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

RecruitingPhase 2Ages 25 Years - 100 YearsFemaleFrantz Viral Therapeutics, LLC
NCT04098744 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
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
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What it tests

  • Artesunate vaginal insert
  • Placebo vaginal insert
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Where

7 sites
Florida Gynecologic Oncology
Fort Myers, United States
University of Michigan
Ann Arbor, United States
Cleveland Clinic Fairview Hospital
Cleveland, United States
Cleveland Clinic Foundation
Cleveland, United States
Hillcrest Hospital
Mayfield Heights, United States
The Harris Health System (L.B.J Hospital)
Houston, United States
University of Texas, M.D. Anderson
Houston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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