RECRUITING

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

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Conditions

CIN 2/3HPV InfectionPre-Cancerous DysplasiaCervical DysplasiaHPV Related Diseasetreatment studycancer preventionnon-surgicalCINtopical treatmentvaginal insertsartesunateartemisininnon-invasivehigh risk HPVvaginal suppository

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2020-09-09
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04098744

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:25 Years to 100 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult females age ≥ 25 years
  2. * Capable of informed consent
  3. * Any HPV genotype detectable by DNA test/HPV genotyping
  4. * Colposcopically-directed, histologically confirmed tissue diagnosis of cervical high grade squamous intraepithelial lesions (CIN2, CIN3, or CIN2/3)
  5. * Women of childbearing potential agree to use birth control through week17 of the study.
  6. * Weight ≥ 50kg
  1. * Pregnant and nursing women
  2. * Active autoimmune disease
  3. * Taking immunosuppressive medication
  4. * HIV seropositivity
  5. * Immunocompromised subjects
  6. * Evidence of concurrent cervical adenocarcinoma in situ
  7. * Concurrent malignancy except for nonmelanoma skin lesions, because treatment for other cancers have systemic effects

Contacts and Locations

Study Contact

Mihaela Plesa, BA, CCRP
CONTACT
440-255-1155
FVTinfo@frantzgroup.com
Ahmad Bayat, MD
CONTACT
(301) 956-2523
ahmadb@amarexcro.com

Study Locations (Sites)

Florida Gynecologic Oncology
Fort Myers, Florida, 33905
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
Cleveland Clinic Fairview Hospital
Cleveland, Ohio, 44111
United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
Hillcrest Hospital
Mayfield Heights, Ohio, 44124
United States
The Harris Health System (L.B.J Hospital)
Houston, Texas, 77026
United States
University of Texas, M.D. Anderson
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Frantz Viral Therapeutics, LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-09-09
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2020-09-09
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • CIN 2/3
  • HPV Infection
  • Pre-Cancerous Dysplasia
  • Cervical Dysplasia
  • HPV Related Disease