Artesunate Vaginal Inserts for the Treatment of Cervical Intraepithelial Neoplasia (CIN2/3)
A Phase II Double Blind, Placebo-controlled, Randomized Trial of Artesunate Vaginal Inserts for the Treatment of Patients With Cervical Intraepithelial Neoplasia (CIN2/3)
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).
Eligible participants in this study are randomized 2:1 to receive either artesunate or placebo vaginal inserts for the treatment of CIN2/3. Both groups receive three 5-day cycles of the respective drug, at weeks 0, 2, and 4. Dosing visits can be done as telehealth visits (medication is mailed to the patient's home). Participants are followed after receiving artesunate at weeks 6, 17, and 40. All participants undergo a LEEP procedure at week 17. Primary Objective: To evaluate the histopathologic response to three 5-day cycles of artesunate vaginal inserts in adult females with biopsy-proven HPV-associated CIN 2/3. Secondary Objectives: - To evaluate the safety of artesunate vaginal inserts for the treatment of CIN2/3 - To evaluate the viral clearance after three 5-day cycles of artesunate vaginal inserts in adult females with biopsy-proven HPV-associated CIN 2/3. - To evaluate viral clearance after three 5-day cycles of artesunate and the LEEP procedure
Proportion of participants with histologic regression by week 17
Number of participants who have achieved clearance of detectable human papilloma virus (HPV) by week 17
Artesunate vaginal insert
Study Arms / Comparison Groups
Artesunate vaginal insert
Description: Participants will receive three 5-day cycles of artesunate vaginal inserts, 200mg/day, at week 0, week 2, week 4.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
September 9, 2020
December 31, 2024
Primary Completion Date
December 31, 2023
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 week 28 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
25 Years - 100 Years
Accepts Healthy Volunteers
, 440-255-1155, [email protected]
Frantz Viral Therapeutics, LLC
Amarex Clinical Research