CompletedPhase 1

Intravaginal Artesunate for the Treatment of HPV+ High Grade Cervical Intraepithelial Neoplasia (CIN2/3)

United States30 participantsStarted 2015-02

Plain-language summary

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.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * ≥ 18 years * Capable of informed consent * HPV-positive by DNA test * Histologically confirmed CIN 2, CIN 3, or CIN 2/3 * Body weight ≥ 50 kg * Immune competent Exclusion Criteria: * Pregnant and nursing women * HIV seropositive * Active autoimmune disease * Taking immunosuppressive medication * Evidence of concurrent adenocarcinoma in situ * Concurrent malignancy except for nonmelanoma skin lesions

What they're measuring

Number of Participants With Serious Adverse Events

Timeframe: 41 weeks

Trial details

NCT IDNCT02354534

SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-07

Results submitted2021-03-08

View on ClinicalTrials.gov More Cervical Intraepithelial Neoplasia Grade 2/3 trials