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Clinical Trials in the USA / NCT04098744
Recruiting Phase 2

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

NCT04098744 · tracked via the Priya Life Science USA tracker
Sponsor
Frantz Viral Therapeutics, LLC
Phase
Phase 2
Started
2020-09-09
Last updated
2025-10-02

Condition(s) studied

CIN 2/3HPV InfectionPre-Cancerous DysplasiaCervical DysplasiaHPV Related Disease

Investigational drug(s) / intervention(s)

Artesunate vaginal insert →Placebo vaginal insert

Artesunate vaginal insert: Artesunate formulated as vaginal inserts, 200mg

Placebo vaginal insert: Placebo for artesunate vaginal inserts

Study 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).

Eligibility

Sex
FEMALE
Min age
25 Years
Max age
100 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Proportion of participants with histologic regression by week 17 — 17 weeks
    Number of participants who undergo histologic regression to cervical intraepithelial neoplasia (CIN) 1 or less by week 17, following three 5-day cycles of artesunate vaginal inserts, as determined by the LEEP histopathologic analysis

Trial sites (7)

FacilityCityRegionStatus
Florida Gynecologic Oncology Fort Myers Florida Recruiting
University of Michigan Ann Arbor Michigan Recruiting
Cleveland Clinic Fairview Hospital Cleveland Ohio Recruiting
Cleveland Clinic Foundation Cleveland Ohio Recruiting
Hillcrest Hospital Mayfield Heights Ohio Recruiting
The Harris Health System (L.B.J Hospital) Houston Texas Recruiting
University of Texas, M.D. Anderson Houston Texas Recruiting

More Frantz Viral Therapeutics, LLC trials in the USA

Artesunate Ointment for the Treatment of Anal HSIL in HIV-negative Participants Recruiting
Phase II Study of Artesunate Ointment for the Treatment of Vulvar High Grade Squamous Intraepithelial Lesions (Vulvar HSIL, VIN2/3) Recruiting
Artesunate Suppositories for the Treatment of HIV-negative Patients With Intra-anal HSIL Active, not recruiting

Other trials for the same condition

Phase II Study of Artesunate Ointment for the Treatment of Vulvar High Grade Squamous Intraepithelial Lesions (Vulvar HSIL, VIN2/3) Recruiting
SELF-CERV Pivotal Study: SELF-Collection for CERVical Cancer Screening Active, not recruiting
Artesunate Suppositories for the Treatment of HIV-negative Patients With Intra-anal HSIL Active, not recruiting
The Use of the LuViva Advanced Cervical Scan to Identify Women at High-Risk for Cervical Neoplasia Enrolling by invitation
Evaluation of the Q-Pad hrHPV Test System for Identifying Precancer Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04098744 on ClinicalTrials.gov ↗ ← All trials in the USA