Artesunate Vaginal Inserts for CIN2/3
This study is testing if artesunate vaginal inserts can help treat cervical intraepithelial neoplasia (CIN2/3), which are pre-cancerous changes in the cervix often caused by HPV (human papillomavirus) infection. You might be able to join if you are a woman aged 25 or older with a confirmed diagnosis of CIN2 or CIN3 and any type of HPV. The study aims to see how many participants show improvement in their cervical tissue by week 17. Participants will receive either artesunate vaginal inserts or a placebo (an inactive substance) for three cycles. The study is currently unclear on its recruitment status and plans to enroll 78 participants.
- Study design
- This is a phase II, double-blind study, meaning neither you nor your doctor will know if you are receiving artesunate or placebo. Participants are randomly assigned in a 2:1 ratio to receive either artesunate or placebo vaginal inserts.
- What's involved
- You would receive three 5-day cycles of vaginal inserts at weeks 0, 2, and 4. Dosing visits can be done via telehealth, with medication mailed to your home. You will have follow-up visits at weeks 6, 17, and 40, and all participants will undergo a LEEP procedure (a common treatment for CIN) at week 17.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants are followed after receiving artesunate at weeks 6, 17, and 40.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Artesunate Vaginal Inserts for the Treatment of Cervical Intraepithelial Neoplasia (CIN2/3)
At a glance
Conditions
Where it's being run
7 sites across 4 statesWho to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Proportion of participants with histologic regression by week 1717 weeks
Number of participants who undergo histologic regression to cervical intraepithelial neoplasia (CIN) 1 or less by week 17, following three 5-day cycles of artesunate vaginal inserts, as determined by the LEEP histopathologic analysis