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02613 CLINICAL SAFETY AND ACCEPTABILITY OF IOCIDE VAGINAL GEL Piper, Jeanna M.* Iocide ® gel is a novel, iodine-based, topical microbicide developed for vaginal use. Initial clinical studies have evaluated the safety of a single treatment (targeted for use intrapartum to prevent early-onset neonatal group B streptococcal infections). Further studies, including multiple exposure testing, are planned. Following IND approval, Phase I human safety trials were initiated (currently on-going). Women were examined and tested for vaginal infections prior to any treatment (those with vaginal lesions or infections are excluded). Treatment visit (3-7 days later) included examination and safety tests obtained immediately prior to and 1 hour after placement of Iocide gel. Participants returned at 1 and 7 days post-treatment for repeat examination and safety testing. Women were questioned at the final visit regarding product acceptability and suggestions for improvement. Thus far, 9 women have completed the study. Post-treatment, none of the women reported vaginal itching, irritation or discharge. No inflammation or lesions were noted on exam. No significant changes were noted on haematology, chemistry, urinalysis or thyroid function. No persistent changes in vaginal flora were noted by culture. BV scores decreased in 2 women (from 10 to 7 and 7 to 4) and remained unchanged in the other 7 women (3 with BV, 4 without). All of the women found the product acceptable and if available for vaginal cleansing would recommend it to their friends. Dr. Jeanna M. Piper |
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