drugset / Trial / NCT00269620
PARIS or PAtch RIng Study: A Trial to Evaluate NuvaRing Versus OrthoEvra
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 ↗
Publications
- Results Creinin MD, Meyn LA, Borgatta L, Barnhart K, Jensen J, Burke AE, Westhoff C, Gilliam M, Dutton C, Ballagh SA. Multicenter comparison of the contraceptive ring and patch: a randomized controlled trial. Obstet Gynecol. 2008 Feb;111(2 Pt 1):267-77. doi: 10.1097/01.AOG.0000298338.58511.d1.
- Gracia CR, Sammel MD, Charlesworth S, Lin H, Barnhart KT, Creinin MD. Sexual function in first-time contraceptive ring and contraceptive patch users. Fertil Steril. 2010 Jan;93(1):21-8. doi: 10.1016/j.fertnstert.2008.09.066. Epub 2008 Oct 31.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ethinyl estradiol/etonogestrel | Unknown | — | Other |
| Subject | ethinyl estradiol/norelgestromin | Unknown | — | Other |
Indications
No indication recorded.