Artesunate Pessaries (Vaginal Inserts) for Cervical Precancer in Kenya

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 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.

Timeline

Start

2024-03-04

Primary completion

2025-01-30

Completion

2025-04-10

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

paper Randomized studies of intravaginal artesunate and other topical therapies are needed to further evaluate their efficacy and acceptability in LMICs. PMID 42403515 ↗

Publications

• Sadana 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.
• Guliam 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.

Drugs

Indications