Phase 2a Topical Sildenafil Proof-of-Concept Study in Men With Mild to Moderate ED
Status:
Completed
Trial end date:
2017-06-01
Target enrollment:
Participant gender:
Summary
This is a Phase 2a, single-dose, double-blind, placebo-controlled, 2-way crossover study in
men with ED. A single 2 gram dose of SST-6006 topical cream 5% w/w (formulated to deliver 100
mg of sildenafil) or a topical placebo cream will be applied to the penile shaft and glans.
There are 4 study phases: the Initial Patient Screening Phase (Visit 1, an Off Site 4-Week
Run-in Period and Visit 2), the Final Patient Screening Phase (Visit 3), the SST-6006/Placebo
Double-Blind Dosing Phase (Visits 4-5), and the Follow-up Phase. Primary outcomes will be be
evaluated at Weeks 7 and 8 of the study