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

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Padagis LLC; Perrigo Company
• Treatments: Butoconazole

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