Status:
RECRUITING
Artesunate Vaginal Inserts for the Treatment of Cervical Intraepithelial Neoplasia (CIN2/3)
Lead Sponsor:
Frantz Viral Therapeutics, LLC
Collaborating Sponsors:
Amarex Clinical Research
M.D. Anderson Cancer Center
Conditions:
CIN 2/3
HPV Infection
Eligibility:
FEMALE
25-100 years
Phase:
PHASE2
Brief Summary
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).
Detailed Description
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 dru...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT04098744
Start Date
September 9 2020
End Date
December 31 2026
Last Update
October 2 2025
Active Locations (7)
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1
Florida Gynecologic Oncology
Fort Myers, Florida, United States, 33905
2
University of Michigan
Ann Arbor, Michigan, United States, 48109
3
Cleveland Clinic Fairview Hospital
Cleveland, Ohio, United States, 44111
4
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195