Actively Recruiting
Artesunate Vaginal Inserts for the Treatment of Cervical Intraepithelial Neoplasia (CIN2/3)
Led by Frantz Viral Therapeutics, LLC · Updated on 2025-10-02
78
Participants Needed
7
Research Sites
329 weeks
Total Duration
On this page
Sponsors
F
Frantz Viral Therapeutics, LLC
Lead Sponsor
A
Amarex Clinical Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Artesunate Vaginal Inserts for the Treatment of Cervical Intraepithelial Neoplasia (CIN2/3)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult females age 65 25 years
- Capable of informed consent
- Any HPV genotype detectable by DNA test or HPV genotyping
- Histologically confirmed cervical high grade squamous intraepithelial lesions (CIN2, CIN3, or CIN2/3) by colposcopically-directed biopsy
- Women of childbearing potential agree to use birth control through week 17 of the study
- Weight 65 50 kg
You will not qualify if you...
- Pregnant and nursing women
- Active autoimmune disease
- Taking immunosuppressive medication
- HIV positive
- Immunocompromised
- Evidence of concurrent cervical adenocarcinoma in situ
- Concurrent malignancy except nonmelanoma skin lesions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Florida Gynecologic Oncology
Fort Myers, Florida, United States, 33905
Actively Recruiting
2
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
3
Cleveland Clinic Fairview Hospital
Cleveland, Ohio, United States, 44111
Actively Recruiting
4
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
5
Hillcrest Hospital
Mayfield Heights, Ohio, United States, 44124
Actively Recruiting
6
The Harris Health System (L.B.J Hospital)
Houston, Texas, United States, 77026
Actively Recruiting
7
University of Texas, M.D. Anderson
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
M
Mihaela Plesa, BA, CCRP
CONTACT
A
Ahmad Bayat, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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