Status:
UNKNOWN
Study Evaluating the Efficacy and Safety of Miconazole Nitrate + Domiphen Bromide Vaginal Cream in the Treatment of Subjects With Acute Vulvovaginal Candidiasis
Lead Sponsor:
Aesculape CRO Belgium BV
Conditions:
Acute Vulvovaginal Candidiasis
Eligibility:
FEMALE
18-50 years
Phase:
PHASE2
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 s...
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 c...
Eligibility Criteria
Inclusion
- Main inclusion criteria:
- Subjects must be generally healthy, non-pregnant females, 18-50 years of age at Screening Visit.
- 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 :
- Subjects with the presence of concomitant vulvovaginitis caused by other pathogens at Screening Visit, or any other infection that requires antibiotic treatment.
- Subjects with visible condylomas on vulvovaginal examination at Screening Visit.
- 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.
- Subjects with a history of cervical cancer.
Exclusion
Key Trial Info
Start Date :
September 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2022
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04813822
Start Date
September 13 2021
End Date
October 1 2022
Last Update
March 14 2022
Active Locations (6)
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1
UZ Antwerpen - Gynaecology department
Edegem, Antwerpen, Belgium, 2650
2
Femicare vzw
Tienen, Brabant, Belgium, 3300
3
Fertiliteitscentrum Dr. Decleer Aalter
Aalter, East Flanders, Belgium, 9880
4
UZ Gent - Gynaecology department
Ghent, East Flanders, Belgium, 9000