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

RECRUITINGPhase 2Sponsored by Frantz Viral Therapeutics, LLC
Actively Recruiting
PhasePhase 2
SponsorFrantz Viral Therapeutics, LLC
Started2020-09-09
Est. completion2026-07-31
Eligibility
Age25 Years – 100 Years
SexFEMALE
Healthy vol.Accepted
Locations7 sites
View on ClinicalTrials.gov →

NCT04098744

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

Age: 25 Years – 100 YearsSex: FEMALEHealthy volunteers 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

Conditions6

CIN 2/3CancerCervical DysplasiaHPV InfectionHPV Related DiseasePre-Cancerous Dysplasia

Locations7 sites

Florida Gynecologic Oncology
Fort Myers, Florida, 33905
Cami Hansen239-334-6626cami.hansen25@gmail.com
University of Michigan
Ann Arbor, Michigan, 48109
Mubeenah Syedah734-998-6349symubeen@med.umich.edu
Cleveland Clinic Fairview Hospital
Cleveland, Ohio, 44111
Donna White216-445-8090whited11@ccf.org
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Donna White216-445-8090whited11@ccf.org
Hillcrest Hospital
Mayfield Heights, Ohio, 44124
Donna White216-445-8090whited11@ccf.org

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