A Phase 3 interventional study of LactiSal vaginal gel 1% and LactiSal vaginal tablet 50mg in Vulvovaginal Candidiasis, sponsored by Medinova AG. Withdrawn. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-08.
Sponsored by Medinova AG · Phase 3, Interventional, and Treatment
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:
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.
265 studies on the registry are indexed under Candidiasis; 20 are open to participants now.
Browse Candidiasis studies →Medinova AG is the lead sponsor of 6 studies on the registry; none are open to participants now.
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Clinical signs \& symptoms of VVC as Total Severity Score, TSC 4 (range 0-15):
Exclusion Criteria:
5g of 1%LactiSal Gel vaginal gel once daily for 6 days
Device: LactiSal vaginal gel 1%
50 mg of LactiSal vaginal tablet daily for 6 days
Device: LactiSal vaginal tablet 50mg
100 mg Clotrimazole vaginal tablet daily for 6 days
Drug: Clotrimazole vaginal tablet 100mg
to be administered daily intravaginally for 6 days
to be administered daily intravaginally for 6 days
to be administered daily intravaginally for 6 days
Also known as: Candibene
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)
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
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is withdrawn, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Medinova AG