Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04098744 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Artesunate Vaginal Inserts for the Treatment of Cervical Intraepithelial Neoplasia (CIN2/3)

Study acronym: ART-CIN_IIB
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 2, 2025 (before its estimated July 31, 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Site contacts updated at 2 of 7 sitesv29
  2. Primary completion date: Jul 31, 2025 to Jul 31, 2026
    • Study completion date: Dec 31, 2025 to Dec 31, 2026
    • Collaborators revised (6)
    v28
  3. Site contacts updated at 1 of 7 sitesv27
  4. 2 versions Re-verified since May 21, 2024, no change to tracked fieldsv25-v26
  5. Primary completion date: Jul 31, 2024 to Jul 31, 2025
    • Study sites: 6 to 7
    • Study completion date: Mar 31, 2025 to Dec 31, 2025
    v24
Show 22 earlier versionsHide 22 earlier versions
  1. Primary completion date: Dec 31, 2023 to Jul 31, 2024
    • Study completion date: Dec 31, 2024 to Mar 31, 2025
    • Site contacts updated at 1 of 6 sites
    v23
  2. Study sites: 7 to 6
    • Eligibility criteria shortened, about 1 word
    v22
  3. Site details revised at 1 of 7 sitesv21
  4. Study sites: 8 to 7
    • Primary completion date: Jul 31, 2023 to Dec 31, 2023
    • Study completion date: Dec 31, 2023 to Dec 31, 2024
    v20
  5. Study sites: 7 to 8
    • Secondary endpoints revised (2)
    • Eligibility criteria expanded, about 5 words
    v19
  6. Primary endpoint revised
    • Secondary endpoints revised (2)
    • Study description shortened, about 45 words
    • Collaborators: 4 to 6
    v18
  7. Primary completion date: Dec 31, 2022 to Jul 31, 2023
    • Study sites: 6 to 7
    • Study completion date: Jul 31, 2023 to Dec 31, 2023
    v17
  8. Enrollment target: 72 to 78v16
  9. Site contacts updated at 1 of 6 sitesv15
  10. Study sites: 5 to 6v14
  11. Primary completion date: Dec 31, 2021 to Dec 31, 2022
    • Study completion date: Dec 31, 2022 to Jul 31, 2023
    v13
  12. Study sites: 4 to 5v12
  13. Re-verified, no change to tracked fieldsv11
  14. Study sites: 2 to 4
    • Study description expanded, about 15 words
    • Collaborators: 3 to 4
    v10
  15. Trial status: Active, Not Recruiting to Recruitingv9 Show 7 more changesShow less
    • Start date: Jul 14, 2020 to Sep 9, 2020
    • Primary endpoint revised
    • Study sites: 3 to 2
    • Secondary endpoints: 1 to 2
    • Study description revised
    • Collaborators: 4 to 3
    • Study title expanded, about 3 words
  16. Trial status: Not Yet Recruiting to Active, Not Recruitingv8 Show 5 more changesShow less
    • Primary completion date: Sep 30, 2021 to Dec 31, 2021
    • Study completion date: Sep 30, 2022 to Dec 31, 2022
    • Start date changed from estimate of Aug 15, 2020 to Jul 14, 2020
    • Eligibility criteria revised
    • Site contacts updated at 2 of 3 sites
  17. Start date: May 15, 2020 to Aug 15, 2020
    • Study sites: 2 to 3
    • Study completion date: Dec 31, 2021 to Sep 30, 2022
    v7
  18. Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins to Frantz Viral Therapeutics, LLC
    • Start date: Apr 1, 2020 to May 15, 2020
    • Collaborators: 2 to 4
    v6
  19. Start date: Mar 1, 2020 to Apr 1, 2020
    • Study sites: 1 to 2
    • Eligibility criteria shortened, about 5 words
    v5
  20. Start date: Jan 1, 2020 to Mar 1, 2020v4
  21. Start date: Oct 1, 2019 to Jan 1, 2020v3
  22. Study title shortened, about 5 wordsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT04098744
Lead Sponsor Frantz Viral Therapeutics, LLC
Collaborators: Amarex Clinical Research, M.D. Anderson Cancer Center, Harris Health System (L.B.J. Hospital), The Cleveland Clinic, University of Michigan, Florida Gynecologic Oncology
Conditions
(from sponsor)		 CIN 2/3, HPV Infection, Pre-Cancerous Dysplasia, Cervical Dysplasia, HPV Related Disease
Related terms Papillomavirus Infections, Uterine Cervical Dysplasia
Enrollment 78 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov