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- W2149308066 abstract "Objective Randomized controlled trial evaluating a topical treatment for cervical intraepithelial neoplasia 2 and 3 (CIN 2+) using cidofovir. Methods Fifty-three women with a biopsy-proven CIN 2+ were randomly assigned, 6 weeks before their planned conisation, either 3 applications of 3 ml 2% cidofovir in Intrasite® gel in a cervical cap or a placebo (the same volume of Intrasite® alone). A cervical sample for high-risk types of human papillomaviruses (HPV) (Hybrid Capture 2 or HC2) was taken before treatment and before conisation. The cone was submitted for pathological examination, and subsequently, along with the initial biopsy, to in situ hybridization (ISH) for high-risk HPV. Results Forty-eight patients were treated and followed according to the protocol, (23 cidofovir, and 25 placebo). Fourteen of the 23 cones were free of any CIN (60.8%) in the cidofovir group. Only 5 of 25 cones were free of any CIN (20%) in the placebo group (p<0.01). The difference remained significant in the ITT group (p<0.05). In the per-protocol and ITT populations, we observed more frequent viral clearance in the cidofovir group, but the difference was significant only when evaluated by ISH and not by HC2. No systemic toxicity was observed. Cervico-vaginal side effects of cidofovir were limited, and not statistically different from placebo. Conclusion The medical topical treatment with cidofovir, at this point, cannot replace conisation, but it is a promising candidate for topical chemotherapy of CIN 2+ lesions; a larger prospective randomized study is needed to confirm our results." @default.
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- W2149308066 date "2009-10-01" @default.
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- W2149308066 title "Topical treatment of CIN 2+ by cidofovir: Results of a phase II, double-blind, prospective, placebo-controlled study" @default.
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- W2149308066 doi "https://doi.org/10.1016/j.ygyno.2009.06.042" @default.
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