drugset / Trial / NCT00269620

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

NCT00269620 ↗

Phase 4 Completed 500 enrolled University of Pittsburgh Organon · collab
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2005-06
Primary completion
2006-12
Completion
2006-12

Outcome

Met primary endpoint

paper Rates of completion of three cycles were 94.6% (95% confidence interval [CI] 91.0-97.1%) and 88.2% (95% CI 83.4-92.0%) for ring and patch users, respectively (P=.03). PMID 18238962 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject ethinyl estradiol/etonogestrel Unknown — Other
Subject ethinyl estradiol/norelgestromin Unknown — Other

Indications

No indication recorded.