Candidiasis, Vulvovaginal Clinical Trial
Official title:
A Multi-Center Randomized Study to Evaluate the Safety, Tolerability, and Efficacy of Oral Encochleated Amphotericin B (CAMB/MAT2203) Compared With Oral Fluconazole in the Treatment of Moderate to Severe Vulvovaginal Candidiasis (VVC)
This is a multi-center, randomized study to evaluate the safety, tolerability, and efficacy of 200 mg CAMB and 400 mg CAMB compared with a single 150 mg dose of fluconazole in the treatment of moderate to severe VVC.
This is a multi-center, randomized study to evaluate the safety, tolerability, and efficacy
of 200 mg CAMB and 400 mg CAMB compared with a single 150 mg dose of fluconazole in the
treatment of moderate to severe VVC.
Approximately 75 women with moderate to severe VVC will be randomized to 1 of 3 treatment
groups (200 mg CAMB, 400 mg CAMB, or fluconazole) to achieve approximately 25 subjects in
each group. The primary objective of this study is to evaluate the safety of 200 mg and 400
mg doses of oral CAMB for 5 days compared with a single 150 mg dose of oral fluconazole in
subjects with moderate to severe VVC. The secondary efficacy objectives of this study
included the clinical cure rate, mycology eradication and responder outcome. Tertiary
objectives include pharmacokinetics.
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