Artesunate Vaginal Inserts for the Treatment of Cervical Intraepithelial Neoplasia (CIN2/3)
NCT ID: NCT04098744
Last Updated: 2025-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
78 participants
INTERVENTIONAL
2020-09-09
2026-12-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Artesunate vaginal insert
Participants will receive three 5-day cycles of artesunate vaginal inserts, 200mg/day, at week 0, week 2, week 4.
Artesunate vaginal insert
Artesunate formulated as vaginal inserts, 200mg
Placebo vaginal inserts
Participants will receive three 5-day cycles of placebo vaginal inserts, at week 0, week 2, and week 4.
Placebo vaginal insert
Placebo for artesunate vaginal inserts
Interventions
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Artesunate vaginal insert
Artesunate formulated as vaginal inserts, 200mg
Placebo vaginal insert
Placebo for artesunate vaginal inserts
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
25 Years
100 Years
FEMALE
No
Sponsors
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Amarex Clinical Research
OTHER
M.D. Anderson Cancer Center
OTHER
Harris Health System (L.B.J. Hospital)
UNKNOWN
The Cleveland Clinic
OTHER
University of Michigan
OTHER
Florida Gynecologic Oncology
UNKNOWN
Frantz Viral Therapeutics, LLC
INDUSTRY
Responsible Party
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Locations
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Florida Gynecologic Oncology
Fort Myers, Florida, United States
University of Michigan
Ann Arbor, Michigan, United States
Cleveland Clinic Fairview Hospital
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Hillcrest Hospital
Mayfield Heights, Ohio, United States
The Harris Health System (L.B.J Hospital)
Houston, Texas, United States
University of Texas, M.D. Anderson
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2020 0237
Identifier Type: OTHER
Identifier Source: secondary_id
20 1148
Identifier Type: OTHER
Identifier Source: secondary_id
ART-CIN IIB
Identifier Type: -
Identifier Source: org_study_id
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