| Methods |
Randomized parallel trial. Seven centers in United States.
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 were unblinded. Investigators and outcome assessors were blinded. |
| Participants |
830 sexually active, healthy couples (women aged 18 to 40 years and men aged 18 to 50 years) in monogamous heterosexual relationship. Exclusions included irregular menses, known STI, known infertility, and allergies to study products. |
| Interventions |
Tactylon (Sensicon Corp., Vista, CA) versus either latex condom Trojan‐Enz (Carter Wallace) or LifeStyles (Ansell). Study groups given Astroglide water‐based lubricant. |
| Outcomes |
Contraceptive efficacy; breakage and slippage; semen exposure from condom failure; safety; acceptability. |
| Notes |
Randomized with computer‐generated batch scheme.
31% loss to follow up and early discontinuation. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
Condoms were supplied in sealed, opaque containers, which were labeled with subject identification numbers. |
