RECRUITING
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Artesunate Vaginal Inserts for the Treatment of Cervical Intraepithelial Neoplasia (CIN2/3)
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).
Conditions:
🦠 CIN 2/3 🦠 HPV Infection 🦠 Pre-Cancerous Dysplasia 🦠 Cervical Dysplasia 🦠 HPV Related Disease
🗓️ Study Start (Actual) 9 September 2020
🗓️ Primary Completion (Estimated) 31 July 2025
✅ Study Completion (Estimated) 31 December 2025
👥 Enrollment (Estimated) 78
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Fort Myers, Florida, United States
📍 Ann Arbor, Michigan, United States
📍 Cleveland, Ohio, United States
📍 Cleveland, Ohio, United States
📍 Mayfield Heights, Ohio, United States
📍 Houston, Texas, United States
📍 Houston, Texas, United States
More locations available...

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * 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 Criteria:

    • * 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
Ages Eligible for Study: 25 Years to 100 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ 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

  • First Submitted 19 September 2019
  • First Submitted that Met QC Criteria 19 September 2019
  • First Posted 23 September 2019

Study Record Updates

  • Last Update Submitted that Met QC Criteria 21 May 2024
  • Last Update Posted 22 May 2024
  • Last Verified May 2024
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