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
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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