A Phase 2, Randomized, Double-Blind, Active-Controlled Study to Evaluate the Efficacy and Safety of Miconazole Nitrate 2% + Domiphen Bromide Vaginal Cream in the Treatment of Subjects With Acute Vulvovaginal Candidiasis
Overview
- Phase
- Phase 2
- Intervention
- Miconazole Nitrate 2% + Domiphen Bromide Low Dose
- Conditions
- Acute Vulvovaginal Candidiasis
- Sponsor
- Aesculape CRO Belgium BV
- Enrollment
- 90
- Locations
- 6
- Primary Endpoint
- The proportion of subjects with clinical cure
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Miconazole Nitrate 2% + Domiphen Bromide Low Dose Vaginal Cream
The content of one applicator (5 g cream) is administered intravaginally once daily for 7 days.
Intervention: Miconazole Nitrate 2% + Domiphen Bromide Low Dose
Miconazole Nitrate 2% + Domiphen Bromide High Dose Vaginal Cream
The content of one applicator (5 g cream) is administered intravaginally once daily for 7 days.
Intervention: Miconazole Nitrate 2% + Domiphen Bromide High Dose
Gyno-Daktarin® Vaginal Cream
The content of one applicator (5 g cream) is administered intravaginally once daily for 7 days.
Intervention: Miconazole Nitrate 2%
Outcomes
Primary Outcomes
The proportion of subjects with clinical cure
Time Frame: 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
Time Frame: First follow-up visit (Day 15)
Achievement of both clinical cure and mycological eradication
The proportion of subjects with mycological eradication
Time Frame: First follow-up visit (Day 15)
A culture negative vaginal swab for growth of baseline Candida species
Secondary Outcomes
- The proportion of subjects with mycological eradication(First follow-up visit through Week 12)
- The proportion of subjects with overall therapeutic success(First follow-up visit through Week 12)
- Change from Baseline in vulvovaginitis symptom questionnaire total score(Through Week 12)
- The proportion of subjects with clinical cure(First follow-up visit through Week 12)
- Change from Baseline in the EQ-5D questionnaire total score(Through Week 12)