title: Contraceptive effectiveness of a polyurethane condom and a latex condom: a randomized controlled trial.
abstract: OBJECTIVE
  To compare the contraceptive effectivenesses of a polyurethane condom and a standard latex condom. Secondary outcomes of interest were safety, functionality, discontinuation, and acceptability.
  
  
  METHODS
  We randomized 901 couples to use either the polyurethane condom or a standard latex condom as their only form of contraception. We tested for pregnancy at enrollment and at every scheduled follow-up visit (weeks 4, 10, 16, 22, and 30).
  
  
  RESULTS
  The 6-month typical-use pregnancy probabilities were 9.0% (95% confidence interval [CI] 5.9, 12.2) for the polyurethane group and 5.4% (95% CI 2.9, 7.8) for the latex group; the hazard ratio was 1.7 (95% CI 1.1, 2.7), and we failed to reject the null hypothesis of our test of noninferiority. Females in the polyurethane group reported fewer genital irritations (hazard ratio 0.6; 95% CI 0.5, 0.8; P <.01), whereas males in both groups reported the same number of genital irritations (hazard ratio 1.0; 95% CI 0.7, 1.5; P =.94). Total clinical failures (breakage and slippage) were 8.4% for the polyurethane condom and 3.2% for the latex condom (difference 5.3%, 90% CI 2.8, 7.7). The risk of discontinuation did not differ between groups. Participants judged both condoms favorably in terms of the four primary acceptability outcomes (willingness to purchase, willingness to recommend, confidence in method, and general comfort).
  
  
  CONCLUSIONS
  The polyurethane condom was not shown to be as effective as the latex comparator condom for pregnancy prevention. However, the risk of pregnancy in the polyurethane group falls in the range of other barrier methods. For people with latex sensitivity or who find latex condoms unacceptable, this polyurethane condom represents one of several synthetic male condom alternatives currently available on the US market.
authors.affiliation: Family Health International, PO Box 13950, Research Triangle Park, NC 27707, USA. msteiner@fhi.org
authors.forename: Markus J
authors.initials: MJ
authors.lastname: Steiner
authors.forename: Rosalie
authors.initials: R
authors.lastname: Dominik
authors.forename: R Wesley
authors.initials: RW
authors.lastname: Rountree
authors.forename: Kavita
authors.initials: K
authors.lastname: Nanda
authors.forename: Laneta J
authors.initials: LJ
authors.lastname: Dorflinger
mesh_terms: D000293:Adolescent; D000328:Adult; D017280:Condoms; D004868:Equipment Failure; D005260:Female; D006801:Humans; D007840:Latex; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D011140:Polyurethanes; D011247:Pregnancy; D018873:Pregnancy Rate; D014481:United States
chemical_list: D007840:Latex; D011140:Polyurethanes