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

Launched by FRANTZ VIRAL THERAPEUTICS, LLC · Sep 19, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the use of Artesunate vaginal inserts as a potential treatment for women with cervical high-grade intraepithelial neoplasia (CIN2/3), a condition that can lead to cervical cancer if not treated. The trial is currently recruiting women aged 25 and older who have been diagnosed with CIN2 or CIN3 through a specific examination and testing for human papillomavirus (HPV), the virus linked to these changes in cervical cells. Participants should also agree to use birth control during the study if they can become pregnant.

Women who join this trial will receive either the Artesunate treatment or a placebo (an inactive substance) without knowing which one they are getting, as this is a double-blind study. This means that neither the participants nor the researchers will know who is receiving the actual treatment, which helps to ensure that the results are unbiased. It's important to note that women who are pregnant, nursing, or have certain health conditions, like active autoimmune diseases or HIV, will not be eligible to participate. If you meet the criteria and are interested in joining, this trial could help researchers learn more about a new way to treat CIN2/3.

Gender

FEMALE

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