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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Perrigo Company
ClinicalTrials.gov Identifier:
NCT01039584
First received: December 23, 2009
Last updated: December 12, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
Vulvovaginal Candidiasis
 Drug: Butoconazole Nitrate Vaginal Cream
Drug: Placebo
Drug: Gynazole 1 vaginal cream

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Yeast Infections
U.S. FDA Resources

Further study details as provided by Perrigo Company:

Primary Outcome Measures:
  • The Test of Equivalence Between the Test and Reference Products Was Based on the Therapeutic Cure Rates at Visit 3/Test-of-Cure. [ Time Frame: Visit 3: Day 22-31 ] [ Designated as safety issue: No ]
    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:
  • Clinical Cure [ Time Frame: Visit 3: Day 22-31 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Visit 3: Day 22-31 ] [ Designated as safety issue: No ]
    Mycological cure was defined as a negative mycological culture (no growth)


Enrollment: 611
Study Start Date: February 2008
Study Completion Date: December 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
vehicle of the test product; applied intravaginally once within 48 hours of randomization
 Drug: Placebo
vaginal cream
Other Name: 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 Name: Gynazole 1

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01039584

Locations
United States, North Carolina
PharmaNet, Inc. (PharmaNet)
Charlotte, North Carolina, United States, 28262
Sponsors and Collaborators
Perrigo Company
  More Information

No publications provided

Responsible Party: Perrigo Company
ClinicalTrials.gov Identifier: NCT01039584     History of Changes
Other Study ID Numbers: PRG-710
Study First Received: December 23, 2009
Results First Received: September 10, 2012
Last Updated: December 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Perrigo Company:
bioequivalence
butoconazole
vulvovaginal
candidiasis

Additional relevant MeSH terms:
Candidiasis
Candidiasis, Vulvovaginal
Mycoses
Vulvovaginitis
Vaginitis
Vaginal Diseases
Genital Diseases, Female
 Vulvitis
Vulvar Diseases
Butoconazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013