Phase 2a Topical Sildenafil Proof-of-Concept Study in Men With Mild to Moderate ED

PHASE2CompletedINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

March 31, 2015

Primary Completion Date

April 30, 2017

Study Completion Date

June 30, 2017

Conditions
Erectile Dysfunction
Interventions
DRUG

Sildenafil Cream

Patients will be instructed to apply pre-weighed SST-6006 to the non-erect penile skin area at the time of dosing. Patients will then massage the cream into the penile shaft and glans for a maximum of 3 minutes.

DRUG

Placebo Cream

Patients will be instructed to apply the pre-weighed placebo cream to the non-erect penile skin area at the time of dosing. Patients will then massage the cream into the penile shaft and glans for a maximum of 3 minutes.

DEVICE

Penile Plethysmography (RigiScan)

During each dosing period, penile plethysmography will be utilized to evaluate efficacy of SST-6006 verses placebo cream. Each plethysmography session will be approximately 75 minutes.This includes a 15 minute 'baseline' period where patients are told to remain in the flaccid state and 60 minutes during which time patients will watch a series of erotic videos.

Trial Locations (3)

10016

Manhattan Medical Research, New York

70112

Tulane Medical Center, New Orleans

92120

San Diego Sexual Medicine, San Diego

All Listed Sponsors
lead

Strategic Science & Technologies, LLC

INDUSTRY

NCT02390960 - Phase 2a Topical Sildenafil Proof-of-Concept Study in Men With Mild to Moderate ED | Biotech Hunter | Biotech Hunter