Vulvovaginal Candidiasis
Conditions
Keywords
bioequivalence, butoconazole, vulvovaginal, candidiasis
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.
Interventions
DRUGButoconazole Nitrate Vaginal Cream
vaginal cream
DRUGPlacebo
vaginal cream
DRUGGynazole 1 vaginal cream
vaginal cream
Sponsors
Padagis LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Test of Equivalence Between the Test and Reference Products Was Based on the Therapeutic Cure Rates at Visit 3/Test-of-Cure. | Visit 3: Day 22-31 | 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
| Measure | Time frame | Description |
|---|---|---|
| Clinical Cure | Visit 3: Day 22-31 | Clinical cure (clinical success) was defined as follows: 1. 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 2. 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) 3. The subject did not require additional vulvovaginal or systemic antifungal therapy 4. 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 | Visit 3: Day 22-31 | Mycological cure was defined as a negative mycological culture (no growth) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Test Product Butoconazole Nitrate Vaginal Cream
Butoconazole Nitrate Vaginal Cream : vaginal cream | 246 |
| Reference Product Gynazole 1 Vaginal Cream
Gynazole 1 vaginal cream : vaginal cream | 243 |
| Placebo vehicle of the test product
Placebo : vaginal cream | 122 |
| Total | 611 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lack of Efficacy | 7 | 6 | 10 |
| Overall Study | Lost to Follow-up | 5 | 3 | 4 |
| Overall Study | Negative Baseline culture for Candida | 59 | 59 | 24 |
| Overall Study | other | 1 | 3 | 1 |
| Overall Study | Pap smear with significant pathology | 10 | 10 | 3 |
| Overall Study | Positive for Chlamydia or gonorrhea | 7 | 10 | 8 |
| Overall Study | Protocol Violation | 10 | 4 | 6 |
| Overall Study | Withdrawal by Subject | 4 | 2 | 1 |
Baseline characteristics
| Characteristic | Test Product | Reference Product | Placebo | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 8 Participants | 5 Participants | 4 Participants | 17 Participants |
| Age, Categorical >=65 years | 2 Participants | 0 Participants | 1 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 236 Participants | 238 Participants | 117 Participants | 591 Participants |
| Age, Continuous | 32.1 years STANDARD_DEVIATION 10.29 | 32.1 years STANDARD_DEVIATION 10.02 | 33.3 years STANDARD_DEVIATION 11.15 | 32.3 years STANDARD_DEVIATION 10.35 |
| Region of Enrollment Central America | 54 participants | 53 participants | 26 participants | 133 participants |
| Region of Enrollment South America | 84 participants | 83 participants | 42 participants | 209 participants |
| Region of Enrollment United States | 108 participants | 107 participants | 54 participants | 269 participants |
| Sex: Female, Male Female | 246 Participants | 243 Participants | 122 Participants | 611 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 246 | 0 / 243 | 0 / 122 |
| serious Total, serious adverse events | 0 / 246 | 0 / 243 | 0 / 122 |
Outcome results
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)
Time frame: Visit 3: Day 22-31
Population: per-protocol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test Product | The Test of Equivalence Between the Test and Reference Products Was Based on the Therapeutic Cure Rates at Visit 3/Test-of-Cure. | 73 participants |
| Reference Product | The Test of Equivalence Between the Test and Reference Products Was Based on the Therapeutic Cure Rates at Visit 3/Test-of-Cure. | 73 participants |
| Placebo | The Test of Equivalence Between the Test and Reference Products Was Based on the Therapeutic Cure Rates at Visit 3/Test-of-Cure. | 16 participants |
90% CI: [-9.1, 12.3]Wald's method
Secondary
Clinical Cure
Clinical cure (clinical success) was defined as follows: 1. 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 2. 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) 3. The subject did not require additional vulvovaginal or systemic antifungal therapy 4. 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
Population: per-protocol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test Product | Clinical Cure | 91 participants |
| Reference Product | Clinical Cure | 92 participants |
| Placebo | Clinical Cure | 32 participants |
90% CI: [-7.3, 12.8]Wald's method
Secondary
Mycological Cure
Mycological cure was defined as a negative mycological culture (no growth)
Time frame: Visit 3: Day 22-31
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test Product | Mycological Cure | 83 participants |
| Reference Product | Mycological Cure | 79 participants |
| Placebo | Mycological Cure | 18 participants |
p-value: 0.0590% CI: [-11.7, 9.4]Wald's method