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This phase I research protocol is designed to assess immunogenicity and clinical endpoints in patients with human papillomavirus (HPV) 16 cervical intraepithelial neoplasia (CIN)2/3. The protocol tests the use of artesunate in suppository formulation applied intravaginally in patients with cervical dysplasia (CIN2/3).
The primary endpoint is to determine and evaluate the safety, tolerability, and feasibility of intravaginal administration of artesunate in health women with CIN2/3.
Full description
Phase I open-label dose escalation study of intravaginal artesunate, formulated in suppositories, in adult females with biopsy-confirmed CIN2/3. Thirty (30) subjects will undergo up to a total of three cycles of intravaginal artesunate. The first cycle will be initiated on Day 0, the second at Week 4, and the third and final cycle at week 8.
Enrollment
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Primary purpose
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Interventional model
Masking
30 participants in 4 patient groups
There are currently no registered sites for this trial.
Start date
Feb 01, 2015 • 10 years ago
End date
Jul 01, 2018 • 6 years ago
Results posted
ViewApr 02, 2021 • 4 years ago
Today
May 12, 2025
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Data sourced from clinicaltrials.gov
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