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news.Polydex Pharmaceuticals has reported that Conrad has commenced a Phase I trial to assess the safety of several vaginal products, including Ushercell, a human pharmaceutical candidate compound.
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This study will recruit 60 women over a six-month period at two sites in the US. Assigned products to be evaluated in this trial include Ushercell, nonoxynol-9 and a placebo. Follow-up visits over a period of three months will help researchers assess the products’ effect on known and exploratory markers of genital inflammation, epithelial integrity and microflora, and the effect of the vaginal environment on the antiviral activity of each of the products. Final analysis from this trial is not expected for at least 18 months.
According to Polydex, Ushercell has demonstrated a high safety and acceptability profile in 13 studies conducted by Conrad within the last decade, and has also demonstrated significant contraceptive properties. The company intends to pursue all development potential for Ushercell including its use as a contraceptive, personal lubricant and other potential applications.