CL3 - NEFERTITI
Research type
Research Study
Full title
A RANDOMISED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE CLINICAL PERFORMANCE AND SAFETY OF THE GEDEA PESSARY IN ADULT WOMEN WITH BACTERIAL VAGINOSIS - NEFERTITI
IRAS ID
282232
Contact name
Annette Säfholm
Contact email
Sponsor organisation
Gedea Biotech AB
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
Clinical Investigation Plan , QRS-CL3-003
Duration of Study in the UK
0 years, 9 months, 16 days
Research summary
Research Summary
Bacterial vaginosis (BV) is the most common cause of foul-smelling vaginal discharge in females of reproductive age. During BV, a polymicrobial microfilm (biofilm) develops, leading to recurrence and inefficiency in the use of antibiotics. Thus, the local application of a vaginal pessary (Gedea Pessary) containing Glucono-delta-lactone (GDL) and sodium gluconate (NaG) is intended to treat and prevent bacterial vaginosis (BV) in adult women by acting upon the biofilm. The purpose of the study is to investigate if Gedea pessary is effective and safe to use in comparison to a placebo treatment. Study will be performed in adult women of reproductive age, diagnosed with BV according to Amsel’s criteria who have not been treated for BV within the last past 14 days. Patients will be recruited at study sites’ gynaecological and sexual health clinics and a total of 150 patients are planned to join the study. On Day 0, patients will have gynaecological examination, vaginal samples taken, and will be randomised in a 4:1 relation to receive treatment with 6 doses of the Gedea Pessary or placebo to be self-administered daily (Days 0 to 5). Patients will be re-examined at Day 7 for clinical cure rate. Patients that are clinically cured at Day 7 will continue to the second part of the study and will be randomised in a 1:1 relation to either Gedea Pessary or placebo treatment, to be self-administered once a week for a duration of 126 days. Patients will be followed up for recurrence up to Day 128.
Summary of Results
There was no statistically significant difference in primary clinical performance endpoint, clinical cure rate on Day 7, between the two groups.
There were no safety concerns identified, treatment with Gedea Pessary and placebo was well tolerated with few patients that reported AEs assessed as probably or possibly related to the device or to the study procedure. No SAE was reported during Part 1 of the study.There were no statistically significant between-group differences in recurrence rate up to Day 128, between the Gedea Pessary group and the placebo group.
There were no safety concerns identified; treatment with the Gedea Pessary and placebo was well tolerated with few reported AEs assessed as probably or possibly related to the device or to the study procedure. No SAE was reported in the FAS population during the study.REC name
North of Scotland Research Ethics Committee 1
REC reference
20/NS/0087
Date of REC Opinion
31 Aug 2020
REC opinion
Favourable Opinion