Study Evaluating the Efficacy and Safety of Miconazole Nitrate + Domiphen Bromide Vaginal Cream in the Treatment of Subjects With Acute Vulvovaginal Candidiasis
NCT ID: NCT04813822
Last Updated: 2022-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
90 participants
INTERVENTIONAL
2021-09-13
2022-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
Miconazole Nitrate 2% + Domiphen Bromide Low Dose
Dosage 1
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.
Miconazole Nitrate 2% + Domiphen Bromide High Dose
Dosage 2
Gyno-Daktarin® Vaginal Cream
The content of one applicator (5 g cream) is administered intravaginally once daily for 7 days.
Miconazole Nitrate 2%
Active Comparator
Interventions
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Miconazole Nitrate 2% + Domiphen Bromide Low Dose
Dosage 1
Miconazole Nitrate 2% + Domiphen Bromide High Dose
Dosage 2
Miconazole Nitrate 2%
Active Comparator
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
18 Years
50 Years
FEMALE
No
Sponsors
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Aesculape CRO Belgium BV
INDUSTRY
Responsible Party
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Principal Investigators
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Jean-Paul Deslypere, MD
Role: STUDY_DIRECTOR
Aesculape CRO Belgium BV
Locations
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UZ Antwerpen - Gynaecology department
Edegem, Antwerpen, Belgium
Femicare vzw
Tienen, Brabant, Belgium
Fertiliteitscentrum Dr. Decleer Aalter
Aalter, East Flanders, Belgium
UZ Gent - Gynaecology department
Ghent, East Flanders, Belgium
Dr. Goessens - Dr. Houben, Private practice - Gynaecology
Bruges, West Flanders, Belgium
Dr. Philip Loquet, Private practice - Gynaecology
Antwerp, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Gilbert Donders, Prof. dr.
Role: primary
Gilbert Donders, Prof. Dr.
Role: primary
Wim Decleer, MD
Role: primary
Hans Verstraelen, Prof. Dr.
Role: primary
Luc Goessens, MD
Role: primary
Philip Loquet, Dr.
Role: primary
Other Identifiers
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FHP-2021-2-26
Identifier Type: -
Identifier Source: org_study_id
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