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

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

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 Overview

• Status: Completed
• Conditions: Vulvovaginal Candidiasis
• Intervention / Treatment: Drug: Placebo; Drug: Butoconazole Nitrate Vaginal Cream; Drug: Gynazole 1 vaginal cream

• Study Type: Interventional
• Enrollment (Actual): 611
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28262
      • PharmaNet, Inc. (PharmaNet)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; vehicle of the test product; applied intravaginally once within 48 hours of randomization	Drug: Placebo; vaginal cream; Other Names: vehicle of the test product
Experimental: Test Product; Butoconazole Nitrate Vaginal Cream; applied intravaginally once within 48 hours of randomization	Drug: Butoconazole Nitrate Vaginal Cream; vaginal cream
Active Comparator: Reference Product; Gynazole 1 Vaginal Cream; applied intravaginally once within 48 hours of randomization	Drug: Gynazole 1 vaginal cream; vaginal cream; Other Names: Gynazole 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Visit 3: Day 22-31

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Cure	Clinical cure (clinical success) was defined as follows: 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; 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); The subject did not require additional vulvovaginal or systemic antifungal therapy; 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	Visit 3: Day 22-31
Mycological Cure	Mycological cure was defined as a negative mycological culture (no growth)	Visit 3: Day 22-31

Collaborators and Investigators

• Sponsor: Padagis LLC

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: December 23, 2009
• First Submitted That Met QC Criteria: December 24, 2009
• First Posted (Estimated): December 25, 2009

Study Record Updates

• Last Update Posted (Actual): July 12, 2023
• Last Update Submitted That Met QC Criteria: July 7, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: candidiasis; bioequivalence; butoconazole; vulvovaginal
• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Mycoses; Vaginal Diseases; Vulvar Diseases; Vaginitis; Vulvitis; Vulvovaginitis; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Candidiasis; Candidiasis, Vulvovaginal; Anti-Infective Agents; Antifungal Agents; Butoconazole
• Other Study ID Numbers: PRG-710