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

Phase 4

Completed

• Conditions: Vulvovaginal Candidiasis
• Interventions: Drug: Terconazole Vaginal Suppository; Drug: Fluconazole

• Registration Number: NCT02180100
• Lead Sponsor: Peking University Shenzhen Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2013-08
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Study First Submitted: 2014-06-30
• Study First Submitted QC: 2014-07-01
• Study First Posted: 2014-07-02
• Results First Submitted: 2019-08-20
• Status Verified: 2020-10
• Results First Submitted QC: 2020-10-22
• Last Update Submitted: 2020-10-22
• Results First Posted: 2020-10-23
• Last Update Posted: 2020-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Terconazole Vaginal Suppository	Terconazole Vaginal Suppository	Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days
Fluconazole	Fluconazole	orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4.

Primary Outcome Measures

Name	Time	Method
Mycological Cure 1	Between day 7-14 after treatment, an average of 10 days	Based on candida culture

Secondary Outcome Measures

Name	Time	Method
Mycological Cure 2	Between day 28-35 after treatment, an average of 30 days	Based on Candida culture

Trial Locations

Locations (1)

Peking University Shenzhen Hosptal; 🇨🇳 Shenzhen, Guangdong, China