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Phase I Dose-Escalation Trial Of Intravaginal Curcumin In Women For Cervical Dysplasia, Leda Gattoc, Paula M. Frew, Shontell N. Thomas, Kirk A. Easley, Laura Ward, H-H Sherry Chow, Chiemi A. Ura, Lisa Flowers

Environmental & Occupational Health Faculty Publications

Background: This is a Phase I trial demonstrating safety and tolerability of intravaginal curcumin for future use in women with cervical neoplasia. Objective: The objective of this study was to assess the safety, tolerability, and pharmacokinetics of intravaginal curcumin in healthy women. Study design: We conducted a 3+3 dose-escalation Phase I trial in a group of women aged 18–45 years. Thirteen subjects were given one of four doses of curcumin powder (500 mg, 1,000 mg, 1,500 mg, and 2,000 mg) packed in gelatin capsules, which was administered intravaginally daily for 14 days. The primary end point for this study was …