A clinical study to demonstrate that the LJLACTO - Lactobacillus plantarum P 17630100.000.000 CFU (Test) and DAKTARIN -miconazole nitrate 400 mg soft capsules resolv in equal way the problems linked to the vulvovaginal candidiasis.in patients

Phase 1

Active, not recruiting

• Conditions: Patientswith clinically symptomatic vulvovaginal candidiasis.The following symptoms will be evaluated: pruritus,discharge, pain, dryness will be done using a dailyVAS scale.; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2018-003095-12-BG
• Lead Sponsor: PROGE FARM SR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-17
• Last Update Posted: 6 October 2020

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Female
• Target Recruitment: 210

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

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.

Study & Design

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