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Evaluating the clinical safety of three vaginal applicators: a pilot study conducted in the Dominican Republic
Vivian Brache1, Jessica A Cohen, Leila Cochon
1Biomedical Research Department, PROFAMILIA, Santo Domingo, Dominican Republic. biomedica@verizon.net.do
Background:
Targeted research on applicator safety has not been conducted as part of microbicide clinical trials and was considered necessary for ensuring safe and effective product use. Colposcopy, regarded as a standard method for assessing the safety of vaginal products, including microbicides, was used in this study to assess the external genitalia, vaginal epithelium and cervical epithelium after a single applicator use.
Objectives:
The objectives of this study were to assess and compare the effects of three vaginal applicators on symptoms and signs of irritation of the external genitalia, vagina and cervix as seen by colposcopy after applicator use.
Methods:
Twenty women used three different vaginal applicators over three separate clinic visits 7-14 days apart and underwent a colposcopic examination before and after each applicator use. In total, the safety of each applicator was assessed over 20 product uses.
Results:
No severe colposcopic finding was reported. Four minor colposcopic findings (petechiae) were considered possibly related to product use. No difference was found between applicators.
Conclusions:
This study provides reassuring data on the safety of the three applicator products from the perspective of causing vaginal trauma or irritation. Epithelial changes that could be more important for risk of disease transmission were not observed.
