PMID- 15325891
OWN - NLM
STAT- MEDLINE
DCOM- 20050331
LR  - 20151119
IS  - 0010-7824 (Print)
IS  - 0010-7824 (Linking)
VI  - 70
IP  - 3
DP  - 2004 Sep
TI  - Male tolerance study of 1% C31G.
PG  - 221-5
AB  - BACKGROUND: C31G is being studied as a vaginal contraceptive and microbicide. 
      This study was conducted to ensure that male partners of the women in future 
      trials of C31G will not be subjected to an undue risk of penile irritation. 
      METHODS: This was a randomized, double-blinded, single-center Phase I study in 
      circumcised and uncircumcised men to assess penile irritation, safety and 
      acceptability of seven consecutive daily doses of 1.0% C31G compared with a 
      marketed spermicide, Extra Strength Gynol II(R) (3% nonoxynol-9) (ES Gynol II). 
      Each participant was instructed to apply 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 
      again asked about adverse events and to complete an acceptability questionnaire. 
      RESULTS: Of the 36 men enrolled, 12.5% of C31G users and 16.7% of Extra Strength 
      Gynol II users reported product-related adverse events (AEs). All product-related 
      AEs were considered mild by the investigator, except for one in the ES Gynol II 
      group. Both products were acceptable. CONCLUSION: The manner in which the 
      products were used in this study is not the route by which men will be exposed to 
      such products in actual use, and results should be considered in this light. 
      Based on the observations in this study, C31G appears to be at least as safe and 
      acceptable for male penile exposure as the marketed product ES Gynol II.
FAU - Mauck, Christine K
AU  - Mauck CK
AD  - CONRAD, Eastern Virginia Medical School, 1611 North Kent Street, Suite 806, 
      Arlington, VA 22209, USA. cmauck@conrad.org
FAU - Frezieres, Ron G
AU  - Frezieres RG
FAU - Walsh, Terri L
AU  - Walsh TL
FAU - Schmitz, Susan W
AU  - Schmitz SW
FAU - Callahan, Marianne M
AU  - Callahan MM
FAU - Bax, Richard
AU  - Bax R
LA  - eng
PT  - Clinical Trial
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Contraception
JT  - Contraception
JID - 0234361
RN  - 0 (Fatty Acids, Unsaturated)
RN  - 0 (Gels)
RN  - 0 (Spermatocidal Agents)
RN  - 26027-38-3 (Nonoxynol)
RN  - 3SCV180C9W (Betaine)
RN  - 86903-77-7 (C 31G)
SB  - IM
MH  - Adult
MH  - Betaine/*adverse effects/*analogs & derivatives
MH  - Circumcision, Male
MH  - Double-Blind Method
MH  - Fatty Acids, Unsaturated/*adverse effects
MH  - Gels
MH  - Humans
MH  - Male
MH  - Nonoxynol/adverse effects
MH  - Patient Satisfaction
MH  - Penis/*drug effects
MH  - Spermatocidal Agents/*adverse effects
MH  - Surveys and Questionnaires
EDAT- 2004/08/25 05:00
MHDA- 2005/04/01 09:00
CRDT- 2004/08/25 05:00
PHST- 2003/11/19 00:00 [received]
PHST- 2003/12/14 00:00 [revised]
PHST- 2003/12/21 00:00 [accepted]
PHST- 2004/08/25 05:00 [pubmed]
PHST- 2005/04/01 09:00 [medline]
PHST- 2004/08/25 05:00 [entrez]
AID - S0010782404000034 [pii]
AID - 10.1016/j.contraception.2003.12.008 [doi]
PST - ppublish
SO  - Contraception. 2004 Sep;70(3):221-5. doi: 10.1016/j.contraception.2003.12.008.