NCT02251093

Study of the Efficacy and Tolerance of Intra-vaginal Treatment With a Total Freeze-dried Culture of Lcr Regenerans® in the Prevention of Relapses of Recurrent Vulvovaginal Candidiasis

Study of the Efficacy and Tolerance of Intra-vaginal Treatment With a Total Freeze-dried Culture of Lcr Regenerans® in the Prevention of Relapses of Recurrent Vulvovaginal Candidiasis. International Phase III, Randomised, Multi-centre, Parallel-group, Two Arm, Double-blind Superiority Trial Versus Placebo.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 350 (actual)
• Sponsor: Probionov · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

The trial medicinal product (Lcr Regenerans®) is obtained from the culture of a strain of Lactobacillus rhamnosus Lcr35®. By virtue of the freeze-drying technique, Lactobacillus rhamnosus Lcr35® is a live bacterium administered with its culture medium. It should be noted that Lcr Regenerans® is already marketed as a medical device (EC marking: 0499). It helps to regenerate the vaginal flora thanks to its physical and chemical effects (lowering the vaginal pH). A number of in vitro and in vivo studies have demonstrated the ability of Lactobacillus rhamnosus Lcr35®: * to establish itself in the vaginal epithelium, along with the durability of this establishment. * and to inhibit the growth of pathogenic organisms responsible for causing bacterial vaginosis (Gardnerella vaginalis and Prevotella bivia) but also for mycoses (Candida albicans), by synthesising various microbicidal substances. This research follows on from the Candiflore observational study in which 514 patients were monitored and which demonstrated a clearly positive result in favour of the use of vaginal Lcr Regenerans® for preventing recurrences of VVC. The purpose of this new research is thus to demonstrate the efficacy of Lcr Regenerans®, in the prevention of vulvovaginal candidiasis recurrences in patients with a history of VVC with recurrent episodes, in view of obtaining a marketing authorisation.

Detailed description

Treatment of RVVC is difficult due to the multi-factor nature of recurrences and of the poorly understood local immune dysfunctions that may arise. The oral or topical antifungal maintenance treatment usually recommended is for a period of 6 months, though the VVC relapse rate is high, with 60 to 70% of women presenting with a recurrence within 2 months following termination of treatment. Moreover, antifungal agent-related adverse events are frequent and their long-term use can be conducive to the onset of bacterial vaginosis (BV). The vaginal administration of probiotic strains (Lactobacillus) capable of regenerating the vaginal flora and of inhibiting the development of Candida albicans and/or its adhesion to the vaginal epithelium, would appear to be an interesting therapeutic alternative for preventing VVC recurrences. The trial medicinal product (Lcr Regenerans®) is obtained from the culture of a strain of Lactobacillus rhamnosus Lcr35®. By virtue of the freeze-drying technique, Lactobacillus rhamnosus Lcr35® is a live bacterium administered with its culture medium. It should be noted that Lcr Regenerans® is already marketed as a medical device (EC marking: 0499). It helps to regenerate the vaginal flora thanks to its physical and chemical effects (lowering the vaginal pH). A number of in vitro and in vivo studies have demonstrated the ability of Lactobacillus rhamnosus Lcr35®: * to establish itself in the vaginal epithelium, along with the durability of this establishment. * and to inhibit the growth of pathogenic organisms responsible for causing bacterial vaginosis (Gardnerella vaginalis and Prevotella bivia) but also for mycoses (Candida albicans), by synthesising various microbicidal substances. This research follows on from the Candiflore observational study in which 514 patients were monitored and which demonstrated a clearly positive result in favour of the use of vaginal Lcr Regenerans® for preventing recurrences of VVC. The purpose of this new research is thus to demonstrate the efficacy of Lcr Regenerans®, in the prevention of vulvovaginal candidiasis recurrences in patients with a history of VVC with recurrent episodes, in view of obtaining a marketing authorisation.

Conditions

• Candidiasis, Vulvovaginal

Interventions

Type	Name	Description
DRUG	Lcr Regenerans	Dosage: 1 vaginal capsule per day Route of administration: intravaginal Treatment duration: One 21-day cycle
DRUG	Placebo	Dosage: 1 vaginal capsule per day Route of administration: intravaginal Treatment duration: One 21-day cycle

Timeline

• Start date: 2014-05-01
• Primary completion: 2016-02-01
• First posted: 2014-09-26
• Last updated: 2016-03-25

Locations

1 site across 1 country: France