A Phase II Double Blind, Placebo-controlled, Randomized Trial of Artesunate Vaginal Inserts for the Treatment of Patients With Cervical Intraepithelial Neoplasia (CIN2/3)

What this Trial Is About

Researchers are evaluating Artesunate vaginal inserts in a phase II, double-blind, placebo-controlled, randomized study for adult women diagnosed with cervical high grade intraepithelial neoplasia (CIN2/3), associated with HPV infection. The study aims to assess the histopathologic response to this treatment along with safety and viral clearance effects in women with biopsy-confirmed CIN2/3. Participants are randomly assigned in a 2:1 ratio to receive either artesunate vaginal inserts or placebo. Both groups undergo three 5-day treatment cycles at weeks 0, 2, and 4. Dosing visits may be conducted via telehealth with medication mailed to participants’ homes. All participants have a LEEP procedure at week 17. Follow-up visits occur at weeks 6, 17, and 40 to evaluate treatment effects and safety. During the study, women will have assessments including histologic evaluations at week 17 to measure tissue response, and HPV viral clearance at weeks 17 and 40. Safety monitoring is ongoing, and participants' adherence to birth control is required through week 17. The primary outcome is the proportion of participants with histologic regression by week 17. Secondary outcomes include HPV clearance after treatment cycles and after the LEEP procedure. The study is expected to continue through the end of 2026.

Artesunate Vaginal Inserts for the Treatment of Cervical Intraepithelial Neoplasia (CIN2/3)