CL4
Research type
Research Study
Full title
A RANDOMISED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE CLINICAL PERFORMANCE OF THE GEDEA PESSARY IN ADULT WOMEN WITH VULVOVAGINAL CANDIDIASIS
IRAS ID
303593
Contact name
Annette Säfholm
Contact email
Sponsor organisation
Gedea Biotech AB
Clinicaltrials.gov Identifier
QRS-CL4-003, Clinical Investigation Plan
Duration of Study in the UK
1 years, 0 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 as compared to placebo, in adult women with confirmed VVC. Patients will be recruited at study sites’ gynaecological and sexual health clinic. A total of 74 patients are planned to be randomised in the study.
On Day 0, patients will have gynaecological examination, vaginal samples taken, and be randomised in a 1:1 ratio to treatment with 6 doses of Gedea Pessary or placebo that will be self-administered daily (Days 0 to 5). Patients will be re-examined at Day 14 for clinical cure rate. On Days 7 and 25, patients will self-perform vaginal swabs at home, for vaginal culture and sequencing. On Day 7, patients will also self-perform a vaginal pH measurement at home. Patients will answer questionnaires during the study which ends at Day 25.
REC name
London - Stanmore Research Ethics Committee
REC reference
21/LO/0790
Date of REC Opinion
17 Nov 2021
REC opinion
Unfavourable Opinion