PMID- 15914134
OWN - NLM
STAT- MEDLINE
DCOM- 20060110
LR  - 20131121
IS  - 0010-7824 (Print)
IS  - 0010-7824 (Linking)
VI  - 71
IP  - 6
DP  - 2005 Jun
TI  - Male tolerance of ACIDFORM gel.
PG  - 443-6
AB  - 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.
FAU - Schwartz, Jill L
AU  - Schwartz JL
AD  - CONRAD, Eastern Virginia Medical School, Arlington, VA 22209, USA. 
      jschwartz@conrad.org
FAU - Poindexter, Alfred
AU  - Poindexter A
FAU - Schmitz, Susan W
AU  - Schmitz SW
FAU - Mauck, Christine
AU  - Mauck C
FAU - Callahan, Marianne M
AU  - Callahan MM
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - United States
TA  - Contraception
JT  - Contraception
JID - 0234361
RN  - 0 (Gels)
RN  - 0 (K-Y jelly)
RN  - 0 (Phosphates)
RN  - 0 (Propylene Glycols)
RN  - 9004-34-6 (Cellulose)
RN  - PDC6A3C0OX (Glycerol)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Cellulose/administration & dosage/adverse effects/*analogs & derivatives
MH  - Double-Blind Method
MH  - Gels/administration & dosage/adverse effects
MH  - Glycerol/*administration & dosage/*adverse effects
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Penis/*drug effects
MH  - Phosphates/*administration & dosage/*adverse effects
MH  - Propylene Glycols/*administration & dosage/*adverse effects
MH  - Treatment Outcome
EDAT- 2005/05/26 09:00
MHDA- 2006/01/13 09:00
CRDT- 2005/05/26 09:00
PHST- 2004/11/03 00:00 [received]
PHST- 2004/11/15 00:00 [revised]
PHST- 2004/11/19 00:00 [accepted]
PHST- 2005/05/26 09:00 [pubmed]
PHST- 2006/01/13 09:00 [medline]
PHST- 2005/05/26 09:00 [entrez]
AID - S0010-7824(04)00325-7 [pii]
AID - 10.1016/j.contraception.2004.11.008 [doi]
PST - ppublish
SO  - Contraception. 2005 Jun;71(6):443-6. doi: 10.1016/j.contraception.2004.11.008.