Artesunate Vaginal Inserts for the Treatment of Cervical Intraepithelial Neoplasia (CIN2/3)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age25-100
SponsorFrantz Viral Therapeutics, LLC
About this trial
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
Qualifiers
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)
Disqualifiers
Pregnant and nursing women
Active autoimmune disease
Taking immunosuppressive medication
HIV seropositivity
Trial design
Treatments tested in this trial
- Artesunate vaginal insert
- Placebo vaginal insert
Treatment groups
78 Participants
are divided into 2 treatment groupsLocations
7Florida Gynecologic Oncology33905, Fort MyersFlorida, United States
University of Michigan48109, Ann ArborMichigan, United States
Cleveland Clinic Fairview Hospital44111, ClevelandOhio, United States
Cleveland Clinic Foundation44195, ClevelandOhio, United States
Sponsors and collaborators
Frantz Viral Therapeutics, LLC
Lead sponsor
Amarex Clinical Research
Collaborator
M.D. Anderson Cancer Center
Collaborator
Harris Health System (L.B.J. Hospital)
Collaborator
The Cleveland Clinic
Collaborator
University of Michigan
Collaborator
Florida Gynecologic Oncology
Collaborator
Source ClinicalTrials.gov