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NCT04098744 | RECRUITING | CIN 2/3

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

Frantz Viral Therapeutics, LLC

Brief 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).

Condition or disease

CIN 2/3

HPV Infection

Pre-Cancerous Dysplasia

Cervical Dysplasia

HPV Related Disease

Intervention/treatment

Artesunate vaginal insert

Placebo vaginal insert

Phase

PHASE2

Detailed Description:

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

Study Type : INTERVENTIONAL
Estimated Enrollment : 78 participants
Masking : DOUBLE
Masking Description : Participants, study team, and sponsor are blinded to the treatment assignment.
Primary Purpose : TREATMENT
Official 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)
Actual Study Start Date : 2020-09-09
Estimated Primary Completion Date : 2025-07-31
Estimated Study Completion Date : 2025-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 25 Years to 100 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
Criteria
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
Artesunate Vaginal Inserts for the Treatment of Cervical Intraepithelial Neoplasia (CIN2/3)

Location Details

NCT04098744

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Florida

Florida Gynecologic Oncology

Fort Myers, Florida, United States, 33905

RECRUITING

United States, Road cancer

University of Michigan

Ann Arbor, Road cancer, United States, 48109

RECRUITING

United States, Ohio

Cleveland Clinic Fairview Hospital

Cleveland, Ohio, United States, 44111

RECRUITING

United States, Ohio

Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44195

RECRUITING

United States, Ohio

Hillcrest Hospital

Mayfield Heights, Ohio, United States, 44124

RECRUITING

United States, Texas

The Harris Health System (L.B.J Hospital)

Houston, Texas, United States, 77026

RECRUITING

United States, Texas

University of Texas, M.D. Anderson

Houston, Texas, United States, 77030