Study First Submitted QC: 2008-03-12
• Study First Posted: 2008-03-13
• Study Start: 2008-07
• Primary Completion: 2009-01
• Study Completion: 2009-07
• Results First Submitted: 2012-10-05
• Results First Submitted QC: 2012-11-05
• Results First Posted: 2012-11-07
• Status Verified: 2013-06
• Last Update Submitted: 2021-01-13
• Last Update Posted: 2021-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 273

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Contraceptive vaginal ring	NuvaRing	Contraceptive vaginal ring (NuvaRing)
Oral contraceptive pill	Ortho Tri-cyclen Lo	Oral contraceptive pill (Ortho Tri-cyclen Lo)

Primary Outcome Measures

Name	Time	Method
Adherence Rate (Rate of Perfect Method Use)	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

Secondary Outcome Measures

Name	Time	Method
Satisfaction Rate	at 3 months
Continuation Rate	at 3 months	Rate of intention to continue the contraceptive method at 3 months

Trial Locations

Locations (3)

University of Chicago; 🇺🇸 Chicago, Illinois, United States

University of Illinois; 🇺🇸 Chicago, Illinois, United States

University of Chicago, Section of Family Planning; 🇺🇸 Chicago, Illinois, United States