Clinical trial · Interventional
Artesunate Pessaries (Vaginal Inserts) for Cervical Precancer in Kenya
Self-administered Artesunate Pessaries for Treatment of Cervical Precancer in Kenya
NCT06165614CI-TRIAL-00093831completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 self-administered intravaginal Artesunate will be safe, and result in a clinical response among both HIV-positive and HIV-negative women with cervical precancer in LMICs.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Precancer | — | UNRESOLVED | — |
| Cervix Cancer | — | UNRESOLVED | — |
| Cervix Neoplasm | Cervical Neoplasm | ALIAS | 0.90 |
| Precancerous Conditions | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Artesunate pessary | Drug | — | UNRESOLVED |
| Colposcopy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Artesunate vaginal inserts/ pessaries
- description
- Artesunate vaginal inserts/pessaries are used as a treatment for cervical precancerous lesions.
- interventionNames
- Drug: Artesunate pessary
- Procedure: Colposcopy
Primary outcomes (1)
- measure
- the type, frequency, severity and duration of adverse events
- timeFrame
- From the first day of the study treatment to week 14 ( 8 weeks after artesunate use)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDSadana A, Guliam A, Opiyo EA, Adundo F, Sorgi K, Agha E, Mungo C. "When a Thorn Comes Into Your Body, You Must Remove It". A Socio-Ecological Analysis of the Acceptability of Intravaginal Artesunate as Cervical Precancer Treatment in a Phase 1 Clinical Trial. Int J Womens Health. 2026 Jun 29;18:573262. doi: 10.2147/IJWH.S573262. eCollection 2026. PMID 42403515
- DERIVEDGuliam A, Sadana A, Opiyo E, Adundo F, Sorgi K, Agha E, Mungo C. Trying to Heal Without "Bringing Problems": Navigating Cervical Precancer Stigma in a Phase I Clinical Trial in Western Kenya. medRxiv [Preprint]. 2025 Dec 17:2025.10.24.25338728. doi: 10.1101/2025.10.24.25338728. PMID 41415498