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

Vulvovaginal Candidiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02180100
• Other study ID #: PKUSH-GNY-2013-01
• Status: Completed
• Phase: Phase 4
• Start date: August 2013
• Est. completion date: June 2014

Study information

• Verified date: October 2020
• Source: Peking University Shenzhen Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 48 Years

Eligibility

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

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Vulvovaginal
• Vulvovaginal Candidiasis

Intervention

Drug:
• Terconazole Vaginal Suppository
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.

Locations

Country	Name	City	State
China	Peking University Shenzhen Hosptal	Shenzhen	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Peking University Shenzhen Hospital	Shanghai Shyndec Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

References & Publications (1)

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/my — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mycological Cure 1	Based on candida culture	Between day 7-14 after treatment, an average of 10 days
Secondary	Mycological Cure 2	Based on Candida culture	Between day 28-35 after treatment, an average of 30 days

External 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