Status:
COMPLETED
Artesunate Pessaries (Vaginal Inserts) for Cervical Precancer in Kenya
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborating Sponsors:
Gilead Sciences
Conditions:
Cervix Cancer
Cervix Neoplasm
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
To investigate the use of self-administered artesunate vaginal pessaries as treatment for cervical precancer in low and middle-income countries (LMIC). The central hypothesis of this study is that sel...
Detailed Description
Despite being preventable, cancer of the cervix is a leading cause of cancer death in Kenya and other low- and middle-income countries (LMIC). Cervical cancer can be prevented if early changes in the ...
Eligibility Criteria
Inclusion
- Cervical lesions referred for excision with CIN2/3 diagnosis on biopsy
- Weight ≥50 kg
- Agreement to use contraception (barriers or hormonal) through week 24 of the study if of childbearing age.
- Ability and willingness to provide informed consent.
Exclusion
- Current pregnancy or breastfeeding status.
- Current or past history of invasive cervical cancer.
- History of total hysterectomy.
- CD4 count less than 200 cells/mm3.
- Presence of adenocarcinoma in situ on cervical biopsy
- Currently receiving systemic chemotherapy or radiation therapy for another cancer
- Current use of systemic immunosuppressants or steroids (\>10 mg of prednisone or equivalent)
- Have a medical comorbidity that in the opinion of the investigator would interfere with study participation.
- Prior chemotherapy within 1 month prior to day 1 of study treatment
- Male at birth
Key Trial Info
Start Date :
March 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 10 2025
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT06165614
Start Date
March 4 2024
End Date
April 10 2025
Last Update
August 19 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Lumumba Sub-County Hospital
Kisumu, Kenya