This study is a multicentre, three-arm, double-blind, randomized controlled, parallel-group, comparative phase II clinical trial to evaluate miconazole nitrate 2% + domiphen bromide vaginal cream in subjects with acute vulvovaginal candidiasis.
Females aged 18-50 years with a clinical diagnosis of an acute VVC episode at Screening Visit will be randomly assigned to either miconazole nitrate 2% + low or high dose of domiphen bromide vaginal cream or to the comparator product Gyno-Daktarin® vaginal cream (miconazole nitrate 2%). The creams will be applied for 7 days and subjects will be followed up for 12 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
90
Active Comparator
UZ Antwerpen - Gynaecology department
Edegem, Antwerpen, Belgium
RECRUITINGFemicare vzw
Tienen, Brabant, Belgium
RECRUITINGFertiliteitscentrum Dr. Decleer Aalter
Aalter, East Flanders, Belgium
The proportion of subjects with clinical cure
Resolution of the VVC signs and symptoms that were present at Screening Visit (Baseline)
Time frame: First follow-up visit (Day 15)
The proportion of subjects with mycological eradication
A culture negative vaginal swab for growth of baseline Candida species
Time frame: First follow-up visit (Day 15)
The proportion of subjects with overall therapeutic success
Achievement of both clinical cure and mycological eradication
Time frame: First follow-up visit (Day 15)
The proportion of subjects with clinical cure
Resolution of the VVC signs and symptoms that were present at Screening Visit (Baseline)
Time frame: First follow-up visit through Week 12
The proportion of subjects with mycological eradication
A culture negative vaginal swab for growth of baseline Candida species at Day 15, a culture and PCR negative vaginal swab for growth of baseline Candida species on the Other follow-up visits
Time frame: First follow-up visit through Week 12
The proportion of subjects with overall therapeutic success
Achievement of both clinical cure and mycological eradication
Time frame: First follow-up visit through Week 12
Change from Baseline in vulvovaginitis symptom questionnaire total score
VSQ: Vulvovaginal symptoms questionnaire
Time frame: Through Week 12
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UZ Gent - Gynaecology department
Ghent, East Flanders, Belgium
RECRUITINGDr. Goessens - Dr. Houben, Private practice - Gynaecology
Bruges, West Flanders, Belgium
RECRUITINGDr. Philip Loquet, Private practice - Gynaecology
Antwerp, Belgium
RECRUITINGChange from Baseline in the EQ-5D questionnaire total score
EQ-5D: health-related quality of life questionnaire
Time frame: Through Week 12