A novel, safe and resistance-free treatment
| Reference number | |
| Coordinator | GEDEA BIOTECH AB - Medicon Village |
| Funding from Vinnova | SEK 1 000 000 |
| Project duration | June 2018 - April 2019 |
| Status | Completed |
| Venture | Swelife and Medtech4Health- Project proposals to improve health |
Purpose and goal
The purpose and aim of the project was to clinically validate the safety and efficacy of Gedea´s vaginal tablet in the treatment of vaginal fungal infections. This has been studied in a clinical trial with 24 patients. In parallel, we also examined in a separate clinical study the effect of treating bacterial vaginosis in 24 patients. Safety and efficacy have been confirmed. Additionally, the user experience during treatment has been investigated. In focus groups, the patient journey for patients with vaginal infections has been mapped.
Expected results and effects
The project has, as expected, provided us with information on the safety, clinical effect and user experience when treating vaginal fungal infections and bacterial vaginosis with Gedea’s vaginal tablet. Furthermore, we have performed focus group surveys with patients affected by vaginal infections. The focus groups have provided us with good knowledge about the patient journey and decisions taken by the patients and will serve as a basis for decisions during the development and for future marketing of the product. Thus, the expected outcome of the project has been fulfilled.
Planned approach and implementation
We have conducted two clinical studies of the effect of the vaginal tablet, on the treatment of vaginal fungal infections and on the treatment of bacterial vaginosis. The studies have been carried out at a total of four private gynecology clinics in Skåne and in collaboration with the Clinical Trial Unit, Region Skåne. In addition to safety, treatment results and user experience, the effect of the treatment on the vaginal microbiome will also be analyzed after the study has ended. The patient journey has been mapped through focus group surveys with women who had vaginal infections.