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

NCT02390960 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2017-10-12

No results posted yet for this study

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

Conditions

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.

Sponsors & Collaborators

  • Strategic Science & Technologies, LLC

    lead INDUSTRY

Principal Investigators

  • Eric Fossel, PhD · Sponsor GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2017-04-30
Completion
2017-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02390960 on ClinicalTrials.gov