Tissue sections from the same paraffin blocks used for RVI scores were assessed by qNPA and the results were first grouped for statistical analysis based on the classic RVI criteria for passing the routine vaginal product safety evaluation as follows: Group 1 with a score of 1 to 3 (no to mild irritation) and Group 2 with a score of 4–7 (moderate irritation).Cited by: 7. Aug 05, 2015 · This is a new application from the Menopause Strategies: Finding Lasting Answers for Symptoms and Health (MsFLASH) Clinical Trials network. Here we propose to conduct a large multicenter trial comparing two common treatments, a vaginal hormone tablet and an over-the-counter gel, with placebo to evaluate their effects on bothersome vaginal symptoms and sexual function, and Other: Placebo tablet.
Jul 14, 2015 · In this study, the clinical efficacy of Vagitocin as a potential treatment for postmenopausal women suffering from moderate to severe symptoms of vaginal atrophy, vaginal irritation/itching and vaginal discomfort and/or pain associated with sexual activity will be explored. ISO Vaginal Irritation Study (TI265) Test Options/Variations. TI265-801: Irritation tests are utilized to assess the irritation potential of medical devices, bio-materials, or their extracts exposed to eye, skin, or mucous membranes. The test(s) are performed using a model appropriate for the route (skin, eye, mucosa) and duration of exposure.
A vaginal gel formulation containing a low concentration of N-9 (52.5 mg) was evaluated in a randomized, placebo-controlled, triple-blind phase 2/3 trial at 4 international sites for its effectiveness in preventing HIV infection. Results of the trial indicated that N-9 did not . In this study we incorporate to the RVI model a novel quantitative nuclease protection assay (qNPA) to quantify mRNA levels of 25 genes representing leukocyte differentiation markers, toll-like receptors (TLR), cytokines, chemokines, epithelial repair, microbicidal and .