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
Inclusion Criteria6
- 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
Exclusion Criteria7
- 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 for other cancers have systemic effects
Interventions
DRUGArtesunate vaginal insert
Artesunate formulated as vaginal inserts, 200mg
DRUGPlacebo vaginal insert
Placebo for artesunate vaginal inserts
Locations(7)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04098744
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