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 I study in circumcised and uncircumcised men to assess penile irritation, safety and acceptability of seven consecutive doses of ACIDFORM gel compared with K-Y 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 gel 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.


CONCLUSIONS
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.
Schwartz
Jill L
JL
CONRAD, Eastern Virginia Medical School, Arlington, VA 22209, USA. jschwartz@conrad.org
Poindexter
Alfred
A
Schmitz
Susan W
SW
Mauck
Christine
C
Callahan
Marianne M
MM
D000328:Adult; D000368:Aged; D002482:Cellulose / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D004311:Double-Blind Method; D005782:Gels / Q000008:administration & dosage / Q000009:adverse effects; D005990:Glycerol / Q000008:administration & dosage* / Q000009:adverse effects*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010413:Penis / Q000187:drug effects*; D010710:Phosphates / Q000008:administration & dosage* / Q000009:adverse effects*; D011409:Propylene Glycols / Q000008:administration & dosage* / Q000009:adverse effects*; D016896:Treatment Outcome
D005782:Gels; C042973:K-Y jelly; D010710:Phosphates; D011409:Propylene Glycols; D002482:Cellulose; D005990:Glycerol