Male tolerance of ACIDFORM gel

Background: ACIDFORM gel is being studied as a vaginal contraceptive and microbicide. This study was conducted to make certain that males will not be subjected to an unacceptable risk of penile irritation as a result of exposure to the product in future studies. Methods: This was a randomized, double-masked, single-center Phase 1 study in circumcised and uncircumcised men to assess penile irritation, safety and acceptability of seven consecutive doses of ACIDFORM gel compared with K-Y-(R) Jelly Personal Lubricant. Each participant was instructed to apply 2 mL of the study product to his penis at bedtime, to wash it off 6-10 h later and to record any symptoms on a diary card. At the follow-up visit, a genital examination was performed and participants were asked about adverse events (AEs) and completed an acceptability questionnaire. Results: Of the 36 men enrolled, 2 out of 24 (8.3%) ACIDFORM gel users and 5 out of 12 (41.7%) K-Y Jelly users reported genital symptoms. Genital examination findings were observed in 2 out of 24 (8.3%) ACIDFORM get users and in 1 out of 12 (8.3%) K-Y Jelly users. All product-related AEs were considered mild except for two in the K-Y Jelly group. Both products were acceptable. Conclusion: ACIDFORM gel applied to the penis for seven consecutive days appears to be at least as safe and well-tolerated as the marketed lubricant K-Y Jelly among healthy low-risk men. (c) 2005 Elsevier Inc. All rights reserved.