Study Evaluating the Efficacy and Safety of Miconazole Nitrate + Domiphen Bromide Vaginal Cream in the Treatment of Subjects With Acute Vulvovaginal Candidiasis
- Conditions
- Acute Vulvovaginal Candidiasis
- Interventions
- Registration Number
- NCT04813822
- Lead Sponsor
- Aesculape CRO Belgium BV
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 90
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Miconazole Nitrate 2% + Domiphen Bromide Low Dose Vaginal Cream Miconazole Nitrate 2% + Domiphen Bromide Low Dose The content of one applicator (5 g cream) is administered intravaginally once daily for 7 days. Miconazole Nitrate 2% + Domiphen Bromide High Dose Vaginal Cream Miconazole Nitrate 2% + Domiphen Bromide High Dose The content of one applicator (5 g cream) is administered intravaginally once daily for 7 days. Gyno-Daktarin® Vaginal Cream Miconazole Nitrate 2% The content of one applicator (5 g cream) is administered intravaginally once daily for 7 days.
- Primary Outcome Measures
Name Time Method 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 overall therapeutic success First follow-up visit (Day 15) Achievement of both clinical cure and mycological eradication
The proportion of subjects with mycological eradication First follow-up visit (Day 15) A culture negative vaginal swab for growth of baseline Candida species
- Secondary Outcome Measures
Name Time Method 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
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)
Change from Baseline in the EQ-5D questionnaire total score Through Week 12 EQ-5D: health-related quality of life questionnaire
Trial Locations
- Locations (6)
Femicare vzw
🇧🇪Tienen, Brabant, Belgium
Fertiliteitscentrum Dr. Decleer Aalter
🇧🇪Aalter, East Flanders, Belgium
UZ Antwerpen - Gynaecology department
🇧🇪Edegem, Antwerpen, Belgium
UZ Gent - Gynaecology department
🇧🇪Gent, East Flanders, Belgium
Dr. Goessens - Dr. Houben, Private practice - Gynaecology
🇧🇪Brugge, West Flanders, Belgium
Dr. Philip Loquet, Private practice - Gynaecology
🇧🇪Antwerpen, Belgium