Acute Vulvovaginal Candidiasis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGMiconazole Nitrate 2% + Domiphen Bromide Low Dose
Dosage 1
DRUGMiconazole Nitrate 2% + Domiphen Bromide High Dose
Dosage 2
DRUGMiconazole Nitrate 2%
Active Comparator
Sponsors
Aesculape CRO Belgium BV
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
Main inclusion criteria: 1. Subjects must be generally healthy, non-pregnant females, 18-50 years of age at Screening Visit. 2. Subjects must have an acute VVC episode at Screening Visit, defined as a total signs and symptoms score of ≥3 and a positive KOH wet mount preparation or Gram stain from a vaginal smear revealing filamentous hyphae/pseudohyphae and/or budding yeast cells. Main
Exclusion criteria
: 1. Subjects with the presence of concomitant vulvovaginitis caused by other pathogens at Screening Visit, or any other infection that requires antibiotic treatment. 2. Subjects with visible condylomas on vulvovaginal examination at Screening Visit. 3. Subjects with the presence or a history of another vaginal or vulvar condition(s) that in the Investigator's opinion would confound the interpretation of the clinical response. 4. Subjects with a history of cervical cancer.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of subjects with clinical cure | First follow-up visit (Day 15) | Resolution of the VVC signs and symptoms that were present at Screening Visit (Baseline) |
| The proportion of subjects with mycological eradication | First follow-up visit (Day 15) | A culture negative vaginal swab for growth of baseline Candida species |
| The proportion of subjects with overall therapeutic success | First follow-up visit (Day 15) | Achievement of both clinical cure and mycological eradication |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of subjects with clinical cure | First follow-up visit through Week 12 | Resolution of the VVC signs and symptoms that were present at Screening Visit (Baseline) |
| The proportion of subjects with mycological eradication | First follow-up visit through Week 12 | 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 |
| The proportion of subjects with overall therapeutic success | First follow-up visit through Week 12 | Achievement of both clinical cure and mycological eradication |
| Change from Baseline in vulvovaginitis symptom questionnaire total score | Through Week 12 | VSQ: Vulvovaginal symptoms questionnaire |
| Change from Baseline in the EQ-5D questionnaire total score | Through Week 12 | EQ-5D: health-related quality of life questionnaire |
Countries
Belgium
Contacts
Primary ContactJean-Paul Deslypere, MD
Outcome results
None listed