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Artesunate Vaginal Inserts for the Treatment of Cervical Intraepithelial Neoplasia (CIN2/3)
Trial Status: active
This is a phase II double blind, placebo-controlled, randomized study of Artesunate
vaginal inserts for the treatment of women who have cervical high grade intraepithelial
neoplasia (CIN2/3).
Inclusion Criteria
Adult females age ≥ 25 years
Capable of informed consent
Any HPV genotype detectable by DNA test/HPV genotyping
Colposcopically-directed, histologically confirmed tissue diagnosis of cervical high grade squamous intraepithelial lesions (CIN2, CIN3, or CIN2/3)
Women of childbearing potential agree to use birth control through week17 of the study.
Weight ≥ 50kg
Exclusion Criteria
Pregnant and nursing women
Active autoimmune disease
Taking immunosuppressive medication
HIV seropositivity
Immunocompromised subjects
Evidence of concurrent cervical adenocarcinoma in situ
Concurrent malignancy except for nonmelanoma skin lesions, because treatment for other cancers have systemic effects
Additional locations may be listed on ClinicalTrials.gov for NCT04098744.
Locations matching your search criteria
United States
Michigan
Ann Arbor
University of Michigan Comprehensive Cancer Center