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

Vulvovaginal Candidiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01039584
• Other study ID #: PRG-710
• Status: Completed
• Phase: N/A
• Start date: February 2008
• Est. completion date: December 2009

Study information

• Verified date: July 2023
• Source: Padagis LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 611
• Est. completion date: December 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Vulvovaginal
• Vulvovaginal Candidiasis

Intervention

Drug:
• Butoconazole Nitrate Vaginal Cream
vaginal cream
• Placebo
vaginal cream
• Gynazole 1 vaginal cream
vaginal cream

Locations

Country	Name	City	State
United States	PharmaNet, Inc. (PharmaNet)	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Padagis LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Mycological Cure	Mycological cure was defined as a negative mycological culture (no growth)	Visit 3: Day 22-31