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

NCT01039584 | Completed Results

• 1 other identifier: PRG-710
• Study Type: interventional
• Target: 611
• Locations: 1 country
• Sites: 1

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.

Conditions

Vulvovaginal Candidiasis

Keywords

bioequivalence; butoconazole; vulvovaginal; candidiasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Clinical Cure

  Visit 3: Day 22-31

• Mycological Cure

  Visit 3: Day 22-31

Study Arms (3)

Placebo

PLACEBO COMPARATOR

vehicle of the test product; applied intravaginally once within 48 hours of randomization

Drug: Placebo

Test Product

EXPERIMENTAL

Butoconazole Nitrate Vaginal Cream; applied intravaginally once within 48 hours of randomization

Drug: Butoconazole Nitrate Vaginal Cream

Reference Product

ACTIVE COMPARATOR

Gynazole 1 Vaginal Cream; applied intravaginally once within 48 hours of randomization

Drug: Gynazole 1 vaginal cream

Interventions

Butoconazole Nitrate Vaginal Cream DRUG

vaginal cream

Test Product

Placebo DRUG

vaginal cream

Also known as: vehicle of the test product

Placebo

Gynazole 1 vaginal cream DRUG

vaginal cream

Also known as: Gynazole 1

Reference Product

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female subjects, at least 18 years of age
• Presented with symptomatic vulvovaginitis consistent with a diagnosis of moniliasis
• Signed and dated informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Padagis LLC: lead

Study Sites (1)

PharmaNet, Inc. (PharmaNet)

Charlotte, North Carolina, 28262, United States

Location

MeSH Terms

Conditions

Candidiasis, Vulvovaginal; Candidiasis

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections; Vulvovaginitis; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vulvitis; Vulvar Diseases; Genital Diseases

Results Point of Contact

• Title: Jonathan Schwartz
• Organization: Perrigo

jonathan.schwartz@perrigo.com

718-960-9900

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2009
• First Posted: December 25, 2009
• Study Start: February 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: December 1, 2009
• Last Updated: July 12, 2023
• Results First Posted: January 21, 2013

Record last verified: 2023-07

Locations

US (1)