NCT00635570

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
273

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2008

Shorter than P25 for phase_4

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 13, 2008

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

November 7, 2012

Completed
Last Updated

February 3, 2021

Status Verified

June 1, 2013

Enrollment Period

6 months

First QC Date

March 5, 2008

Results QC Date

October 5, 2012

Last Update Submit

January 13, 2021

Conditions

Birth Control Compliance

Keywords

Contraception, Compliance, Acceptability

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Satisfaction Rate

    at 3 months

  • Continuation Rate

    at 3 months

Study Arms (2)

Contraceptive vaginal ring

ACTIVE COMPARATOR

Contraceptive vaginal ring (NuvaRing)

Device: NuvaRing

Oral contraceptive pill

ACTIVE COMPARATOR

Oral contraceptive pill (Ortho Tri-cyclen Lo)

Drug: Ortho Tri-cyclen Lo

Interventions

Ortho Tri-cyclen LoDRUG

Low dose oral contraceptive

Oral contraceptive pill
NuvaRingDEVICE

Contraceptive vaginal ring

Contraceptive vaginal ring

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Chicago, Section of Family Planning

Chicago, Illinois, 60637, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

University of Illinois

Chicago, Illinois, United States

Location

Related Publications (2)

  • Gilliam M, Holmquist S, Berlin A. Factors associated with willingness to use the contraceptive vaginal ring. Contraception. 2007 Jul;76(1):30-4. doi: 10.1016/j.contraception.2007.03.009. Epub 2007 May 24.

    PMID: 17586133BACKGROUND

  • Gilliam ML, Neustadt A, Kozloski M, Mistretta S, Tilmon S, Godfrey E. Adherence and acceptability of the contraceptive ring compared with the pill among students: a randomized controlled trial. Obstet Gynecol. 2010 Mar;115(3):503-510. doi: 10.1097/AOG.0b013e3181cf45dc.

    PMID: 20177280DERIVED

MeSH Terms

Conditions

Patient Compliance

Interventions

Moxifloxacin

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Limitations and Caveats

This study is an randomized controlled trial offering internal but not necessarily external validity. Thus, we do not know whether these findings would be replicable in other populations.

Results Point of Contact

Title
Melissa Gilliam
Organization
Department of Obstetrics and Gynecology, The University of Chicago
mgilliam@babies.bsd.uchicago.edu
773-834-0840

Study Officials

  • Melissa L Gilliam, MD, MPH

    University of Chicago, Section of Family Planning

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2008

First Posted

March 13, 2008

Study Start

July 1, 2008

Primary Completion

January 1, 2009

Study Completion

July 1, 2009

Last Updated

February 3, 2021

Results First Posted

November 7, 2012

Record last verified: 2013-06

Locations

US(3)