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02618_2 CLINICAL SAFETY EVALUATION OF MICROBICIDE APPLICATORS Cohen, Jessica* Program for Appropriate Technology in Health (PATH) in collaboration with Profamilia in the Dominican Republic conducted a clinical evaluation of three microbicide applicators. The purpose of the study was to assess and compare the effect of these applicators on symptoms and signs of irritation of the external genitalia, cervix, and vagina as seen on colposcopy after a single applicator use. The three applicators evaluated were a single-use applicator from HTI Plastics, a reusable applicator from HTI Plastics, and a single-use applicator from Norden-Pac International. Both the HTI single-use and Norden-Pac International single-use applicators are currently being used in microbicide clinical trials. Twenty women were enrolled in this study through a Profamilia Clinic in Santo Domingo. Over the course of three months, each participant evaluated each of the three applicators in a separate clinic visit. At each visit, the participant underwent a baseline colposcopy, then vaginally inserted and removed a single applicator, and then underwent a follow-up colposcopy. All applicators were empty and therefore did not deliver any gel or product during the course of this study. Results of this study will be discussed, including implications for further applicator safety research and applicator selection for future clinical trials. Ms. Jessica Cohen |
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