The purpose of this study is to determine if SPL7013 Gel (VivaGel™) is safe when applied topically once a day for seven consecutive days to the shaft and glans of the penis in healthy male volunteers. The study will compare the safety of SPL7013 Gel on the penile epithelium and urethral mucosa to the safety of a placebo gel. The study will also assess the systemic safety of SPL7013 Gel, systemic absorption of the active ingredient of SPL7013 Gel, and the acceptability of the study products to the male volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
36
Melbourne Sexual Health Centre
Carlton, Victoria, Australia
Participant reports of genital pain, genital burning, penile itching, penile rash, penile ulceration or other genital symptoms
Erythema, vesiculation, bullous reaction, ulceration or other genital findings of the penile shaft, foreskin, glans or meatus as observed by visual examination
All other adverse events
Laboratory abnormalities
Plasma concentrations of SPL7013
Expectations and experiences of the study products described by participant interviews
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