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

P

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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