Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06165614 | Artesunate Pessaries (Vaginal Inserts) for Cervical Precancer in Kenya | PHASE1 | COMPLETED | 17 | — | — | Mar 4, 2024 | Apr 10, 2025 | Aug 19, 2025 | 1 | Kenya |
Safety will be assessed by evaluating the type, frequency, severity, and duration of adverse events (AEs) using the U.S National Cancer Institute Common Terminology Criteria for Adverse Events, v5.0 (CTCAE 5.0). The NCI Common Terminology Criteria for Adverse Events is a descriptive terminology that can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
| Arm | Type | Description |
|---|---|---|
| Artesunate vaginal inserts/ pessaries | EXPERIMENTAL | Artesunate vaginal inserts/pessaries are used as a treatment for cervical precancerous lesions. |
| Name | Type | Description |
|---|---|---|
| Artesunate pessary | DRUG | Subjects will self-administer 200 mg of Artesunate pessary (vaginal insert) daily for 5 days, on weeks 1, 3, 5, 7. |
| Colposcopy | PROCEDURE | Colposcopy is a procedure that allows close examination of the cervix, vagina, and vulva, performed on weeks 8 and 14. |
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: ...