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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Vulvovaginal Candidiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Terconazole Vaginal Suppository

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

Group Type EXPERIMENTAL

Terconazole Vaginal Suppository

Intervention Type DRUG

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

Fluconazole

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

Group Type ACTIVE_COMPARATOR

Fluconazole

Intervention Type DRUG

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

Interventions

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Terconazole Vaginal Suppository

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

Intervention Type DRUG

Fluconazole

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

Intervention Type DRUG

Other Intervention Names

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Tekangzuo Yindao Shuan Diflucan

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

48 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No