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

Padagis

Status: Completed

Conditions: Vulvovaginal Candidiasis

Treatments: Drug: Gynazole 1 vaginal cream; Drug: Butoconazole Nitrate Vaginal Cream; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01039584

PRG-710

Details and patient eligibility

About

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.

Enrollment: 611 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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611 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Test Product

Experimental group

Description:

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

Treatment:

Drug: Butoconazole Nitrate Vaginal Cream

Reference Product

Active Comparator group

Description:

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

Treatment:

Drug: Gynazole 1 vaginal cream