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

Peking University

Status and phase

Completed

Phase 4

Conditions

Vulvovaginal Candidiasis

Treatments

Drug: Terconazole Vaginal Suppository

Drug: Fluconazole

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02180100

PKUSH-GNY-2013-01

Details and patient eligibility

About

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.

Full description

This study were to demonstrate comparable safety and efficacy of Terconazole Vaginal Suppository 80 mg inserted intravaginally once daily before bedtime for 6 consecutive days and oral fluconazole 150mg at day 1 and day 4 in the treatment of subjects with severe vulvovaginal candidiasis.

Enrollment

140 patients

Sex

Female

Ages

18 to 48 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Vulvovaginal candidiasis infection is diagnosed, the symptoms evaluated using a numerical rating system based on severity (absent=0; mild=1; moderate=2; severe=3) with a minimum VVC Composite Signs/Symptoms score of 7
Subject completes the informed consent process
Subject agrees to take study medication when scheduled
Subject complies with all clinical trial instructions. Commits to all follow-up visits
Subject agrees to abstain from sexual intercourse from the time of randomization through the first seven days immediately following treatment

Exclusion criteria

had any other sexually transmitted disease or gynaecological abnormality requiring treatment
had a disease known to predispose to candidiasis such as diabetes mellitus, or were receiving antibiotics or corticosteriods
had used antifungal medication in the week before entry; or
were expected to menstruate within seven days of the start of treatment
infected more than one candida species