| Methods |
Randomized crossover trial.
Ten centers in United States.
Participant and investigator were unblinded. Outcome assessor was blinded. |
| Participants |
Healthy, sexually active females aged 18 to 35 years in a stable, mutually monogamous relationship with regular menses and willing to use condoms only for contraception.
Excluded recent, current or contraindications to pregnancy; lactation; certain pap exam results; infertility or conditions associated with infertility; or HIV or STI or high risk for HIV. |
| Interventions |
Women were assigned to one condom type for 30 weeks.
The eZ·on condom (Family Health International, Research Triangle Park, NC and Mayer Laboratories, Inc., Oakland, CA) versus a latex condom (Kimono Select, Mayer Laboratories, Inc., Oakland, CA). |
| Outcomes |
Contraceptive efficacy; breakage and slippage; safety; acceptability.
Breakage and slippage outcomes were abstracted in method consistent with Steiner 1994 definitions. |
| Notes |
Randomized with computer‐generated, permuted blocked randomization scheme, stratified by site and prior condom experience.
27% loss to follow up and early discontinuation. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
Allocation concealed with centralized telephone system. |
