Clotrimazole Vaginal Tablet vs Fluconazole for Severe Vulvovaginal Candidiasis

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

Detailed Description
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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.

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

Conditions
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Candidiasis, Vulvovaginal

Intervention / Treatment
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* Drug: Clotrimazole vaginal tablet
* Drug: Fluconazole


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 48 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clotrimazole vaginal tablet<br>2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4) | Drug: Clotrimazole vaginal tablet<br>* 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)<br>* Other names: Canesten;|
| Active Comparator: Fluconazole<br>2 doses of 150 mg oral Fluconazole (at day1 and day4) | Drug: Fluconazole<br>* 2 doses of 150 mg oral Fluconazole (at day1 and day4)<br>* Other names: Diflucan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapeutic Efficacy 1 | 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 | The clinical cure rates of clotrimazole and fluconazol | at days 30-35 follow-up | 
| Therapeutic Efficacy 3 | Mycological cure of clotrimazole group and fluconazole group | at days 7-14 follow-up | 
| Therapeutic Efficacy 4 | 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 | Systemic: weak, palpitation, tachycardia, migraine, headache, dizzy, rhinorrhea, numb, dizziness, fatigue. | at day 7-14 follow up | 
| Adverse Events 2 | Vulvovaginal pruritus, burning, irritation, and bleeding | at day 7-14 follow up | 
| Adverse Events 3 | Gastrointestinal tract: abdominal pain, diarrhoea, nausea | at day 7-14 follow up | 
| Adverse Events 4 | Skin sensitivity, urticaria rash, erythematous rash, irritation | at day 7-14 follow up | 
| Total Adverse Events | Total adverse events(cases) | at day 7-14 follow up |