Artesunate Pessaries (Vaginal Inserts) for Cervical Precancer in Kenya

Launched by UNC LINEBERGER COMPREHENSIVE CANCER CENTER · Dec 8, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring the use of artesunate vaginal pessaries, which are small inserts that women can use themselves, to treat cervical precancer in Kenya. The goal is to see if these pessaries are safe and effective for women, both HIV-positive and HIV-negative, who have been diagnosed with certain types of cervical lesions. The study is particularly focused on women living in low and middle-income countries, where access to cervical cancer treatment can be limited.

To participate in this trial, women must be between the ages of 18 and 75, have a specific type of cervical lesion known as CIN2/3, and weigh at least 50 kg. They should also be willing to use contraception if they can become pregnant. Women who are pregnant, breastfeeding, or have a history of invasive cervical cancer or certain other health conditions are not eligible to join the study. Participants can expect to use the pessaries over the course of the study and will receive guidance and support throughout the process. This trial aims to provide more options for treating cervical precancer, which can help prevent the development of cervical cancer in the future.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Cervical lesions referred for excision with CIN2/3 diagnosis on biopsy
• • 2. Weight ≥50 kg
• • 3. Agreement to use contraception (barriers or hormonal) through week 24 of the study if of childbearing age.
• • 4. Ability and willingness to provide informed consent.
• Exclusion Criteria:
• • 1. Current pregnancy or breastfeeding status.
• • 2. Current or past history of invasive cervical cancer.
• • 3. History of total hysterectomy.
• • 4. CD4 count less than 200 cells/mm3.
• • 5. Presence of adenocarcinoma in situ on cervical biopsy
• • 6. Currently receiving systemic chemotherapy or radiation therapy for another cancer
• • 7. Current use of systemic immunosuppressants or steroids (\>10 mg of prednisone or equivalent)
• • 8. Have a medical comorbidity that in the opinion of the investigator would interfere with study participation.
• • 9. Prior chemotherapy within 1 month prior to day 1 of study treatment
• • 10. Male at birth