A multicenter, randomised, double- blind, between-patient, dose finding study to assess the safety, tolerability and efficacy of three different dosages (500, 1000 and 2000 mcg/g) of ABIO 12/01 gel, in comparison to an open active treatment, after a five-day vaginal administration to females with a confirmed clinical diagnosis of vulvovaginal candidiasis.
- Conditions
- VULVOVAGINAL CANDIDIASISMedDRA version: 6.1Level: PTClassification code 10046898
- Registration Number
- EUCTR2005-001360-31-IT
- Lead Sponsor
- ABIOGEN PHARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 200
Inclusion Criteria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: ;Secondary Objective: ;Primary end point(s):
- Secondary Outcome Measures
Name Time Method