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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Padagis LLC
- Enrollment
- 611
- Locations
- 1
- Primary Endpoint
- The Test of Equivalence Between the Test and Reference Products Was Based on the Therapeutic Cure Rates at Visit 3/Test-of-Cure.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts 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
Arms & Interventions
Placebo
vehicle of the test product; applied intravaginally once within 48 hours of randomization
Intervention: Placebo (Drug)
Test Product
Butoconazole Nitrate Vaginal Cream; applied intravaginally once within 48 hours of randomization
Intervention: Butoconazole Nitrate Vaginal Cream (Drug)
Reference Product
Gynazole 1 Vaginal Cream; applied intravaginally once within 48 hours of randomization
Intervention: Gynazole 1 vaginal cream (Drug)
Outcomes
Primary Outcomes
The Test of Equivalence Between the Test and Reference Products Was Based on the Therapeutic Cure Rates at Visit 3/Test-of-Cure.
Time Frame: 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 Outcomes
- Clinical Cure(Visit 3: Day 22-31)
- Mycological Cure(Visit 3: Day 22-31)