Pilot study of short-term acceptability and breakage and slippage rates for the loose-fitting polyurethane male condom eZ.on bi-directional: a randomized cross-over trial.
OBJECTIVE
To assess the short-term acceptability and functionality of the eZ.on condom compared with currently marketed latex (Gossamer) and polyurethane (Avanti) condoms. Method Healthy, sexually active volunteers aged 18-50 years, self-selected from among the UK population, were enrolled in a randomized cross-over trial. Participants were required to test six of each of three condom variants. Data were collected on structured questionnaires by means of postal and telephone contacts. Main outcome measures were breakage and slippage rates, and short-term user acceptability based on participants' ratings documented in end-of-study questionnaires.


RESULTS
Forty-three couples entered the study, of whom 37 tested the condoms on 512 occasions. There was no statistically significant difference in the clinical breakage rate between eZ.on (3.7%) and the comparator condoms (3.5% for Gossamer and 2.9% for Avanti). Complete slippage rates were similar for eZ.on (2.4%) and Avanti (2.9%). Gossamer had the lowest slippage rate (1.2%), but this difference was not statistically significant. User acceptability was similar for the three condom types; however, there was a trend for more participants to express dissatisfaction with eZ.on, including difficulties with putting on the condom.


CONCLUSIONS
No firm conclusions can be drawn from this pilot study, but our observations suggest that eZ.on may be an acceptable option for some couples unwilling or unable to use a latex condom.
Bounds
W
W
Department of Obstetrics and Gynaecology, University College London, UK.
Molloy
S
S
Guillebaud
J
J
D000328:Adult; D017280:Condoms / Q000009:adverse effects* / Q000592:standards* / Q000706:statistics & numerical data; D003258:Consumer Behavior; D003268:Contraception Behavior / Q000706:statistics & numerical data; D018592:Cross-Over Studies; D004868:Equipment Failure; D005260:Female; D006801:Humans; D007840:Latex / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011140:Polyurethanes / Q000009:adverse effects; D011786:Quality Control; D012307:Risk Factors; D011795:Surveys and Questionnaires; D013997:Time Factors; D006113:United Kingdom
D007840:Latex; D011140:Polyurethanes