Back to resultsA Randomized Study Evaluating the Therapeutic Equivalence of Two Butoconazole Nitrate Vaginal Cream, 2% Formulations
Primary Purpose
Vulvovaginal Candidiasis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Butoconazole Nitrate Vaginal Cream
Placebo
Gynazole 1 vaginal cream
Sponsored by
About this trial
This is an interventional treatment trial for Vulvovaginal Candidiasis focused on measuring bioequivalence, butoconazole, vulvovaginal, candidiasis
Eligibility Criteria
Inclusion Criteria:
- Female subjects, at least 18 years of age
- Presented with symptomatic vulvovaginitis consistent with a diagnosis of moniliasis
- Signed and dated informed consent
Exclusion Criteria:
- Were pregnant, nursing, or planning a pregnancy within the study participation period
- Had evidence of any bacterial, viral, or protozoal infection
- Had hypersensitivity or allergy to the imidazoles, their analogues, and/or any of the Test Product ingredients
- Had any medical condition, or used any medication which, in the opinion of the investigator, could have interfered with the conduct of the study
Sites / Locations
- PharmaNet, Inc. (PharmaNet)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Active Comparator
Arm Label
Placebo
Test Product
Reference Product
Arm Description
vehicle of the test product; applied intravaginally once within 48 hours of randomization
Butoconazole Nitrate Vaginal Cream; applied intravaginally once within 48 hours of randomization
Gynazole 1 Vaginal Cream; applied intravaginally once within 48 hours of randomization
Outcomes
Primary Outcome Measures
The Test of Equivalence Between the Test and Reference Products Was Based on the Therapeutic Cure Rates at Visit 3/Test-of-Cure.
Therapeutic cure is defined as both the mycologically-proven eradication of infection caused by Candida species (mycological cure) and evidence of clinical success (clinical cure)
Secondary Outcome Measures
Clinical Cure
Clinical cure (clinical success) was defined as follows:
All signs or symptoms with a score of 1 (mild) or 2 (moderate) at Visit 1/Baseline had a score of 0 (absent) at Visit 3/Test-of-Cure, or all signs or symptoms with a score of 3 (severe) at Visit 1/Baseline had a score of 0 (absent) or 1 (mild) at Visit 3/Test-of-Cure
A new sign or symptoms was observed at Visit 3/Test-of-Cure that was not present at entry and was determined by the investigator to not be related to VVC (if related, the subject was considered a failure; if not related, the subject could have been considered a cure)
The subject did not require additional vulvovaginal or systemic antifungal therapy
The subject did not use any topical drug therapy other than the study medication for the treatment of vulvovaginal irritation and/or pruritus, such as topical analgesics or corticosteroid products
Mycological Cure
Mycological cure was defined as a negative mycological culture (no growth)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01039584
Brief Title
A Randomized Study Evaluating the Therapeutic Equivalence of Two Butoconazole Nitrate Vaginal Cream, 2% Formulations
Official Title
A Randomized Study Evaluating the Therapeutic Equivalence and Safety of Butoconazole Nitrate Vaginal Cream, 2% and Gynazole 1 (Butoconazole Nitrate) Vaginal Cream, 2%, Against a Vehicle Control in the Treatment of Vulvovaginal Candidiasis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Padagis LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This was a study that compared the efficacy and safety of a generic butoconazole nitrate vaginal cream, 2% to Gynazole-1 (butoconazole nitrate) Vaginal Cream, 2% in the treatment of vulvovaginal candidiasis caused by Candida species.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvovaginal Candidiasis
Keywords
bioequivalence, butoconazole, vulvovaginal, candidiasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
611 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
vehicle of the test product; applied intravaginally once within 48 hours of randomization
Arm Title
Test Product
Arm Type
Experimental
Arm Description
Butoconazole Nitrate Vaginal Cream; applied intravaginally once within 48 hours of randomization
Arm Title
Reference Product
Arm Type
Active Comparator
Arm Description
Gynazole 1 Vaginal Cream; applied intravaginally once within 48 hours of randomization
Intervention Type
Drug
Intervention Name(s)
Butoconazole Nitrate Vaginal Cream
Intervention Description
vaginal cream
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
vehicle of the test product
Intervention Description
vaginal cream
Intervention Type
Drug
Intervention Name(s)
Gynazole 1 vaginal cream
Other Intervention Name(s)
Gynazole 1
Intervention Description
vaginal cream
Primary Outcome Measure Information:
Title
The Test of Equivalence Between the Test and Reference Products Was Based on the Therapeutic Cure Rates at Visit 3/Test-of-Cure.
Description
Therapeutic cure is defined as both the mycologically-proven eradication of infection caused by Candida species (mycological cure) and evidence of clinical success (clinical cure)
Time Frame
Visit 3: Day 22-31
Secondary Outcome Measure Information:
Title
Clinical Cure
Description
Clinical cure (clinical success) was defined as follows:
All signs or symptoms with a score of 1 (mild) or 2 (moderate) at Visit 1/Baseline had a score of 0 (absent) at Visit 3/Test-of-Cure, or all signs or symptoms with a score of 3 (severe) at Visit 1/Baseline had a score of 0 (absent) or 1 (mild) at Visit 3/Test-of-Cure
A new sign or symptoms was observed at Visit 3/Test-of-Cure that was not present at entry and was determined by the investigator to not be related to VVC (if related, the subject was considered a failure; if not related, the subject could have been considered a cure)
The subject did not require additional vulvovaginal or systemic antifungal therapy
The subject did not use any topical drug therapy other than the study medication for the treatment of vulvovaginal irritation and/or pruritus, such as topical analgesics or corticosteroid products
Time Frame
Visit 3: Day 22-31
Title
Mycological Cure
Description
Mycological cure was defined as a negative mycological culture (no growth)
Time Frame
Visit 3: Day 22-31
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Female subjects, at least 18 years of age
Presented with symptomatic vulvovaginitis consistent with a diagnosis of moniliasis
Signed and dated informed consent
Exclusion Criteria:
Were pregnant, nursing, or planning a pregnancy within the study participation period
Had evidence of any bacterial, viral, or protozoal infection
Had hypersensitivity or allergy to the imidazoles, their analogues, and/or any of the Test Product ingredients
Had any medical condition, or used any medication which, in the opinion of the investigator, could have interfered with the conduct of the study
Facility Information:
Facility Name
PharmaNet, Inc. (PharmaNet)
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28262
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Randomized Study Evaluating the Therapeutic Equivalence of Two Butoconazole Nitrate Vaginal Cream, 2% Formulations
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