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

Last updated: November 12, 2024
Sponsor: Frantz Viral Therapeutics, LLC
Overall Status: Active - Recruiting

Phase

2

Condition

Cervical Dysplasia

Cervical Intraepithelial Neoplasia

Treatment

Placebo vaginal insert

Artesunate vaginal insert

Clinical Study ID

NCT04098744
ART-CIN IIB
20 1148
2020 0237
  • Ages 25-100
  • Female

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 Criteria

Inclusion

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 highgrade squamous intraepithelial lesions (CIN2, CIN3, or CIN2/3)

  • Women of childbearing potential agree to use birth control through week17 of thestudy.

  • Weight ≥ 50kg

Exclusion

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 forother cancers have systemic effects

Study Design

Total Participants: 78
Treatment Group(s): 2
Primary Treatment: Placebo vaginal insert
Phase: 2
Study Start date:
September 09, 2020
Estimated Completion Date:
December 31, 2025

Study Description

Eligible participants in this study are randomized 2:1 to receive either artesunate or placebo vaginal inserts for the treatment of CIN2/3. Both groups receive three 5-day cycles of the respective drug, at weeks 0, 2, and 4. Dosing visits can be done as telehealth visits (medication is mailed to the patient's home). Participants are followed after receiving artesunate at weeks 6, 17, and 40. All participants undergo a LEEP procedure at week 17.

Primary Objective: To evaluate the histopathologic response to three 5-day cycles of artesunate vaginal inserts in adult females with biopsy-proven HPV-associated CIN 2/3.

Secondary Objectives:

  • To evaluate the safety of artesunate vaginal inserts for the treatment of CIN2/3

  • To evaluate the viral clearance after three 5-day cycles of artesunate vaginal inserts in adult females with biopsy-proven HPV-associated CIN 2/3.

  • To evaluate viral clearance after three 5-day cycles of artesunate and the LEEP procedure

Connect with a study center

  • Florida Gynecologic Oncology

    Fort Myers, Florida 33905
    United States

    Active - Recruiting

  • Grady Health System

    Atlanta, Georgia 30303
    United States

    Site Not Available

  • Johns Hopkins Outpatient Center

    Baltimore, Maryland 21205
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • Northwell Health Physician Partners Gynecologic Oncology

    Brightwaters, New York 11718
    United States

    Site Not Available

  • Cleveland Clinic Fairview Hospital

    Cleveland, Ohio 44111
    United States

    Active - Recruiting

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Hillcrest Hospital

    Mayfield Heights, Ohio 44124
    United States

    Active - Recruiting

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

    Houston, Texas 77026
    United States

    Active - Recruiting

  • University of Texas, M.D. Anderson

    Houston, Texas 77030
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.