Study of the efficacy and safety of treatment administered intravaginallyin the treatment of bacterial vaginosis.

Phase 1

• Conditions: Bacterial vaginosis; MedDRA version: 19.0Level: LLTClassification code 10046960Term: Vaginosis bacterialSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2015-004563-37-PL
• Lead Sponsor: aboratoires IPRAD PHARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-01
• Last Update Posted: 8 January 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 530

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

• 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified