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NCT Number: NCT04098744

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).

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Key information

Conditions

CIN 2/3 Cervical Dysplasia Communicable Diseases DNA Virus Infections Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female HPV Infection HPV Related Disease Infections Neoplasms Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pre-Cancerous Dysplasia Precancerous Conditions Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Diseases Virus Diseases

Age range

25 year–100 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Florida Gynecologic Oncology, Fort Myers, Florida, United States

Loading trial locations.

About this study

Eligible participants in this study are randomized 2:1 to receive either artesunate or placebo vaginal inserts for the treatment of CIN2/3. Both groups receive three 5-day cycles of the respective drug, at weeks 0, 2, and 4. Dosing visits can be done as telehealth visits (medication is mailed to the patient's home). Participants are followed after receiving artesunate at weeks 6, 17, and 40. All participants undergo a LEEP procedure at week 17.

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Artesunate vaginal insert

Drug

Artesunate formulated as vaginal inserts, 200mg

Other names: Artesunic acid, DHA, artemisinin

Placebo Vaginal Insert

Drug

Placebo for artesunate vaginal inserts

Primary outcomes

  1. Proportion of participants with histologic regression by week 17

    Time frame: 17 weeks

    Number of participants who undergo histologic regression to cervical intraepithelial neoplasia (CIN) 1 or less by week 17, following three 5-day cycles of artesunate vaginal inserts, as determined by the LEEP histopathologic analysis

Secondary outcomes

  1. Number of participants who have achieved clearance of detectable human papilloma virus (HPV) by week 17

    Time frame: 17 weeks

    Number of participants who had HPV strains detected at study entry which become undetectable by week 17

  2. Number of participants who have achieved clearance of detectable human papilloma virus (HPV) after three 5-day cycles of artesunate and the LEEP procedure.

    Time frame: 40 weeks

    Number of participants who had HPV strains detected at study entry which become undetectable after three 5-day cycles of artesunate and the LEEP procedure

Other outcomes

  1. Number of participants with Treatment-Emergent Adverse Events (TEAE)

    Time frame: 6 weeks

    Number of participants who had adverse events, as defined by CTCAE v5.0, related to the study intervention

  2. Number of participants who withdrew from the study due to TEAEs

    Time frame: 6 weeks

    Number of participants who were withdrawn from the study due to adverse events related to the study drug

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmad Bayat, MD

CONTACT

[email protected]

(301) 956-2523

Mihaela Plesa, BA, CCRP

CONTACT

[email protected]

440-255-1155 ext. 100

Sponsors and collaborators

Lead sponsor

Frantz Viral Therapeutics, LLC

Industry

Collaborators

  • Amarex Clinical Research
  • Florida Gynecologic Oncology
  • Harris Health System (L.B.J. Hospital)
  • M.D. Anderson Cancer Center
  • The Cleveland Clinic
  • University of Michigan

Registry information

Official study title

A Phase II Double Blind, Placebo-controlled, Randomized Trial of Artesunate Vaginal Inserts for the Treatment of Patients With Cervical Intraepithelial Neoplasia (CIN2/3)

Acronym: ART-CIN_IIB

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Sep 23, 2019
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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