Clinical Trial of Topically-applied Glyceryl Trinitrate (GTN) for the Treatment of Erectile Dysfunction (ED)

NCT02495467 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 232

Last updated 2020-02-12

Study results available
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Summary

This study is designed to evaluate the efficacy and safety of MED2005, a topically applied glyceryl trinitrate (GTN) gel administered to the penis of male subjects self-diagnosed with erectile dysfunction (ED) immediately before sexual intercourse.

Conditions

Interventions

DRUG

Glyceryl trinitrate

At least 4 applications of MED2005 prior to intercourse over a period of 4 weeks

DRUG

MED Placebo

At least 4 applications of MED2005 prior to intercourse over a period of 4 weeks

Sponsors & Collaborators

  • Richmond Pharmacology Limited

    collaborator INDUSTRY
  • Futura Medical Developments Ltd.

    lead INDUSTRY

Principal Investigators

  • Tim J Holland, MSc · Futura Medical Developments Ltd.

  • Jörg Täubel, MD FFPM · Richmond Pharmacology Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-05-15
Primary Completion
2016-07-30
Completion
2016-07-30

Countries

  • United Kingdom

Study Locations

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Entities

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 NCT02495467 on ClinicalTrials.gov