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Completed

NCT Number: NCT01039584

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

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

PharmaNet, Inc. (PharmaNet)

Charlotte, North Carolina, 28262, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Butoconazole Nitrate Vaginal Cream

Drug

vaginal cream

Placebo

Drug

vaginal cream

Other names: vehicle of the test product

Gynazole 1 vaginal cream

Drug

vaginal cream

Other names: Gynazole 1

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.

    Time frame: 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 outcomes

  1. Clinical Cure

    Time frame: Visit 3: Day 22-31

    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

  2. Mycological Cure

    Time frame: Visit 3: Day 22-31

    Mycological cure was defined as a negative mycological culture (no growth)

Sponsors and collaborators

Lead sponsor

Padagis LLC

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Dec 25, 2009
Registry last updated
Jul 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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