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02676_1 SAFETY OF CARRAGUARD USE BY HETEROSEXUAL MEN IN A SIX MONTH CLINICAL TRIAL IN THAILAND Kilmarx P,1 In phase II trials Carraguard use has been shown to be safe and acceptable in women. We conducted a six-month, randomized, triple-blinded trial of Carraguard (3% carrageenan) compared to 2.5% methyl cellulose placebo in Chiang Rai, Thailand, to evaluate safety and acceptability among heterosexual couples. We enrolled 55 low-risk couples who were in good health, were monogamous, did not use condoms regularly, and were free of HIV/STI. Couples were randomized to Carraguard or placebo gel and were asked to use the gel each time they had vaginal sex. Men and women came for monthly follow-up visits including genital/pelvic exams, STI testing, interview and counseling. Follow up and adherence with gel use instructions were >90% at each scheduled visit. During follow up four men in group I (15%) and five men in group II (18%) ever reported any genital itching, burning or pain; one man in each group reported that the gel ever caused itching, burning or pain, and one man in each group reported the gel caused other (mild) symptoms. Four men in group I (15%) and six men in group II (21%) ever had a (small) superficial epithelial disruption during the study. There were no cases of deep epithelial disruptions in any men during the study, nor were there any cases of balanitis or urethral discharge. These data indicate that Carraguard did not cause significant irritation or harm to the male genitalia when used by low-risk heterosexual couples during vaginal intercourse. Dr. Peter H Kilmarx |
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