- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02180828
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
Conditions
Intervention / Treatment
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
-
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Guangdong
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Shenzhen, Guangdong, China, 518036
- Peking University Shenzhen Hospital
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-
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:
- 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
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
- were pregnant
- had used antifungal medication in the week before entry
- were expected to menstruate within seven days of the start of treatment
- 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:
|
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:
|
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.
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7-14 days after treatment (=visit 2)
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Therapeutic Efficacy 2
Time Frame: at days 30-35 follow-up
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The clinical cure rates of clotrimazole and fluconazol
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at days 30-35 follow-up
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Therapeutic Efficacy 3
Time Frame: at days 7-14 follow-up
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Mycological cure of clotrimazole group and fluconazole group
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at days 7-14 follow-up
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Therapeutic Efficacy 4
Time Frame: at days30-35 follow-up
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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.
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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
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Adverse Events 2
Time Frame: at day 7-14 follow up
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Vulvovaginal pruritus, burning, irritation, and bleeding
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at day 7-14 follow up
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Adverse Events 3
Time Frame: at day 7-14 follow up
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Gastrointestinal tract: abdominal pain, diarrhoea, nausea
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at day 7-14 follow up
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Adverse Events 4
Time Frame: at day 7-14 follow up
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Skin sensitivity, urticaria rash, erythematous rash, irritation
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at day 7-14 follow up
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Total Adverse Events
Time Frame: at day 7-14 follow up
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Total adverse events(cases)
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at day 7-14 follow up
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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
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, Local
- Anti-Infective Agents
- Enzyme Inhibitors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Cytochrome P-450 CYP3A Inhibitors
- 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
- Clotrimazole
- Miconazole
- Fluconazole
Other Study ID Numbers
- pkuszh-2014-02
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
-
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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