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Clotrimazole Vaginal Tablet vs Fluconazole for Severe Vulvovaginal Candidiasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02180828
Recruitment Status : Completed
First Posted : July 3, 2014
Results First Posted : September 30, 2016
Last Update Posted : May 2, 2017
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Shangrong Fan, Peking University Shenzhen Hospital

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

Condition or disease Intervention/treatment Phase
Candidiasis, Vulvovaginal Drug: Clotrimazole vaginal tablet Drug: Fluconazole Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Case-controlled Randomized Study to the Efficacy of Clotrimazole Vaginal Tablet vs Fluconazole for Severe Vulvovaginal Candidiasis
Study Start Date : July 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Yeast Infections

Arm Intervention/treatment
Experimental: Clotrimazole vaginal tablet
2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)
Drug: Clotrimazole vaginal tablet
2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)
Other Name: Canesten

Active Comparator: Fluconazole
2 doses of 150 mg oral Fluconazole (at day1 and day4)
Drug: Fluconazole
2 doses of 150 mg oral Fluconazole (at day1 and day4)
Other Name: Diflucan




Primary Outcome Measures :
  1. 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.

  2. Therapeutic Efficacy 2 [ Time Frame: at days 30-35 follow-up ]
    The clinical cure rates of clotrimazole and fluconazol

  3. Therapeutic Efficacy 3 [ Time Frame: at days 7-14 follow-up ]
    Mycological cure of clotrimazole group and fluconazole group

  4. 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.


Secondary Outcome Measures :
  1. Adverse Events 1 [ Time Frame: at day 7-14 follow up ]
    Systemic: weak, palpitation, tachycardia, migraine, headache, dizzy, rhinorrhea, numb, dizziness, fatigue.

  2. Adverse Events 2 [ Time Frame: at day 7-14 follow up ]
    Vulvovaginal pruritus, burning, irritation, and bleeding

  3. Adverse Events 3 [ Time Frame: at day 7-14 follow up ]
    Gastrointestinal tract: abdominal pain, diarrhoea, nausea

  4. Adverse Events 4 [ Time Frame: at day 7-14 follow up ]
    Skin sensitivity, urticaria rash, erythematous rash, irritation

  5. Total Adverse Events [ Time Frame: at day 7-14 follow up ]
    Total adverse events(cases)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 48 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02180828


Locations
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China, Guangdong
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China, 518036
Sponsors and Collaborators
Peking University Shenzhen Hospital
Bayer
Investigators
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Principal Investigator: Shangrong Fan, M.D. Peking University Shenzhen Hospital

Additional Information:
Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site
The efficacy and safety of clotrimazole vaginal tablet vs. oral fluconazole in treating severe vulvovaginal candidiasis

Publications of Results:
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Responsible Party: Shangrong Fan, Prof of Dept of Obstetrics and Gynecology, Peking University Shenzhen Hospital
ClinicalTrials.gov Identifier: NCT02180828     History of Changes
Other Study ID Numbers: pkuszh-2014-02
First Posted: July 3, 2014    Key Record Dates
Results First Posted: September 30, 2016
Last Update Posted: May 2, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://onlinelibrary.wiley.com/doi/10.1111/myc.12485/epdf

Additional relevant MeSH terms:
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Candidiasis
Candidiasis, Vulvovaginal
Mycoses
Vulvovaginitis
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Vulvitis
Vulvar Diseases
Fluconazole
Clotrimazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Anti-Infective Agents, Local