Contraceptive efficacy, safety, fit, and acceptability of a single-size diaphragm developed with end-user input
Schwartz, J.L.; Weiner, D.H.; Lai, J.J.; Frezieres, R.G.; Creinin, M.D.; Archer, D.F.; Bradley, L.; Barnhart, K.T.; Poindexter, A.; Kilbourne-Brook, M.; Callahan, M.M.; Mauck, C.K.
Obstetrics and Gynecology 125(4): 895-903
2015
ISSN/ISBN: 1873-233X PMID: 25751199 DOI: 10.1097/aog.0000000000000721Document Number: 626104
To estimate contraceptive efficacy, safety, acceptability, and fit of a single-size diaphragm used with contraceptive gel. We conducted a multicenter trial in which 450 couples used the single-size diaphragm, 300 randomized to acid-buffering gel and 150 to nonoxynol-9, for at least 190 days and six menstrual cycles. Visits were at enrollment and after menstrual cycles 1, 3, and 6. Study outcomes included pregnancy probability, safety, acceptability, and fit. Pregnancy and safety were compared with an historical control group who used a standard diaphragm with these gels. Most (439/450 ) liked the diaphragm. Results suggest that if provided by a clinician, 94% (95% CI 92-96%) could insert, correctly position, and remove the diaphragm. The single-size diaphragm was safe, as effective as a standard diaphragm, and acceptable when used with contraceptive gel. ClinicalTrials.gov, www.clinicaltrials.gov, NCT00578877.