Recruiting
Phase 2

Artesunate Vaginal Inserts

Sponsor:

Frantz Viral Therapeutics, LLC

Code:

NCT04098744

Conditions

CIN 2/3

HPV Infection

Pre-Cancerous Dysplasia

Cervical Dysplasia

HPV Related Disease

Eligibility Criteria

Sex: Female

Age: 25 - 70+

Healthy Volunteers: Not accepted

Interventions

Artesunate vaginal insert

Placebo vaginal insert

Study Details

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).

Conditions

CIN 2/3

HPV Infection

Pre-Cancerous Dysplasia

Cervical Dysplasia

HPV Related Disease

Study ID

NCT04098744

Start date

Sep 9, 2020

Status verified date

Sep, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Jul 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 25 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

78 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Artesunate vaginal insert

Participants will receive three 5-day cycles of artesunate vaginal inserts, 200mg/day, at week 0, week 2, week 4.

placebo comparator: Placebo vaginal inserts

Participants will receive three 5-day cycles of placebo vaginal inserts, at week 0, week 2, and week 4.

Interventions

Artesunate vaginal insert

Artesunate formulated as vaginal inserts, 200mg

Placebo vaginal insert

Placebo for artesunate vaginal inserts

Primary outcome measure

  • Proportion of participants with histologic regression by week 17 [ Time Frame: 17 weeks ]

Central Contacts and Locations

Central contacts

Mihaela Plesa, BA, CCRP

440-255-1155FVTinfo@frantzgroup.com

Ahmad Bayat, MD

(301) 956-2523ahmadb@amarexcro.com

Locations

Florida Gynecologic Oncology

Recruiting

Fort Myers, Florida, United States, 33905

Contacts

Cami Hansen

239-334-6626cami.hansen25@gmail.com

Principal Investigator:

Fadi Abu Shahin, MD

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Mubeenah Syedah

734-998-6349symubeen@med.umich.edu

Principal Investigator:

Diane Harper, MD

Cleveland Clinic Fairview Hospital

Recruiting

Cleveland, Ohio, United States, 44111

Contacts

Donna White

216-445-8090whited11@ccf.org

Megan Park

216-445-8090parkm2@ccf.org

Principal Investigator:

Chad Michener, MD

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Donna White

216-445-8090whited11@ccf.org

Megan Park

216-445-8090parkm2@ccf.org

Principal Investigator:

Chad Michener, MD

Hillcrest Hospital

Recruiting

Mayfield Heights, Ohio, United States, 44124

Contacts

Donna White

216-445-8090whited11@ccf.org

Megan Park

216-445-8090parkm2@ccf.org

Principal Investigator:

Chad Michener, MD

The Harris Health System (L.B.J Hospital)

Recruiting

Houston, Texas, United States, 77026

Contacts

Jessica Gallegos

713-563-4580jrgalleg@mdanderson.org

Cindy Melendez

713-563-4582cvmelend@mdanderson.org

Principal Investigator:

Andrea Milbourne, MD

University of Texas, M.D. Anderson

Recruiting

Houston, Texas, United States, 77030

Contacts

Jessica Gallegos

713-563-4580jrgalleg@mdanderson.org

Cindy Melendez

713-563-4582cvmelend@mdanderson.org

Principal Investigator:

Andrea Milbourne, MD

More Information

Sponsor

Frantz Viral Therapeutics, LLC

Last update posted

Oct 2, 2025

Last verified

Sep, 2025

Keywords

  • treatment study
  • cancer prevention
  • non-surgical
  • HPV related disease
  • CIN
  • topical treatment
  • vaginal inserts
  • artesunate
  • artemisinin
  • non-invasive
  • high risk HPV
  • vaginal suppository

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Frantz Viral Therapeutics, LLC on 2025-10-02.