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 Vulvovaginal Candidiasis (VVC)

NCT02907307 Phase 3 WITHDRAWN

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)

Details

Lead sponsor	Medinova AG
Phase	Phase 3
Status	WITHDRAWN
Start date	2018-12
Completion	2020-07

Conditions

• Vulvovaginal Candidiasis

Interventions

• LactiSal vaginal gel 1%
• LactiSal vaginal tablet 50mg
• Clotrimazole vaginal tablet 100mg

Primary outcomes

• Clinical cure rate — 10 days after entry (C1)
  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.