Status:
COMPLETED
PARIS or PAtch RIng Study: A Trial to Evaluate NuvaRing Versus OrthoEvra
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
Organon
Conditions:
Contraception
Eligibility:
FEMALE
Phase:
PHASE4
Brief 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 recruit...
Detailed Description
The present study is designed primarily to compare continuation rates after three months of use of NuvaRing® and OrthoEvra® in women who had been previously using oral contraceptives. The study attemp...
Eligibility Criteria
Inclusion
- Currently or recently (within 3 months of enrollment) using oral contraceptives and content with use.
- In good general health with no contraindications to combined hormonal contraceptive use; premenopausal; and willing to be randomly assigned to use the patch or ring for the next 4 cycles.
- Willing to forego the use of vaginal products and anal intercourse for study duration; if heterosexually active, must be with a single partner for at least the past 3 months and not planning a change during study participation.
Exclusion
- Known or suspected pregnancy; hypersensitivity to NuvaRing or OrthoEvra; present or use within 2 months of liver-enzyme-inducing medications or St. John's Wort; breastfeeding currently or within 60 days; abortion or delivery of pregnancy at 15 weeks or greater within 49 days; or abortion within 21 days at 14 weeks or less.
- Previous use of patch or ring for contraception; use of an injectable contraceptive within 6 months; use of an investigational drug within 2 months; or planning a pregnancy within 6 months.
- Diagnosis of gonorrhea or chlamydia at screening, or any vaginal or cervical abnormality that would require colposcopy during the course of the study.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00269620
Start Date
June 1 2005
End Date
December 1 2006
Last Update
October 21 2008
Active Locations (10)
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1
UCLA-Harbor
Los Angeles, California, United States
2
University of Chicago
Chicago, Illinois, United States
3
Johns Hopkins
Baltimore, Maryland, United States
4
Boston University
Boston, Massachusetts, United States