An interventional study of Butoconazole Nitrate Vaginal Cream and Placebo in Vulvovaginal Candidiasis, sponsored by Padagis LLC. Completed at 1 site in United States. Open to female participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-12.
Sponsored by Padagis LLC · Not applicable, Interventional, and Treatment
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.
265 studies on the registry are indexed under Candidiasis; 20 are open to participants now.
This study's enrollment of 611 is above the median of 99 across 186 interventional studies indexed under Candidiasis.
Browse Candidiasis studies →Padagis LLC is the lead sponsor of 36 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
vehicle of the test product; applied intravaginally once within 48 hours of randomization
Drug: Placebo
Butoconazole Nitrate Vaginal Cream; applied intravaginally once within 48 hours of randomization
Drug: Butoconazole Nitrate Vaginal Cream
Gynazole 1 Vaginal Cream; applied intravaginally once within 48 hours of randomization
Drug: Gynazole 1 vaginal cream
vaginal cream
vaginal cream
Also known as: vehicle of the test product
vaginal cream
Also known as: Gynazole 1
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
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
Mycological Cure
Mycological cure was defined as a negative mycological culture (no growth)
Time frame: Visit 3: Day 22-31
| Milestone | Test Product | Reference Product | Placebo |
|---|---|---|---|
| Started | 246 | 243 | 122 |
| Completed | 143 | 146 | 65 |
| Not completed | 103 | 97 | 57 |
| Withdrew: Withdrawal by subject | 4 | 2 | 1 |
| Withdrew: Protocol violation | 10 | 4 | 6 |
| Withdrew: Lost to follow-up | 5 | 3 | 4 |
| Withdrew: Negative baseline culture for candida | 59 | 59 | 24 |
| Withdrew: Lack of efficacy | 7 | 6 | 10 |
| Withdrew: Other | 1 | 3 | 1 |
| Withdrew: Pap smear with significant pathology | 10 | 10 | 3 |
| Withdrew: Positive for chlamydia or gonorrhea | 7 | 10 | 8 |
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)
| participants | Test Product | Reference Product | Placebo |
|---|---|---|---|
| The Test of Equivalence Between the Test and Reference Products Was Based on the Therapeutic Cure Rates at Visit 3/Test-of-Cure. | 73 | 73 | 16 |
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
| participants | Test Product | Reference Product | Placebo |
|---|---|---|---|
| Clinical Cure | 91 | 92 | 32 |
Mycological cure was defined as a negative mycological culture (no growth)
| participants | Test Product | Reference Product | Placebo |
|---|---|---|---|
| Mycological Cure | 83 | 79 | 18 |
Collected over From the signing of informed consent to 30 days post subject participation.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Test Product | — | 0/246 (0%) | 0/246 (0%) |
| Reference Product | — | 0/243 (0%) | 0/243 (0%) |
| Placebo | — | 0/122 (0%) | 0/122 (0%) |
| Age, Categorical(Participants) | Test Product | Reference Product | Placebo | Total |
|---|---|---|---|---|
| <=18 years | 8 | 5 | 4 | 17 |
| Between 18 and 65 years | 236 | 238 | 117 | 591 |
| >=65 years | 2 | 0 | 1 | 3 |
| Age, Continuous(years) | Test Product | Reference Product | Placebo | Total |
|---|---|---|---|---|
| Mean | 32.1 ± 10.29 | 32.1 ± 10.02 | 33.3 ± 11.15 | 32.3 ± 10.35 |
| Sex: Female, Male(Participants) | Test Product | Reference Product | Placebo | Total |
|---|---|---|---|---|
| Female | 246 | 243 | 122 | 611 |
| Male | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Test Product | Reference Product | Placebo | Total |
|---|---|---|---|---|
| United States | 108 | 107 | 54 | 269 |
| Central America | 54 | 53 | 26 | 133 |
| South America | 84 | 83 | 42 | 209 |
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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