Efficacy, Safety LactiSal 1% Gel, LactSal 50 mg, Clotrimazole 100 mg Tablet in Treatment Vulvovaginal Candidiasis
NCT02907307 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL
Last updated 2019-03-08
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)
Conditions
- Vulvovaginal Candidiasis
Interventions
- DEVICE
-
LactiSal vaginal gel 1%
to be administered daily intravaginally for 6 days
- DEVICE
-
LactiSal vaginal tablet 50mg
to be administered daily intravaginally for 6 days
- DRUG
-
Clotrimazole vaginal tablet 100mg
to be administered daily intravaginally for 6 days
Sponsors & Collaborators
-
Medinova AG
lead INDUSTRY
Principal Investigators
-
Michael Halaška, MD · Nemocnice Bulovka, 1. LF UK
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-12-31
- Primary Completion
- 2019-12-31
- Completion
- 2020-07-31
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