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

NCT02251093 | Completed Phase 3 DMC

• 2 other identifiers: PRO_2013 - 022013-002480-26
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Candidiasis, Vulvovaginal

Keywords

mycosis; vulvovaginal candidiasis; lcr35; Lcr Regenerans®

Outcome Measures

Primary Outcomes (1)

• Recurrence confirmed by a mycological test, occurring during the treatment period, or within 5 months of trial treatment termination

  The main outcome measure chosen for this trial is the rate of clinical recurrence confirmed by a mycological test, occurring during the treatment period, or within 5 months of trial treatment termination (fraction of patients presenting with at least one recurrence during the treatment period or during the 5-month monitoring period).

  5 months

Study Arms (2)

Lcr Regenerans

EXPERIMENTAL

Drug: Lcr Regenerans

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Lcr Regenerans DRUG

Dosage: 1 vaginal capsule per day Route of administration: intravaginal Treatment duration: One 21-day cycle

Also known as: GYNOPHILUS

Lcr Regenerans

Placebo DRUG

Dosage: 1 vaginal capsule per day Route of administration: intravaginal Treatment duration: One 21-day cycle

Placebo

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient suffering from recurrent VVC (RVVC) defined by the existence of at least 4 VVC episodes during the past year, including the one concerned by the screening visit In addition to the current episode, at least one episode occurring during the two previous years must also have been documented by mycological examination
• Patient suffering from acute vulvovaginitis characterised by the presence of the following clinical criteria at V1 (pruritus symptoms, vulvovaginal signs such as erythema, vaginal discharge)
• Patient with a positive mycological examination at V1
• Patient cured in clinical terms 8 days after treatment with MONAZOL 300 mg vaginal suppositories (one suppository at night before sleep, single administration) and followed by the application of MONAZOL 2 pourcent cream (8-day treatment)
• Woman of child-bearing age with a negative urine pregnancy test and using a means of contraception deemed effective by the investigator (excluding spermicides) throughout the trial
• Patient/Legal representative able to speak and read the local language, having been informed of the trial and having voluntarily signed an Informed Consent Form
• Patient/Legal representative registered with a social insurance scheme

You may not qualify if:

• Presence of an existing gynaecological infection that could interfere with the assessment of the trial treatment (severe cervical dysplasia or carcinoma in situ, invasive carcinoma, intra-epithelial cervical neoplasia, squamous intra-epithelial lesions etc.)
• Patients with a negative mycological examination at V1
• Lack of adequately documented previous episodes to assert the recurrent nature of the VVC (4 episodes in one year, two of which documented by mycological examination over the past two years \[thus, in addition to the current episode, at least one episode occurring during the two previous years must also have been documented by mycological examination\])
• Use of probiotics in the month preceding the screening visit.
• Use of prebiotics (acidifiers) during the two weeks preceding the screening visit.
• Allergy to one of the active ingredients or one of the excipients in the products.
• Patient unable to comply with the constraints of the Protocol.
• Breastfeeding patient.
• Patient with menstrual bleeding lasting more than 8 days a month.
• Post-menopausal women with last menstrual period at least 12 months prior to screening
• Patient with a severe acute or chronic disease deemed by the Investigator to be incompatible with participation in the trial, or a serious infection that is life-threatening in the short term.
• Immuno-suppressed patient.
• Patient presenting with a previous illness which, according to the Investigator, is likely to interfere with the results of the trial or expose the patient to an additional risk.
• Patient linguistically (unable to speak or write the local language) or mentally unable to understand and sign the Informed Consent Form.
• Patient deprived of her liberty by order of the Courts or civil authorities or subject to a guardianship order.

Sponsors & Collaborators

• Probionov: lead

Study Sites (1)

Probionov

Aurillac, 15130, France

Location

MeSH Terms

Conditions

Candidiasis, Vulvovaginal; Mycoses

Condition Hierarchy (Ancestors)

Candidiasis; Bacterial Infections and Mycoses; Infections; Vulvovaginitis; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vulvitis; Vulvar Diseases; Genital Diseases

Study Officials

• Philippe JUDLIN

  Maternité Régionale Universitaire de Nancy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2014
• First Posted: September 26, 2014
• Study Start: May 1, 2014
• Primary Completion: February 1, 2016
• Last Updated: March 25, 2016

Record last verified: 2016-03

Locations

FR (1)