A Phase 2 interventional study of Artesunate vaginal insert and Placebo vaginal insert in CIN 2/3, HPV Infection and Pre-Cancerous Dysplasia, sponsored by Frantz Viral Therapeutics, LLC. Recruiting at 7 sites in United States. Open to female participants aged 25 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-10-02.
Sponsored by Frantz Viral Therapeutics, LLC · Phase 2, Interventional, and Treatment
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:
Exclusion Criteria:
Participants will receive three 5-day cycles of artesunate vaginal inserts, 200mg/day, at week 0, week 2, week 4.
Drug: Artesunate vaginal insert
Participants will receive three 5-day cycles of placebo vaginal inserts, at week 0, week 2, and week 4.
Drug: Placebo vaginal insert
Artesunate formulated as vaginal inserts, 200mg
Also known as: Artesunic acid, DHA, artemisinin
Placebo for artesunate vaginal inserts
Proportion of participants with histologic regression by week 17
Number of participants who undergo histologic regression to cervical intraepithelial neoplasia (CIN) 1 or less by week 17, following three 5-day cycles of artesunate vaginal inserts, as determined by the LEEP histopathologic analysis
Time frame: 17 weeks
Number of participants who have achieved clearance of detectable human papilloma virus (HPV) by week 17
Number of participants who had HPV strains detected at study entry which become undetectable by week 17
Time frame: 17 weeks
Number of participants who have achieved clearance of detectable human papilloma virus (HPV) after three 5-day cycles of artesunate and the LEEP procedure.
Number of participants who had HPV strains detected at study entry which become undetectable after three 5-day cycles of artesunate and the LEEP procedure
Time frame: 40 weeks
Number of participants with Treatment-Emergent Adverse Events (TEAE)
Number of participants who had adverse events, as defined by CTCAE v5.0, related to the study intervention
Time frame: 6 weeks
Number of participants who withdrew from the study due to TEAEs
Number of participants who were withdrawn from the study due to adverse events related to the study drug
Time frame: 6 weeks
Plan to share: No
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Frantz Viral Therapeutics, LLC