Clotrimazole Vaginal Tablet vs Fluconazole for Severe Vulvovaginal Candidiasis

April 28, 2017 updated by: Shangrong Fan, Peking University Shenzhen Hospital

An Case-controlled Randomized Study to the Efficacy of Clotrimazole Vaginal Tablet vs Fluconazole for Severe Vulvovaginal Candidiasis

The study is focused to prove that the efficacy and safety of Clotrimazole vaginal tablet vs Fluconazole for the treatment of severe vulvovaginal candidiasis

Study Overview

Status

Completed

Detailed Description

The current study is evaluating both the efficacy and safety of the 2 doses of 500 mg clotrimazole vaginal tablet administered intravaginally( at day 1 and day 4) v.s 2 doses of 150 mg fluconazole( at day 1 and day 4) for treatment of severe vulvovaginal candidiasis.The number of participants with adverse events as a measure of safety and tolerability.

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. 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
  2. Subject completes the informed consent process
  3. Subject agrees to take study medication when scheduled
  4. Subject complies with all clinical trial instructions. Commits to all follow-up visits

Exclusion Criteria:

  1. had any other sexually transmitted disease or gynaecological abnormality requiring treatment
  2. had a disease known to predispose to candidiasis such as diabetes mellitus, or were receiving antibiotics or corticosteriods
  3. were pregnant
  4. had used antifungal medication in the week before entry
  5. were expected to menstruate within seven days of the start of treatment
  6. infected more than one candida species

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Clotrimazole vaginal tablet
2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)
2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)
Other Names:
  • Canesten
Active Comparator: Fluconazole
2 doses of 150 mg oral Fluconazole (at day1 and day4)
2 doses of 150 mg oral Fluconazole (at day1 and day4)
Other Names:
  • Diflucan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Therapeutic Efficacy 1
Time Frame: 7-14 days after treatment (=visit 2)
The clinical cure rates of clotrimazole and fluconazol: Clinical cure was defined as the resolution of symptoms present at baseline with a total severity score of ≤2. Improvement was defined as considerable reduction in the severity of baseline signs and symptoms with a decrease in the total score by ≥50%.Patients not clinically cured or showing improvement were considered clinical failures.
7-14 days after treatment (=visit 2)
Therapeutic Efficacy 2
Time Frame: at days 30-35 follow-up
The clinical cure rates of clotrimazole and fluconazol
at days 30-35 follow-up
Therapeutic Efficacy 3
Time Frame: at days 7-14 follow-up
Mycological cure of clotrimazole group and fluconazole group
at days 7-14 follow-up
Therapeutic Efficacy 4
Time Frame: at days30-35 follow-up
Mycological cure of clotrimazole group and fluconazole group: Mycological cure or failure was referred to as Candida negative or positive,respectively, on Candida culture at follow-up visits.
at days30-35 follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events 1
Time Frame: at day 7-14 follow up
Systemic: weak, palpitation, tachycardia, migraine, headache, dizzy, rhinorrhea, numb, dizziness, fatigue.
at day 7-14 follow up
Adverse Events 2
Time Frame: at day 7-14 follow up
Vulvovaginal pruritus, burning, irritation, and bleeding
at day 7-14 follow up
Adverse Events 3
Time Frame: at day 7-14 follow up
Gastrointestinal tract: abdominal pain, diarrhoea, nausea
at day 7-14 follow up
Adverse Events 4
Time Frame: at day 7-14 follow up
Skin sensitivity, urticaria rash, erythematous rash, irritation
at day 7-14 follow up
Total Adverse Events
Time Frame: at day 7-14 follow up
Total adverse events(cases)
at day 7-14 follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Shangrong Fan, M.D., Peking University Shenzhen Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

June 30, 2014

First Submitted That Met QC Criteria

July 1, 2014

First Posted (Estimate)

July 3, 2014

Study Record Updates

Last Update Posted (Actual)

May 2, 2017

Last Update Submitted That Met QC Criteria

April 28, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

http://onlinelibrary.wiley.com/doi/10.1111/myc.12485/epdf

Study Data/Documents

  1. Clinical Study Report
    Information comments: The efficacy and safety of clotrimazole vaginal tablet vs. oral fluconazole in treating severe vulvovaginal candidiasis

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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