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

Primary Purpose

Vulvovaginal Candidiasis

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Terconazole Vaginal Suppository
Fluconazole
Sponsored by
Peking University Shenzhen Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vulvovaginal Candidiasis

Eligibility Criteria

18 Years - 48 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Peking University Shenzhen Hosptal

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Terconazole Vaginal Suppository

Fluconazole

Arm Description

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

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

Outcomes

Primary Outcome Measures

Mycological Cure 1
Based on candida culture

Secondary Outcome Measures

Mycological Cure 2
Based on Candida culture

Full Information

First Posted
June 30, 2014
Last Updated
October 22, 2020
Sponsor
Peking University Shenzhen Hospital
Collaborators
Shanghai Shyndec Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02180100
Brief Title
Terconazole Vaginal Suppository vs Fluconazole for the Treatment of Severe Vulvovaginal Candidiasis
Official Title
A Randomized, Parallel-group Study of Terconazole Vaginal Suppository vs Fluconazole for the Treatment of Severe
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University Shenzhen Hospital
Collaborators
Shanghai Shyndec Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvovaginal Candidiasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Terconazole Vaginal Suppository
Arm Type
Experimental
Arm Description
Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days
Arm Title
Fluconazole
Arm Type
Active Comparator
Arm Description
orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4.
Intervention Type
Drug
Intervention Name(s)
Terconazole Vaginal Suppository
Other Intervention Name(s)
Tekangzuo Yindao Shuan
Intervention Description
Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days
Intervention Type
Drug
Intervention Name(s)
Fluconazole
Other Intervention Name(s)
Diflucan
Intervention Description
orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4.
Primary Outcome Measure Information:
Title
Mycological Cure 1
Description
Based on candida culture
Time Frame
Between day 7-14 after treatment, an average of 10 days
Secondary Outcome Measure Information:
Title
Mycological Cure 2
Description
Based on Candida culture
Time Frame
Between day 28-35 after treatment, an average of 30 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
48 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shangrong Fan, M.D.
Organizational Affiliation
Peking University Shenzhen Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Shenzhen Hosptal
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518036
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
25877666
Citation
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.
Results Reference
result
Links:
URL
http://mmy.oxfordjournals.org/content/early/2015/04/14/mmy.myv017.long
Description
Terconazole Vaginal Suppository vs Fluconazole for the Treatment of Severe Vulvovaginal Candidiasis
URL
http://www.ncbi.nlm.nih.gov/pubmed/25877666
Description
Terconazole Vaginal Suppository vs Fluconazole for the Treatment of Severe Vulvovaginal Candidiasis

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

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