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

NCT01039584 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 611

Last updated 2023-07-12

Study results available
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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.

Conditions

  • Vulvovaginal Candidiasis

Interventions

DRUG

Butoconazole Nitrate Vaginal Cream

vaginal cream

DRUG

Placebo

vaginal cream

DRUG

Gynazole 1 vaginal cream

vaginal cream

Sponsors & Collaborators

  • Padagis LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2009-09-30
Completion
2009-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01039584 on ClinicalTrials.gov