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Terconazole Vaginal Suppository vs Fluconazole for the Treatment of Severe Vulvovaginal Candidiasis

NCT02180100 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2020-10-23

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 and fluconazole in the treatment of subjects with severe vulvovaginal candidiasis.

Conditions

  • Vulvovaginal Candidiasis

Interventions

DRUG

Terconazole Vaginal Suppository

Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days

DRUG

Fluconazole

orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4.

Sponsors & Collaborators

  • Shanghai Shyndec Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Peking University Shenzhen Hospital

    lead OTHER

Principal Investigators

  • Shangrong Fan, M.D. · Peking University Shenzhen Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
48 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • China

Study Locations

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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 NCT02180100 on ClinicalTrials.gov