Artesunate Vaginal Inserts for the Treatment of Cervical Intraepithelial Neoplasia (CIN2/3)
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: CIN 2/3, HPV Infection, Pre-Cancerous Dysplasia, Cervical Dysplasia, HPV Related Disease
In brief
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).
Key facts
- Study ID
- NCT04098744
- Run by
- Frantz Viral Therapeutics, LLC
- People needed
- 78
- Starts
- 2020-09-09
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2025-10-02
Who can join
Age: 25 and older, up to 100. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Florida Gynecologic Oncology — Fort Myers, Florida, United States (enrolling)
- University of Michigan — Ann Arbor, Michigan, United States (enrolling)
- Cleveland Clinic Fairview Hospital — Cleveland, Ohio, United States (enrolling)
- Cleveland Clinic Foundation — Cleveland, Ohio, United States (enrolling)
- Hillcrest Hospital — Mayfield Heights, Ohio, United States (enrolling)
- The Harris Health System (L.B.J Hospital) — Houston, Texas, United States (enrolling)
- University of Texas, M.D. Anderson — Houston, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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