Bacterial vaginosis MedDRA version: 19.0 Level: LLT Classification code 10046960 Term: Vaginosis bacterial System Organ Class: 100000004862
Conditions
Interventions
Product Name: Lactobacillus crispatus
Product Code: IP174 178
Pharmaceutical Form: Vaginal capsule
INN or Proposed INN: Lactobacillus Crispatus IP174178
CAS Number: D007778000
Current Sponsor code: IP
Sponsors
Laboratoires IPRAD PHARMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Woman over 18 years old, • Patients with clinical symptoms suggestive of bacterial vaginosis, linked to an imbalance of vaginal flora, characterised by the presence of at least 3 of 4 of the following Amsel clinical criteria: uniform greyish vaginal discharge, characteristic odour of "rotten fish" caused by the spontaneous release of amine or during the potassium test or "sniff test", vaginal pH greater than 4.5, presence of "clue cells" (at least 20%) during the vaginal secretions direct exam • Patient with negative pregnancy test at V1, • Patient using a contraceptive method considered effective by the investigator (excluding spermicides), • Patient having received all the information on the study and having voluntarily given her written informed consent, • Patient registered with social security or other social protection. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 530 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Presence of an existing gynaecological infection that may affect the evaluation of the trial treatment (severe dysplasia or cervical carcinoma in situ, invasive carcinoma, cervical intraepithelial neoplasia, squamous intraepithelial lesions etc.), • Patient having taken an antibiotic or antifungal treatment within 14 days prior to V1 (after administration by any route). • Patient unable to comply with the constraints of the protocol, • Patients having more than 12 days of menses per month, • Patient pregnant or breastfeeding, • Menopausal patient, • Patient with a known allergy to any of the active substances or to any of the excipients of the study products, • Patient with severe acute or chronic disease considered by the investigator as being incompatible with participation in this study, or with a serious infection that may endanger the life of the patient in the short term, • Immunosuppressed patient, • Patient with a previous illness that, according to the investigator, could compromise the results of the study or expose the patient to additional risk, • Patient with psychological or linguistic factors limiting the understanding and signature for the informed consent form, • Patient deprived of their liberty by court judgement or subject to guardianship, • Patient at risk of failing to follow the treatment (compliance problem), • Patient impossible to contact in an emergency. • Antibiotics or fungicides taken systemically during the month preceding the screening visit, excluding treatments for the bacterial vaginosis episode. • Use of local probiotics in the months preceding the screening visit. • Use of antiseptics in the months preceding the screening visit, excluding treatments for the bacterial vaginosis episode. • Use of prebiotics (acidifiers) during the two weeks preceding the screening visit. • Use of products containing topical oestrogen in the month before the screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess the efficacy of Lactobacillus crispatus – IP174178 in the normalisation of AMSEL criteria on D14 in the 2 arms.;Secondary Objective: Assess the efficacy of Lactobacillus crispatus – IP174178 in the normalisation of AMSEL criteria on D28 in the 2 arms. Assess the efficacy of Lactobacillus crispatus – IP174178 in the normalisation of AMSEL criteria on D14 in the 2 arms, in 3 subpopulations. Assess the efficacy of Lactobacillus crispatus – IP174178 in the normalisation of AMSEL criteria on D28 in the 2 arms, in 3 subpopulations. Assessment of clinical response by the normalisation of AMSEL criteria AND bacteriological response (Nugent = 3) on D14 and D28 globally and in three subpopulations. Assessment of bacteriological response (Nugent = 3) on D14 and D28 globally and in three subpopulations. Evaluate the safety of Lactobacillus crispatus – IP174178 and compare it to standard treatment.;Primary end point(s): Proportion of patients with normalisation of AMSEL criteria at D14 in the 2 arms.;Timepoint(s) of evaluation of this end point: Proportion of patients with normalisation of AMSEL criteria at D14 in the 2 arms. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Proportion of patients with normalisation of AMSEL criteria at D28 in the 2 arms. Proportion of patients with normalisation of AMSEL criteria at D14 in the 2 arms in the 3 populations. Proportion of patients with normalisation of AMSEL criteria at D28 in the 2 arms in the 3 subpopulations. Assessment of clinical response by the normalisation of AMSEL criteria AND bacteriological response (Nugent = 3) on D14 and D28 globally and in the three subpopulations. Assessment of bacteriological response (Nugent = 3) on D14 and D28 globally and in the three subpopulations. Adverse events: Adverse events occurring during the study, as noted by the patient in her self-assessment log (diary) or gathered by the Investigator during visits, will be recorded in the Case Report Form (e-CRF). Evaluation of overall tolerance by the Investigator, after questioning the patient. This evaluation will be carried out using the following grading scheme: 1 = Very good tolerance: no functional sign of discomfort and no objective signs on examination. 2 = Good tolerance: a few functional signs of discomfort but minimum and short-lived in nature, not causing temporary cessation of applications. No objective signs on examination. 3 = Moderate tolerance: marked or persistent functional signs of discomfort or objective signs on examination but not causing application of the trial product to cease temporarily. 4 = Poor tolerance: functional and/or objective signs leading the patient to stop using the trial product.;Timepoint(s) of evaluation of this end point: Timepoints already indicated in the "secondary end point(s)" part (E.5.2). | — |
Countries
Poland
Contacts
Public ContactNathalie CIENCIEWIEZ
ITEC Services
Outcome results
None listed