Safety and Efficacy of Oral Encochleated Amphotericin B (CAMB/MAT2203) in the Treatment of Vulvov… (NCT02971007) | Clinical Trial Compass
CompletedPhase 2
Safety and Efficacy of Oral Encochleated Amphotericin B (CAMB/MAT2203) in the Treatment of Vulvovaginal Candidiasis (VVC)
United States137 participantsStarted 2016-11
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexFEMALE
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Key Inclusion Criteria:
Informed consent
Clinical diagnosis of moderate to severe VVC
Negative pregnancy test
Vaginal pH less than 4.5
Key Exclusion Criteria:
Has an intolerance or hypersensitivity to any amphotericin B (AMB) product, or to azole antifungal drugs
Receiving antifungal therapy unrelated to VVC or has evidence of systemic fungal infections requiring antifungal therapy
Has received treatment for VVC within the past 30 days or has experienced 4 or more episodes of VVC in the past 12 months
Has another cause of vulvovaginitis
Has other urogenital infection(s) that would potentially alter their response to disease
Has another vaginal or vulvar condition that would confound the interpretation of clinical response
Has significant laboratory abnormality at screening
Has any known azole-resistant Candida infection;
Has any other condition the Investigator believes would interfere with the subject's ability to provide informed consent, comply with study instructions, or puts the subject at undue risk