Clotrimazole Vaginal Tablet vs Fluconazole for Severe Vulvovaginal Candidiasis

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

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

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.

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