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02249 PHASE 1 MULTI-DOSE SAFETY AND ACCEPTABILITY STUDY OF 6% CELLULOSE SULFATE (CS) Doh, Anderson* Primary Objective: To assess the local effect of four times daily vaginal applications of 3.5 ml 6% CS gel or K-Y® Jelly for 14 consecutive days. Methods: Women were randomized to receive either CS or K-Y Jelly. Follow-up visits were conducted on days 8 and 15. Colposcopy assessed epithelial disruption, a wet mount assessed bacterial vaginosis and candidiasis, and a questionnaire assessed acceptability. Results: 134 women were referred for screening and 75 of them were screened for enrolment. Twenty-seven women were enrolled in each group and 25 women from each group completed the 15 days of follow-up. During follow-up, 2 women in each group had epithelial disruption, 1 woman in each group had candidiasis, and 1 woman in the K-Y group had bacterial vaginosis. Adverse event frequencies were similar in both groups. The products were equally acceptable to the participants. Conclusion: There was no evidence that 6% CS was different from K-Y Jelly with respect to epithelial disruption, candidiasis, bacterial vaginosis, and acceptability when used four times per day for 14 days. BP 13401, Yaoundé Cameroon |
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