Actively Recruiting

Phase 2
Age: 25Years - 100Years
FEMALE
NCT04098744

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

Age: 25Years - 100Years
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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