Patients with clinically symptomatic vulvovaginal candidiasis. The following symptoms will be evaluated: pruritus, discharge, pain, dryness will be done using a daily VAS scale.
Conditions
Interventions
Trade Name: LJ LACTO
Pharmaceutical Form: Vaginal capsule, soft
INN or Proposed INN: Lactobacillus plantarum P 17630
Other descriptive name: LACTOBACILLUS PLANTARUM P 17630
Concentration unit: CFU/g c
Sponsors
PROGE FARM SRL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Pre-menopausal women of any race and between 18 to 45 years of age; ? Diagnosis of VVC based on the presence of the following four criteria: pruritus, discharge, pain, dryness; ? Negative results on the Bayer evaluating kit (Gyno-Canestest®); ? Negative pregnancy test ? Willing to refrain from using any vaginal product (e.g. spermicide, tampon, douche, diaphragm or condom), other than study product, on study Days 0-7; ? Willing to refrain from sexual intercourse on study Days 0-7; ? 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 trail 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 210 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Menstruating when diagnosis of vulvovaginal candidiasis is determined at Baseline visit; ? Primary or secondary immunodeficiency; ? Severe liver disease; ? History of regional enteritis or ulcerative 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) in the previous 4 months; ? Subject will be under treatment during the study period for cervical intraepithelial neoplasia or cervical carcinoma; ? History of hypersensitivity to miconazole nitrate, Lactobacillus plantarum 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 0; ? Current participation or not yet completed period of at least 30 days since ending other investigational device or drug trial(s). Use of any experimental medicinal product within the 3 months prior to screening. ? Unwillingness or inability to comply with the clinical trial procedures; ? Who are legally incapacitated; ? Who are legally detained in an official institute.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the non-inferiority efficacy of LJ LACTO - Lactobacillus plantarum P 17630 100.000.000 CFU (Test) versus DAKTARIN - miconazole nitrate 400 mg soft capsules in patients with clinically symptomatic vulvovaginal candidiasis. The evaluation of the following symptoms: pruritus, discharge, pain, dryness will be done using a daily VAS scale.;Secondary Objective: Evaluation of the interleukin (IL6) concentration in the vaginal secretion as parameter of vulvovaginal candidiasis. The safety and tolerability profile of Test product compared to Reference by assessing the occurrence of either topical or systemic AEs.;Primary end point(s): According to the literature (Van Leusden H.A.I.M., et al. Europ. J. Obstet. Gynec. Reprod. Biol., 1980:10/3:203-211), in which is stated that the positive results obtained with the miconazole treatment is more than 90%, it is reasonably accept a decrese of at maximum of the 20% as positive result. ;Timepoint(s) of evaluation of this end point: Compare the number of patients stopped the treatment after 3 days either the VAS score values at baseline, at Day 3, at Day 6 and at Day 21 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endopoints, will be evaluated measured interleukin (IL6) in the vaginal secretion as parameter of vulvovaginal candidiasis. ;Timepoint(s) of evaluation of this end point: Day 0, Day 3 and Day 6 | — |
Countries
Bulgaria
Contacts
Public ContactClinical Trials Information
R&D Solutions srl
Outcome results
None listed