Case study in Clinical trials
Evaluation of the efficacy, safety, and dose-response of a Live Biotherapeutic Product in women with acute vaginal infection: A randomized, double-blind, placebo-controlled study. See all the case studiesGet in touchKey information
Study endpoints
– Percentage of responders in clinical cure
– Improved symptoms
– Quantification of the strain in the vaginal microbiota
Population
165 adult post-menarche women
Tested product
Live Biotherapeutic Product (LBP), tablets
Investigations
10 centres (Hospitals and private gynaecology practices) in France and Germany
Key challenge
CTIS submission