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

Not Applicable

Completed

• Conditions: Vulvovaginal Candidiasis
• Interventions: Drug: Gynazole 1 vaginal cream; Drug: Placebo; Drug: Butoconazole Nitrate Vaginal Cream

• Registration Number: NCT01039584
• Lead Sponsor: Padagis LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Primary Completion: 2009-09
• Study Completion: 2009-12
• Study First Submitted: 2009-12-23
• Study First Submitted QC: 2009-12-24
• Study First Posted: 2009-12-25
• Disposition First Submitted: 2012-03-15
• Disposition First Submitted QC: 2012-03-15
• Disposition First Posted: 2012-03-19
• Results First Submitted: 2012-09-10
• Results First Submitted QC: 2012-12-12
• Results First Posted: 2013-01-21
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-07
• Last Update Posted: 2023-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 611

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reference Product	Gynazole 1 vaginal cream	Gynazole 1 Vaginal Cream; applied intravaginally once within 48 hours of randomization
Placebo	Placebo	vehicle of the test product; applied intravaginally once within 48 hours of randomization
Test Product	Butoconazole Nitrate Vaginal Cream	Butoconazole Nitrate Vaginal Cream; applied intravaginally once within 48 hours of randomization

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

PharmaNet, Inc. (PharmaNet); 🇺🇸 Charlotte, North Carolina, United States