Clinical Trial: Efficacy, Safety LactiSal 1% Gel, LactSal 50 mg, Clotrimazole 100 mg Tablet in Treatment Vulvovaginal Candidiasis
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Comparative Study of the Efficacy and Safety of LactiSal 1% Vaginal Gel and LactSal 50 mg Vaginal Tablet Versus Clotrimazole 100 mg Vaginal Tablet in the Treatment of Vulvovagina
Brief Summary: 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)
Detailed Summary:
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.
Sponsor: Medinova AG
Current Primary Outcome: Clinical cure rate [ Time Frame: 10 days after entry (C1) ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Clinical cure rate [ Time Frame: 4 weeks after control visit 1 ]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.
- Microbiological cure rate [ Time Frame: 10 days after entry visit and 4 weeks after control visit 1 ]Negative for Candida in microscopy and culture
- Therapeutic cure rate [ Time Frame: 10 days after entry visit and 4 weeks after control visit 1 ]Clinically and microbiologically cure combined
- The Total Severity Score (TSC) Individual clinical signs and symptoms [ Time Frame: 10 days after entry visit and 4 weeks after control visit 1 ]
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)
- Dyspareunia and external dysuria [ Time Frame: 10 days after entry visit and 4 weeks after control visit 1 ]Presence of dyspareunia and external dysuria (yes/no)
- Direct microscopy (Wet smear) [ Time Frame: 10 days after entry visit and 4 weeks after control visit 1 ]Number of positive findings in Direct microscopy (Wet smear) in comparison to visit E
- pH [ Time Frame: 10 days after entry visit and 4 weeks after control visit 1 ]Mean vaginal pH in comparison to visit E
- Candida culture [ Time Frame: 10 days after entry visit and 4 weeks after control visit 1 ]Number of positive Candida cultures in comparison to visit E
- Efficacy assessment [ Time Frame: 10 days after entry visit and 4 weeks after control visit 1 ]Global assessment of efficacy by patient and investigator
- Patients diary [ Time Frame: 10 days after entry visit and 4 weeks after control visit 1 ]Assessment clinical symptoms from patient?s diary
- Patient's satisfaction [ Time Frame: 10 days after entry visit and 4 weeks after control visit 1 ]Patient will be asked how satisfied she was with the treatment received based on 8 standardized questions.
Original Secondary Outcome: Same as current
Information By: Medinova AG
Dates:
Date Received: September 23, 2015
Date Started: May 2017
Date Completion: July 2018
Last Updated: September 14, 2016
Last Verified: September 2016