RecruitingPhase 2NCT04098744

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

A Phase II Double Blind, Placebo-controlled, Randomized Trial of Artesunate Vaginal Inserts for the Treatment of Patients With Cervical Intraepithelial Neoplasia (CIN2/3)


Sponsor

Frantz Viral Therapeutics, LLC

Enrollment

78 participants

Start Date

Sep 9, 2020

Study Type

INTERVENTIONAL

Conditions

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: FEMALEMin Age: 25 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study tests artesunate vaginal inserts — a medication derived from a malaria drug — as a treatment for high-grade precancerous lesions on the cervix (called CIN2 or CIN3). These lesions are caused by HPV infection and, if untreated, can develop into cervical cancer. **You may be eligible if...** - You are a woman aged 25 or older - You have been diagnosed with CIN2, CIN3, or CIN2/3 confirmed by biopsy - You have a detectable HPV infection - You weigh at least 50 kg - You agree to use birth control during the study **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have an active autoimmune disease - You are taking immunosuppressive medications - You are HIV-positive or have a weakened immune system - You have cervical adenocarcinoma in situ (a different type of precancer) or another active cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGArtesunate vaginal insert

Artesunate formulated as vaginal inserts, 200mg

DRUGPlacebo vaginal insert

Placebo for artesunate vaginal inserts


Locations(7)

Florida Gynecologic Oncology

Fort Myers, Florida, United States

University of Michigan

Ann Arbor, Michigan, United States

Cleveland Clinic Fairview Hospital

Cleveland, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Hillcrest Hospital

Mayfield Heights, Ohio, United States

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

Houston, Texas, United States

University of Texas, M.D. Anderson

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT04098744


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