We are inviting volunteers to take part in a clinical research study investigating a potential new treatment for Human papillomavirus (HPV).

Human papillomavirus (HPV) is a common sexually transmitted infection that infects nearly everyone at some point in their lives and can sometimes go undetected as it often doesn't have symptoms. Some types of HPV are called high-risk HPV because they can cause cancers if they persist. Cervical screening and HPV vaccination is important. However, not all high-risk HPV types are covered by vaccination, which means cervical cancer remains a significant health concern. Globally, it is the fourth most common cancer in women.

Currently, there are no approved therapeutic treatments for high-risk HPV infections. Because of that, people with HPV must wait and see if their immune systems can clear it naturally. Therefore, there is a need for a safe and effective treatment which can be administered before cancerous lesions develop.  

This study is looking at a potential new treatment for certain HPV-related conditions, including persistent HPV infection. Your participation in this study is voluntary and if you choose to take part, you are free to leave study participation at any time during the study. 

Researchers want to learn if this investigational treatment, which is a vaginally Inserted medication, stops the HPV virus from making copies of itself in infected cells, by fighting the virus and causing abnormal cells to die, while leaving healthy tissue unharmed. This treatment aims to eliminate HPV infection in affected cells. 

During the study, participants will be required to self-administer the study treatment or placebo at home before bedtime. The research doctor or nurse will train you how to administer the vaginal insert/tablets.

Participants will also be asked to take a vaginal HPV swab at home. The research doctor or nurse will provide the swab and will train you how to collect these samples.

The primary objective of this study is to check if the investigational treatment is safe and well-tolerated compared to a placebo (i.e., a placebo tablet looks just like active study drug but has no active properties/ingredients). It is also evaluating whether persistent high-risk HPV infection in the cervix clears up after 12 weeks of treatment when compared to a placebo.  If someone still has high-risk HPV after 4 weeks, they may get treated again.