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

A Randomized, Parallel-group Study of Terconazole Vaginal Suppository vs Fluconazole for the Treatment of Severe

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.

Study Overview

• Status: Completed
• Conditions: Vulvovaginal Candidiasis
• Intervention / Treatment: Drug: Terconazole Vaginal Suppository; Drug: Fluconazole

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 Type: Interventional
• Enrollment (Actual): 140
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China, 518036
      • Peking University Shenzhen Hosptal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Terconazole Vaginal Suppository; Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days	Drug: Terconazole Vaginal Suppository; Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days; Other Names: Tekangzuo Yindao Shuan
Active Comparator: Fluconazole; orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4.	Drug: Fluconazole; orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4.; Other Names: Diflucan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mycological Cure 1	Based on candida culture	Between day 7-14 after treatment, an average of 10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mycological Cure 2	Based on Candida culture	Between day 28-35 after treatment, an average of 30 days

Collaborators and Investigators

• Sponsor: Peking University Shenzhen Hospital
• Collaborators: Shanghai Shyndec Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Shangrong Fan, M.D., Peking University Shenzhen Hospital

Publications and helpful links

General Publications

• Li T, Zhu Y, Fan S, Liu X, Xu H, Liang Y. A randomized clinical trial of the efficacy and safety of terconazole vaginal suppository versus oral fluconazole for treating severe vulvovaginal candidiasis. Med Mycol. 2015 Jun;53(5):455-61. doi: 10.1093/mmy/myv017. Epub 2015 Apr 15.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: June 30, 2014
• First Submitted That Met QC Criteria: July 1, 2014
• First Posted (Estimate): July 2, 2014

Study Record Updates

• Last Update Posted (Actual): October 23, 2020
• Last Update Submitted That Met QC Criteria: October 22, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Mycoses; Vaginal Diseases; Vulvar Diseases; Vaginitis; Vulvitis; Vulvovaginitis; Candidiasis; Candidiasis, Vulvovaginal; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Cytochrome P-450 CYP2C19 Inhibitors; Fluconazole; Terconazole
• Other Study ID Numbers: PKUSH-GNY-2013-01