Clinical Trial: Clotrimazole Vaginal Tablet vs Fluconazole for Severe Vulvovaginal Candidiasis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: An Case-controlled Randomized Study to the Efficacy of Clotrimazole Vaginal Tablet vs Fluconazole for Severe Vulvovaginal Candidiasis
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
Detailed Summary: 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.
Sponsor: Peking University Shenzhen Hospital
Current Primary Outcome:
- 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.
- Therapeutic Efficacy 2 [ Time Frame: at days 30-35 follow-up ]The clinical cure rates of clotrimazole and fluconazol
- Therapeutic Efficacy 3 [ Time Frame: at days 7-14 follow-up ]Mycological cure of clotrimazole group and fluconazole group
- 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.
Original Primary Outcome: Subjects with mycological and clinical cure [ Time Frame: 35-42 days after treatment (=visit 3) ]
Current Secondary Outcome:
- Adverse Events 1 [ Time Frame: at day 7-14 follow up ]Systemic: weak, palpitation, tachycardia, migraine, headache, dizzy, rhinorrhea, numb, dizziness, fatigue.
- Adverse Events 2 [ Time Frame: at day 7-14 follow up ]Vulvovaginal pruritus, burning, irritation, and bleeding
- Adverse Events 3 [ Time Frame: at day 7-14 follow up ]Gastrointestinal tract: abdominal pain, diarrhoea, nausea
- Adverse Events 4 [ Time Frame: at day 7-14 follow up ]Skin sensitivity, urticaria rash, erythematous rash, irritation
- Total Adverse Events [ Time Frame: at day 7-14 follow up ]Total adverse events(cases)
Original Secondary Outcome: vaginal microecology [ Time Frame: 35-42 days after treatment (=visit 3) ]
Information By: Peking University Shenzhen Hospital
Dates:
Date Received: June 30, 2014
Date Started: July 2014
Date Completion:
Last Updated: April 28, 2017
Last Verified: April 2017
