Clinical trial NCT04813822: Study Evaluating the Efficacy and Safety of Miconazole Nitrate + Domiphen Bromide Vaginal Cream in the Treatment of Subjects With Acute Vulvovaginal Candidiasis
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Acute Vulvovaginal Candidiasis
Lead sponsor: Aesculape CRO Belgium BV
Sponsor class: INDUSTRY
First posted: 2021-03-24
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: The proportion of subjects with clinical cure
timeFrame: First follow-up visit (Day 15)
measure: The proportion of subjects with mycological eradication
timeFrame: First follow-up visit (Day 15)
measure: The proportion of subjects with overall therapeutic success
timeFrame: First follow-up visit (Day 15)
Secondary outcomes:
measure: The proportion of subjects with clinical cure
timeFrame: First follow-up visit through Week 12
measure: The proportion of subjects with mycological eradication
timeFrame: First follow-up visit through Week 12
measure: The proportion of subjects with overall therapeutic success
timeFrame: First follow-up visit through Week 12
measure: Change from Baseline in vulvovaginitis symptom questionnaire total score
timeFrame: Through Week 12
measure: Change from Baseline in the EQ-5D questionnaire total score
timeFrame: Through Week 12
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: UZ Antwerpen - Gynaecology department
state: Antwerpen
city: Tienen
country: Belgium
facility: Femicare vzw
state: Brabant
city: Aalter
country: Belgium
facility: Fertiliteitscentrum Dr. Decleer Aalter
state: East Flanders
city: Gent
country: Belgium
facility: UZ Gent - Gynaecology department
state: East Flanders
city: Brugge
country: Belgium
facility: Dr. Goessens - Dr. Houben, Private practice - Gynaecology
state: West Flanders
city: Antwerpen
country: Belgium
facility: Dr. Philip Loquet, Private practice - Gynaecology
Study officials:
affiliation: Aesculape CRO Belgium BV
name: Jean-Paul Deslypere, MD
role: STUDY_DIRECTOR
References: