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A Phase 2a, Single-Dose, Double-Blind, Placebo-Controlled, 2-Way Crossover Study to Evaluate the Efficacy and Safety of SST-6006 Compared to Placebo in the Treatment of Erectile Dysfunction
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
Details
| Lead sponsor | Strategic Science & Technologies, LLC |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 33 |
| Start date | 2015-03 |
| Completion | 2017-06 |
Conditions
- Erectile Dysfunction
Interventions
- Sildenafil Cream
- Placebo Cream
- Penile Plethysmography (RigiScan)
Primary outcomes
- Cumulative duration of ≥ 60% rigidity at the base of the penis during 60 minutes of VSS (SST-6006 compared to placebo cream) — 60 minutes
Countries
United States