Clotrimazole Vaginal Tablet vs Fluconazole for Severe Vulvovaginal Candidiasis
- Conditions
- Candidiasis, Vulvovaginal
- Interventions
- Registration Number
- NCT02180828
- Lead Sponsor
- 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
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 240
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Clotrimazole vaginal tablet Clotrimazole vaginal tablet 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4) Fluconazole Fluconazole 2 doses of 150 mg oral Fluconazole (at day1 and day4)
- Primary Outcome Measures
Name Time Method Therapeutic Efficacy 2 at days 30-35 follow-up The clinical cure rates of clotrimazole and fluconazol
Therapeutic Efficacy 3 at days 7-14 follow-up Mycological cure of clotrimazole group and fluconazole group
Therapeutic Efficacy 4 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.
Therapeutic Efficacy 1 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.
- Secondary Outcome Measures
Name Time Method Adverse Events 1 at day 7-14 follow up Systemic: weak, palpitation, tachycardia, migraine, headache, dizzy, rhinorrhea, numb, dizziness, fatigue.
Adverse Events 3 at day 7-14 follow up Gastrointestinal tract: abdominal pain, diarrhoea, nausea
Total Adverse Events at day 7-14 follow up Total adverse events(cases)
Adverse Events 2 at day 7-14 follow up Vulvovaginal pruritus, burning, irritation, and bleeding
Adverse Events 4 at day 7-14 follow up Skin sensitivity, urticaria rash, erythematous rash, irritation
Trial Locations
- Locations (1)
Peking University Shenzhen Hospital
🇨🇳Shenzhen, Guangdong, China