| Methods |
Randomized parallel trial.
One center in United States.
Participants were not blinded. Investigators and research staff were blinded.
Six‐month trial. Nested breakage, slippage and acceptability study within the efficacy study based on data from the condoms used for the first five acts of intercourse. |
| Participants |
805 couples aged 18 to 45 years in monogamous heterosexual relationship without known risk of STD or infertility. |
| Interventions |
Polyurethane condom (similar to the Avanti, London International Group condom commercially produced after April 1996) versus the latex condom Ramses Sensitol (London International Group). |
| Outcomes |
Contraceptive efficacy; breakage and slippage; continuation; acceptability. |
| Notes |
Randomized with computer‐generated sequence of binary numbers.
64% of eligible couples declined participation. 31% loss to follow up and early discontinuation. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
Manufacturer provided study condoms packaged in sealed opaque foil wrappers, which were then sealed in opaque containers labeled with the couple identification number. |
