Mauck CK, Weiner DH, Creinin M, Barnhart K, Ballagh S, Archer D, Callahan MM, Schmitz S, Bax R; International Conference on AIDS.

Int Conf AIDS. 2002 Jul 7-12; 14: abstract no. MoPeD3648.

CONRAD, Arlington, VA, United States

BACKGROUND: C31G contains two surface-active compounds, cetyl betaine and myristamine oxide. It is a antimicrobial and spermicidal agent. Three C31G concentrations (0.5%, 1.0%, and 1.7%) were tested in a dose escalation safety study and a concurrent postcoital test (PCT) study. METHODS: Both studies were Phase I, randomized, masked studies. In the safety study, 16 women in each of 4 treatment groups used 3.5 ml of vaginal gel containing one concentration of C31G or Extra Strength Gynol II (3% N-9) once daily for 7 days followed by 7 additional days of twice-daily use. The aims were to assess genital irritation (including colposcopy), vaginal cytology, vaginal cultures/gram stains, plasma and vaginal lavage levels of C31G, vaginal leakage, systemic safety, and acceptability. In the PCT study, 61women enrolled to assess: the effectiveness of the 3 concentrations in preventing sperm from penetrating mid-cycle cervical mucus; genital irritation; and acceptability. RESULTS: The percent of women experiencing irritation in the 0.5% and 1.0% C31G groups in the safety study were similar to each other and were lower than the percent experiencing irritation in the 1.7% and N-9 groups, which were also similar to each other. Differences were significant between 1.0% vs. N-9 at 7 days and between 0.5% and 1.0% C31G vs. N-9 at 14 days. There was no significant difference between groups in leakage or acceptability. Changes in microflora were similar between groups. No C31G was detected in the plasma of any volunteer. Data from the PCT study will include: % of women with >5 progressively motile sperm per high power field (HPF) and average number of progressively motile sperm per HPF for all women for each concentration, adverse experiences, and acceptability.

Publication Types:

• Meeting Abstracts

Keywords:

• Anti-Infective Agents
• Betaine
• Biomedical Research
• C 31G
• Cervix Mucus
• Colposcopy
• Fatty Acids, Unsaturated
• Female
• Humans
• Male
• Nonoxynol
• Spermatocidal Agents
• Spermatozoa
• Vagina
• Vaginal Creams, Foams, and Jellies

Other ID:

• GWAIDS0015172

UI: 102252670

From Meeting Abstracts