A Phase II Double Blind, Placebo-controlled, Randomized Trial of Artesunate Vaginal Inserts for the Treatment of Patients With Cervical Intraepithelial Neoplasia (CIN2/3)
Who is this study for? Adult female patients with Cervical Intraepithelial Neoplasm 2, 3, or 2/3
What treatments are being studied? Artesunate
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: Female
Minimum Age: 25
Maximum Age: 100
Healthy Volunteers: f
View:
• 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
Locations
United States
Florida
Florida Gynecologic Oncology
RECRUITING
Fort Myers
Michigan
University of Michigan
RECRUITING
Ann Arbor
Ohio
Cleveland Clinic Fairview Hospital
RECRUITING
Cleveland
Cleveland Clinic Foundation
RECRUITING
Cleveland
Hillcrest Hospital
RECRUITING
Mayfield Heights
Texas
The Harris Health System (L.B.J Hospital)
RECRUITING
Houston
University of Texas, M.D. Anderson
RECRUITING
Houston
Contact Information
Primary
Mihaela Plesa, BA, CCRP
FVTinfo@frantzgroup.com
440-255-1155
Backup
Ahmad Bayat, MD
ahmadb@amarexcro.com
(301) 956-2523
Time Frame
Start Date: 2020-09-09
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 78
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Harris Health System (L.B.J. Hospital), Florida Gynecologic Oncology, University of Michigan, Amarex Clinical Research, The Cleveland Clinic, M.D. Anderson Cancer Center
Leads: Frantz Viral Therapeutics, LLC