Clotrimazole Vaginal Tablet vs Fluconazole for Severe Vulvovaginal Candidiasis

Launched by PEKING UNIVERSITY SHENZHEN HOSPITAL · Jul 1, 2014

Keywords

ClinConnect 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.

Gender

FEMALE

Eligibility 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

Trial Officials