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 insertPlacebo 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

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)

Facility	City	Region	Status
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 Suppositories for the Treatment of HIV-negative Patients With Intra-anal HSIL Active, not recruiting

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

Other trials for the same condition

Evaluation of the Q-Pad hrHPV Test System for Identifying Precancer 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

SELF-CERV Pivotal Study: SELF-Collection for CERVical Cancer Screening Active, not recruiting

Early Phase Clinical Trial About Therapeutic Biological Product Mix for Treating HPV Active, not 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