Study of the efficacy and safety of treatment with completely lyophilisedcultures of Lactobacillus crispatus - IP 174178 administered intravaginallyin the treatment of bacterial vaginosis. - IPR_GARDEFLORA_15-2

aboratoires IPRAD PHARMA0 sites530 target enrollmentApril 1, 2016

Overview

No summary available.

Registry

who.int

Start Date

April 1, 2016

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

aboratoires IPRAD PHARMA

•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

•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,