This trial studies how well artesunate vaginal inserts work for women with cervical intraepithelial neoplasia (CIN2/3), which are high-grade changes in the cervix. It is a phase II study that is randomized and double-blind. This means that neither the participants nor the doctors know who is receiving the artesunate or a placebo. The main goal is to see how effective the treatment is and to check for any side effects.
The trial's ID number is NCT04098744. It is a Phase 2 study, which means it looks at how well the treatment works and how safe it is. About 78 participants are expected to join, and it is regulated by the FDA.
Who can join
This study is open to adult women aged 25 to 100 who can give informed consent. They should have a confirmed diagnosis of CIN2 or CIN3 and agree to use birth control if they can become pregnant. Women who are pregnant, nursing, have certain autoimmune diseases, or are taking immunosuppressive medications cannot join. The trial team will confirm eligibility for each participant.
The study team makes the final call on eligibility.
What happens in the study
Participants will be placed into two groups by chance. One group will receive artesunate vaginal inserts for three cycles of five days each. The other group will receive placebo vaginal inserts for the same schedule. Everyone will attend follow-up visits after treatment. A LEEP procedure will be done at week 17 to check the results.
Where
This trial is running at 7 locations in the United States. All of them are currently recruiting.