Study Evaluating the Efficacy and Safety of Miconazole Nitrate + Domiphen Bromide Vaginal Cream in the Treatment of Subjects With Acute Vulvovaginal Candidiasis
Primary Purpose
Acute Vulvovaginal Candidiasis
Status
Recruiting
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Miconazole Nitrate 2% + Domiphen Bromide Low Dose
Miconazole Nitrate 2% + Domiphen Bromide High Dose
Miconazole Nitrate 2%
Sponsored by
About this trial
This is an interventional treatment trial for Acute Vulvovaginal Candidiasis
Eligibility Criteria
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.
Sites / Locations
- UZ Antwerpen - Gynaecology departmentRecruiting
- Femicare vzwRecruiting
- Fertiliteitscentrum Dr. Decleer AalterRecruiting
- UZ Gent - Gynaecology departmentRecruiting
- Dr. Goessens - Dr. Houben, Private practice - GynaecologyRecruiting
- Dr. Philip Loquet, Private practice - GynaecologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Miconazole Nitrate 2% + Domiphen Bromide Low Dose Vaginal Cream
Miconazole Nitrate 2% + Domiphen Bromide High Dose Vaginal Cream
Gyno-Daktarin® Vaginal Cream
Arm Description
The content of one applicator (5 g cream) is administered intravaginally once daily for 7 days.
The content of one applicator (5 g cream) is administered intravaginally once daily for 7 days.
The content of one applicator (5 g cream) is administered intravaginally once daily for 7 days.
Outcomes
Primary Outcome Measures
The proportion of subjects with clinical cure
Resolution of the VVC signs and symptoms that were present at Screening Visit (Baseline)
The proportion of subjects with mycological eradication
A culture negative vaginal swab for growth of baseline Candida species
The proportion of subjects with overall therapeutic success
Achievement of both clinical cure and mycological eradication
Secondary Outcome Measures
The proportion of subjects with clinical cure
Resolution of the VVC signs and symptoms that were present at Screening Visit (Baseline)
The proportion of subjects with mycological eradication
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
Achievement of both clinical cure and mycological eradication
Change from Baseline in vulvovaginitis symptom questionnaire total score
VSQ: Vulvovaginal symptoms questionnaire
Change from Baseline in the EQ-5D questionnaire total score
EQ-5D: health-related quality of life questionnaire
Full Information
NCT ID
NCT04813822
First Posted
March 10, 2021
Last Updated
March 11, 2022
Sponsor
Aesculape CRO Belgium BV
1. Study Identification
Unique Protocol Identification Number
NCT04813822
Brief Title
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
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 13, 2021 (Actual)
Primary Completion Date
May 2022 (Anticipated)
Study Completion Date
October 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aesculape CRO Belgium BV
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Vulvovaginal Candidiasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Miconazole Nitrate 2% + Domiphen Bromide Low Dose Vaginal Cream
Arm Type
Experimental
Arm Description
The content of one applicator (5 g cream) is administered intravaginally once daily for 7 days.
Arm Title
Miconazole Nitrate 2% + Domiphen Bromide High Dose Vaginal Cream
Arm Type
Experimental
Arm Description
The content of one applicator (5 g cream) is administered intravaginally once daily for 7 days.
Arm Title
Gyno-Daktarin® Vaginal Cream
Arm Type
Active Comparator
Arm Description
The content of one applicator (5 g cream) is administered intravaginally once daily for 7 days.
Intervention Type
Drug
Intervention Name(s)
Miconazole Nitrate 2% + Domiphen Bromide Low Dose
Intervention Description
Dosage 1
Intervention Type
Drug
Intervention Name(s)
Miconazole Nitrate 2% + Domiphen Bromide High Dose
Intervention Description
Dosage 2
Intervention Type
Drug
Intervention Name(s)
Miconazole Nitrate 2%
Intervention Description
Active Comparator
Primary Outcome Measure Information:
Title
The proportion of subjects with clinical cure
Description
Resolution of the VVC signs and symptoms that were present at Screening Visit (Baseline)
Time Frame
First follow-up visit (Day 15)
Title
The proportion of subjects with mycological eradication
Description
A culture negative vaginal swab for growth of baseline Candida species
Time Frame
First follow-up visit (Day 15)
Title
The proportion of subjects with overall therapeutic success
Description
Achievement of both clinical cure and mycological eradication
Time Frame
First follow-up visit (Day 15)
Secondary Outcome Measure Information:
Title
The proportion of subjects with clinical cure
Description
Resolution of the VVC signs and symptoms that were present at Screening Visit (Baseline)
Time Frame
First follow-up visit through Week 12
Title
The proportion of subjects with mycological eradication
Description
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
Time Frame
First follow-up visit through Week 12
Title
The proportion of subjects with overall therapeutic success
Description
Achievement of both clinical cure and mycological eradication
Time Frame
First follow-up visit through Week 12
Title
Change from Baseline in vulvovaginitis symptom questionnaire total score
Description
VSQ: Vulvovaginal symptoms questionnaire
Time Frame
Through Week 12
Title
Change from Baseline in the EQ-5D questionnaire total score
Description
EQ-5D: health-related quality of life questionnaire
Time Frame
Through Week 12
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Paul Deslypere, MD
Phone
+32492735931
Email
jpdeslypere@aesculape.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Paul Deslypere, MD
Organizational Affiliation
Aesculape CRO Belgium BV
Official's Role
Study Director
Facility Information:
Facility Name
UZ Antwerpen - Gynaecology department
City
Edegem
State/Province
Antwerpen
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gilbert Donders, Prof. dr.
Facility Name
Femicare vzw
City
Tienen
State/Province
Brabant
ZIP/Postal Code
3300
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gilbert Donders, Prof. Dr.
Facility Name
Fertiliteitscentrum Dr. Decleer Aalter
City
Aalter
State/Province
East Flanders
ZIP/Postal Code
9880
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wim Decleer, MD
Facility Name
UZ Gent - Gynaecology department
City
Gent
State/Province
East Flanders
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hans Verstraelen, Prof. Dr.
Facility Name
Dr. Goessens - Dr. Houben, Private practice - Gynaecology
City
Brugge
State/Province
West Flanders
ZIP/Postal Code
8000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luc Goessens, MD
Facility Name
Dr. Philip Loquet, Private practice - Gynaecology
City
Antwerpen
ZIP/Postal Code
2018
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philip Loquet, Dr.
12. IPD Sharing Statement
Learn more about this trial
Study Evaluating the Efficacy and Safety of Miconazole Nitrate + Domiphen Bromide Vaginal Cream in the Treatment of Subjects With Acute Vulvovaginal Candidiasis
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