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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | vehicle of the test product; applied intravaginally once within 48 hours of randomization |
|
| Test Product | Experimental | Butoconazole Nitrate Vaginal Cream; applied intravaginally once within 48 hours of randomization |
|
| Reference Product | Active Comparator | Gynazole 1 Vaginal Cream; applied intravaginally once within 48 hours of randomization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Butoconazole Nitrate Vaginal Cream | Drug | vaginal cream |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Visit 3: Day 22-31 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Cure | Clinical cure (clinical success) was defined as follows:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PharmaNet, Inc. (PharmaNet) | Charlotte | North Carolina | 28262 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Product | Butoconazole Nitrate Vaginal Cream Butoconazole Nitrate Vaginal Cream : vaginal cream |
| FG001 | Reference Product | Gynazole 1 Vaginal Cream Gynazole 1 vaginal cream : vaginal cream |
| FG002 | Placebo | vehicle of the test product Placebo : vaginal cream |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Test Product | Butoconazole Nitrate Vaginal Cream Butoconazole Nitrate Vaginal Cream : vaginal cream |
| BG001 | Reference Product | Gynazole 1 Vaginal Cream Gynazole 1 vaginal cream : vaginal cream |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | per-protocol | Posted | Number | participants | Visit 3: Day 22-31 |
|
From the signing of informed consent to 30 days post subject participation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Test Product | Butoconazole Nitrate Vaginal Cream Butoconazole Nitrate Vaginal Cream : vaginal cream |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Schwartz | Perrigo | 718-960-9900 | jonathan.schwartz@perrigo.com |
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| ID | Term |
|---|---|
| D002181 | Candidiasis, Vulvovaginal |
| D002177 | Candidiasis |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D014848 | Vulvovaginitis |
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| Placebo |
| Drug |
vaginal cream |
|
|
| Gynazole 1 vaginal cream | Drug | vaginal cream |
|
|
| Visit 3: Day 22-31 |
| Mycological Cure | Mycological cure was defined as a negative mycological culture (no growth) | Visit 3: Day 22-31 |
| Lost to Follow-up |
|
| Negative Baseline culture for Candida |
|
| Lack of Efficacy |
|
| other |
|
| Pap smear with significant pathology |
|
| Positive for Chlamydia or gonorrhea |
|
| BG002 | Placebo | vehicle of the test product Placebo : vaginal cream |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Placebo | vehicle of the test product Placebo : vaginal cream |
|
|
|
| Secondary | Clinical Cure | Clinical cure (clinical success) was defined as follows:
| per-protocol | Posted | Number | participants | Visit 3: Day 22-31 |
|
|
|
|
| Secondary | Mycological Cure | Mycological cure was defined as a negative mycological culture (no growth) | Posted | Number | participants | Visit 3: Day 22-31 |
|
|
|
|
| 0 |
| 246 |
| 0 |
| 246 |
| EG001 | Reference Product | Gynazole 1 Vaginal Cream Gynazole 1 vaginal cream : vaginal cream | 0 | 243 | 0 | 243 |
| EG002 | Placebo | vehicle of the test product Placebo : vaginal cream | 0 | 122 | 0 | 122 |
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| D014627 |
| Vaginitis |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014847 | Vulvitis |
| D014845 | Vulvar Diseases |
| D000091662 | Genital Diseases |