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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

611 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2009-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Vulvovaginal Candidiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

vaginal cream

Test Product

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

Group Type EXPERIMENTAL

Butoconazole Nitrate Vaginal Cream

Intervention Type DRUG

vaginal cream

Reference Product

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

Group Type ACTIVE_COMPARATOR

Gynazole 1 vaginal cream

Intervention Type DRUG

vaginal cream

Interventions

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Butoconazole Nitrate Vaginal Cream

vaginal cream

Intervention Type DRUG

Placebo

vaginal cream

Intervention Type DRUG

Gynazole 1 vaginal cream

vaginal cream

Intervention Type DRUG

Other Intervention Names

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vehicle of the test product Gynazole 1

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes