| Methods |
Randomized crossover trial.
One center in United States.
Unblinded. |
| Participants |
320 couples aged 21 years or older in monogamous, heterosexual relationship and currently using hormonal method, IUD or sterilization for contraception. Excluded pregnancy, lactation, STI, and allergies or sensitivities to latex. |
| Interventions |
Couples were assigned to use 2 condoms of each of the 4 condom types in a randomized sequence during the 6‐week study period. Standard Tactylon versus Baggy Tactylon versus Low‐Modulus Tactylon versus the standard lubricated USAID latex condom (Ansell, Inc.). All Tactylon condoms were manufactured by Sensicon Corp., Vista, CA. |
| Outcomes |
Condom breakage and slippage; acceptability. |
| Notes |
Randomization and allocation concealment methods not reported.
11% did not complete questionnaires; 24% did not follow perfectly the randomized order for condoms; and 9% did not use the two condoms of the same type consecutively.
11% loss to follow up and early discontinuation. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
No information |
