CL4 - UK
Research type
Research Study
Full title
AN OPEN-LABEL STUDY TO EVALUATE CLINICAL PERFORMANCE OF THE GEDEA PESSARY IN ADULT WOMEN WITH VULVOVAGINAL CANDIDIASIS
IRAS ID
313439
Contact name
Kate Walker
Contact email
Sponsor organisation
Gedea Biotech AB
Clinicaltrials.gov Identifier
QRS-CL4-003, Clinical Investigation Plan
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
Vaginal infection affects a huge majority of women at some point in their life. The vaginal microbiome maintains a weakly acidic environment and changes to vaginal microflora increase the pH, thereby forming a favourable environment for vaginal pathogens. Additionally, vaginal or systemic antibiotics treatment is frequently followed by vulvovaginal candidiasis (VVC).
During VVC, a fungal microfilm (biofilm) develops, leading to vaginal inflammation,and in severe cases of VVC also to extensive vulvar oedema, excoriations, and fissure formation. Thus, the local application of an improved vaginal pessary (Gedea Pessary) containing Glucono-delta-lactone (GDL) and sodium gluconate (NaG) is intended to treat VVC in adult women by acting upon the biofilm.
The purpose of the study is to investigate the clinical performance of acute treatment with Gedea Pessary in patients with vulvovaginal candidiasis (VVC). Patients will be recruited at study sites’ gynaecological and sexual health clinic. A total of 26 patients are planned to be enrolled in the study.
REC name
London - Stanmore Research Ethics Committee
REC reference
22/LO/0271
Date of REC Opinion
23 May 2022
REC opinion
Further Information Favourable Opinion