Recurrent vulvo-vaginal candidiasis MedDRA version: 19.0 Level: PT Classification code 10047784 Term: Vulvovaginal candidiasis System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: GYNOPHILUS
Pharmaceutical Form: Vaginal capsule, hard
INN or Proposed INN: Lcr Regenerans
Concentration unit: billion CFU billion colony forming units
Concentration type: not less then
C
Sponsors
BIOSE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 - Patient / legal representative speak and read the local language and having been informed of the study and has voluntarily signed an Informed Consent Form - Patient / legal representative affiliated with a social insurance scheme Are the trial subjects under 18? yes Number of subjects for this age range: 6 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 228 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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. Relating to the population: - Patients unable to comply with the constraints of the protocol. - Breastfeeding women. - Patients with bleeds for more than 12 days per month. - Patients who have taken part in a clinical study in the last month preceding inclusion in the present protocol. - Patients with severe disease, whether acute or chronic, deemed by the investigator to be incompatible with participation in the trial or a serious condition which is life-threatening in the short term. - Immunocompromised patients. - Patients with a previous illness which, according to the investigator, may interfere with the results of the study or expose the patient to an additional risk. - Patients linguistically (unable to speak or write French) or mentally unable to understand and sign the Informed Consent Form. - Patients deprived of their liberty by administrative or legal decision or under guardianship. - Patients who may not comply with treatment. - Patients unable to be contacted in the case of an emergency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The principle objective of this study is to assess the efficacy of Lcr Regenerans® by comparing the rate of clinical recurrence bacteriologically confirmed by mycological tests occurring in the treatment period or in the 5 months following discontinuation of the study treatment in patients with recurrent vulvovaginal candidiasis treated with Lcr Regenerans® according to a 1-cycle treatment regimen versus placebo. The efficacy of Lcr Regenerans® is compared to the efficacy of placebo.;Secondary Objective: The secondary objectives are to assess the efficacy and safety of Lcr Regenerans® by comparing therapeutic agent versus placebo using the same treatment regimen: 1. Efficacy is assessed by comparing the time before the first clinical recurrence confirmed by mycological tests. The time before the first recurrence is calculated from visit V2. 2. Efficacy is assessed by comparing the number of episodes of clinical recurrence confirmed by mycological tests per patient observed during the trial. 3. The same criteria as those defined in the principle and secondary objectives (1 to 2), but including only episodes of recurrence related to Candida albicans 4. Clinical safety of treatment 5. The investigator’s opinion of overall safety;Primary end point(s): The principle objective of this study is to assess the efficacy of Lcr Regenerans® by comparing the rate of clinical recurrence bacteriologically confirmed by mycological tests occurring in the treatment period or in the 5 months following discontinuation of the study treatment in patients with recurrent vulvovaginal candidiasis treated with Lcr Regenerans® according to a 1-cycle treatment regimen versus placebo. The efficacy of Lcr Regenerans® is compared to the efficacy of placebo.;Timepoint(s) of evaluation of this end point: Occurring in the treatment period or in the 5 months following discontinuation of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary objectives are to assess the efficacy and safety of Lcr Regenerans® by comparing therapeutic agent versus placebo using the same treatment regimen: 1. Efficacy is assessed by comparing the time before the first clinical recurrence confirmed by mycological tests. The time before the first recurrence is calculated from visit V2. 2. Efficacy is assessed by comparing the number of episodes of clinical recurrence confirmed by mycological tests per patient observed during the trial. 3. The same criteria as those defined in the principle and secondary objectives (1 to 2), but including only episodes of recurrence related to Candida albicans 4. Clinical safety of treatment 5. The investigator’s opinion of overall safety;Timepoint(s) of evaluation of this end point: 1. The time before the first recurrence is calculated from visit V2. 2, 3, 4, 5. During the trial. | — |
Countries
France, Poland
Contacts
Public ContactClinical Monitoring Manager
BIOSE
Outcome results
None listed