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

NCT02495467 | Completed Phase 2 Results

• 1 other identifier: FM53
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 1

Brief 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

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• Erectile Function (EF) Domain Score of the International Index of Erectile Function (IIEF)

  Erectile Function (EF) domain of the International Index of Erectile Function (IIEF) questionnaire. This will be measured at the end of the treatment periods of 4 weeks (+/- 1 week). The minimum and maximum values are 1-30, a lower score is regarded as more severe.

  4 Weeks

Secondary Outcomes (11)

• Orgasmic Function Domain Score of the International Index of Erectile (IIEF)

  4 Weeks

• Sexual Desire Domain Score of the International Index of Erectile Function (IIEF)

  4 Weeks

• Intercourse Satisfaction Domain Score of the International Index of Erectile Function (IIEF)

  4 Weeks

• Overall Satisfaction Domain Score of the International Index of Erectile Function (IIEF)

  4 weeks

• Percentage of Affirmative Responses to Sexual Encounter Profile (SEP) Question 1

  4 Weeks

Study Arms (2)

MED Placebo then MED2005

EXPERIMENTAL

Participants first receive MED Placebo to be used at least 4 times during a 4 week period. Following a 1-week treatment-free cross-over period participants receive MED2005 (0.2% glyceryl trinitrate gel) to be used at least 4 times during a 4 week period. Treatments are provided in single unit dose aluminium tubes packed in boxes of 5. Each tube will contain sufficient gel to apply a pea sized amount (approximately 300 mg).

Drug: Glyceryl trinitrate; Drug: MED Placebo

MED2005 then MED Placebo

EXPERIMENTAL

Participants first receive MED2005 (0.2% glyceryl trinitrate gel) to be used at least 4 times during a 4 week period. Following a 1-week treatment-free cross-over period participants receive MED Placebo to be used at least 4 times during a 4 week period. Treatments are provided in single unit dose aluminium tubes packed in boxes of 5. Each tube will contain sufficient gel to apply a pea sized amount (approximately 300 mg).

Drug: Glyceryl trinitrate; Drug: MED Placebo

Interventions

Glyceryl trinitrate DRUG

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

Also known as: MED2005

MED Placebo then MED2005; MED2005 then MED Placebo

MED Placebo DRUG

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

Also known as: MED2005 Vehicle

MED Placebo then MED2005; MED2005 then MED Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male aged between 18 and 70 years of age inclusive.
• Confirmed self-diagnosis of ED for more than 3 months.
• Subject answers "yes" to the question "At home over the past 3 months, have you experienced at least some growth of your penis in response to: (1) mechanical stimulation, or (2) visual stimulation?"
• In a continuous heterosexual relationship for at least 6 months prior to screening.
• Documented written informed consent from both subject and his female partner.
• Both partners must agree to use one of the acceptable methods of contraception listed below:
• Occlusive cap (diaphragm or cervical/vault caps).
• Surgical sterilisation (vasectomy with documentation of azoospermia).
• The female partner uses oral contraceptives, injectable progesterone or subdermal implants.
• The female partner uses medically prescribed topically-applied transdermal contraceptive patch.
• The female partner has undergone documented tubal ligation (female sterilisation).
• The female partner has undergone documented placement of an Intra Uterine Device (IUD).
• Both partners are capable of understanding and complying with the requirements of the protocol and must have signed the informed consent form.

You may not qualify if:

• Any significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrinological, metabolic, neurological, psychiatric, or other disease.
• Any history of an unstable medical or psychiatric condition or using any medication that, in the opinion of the PI, is likely to affect the subject's ability to complete the study or precludes the subject's participation in the study.
• Any presence of a symptomatic, active urinary tract infection diagnosed by the PI or delegate at screening.
• Any presence of chronic indwelling urethral catheterization or penile anatomical abnormalities (e.g. penile fibrosis) that would significantly impair erectile function.
• Any history of operations for Peyronie's disease.
• Primary hypoactive sexual desire or any history of hypogonadism
• Any history of radical prostatectomy.
• Any history of severe / uncontrolled diabetes.
• Subjects taking two or more anti-hypertensives for the treatment of blood pressure.
• Subjects with nursing partners, known pregnant partners or wish to become pregnant during the course of the study.
• Confirmed positive results from urine drug screen or from the alcohol breath test at screening and on admission (Day -1).
• Subject has recent (last 12 months) clinical evidence of alcoholism or drug abuse.
• Subject has a positive screen for hepatitis B consisting of Hepatitis B surface antigen (HBsAG), hepatitis C antibody, and human immunodeficiency virus (HIV).
• Any clinically significant abnormal laboratory, vital signs or other safety findings at screening or on admission.
• Subjects unwilling to cease use of vacuum devices, intracavernosal injection, Viagra ® or other therapy for ED.

Sponsors & Collaborators

• Futura Medical Developments Ltd.: lead
• Richmond Pharmacology Limited: collaborator

Study Sites (1)

Richmond Pharmacology Ltd.

Croydon, Surrey, CR7 7YE, United Kingdom

Location

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Nitroglycerin

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Nitro Compounds; Organic Chemicals

Results Point of Contact

• Title: Dr Jorg Taubel
• Organization: Richmond Pharmacology Limited

j.taubel@richmondpharmacology.com

020 8664 5200

Study Officials

• Tim J Holland, MSc

  Futura Medical Developments Ltd.

  STUDY DIRECTOR

• Jörg Täubel, MD FFPM

  Richmond Pharmacology Limited

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2015
• First Posted: July 13, 2015
• Study Start: May 15, 2015
• Primary Completion: July 30, 2016
• Study Completion: July 30, 2016
• Last Updated: February 12, 2020
• Results First Posted: January 29, 2020

Record last verified: 2020-01

Locations

GB (1)