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[CASE STUDY] Evaluation of the efficacy, safety, and dose-response of a Live Biotherapeutic Product in women with acute vaginal infection - Biofortis
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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.
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Key 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

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