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Safety and Equivalence of a Terconazole Vaginal Suppository (Test Product) Compared to the Reference Terconazole Vaginal Suppository in the Treatment of Vulvovaginal Candidiasis

NCT00803738 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 572

Last updated 2021-10-13

Study results available
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Summary

The objectives of this study were to demonstrate comparable safety and efficacy of Terconazole Vaginal Suppositories, 80 mg(Test Product) and Terconazole Vaginal Suppositories, 80 mg(Reference Product) in the treatment of subjects with vulvovaginal candidiasis in order to establish bioequivalence.

Conditions

  • Vulvovaginal Candidiasis

Interventions

DRUG

Terconazole Vaginal Suppository

Vaginal Suppository inserted intravaginally once daily before bedtime for 3 consecutive days

DRUG

Terazol Vaginal Suppository

Vaginal Suppository inserted intravaginally once daily before bedtime for 3 consecutive days

Sponsors & Collaborators

  • Padagis LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-12-31
Primary Completion
2003-12-31
Completion
2003-12-31

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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 NCT00803738 on ClinicalTrials.gov