Study of the efficacy and safety of treatment with total freeze-dried culture of Lcr Regenerans® administered intravaginally in the prevention of recurrent vulvovaginal candidiasis.International, randomized, phase III, multi-centre, 2-arm, parallel group, double-blind, placebo-controlled superiority trial. - Study of the efficacy and safety of Lcr Regenerans®_GynoCans.

BIOSE0 sites234 target enrollmentJuly 30, 2014

Overview

No summary available.

Registry

who.int

Start Date

July 30, 2014

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

BIOSE

•Disease\-related criteria:
•\- Patients with recurrent vulvo\-vginal candidiasis, defined by the existence of at least 4 episodes of VVC during the previous year including the episode which was the subject of the screening visit
•In addition to the current episode, at least one episode that occurred in the previous two years should also be documented by mycological examination.)
•\- Patients with acute vulvovaginitis characterised by the presence of the following clinical criteria (i at V1: symptoms of pruritus, vulvovaginal signs such as erythema, vaginal discharge
•\- Patients with a positive mycological examination at V1
•\- Patients who are clinically cured at the end of Day 8 after treatment with MONAZOL Ovule (one ovule at bedtime) and so just after treatment with MONAZOL cream (treatment lasting 8 days).
•Relating to the population:
•\- Women of childbearing age:
•Urinary pregnancy test negative
•Use of a contraceptive method considered effective by the investigator (except spermicides) throughout the test

•Relating to the disease or gynaecological issues:
•\- Presence of an infection, bacterial or viral, assumed or demonstrated to be gynaecological, whether treated or not in the month prior to inclusion or present at inclusion.
•\- Presence of an existing gynaecological infection that may interfere with the assessment of the trial treatment (severe dysplasia of the cervix or in situ carcinoma, invasive carcinoma, intra\-epithelial cervical neoplasia, squamous intra\-epithelial lesions etc.)
•\- Patients with a negative mycological examination at V1
•\- No adequate documentation of earlier episodes to confirm the recurrent character of the VVC (4 episodes in one year, two of which documented a mycological examination in the past two years \[and, in addition to the current episode, at least one episode occurred in the previous two years should also be documented in a mycological examination])
•Relating to treatment:
•\- Taking systemic antifungals (particularly Fluconazole, see the list in 17\.2\) in the month prior to the screening visit to prevent recurrence, (treatment of an acute episode of VVC is not an exclusion criterion).
•\- Use of probiotics (see the list in 17\.2\) in the 3 months preceding the screening visit.
•\- Use of prebiotics (acidifying) (see the list in 17\.2\) in the 15 days preceding the screening visit.
•\- Allergy to one of the active substances or one of the excipients in the products.