A Randomized Study Evaluating the Therapeutic Equivalence of Two Butoconazole Nitrate Vaginal Cream, 2% Formulations

Padagis LLC611 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

611

Conditions

Vulvovaginal Candidiasis

Interventions

Butoconazole Nitrate Vaginal CreamDRUG

vaginal cream

PlaceboDRUG

vaginal cream

Gynazole 1 vaginal creamDRUG

vaginal cream

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

PharmaNet, Inc. (PharmaNet)

Charlotte, North Carolina, United States

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.

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 Outcomes

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

Data from ClinicalTrials.gov

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