Menu
Recruiting NCT04098744

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

Phase II Interventional CIN 2/3 HPV Infection Pre-Cancerous Dysplasia Cervical Dysplasia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Artesunate vaginal insert, Placebo vaginal insert.
Who it may be relevant to
Registry conditions: CIN 2/3, HPV Infection, Pre-Cancerous Dysplasia, Cervical Dysplasia. Basic parameters: 25 years — 100 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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)

Overview

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).

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

Interventions

  • Drug Artesunate vaginal insert
    Artesunate formulated as vaginal inserts, 200mg
  • Drug Placebo vaginal insert
    Placebo for artesunate vaginal inserts

Primary outcome measures

  • Proportion of participants with histologic regression by week 17 [Time frame: 17 weeks]
Secondary outcome measures (2)
  • Number of participants who have achieved clearance of detectable human papilloma virus (HPV) by week 17 [Time frame: 17 weeks]
  • 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]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 7 centers
  • Florida Gynecologic Oncology — Fort Myers
  • University of Michigan — Ann Arbor
  • Cleveland Clinic Fairview Hospital — Cleveland
  • Cleveland Clinic Foundation — Cleveland
  • Hillcrest Hospital — Mayfield Heights
  • The Harris Health System (L.B.J Hospital) — Houston
  • University of Texas, M.D. Anderson — Houston

Identifiers

NCT: NCT04098744 · ART-CIN IIB · 2020 0237 · 20 1148

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗