Male tolerance of ACIDFORM gel

Contraception. 2005 Jun;71(6):443-6. doi: 10.1016/j.contraception.2004.11.008.


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.

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.

Publication types

  • Clinical Trial, Phase I
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Cellulose / administration & dosage
  • Cellulose / adverse effects
  • Cellulose / analogs & derivatives*
  • Double-Blind Method
  • Gels / administration & dosage
  • Gels / adverse effects
  • Glycerol / administration & dosage*
  • Glycerol / adverse effects*
  • Humans
  • Male
  • Middle Aged
  • Penis / drug effects*
  • Phosphates / administration & dosage*
  • Phosphates / adverse effects*
  • Propylene Glycols / administration & dosage*
  • Propylene Glycols / adverse effects*
  • Treatment Outcome


  • Gels
  • K-Y jelly
  • Phosphates
  • Propylene Glycols
  • Cellulose
  • Glycerol