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PARIS or PAtch RIng Study: A Trial to Evaluate NuvaRing Versus OrthoEvra

NCT00269620 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2008-10-21

No results posted yet for this study

Summary

This is an open-label prospective, multicenter, randomized trial to compare continuation rates into the fourth cycle of women using either the NuvaRing or OrthoEvra. Five hundred women will be recruited at 9 centers nationwide to be randomly assigned to use either the NuvaRing or OrthoEvra for four months. Women must either be on the pill or have recently stopped the pill and be relatively satisfied with oral contraceptive use to qualify for enrollment. Two visits and two phone calls will be required.

Conditions

  • Contraception

Interventions

DRUG

ethinyl estradiol/etonogestrel vaginal ring

vaginal ring for cyclic use (3 weeks in, 1 week out)

DRUG

ethinyl estradiol/norelgestromin transdermal contraceptive

contraceptive patch worn for 7 days and replaced for use for 3 consecutive weeks followed by a one-week patch free interval

Sponsors & Collaborators

  • University of Pittsburgh

    lead OTHER

  • Organon

    collaborator INDUSTRY

Principal Investigators

  • Mitchell D Creinin, MD · University of Pittsburgh/Magee-Womens Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2006-12-31
Completion
2006-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00269620 on ClinicalTrials.gov