Bacterial Vaginosis MedDRA version: 20.0 Level: LLT Classification code 10046960 Term: Vaginosis bacterial System Organ Class: 100000004862
Conditions
Interventions
Trade Name: YENLIP
Pharmaceutical Form: Pessary
INN or Proposed INN: Clindamycin Phosphate
CAS Number: 24729-96-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10
Sponsors
Verisfield (UK) Ltd., Greek branch
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria: In order to be included, subjects will have to meet all of the following criteria: •Pre- and post-menopausal women of any race and =18 years of age; •Diagnosis of bacterial vaginosis based on Amsel’s criteria: presence of at least 3 of the following four criteria: i) increased homogeneous thin vaginal discharge, ii) pH of the secretion greater than 4.5, iii) amine odor when potassium hydroxide 10% solution is added to a drop of vaginal secretions-whiff test and iv) presence of clue cells in wet preparations on microspcopy; •willing to refrain from using any vaginal product (e.g., spermicide, tampon, douche, diaphragm, or condom), other than study product, on study Days 1-6, for 48 hours prior to the first dose of study product, and for 48 hours prior to Test of Cure visit; •willing to refrain from sexual intercourse on study Days 1-3 and for 48 hours prior to Test of Cure visit; •able to understand the requirements of the clinical trial and to agree to return for the required follow-up visits; •willing to provide voluntary written informed consent and data protection declaration before any clinical trial related procedure is performed 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 292 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 292
Exclusion criteria
Exclusion criteria: Exclusion Criteria In order to be included, subjects will have to meet none of the following criteria: •pregnancy or breast-feeding or childbearing potential not protected by a highly effective contraceptive method of birth control; •menstruating when diagnosis of BV is determined at Baseline visit; •primary or secondary immunodeficiency; •severe liver disease; •history of regional enteritis, ulcerative colitis, or a history of “antibiotic-associated” colitis; •current or past evidence of any vulvovaginitis other than bacterial vaginosis (e.g., candidiasis, Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Herpes simplex, or human papilloma virus); •subject will be under treatment during the study period for cervical intraepithelial neoplasia (CIN) or cervical carcinoma; •history of hypersensitivity to clindamycin, lincomycin, or any of the components of the formulation; •use within 2 weeks prior to baseline of topical or systemic antibiotics/antifungal; •use of spermicides, tampons, douches, diaphragms, condoms or other intra-vaginal product within 48 hours prior to dosing on study Day 1; •current participation or not yet completed period of at least 30 days since ending other investigational device or drug trial(s); •unwillingness or inability to comply with the clinical trial procedures; •unwillingness to consent to storage, saving and transmission of pseudonymous medical data for clinical trial reasons; •who are legally incapacitated; •who are legally detained in an official institute.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To confirm the non-inferiority of a generic vaginal ovule formulation containing clindamycin (as phosphate) 100 mg/ovule (Test product) vs. Dalacin® 100 mg vaginal ovules/Pfizer (Reference product) in patients with bacterial vaginosis by examining the Amsel’s clinical criteria (vaginal fluid amine odor, pH of vaginal fluid, vaginal discharge and clue cells on microscopy) at the Test of Cure visit (28 ± 7 days from the day of administrating the medicinal product). •To estimate the bacteriological cure rate of Test product compared to Reference at the Test of Cure visit. •To estimate the clinical cure rate of Test product compared to Reference at the Intermediate visit (14 ± 3 days). •To estimate the bacteriological cure rate of Test product compared to Reference at the Intermediate visit. •To demonstrate the safety and tolerability profile of Test product compared to Reference by assessing the occurrence of either topical or systemic AEs. ;Secondary Objective: ?ot Applicable;Primary end point(s): •Proportion of patients with clinical cure (i.e., resolution of clinical signs and symptoms, e.g., normal physiological vaginal discharge, whiff test is negative for any amine “fishy” odor, saline wet mount is negative for clue cells, and vaginal pH is < 4.5) at the Test of Cure visit;Timepoint(s) of evaluation of this end point: 28± 7 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Proportion of patients with bacteriological cure (i.e., Nugent score<4) at the Test of Cure visit. •The proportion of patients with both clinical and bacteriological cure in patients with both clinical and microbiological diagnosis of BV Test of Cure visit. •Proportion of patients with clinical cure at the Intermediate visit (14 ± 3 days) •Proportion of patients with bacteriological cure at the Intermediate visit. •Proportion of patients with treatment failure at the Test of Cure visit. Safety: •Proportion of patients withdrawn for reasons related to treatment and the proportion of patients experiencing adverse events ;Timepoint(s) of evaluation of this end point: 14 ± 3 days ?a? 28± 7 days | — |
Countries
Greece
Contacts
Public ContactCLINICAL TRIAL INFORMATION
BECRO
Outcome results
None listed