The purpose of this study is to compare the efficacy and safety of LactiSal 1%vaginal gel and LactiSal 50 mg vaginal tablet with the standart treatment of clotrimazole 100 mg vaginal tablet in woman with vulvovaginal candidiasis (VVC)
National multicenter,randomized, open-label, active-controlled with three parallel groups.Eligible patients are randomized to receive LactiSal 1% vaginal gel, LactiSal 50 mg vaginal tablet or clotrimazole 100 mg vaginal tablet for 6 days. Control examaminations are performed 10 after entry and 4 weeks after control visit 1. The study investigates the clinical efficacy and safety of Lactisal 1% vaginal gel and LactiSal 50mg vaginal tablets in the intended use, i.e. vaginal application, and the following intended claims: * Treatment of vaginal yeast vaginitis * Relieves vaginal itching, burning, redness and discharge in case of yeast vaginitis * Inhibition of yeast colonization in the vagina in case of yeast vaginitis. The study is designed to compare the clinical efficacy and safety of Lactisal 1% vaginal gel and LactiSal 50 mg vaginal tablets to a current standard drug therapy, i.e. clotrimazole 100 mg vaginal tablets. While LactiSal is classified as medical device class IIa, the comparator is a medicinal (pharmaceutical) product. The study represents a "mixed" study, comparing the efficacy of a medical device with a pharmaceutical product.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
to be administered daily intravaginally for 6 days
to be administered daily intravaginally for 6 days
to be administered daily intravaginally for 6 days
Clinical cure rate
Clinical cure is defined as patient having a Total Severity Score of less than 3. The Total Severity Score (TSC) is assessed by the Investigator, examining and interviewing the patient. The TSC is the sum score of the 5 individual signs symptoms - vaginal itching, vaginal burning or soreness, abnormal vaginal discharge, vulvovaginal erythema or oedema and vulval excoriation or fissure formation. Each sign and symptom is assessed with a score from 0 to 3, resulting in total score for TSC of 0 to 15.
Time frame: 10 days after entry (C1)
Clinical cure rate
Clinical cure is defined as patient having a Total Severity Score of less than 3. The Total Severity Score (TSC) is assessed by the Investigator, examining and interviewing the patient. The TSC is the sum score of the 5 individual signs symptoms - vaginal itching, vaginal burning or soreness, abnormal vaginal discharge, vulvovaginal erythema or oedema and vulval excoriation or fissure formation. Each sign and symptom is assessed with a score from 0 to 3, resulting in total score for TSC of 0 to 15.
Time frame: 4 weeks after control visit 1
Microbiological cure rate
Negative for Candida in microscopy and culture
Time frame: 10 days after entry visit and 4 weeks after control visit 1
Therapeutic cure rate
Clinically and microbiologically cure combined
Time frame: 10 days after entry visit and 4 weeks after control visit 1
The Total Severity Score (TSC) Individual clinical signs and symptoms
The TCS assessed by the investigator * vaginal itching (range 0-3) * vaginal burning or soreness (range 0-3) * abnormal vaginal discharge (range 0-3) * vulvo/vaginal erythema or oedema (range 0-3) * vulvar excoriation or fissure formation (range 0-3)
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Time frame: 10 days after entry visit and 4 weeks after control visit 1
Dyspareunia and external dysuria
Presence of dyspareunia and external dysuria (yes/no)
Time frame: 10 days after entry visit and 4 weeks after control visit 1
Direct microscopy (Wet smear)
Number of positive findings in Direct microscopy (Wet smear) in comparison to visit E
Time frame: 10 days after entry visit and 4 weeks after control visit 1
pH
Mean vaginal pH in comparison to visit E
Time frame: 10 days after entry visit and 4 weeks after control visit 1
Candida culture
Number of positive Candida cultures in comparison to visit E
Time frame: 10 days after entry visit and 4 weeks after control visit 1
Efficacy assessment
Global assessment of efficacy by patient and investigator
Time frame: 10 days after entry visit and 4 weeks after control visit 1
Patients diary
Assessment clinical symptoms from patient?s diary
Time frame: 10 days after entry visit and 4 weeks after control visit 1
Patient's satisfaction
Patient will be asked how satisfied she was with the treatment received based on 8 standardized questions.
Time frame: 10 days after entry visit and 4 weeks after control visit 1