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

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ClinicalTrials.gov Identifier: NCT02495467
Recruitment Status : Unknown
Verified January 2016 by Futura Medical Developments Ltd..
Recruitment status was:  Recruiting
First Posted : July 13, 2015
Last Update Posted : January 26, 2016
Sponsor:
Collaborator:
Richmond Pharmacology Limited
Information provided by (Responsible Party):
Futura Medical Developments Ltd.

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.

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Drug: Glyceryl trinitrate Drug: MED Placebo Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled, Home Use, Cross-over Clinical Trial of Topically-applied Glyceryl Trinitrate (GTN) for the Treatment of Erectile Dysfunction (ED)
Study Start Date : July 2015
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MED2005
MED2005 (0.2% glyceryl trinitrate gel) will be provided in single unit dose aluminium tubes packed in boxes of 5 per subject and per treatment period. Each tube will contain sufficient gel to apply a pea sized amount (approximately 300 mg) of MED2005 (0.2% glyceryl trinitrate gel).
Drug: Glyceryl trinitrate
At least 4 applications of MED2005 prior to intercourse over a period of 4 weeks
Other Name: MED2005

Placebo Comparator: MED Placebo
MED2005 Placebo will be provided in single unit dose aluminium tubes packed in boxes of 5 per subject and per treatment period. Each tube will contain sufficient gel to apply a pea sized amount (approximately 300 mg) of MED2005 Placebo.
Drug: MED Placebo
At least 4 applications of MED2005 prior to intercourse over a period of 4 weeks
Other Name: MED2005 Vehicle




Primary Outcome Measures :
  1. Changes in the Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF) between treatment periods and baseline [ Time Frame: Up to 19 weeks ]
    Measured at the end of a 4 week (+/- 1 week) run-in period and two subsequent treatment periods of 4 weeks (+/- 1 week)


Secondary Outcome Measures :
  1. Changes in the IIEF scores between treatment periods and baseline [ Time Frame: Up to 19 weeks ]
    Measured at the end of a 4 week (+/- 1 week) run-in period and two subsequent treatment periods of 4 weeks (+/- 1 week)

  2. Changes in the orgasmic function domain scores of the IIEF between treatment periods and baseline [ Time Frame: Up to 19 weeks ]
    Measured at the end of a 4 week (+/- 1 week) run-in period and two subsequent treatment periods of 4 weeks (+/- 1 week)

  3. Changes in the sexual desire domain scores of the IIEF between treatment periods and baseline [ Time Frame: Up to 19 weeks ]
    Measured at the end of a 4 week (+/- 1 week) run-in period and two subsequent treatment periods of 4 weeks (+/- 1 week)

  4. Changes in the intercourse satisfaction domain scores the IIEF between treatment periods and baseline [ Time Frame: Up to 19 weeks ]
    Measured at the end of a 4 week (+/- 1 week) run-in period and two subsequent treatment periods of 4 weeks (+/- 1 week)

  5. Changes in the overall satisfaction domain scores of the IIEF between treatment periods and baseline [ Time Frame: Up to 19 weeks ]
    Measured at the end of a 4 week (+/- 1 week) run-in period and two subsequent treatment periods of 4 weeks (+/- 1 week)

  6. Changes in the Sexual Event Profile (SEP) scores between treatment periods and baseline [ Time Frame: Up to 19 weeks ]
    After each intercourse event during of a 4 week (+/- 1 week) run-in period and two subsequent treatment periods of 4 weeks (+/- 1 week)

  7. Changes in the Global Assessment Questionnaire (GAQ) scores between treatment periods [ Time Frame: Up to 19 weeks ]
    End of each treatment period of 4 weeks (+/- 1 week)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male aged between 18 and 70 years of age inclusive.
  2. Confirmed self-diagnosis of ED for more than 3 months.
  3. IIEF question 1 -5 and 15 score of 25 or less will be acceptable for inclusion to the run-in period.
  4. 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?"
  5. In a continuous heterosexual relationship for at least 6 months prior to screening.
  6. Documented written informed consent from both subject and his female partner.
  7. 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).
  8. Both partners are capable of understanding and complying with the requirements of the protocol and must have signed the informed consent form.

Exclusion Criteria:

  1. Any significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrinological, metabolic, neurological, psychiatric, or other disease.
  2. 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.
  3. Any presence of a symptomatic, active urinary tract infection diagnosed by the PI or delegate at screening.
  4. Any presence of chronic indwelling urethral catheterization or penile anatomical abnormalities (e.g. penile fibrosis) that would significantly impair erectile function.
  5. Any history of operations for Peyronie's disease.
  6. Primary hypoactive sexual desire or any history of hypogonadism
  7. Any history of radical prostatectomy.
  8. Any history of severe / uncontrolled diabetes.
  9. Subjects taking two or more anti-hypertensives for the treatment of blood pressure.
  10. Subjects with nursing partners, known pregnant partners or wish to become pregnant during the course of the study.
  11. Confirmed positive results from urine drug screen or from the alcohol breath test at screening and on admission (Day -1).
  12. Subject has recent (last 12 months) clinical evidence of alcoholism or drug abuse.
  13. Subject has a positive screen for hepatitis B consisting of Hepatitis B surface antigen (HBsAG), hepatitis C antibody, and human immunodeficiency virus (HIV).
  14. Any clinically significant abnormal laboratory, vital signs or other safety findings at screening or on admission.
  15. Subjects unwilling to cease use of vacuum devices, intracavernosal injection, Viagra ® or other therapy for ED.
  16. Unwillingness of the subject to agree to make four attempts at sexual intercourse on four separate days during each treatment period.
  17. Any history of unresponsiveness to Viagra ® treatment due to lack of efficacy with sexual stimulation after multiple attempts of sexual intercourse, or significant side effects excluding visual disturbances of Viagra ®.
  18. Less than 4 attempts at sexual intercourse or high IIEF scores (> 25) during the run-in period.
  19. Any known hypersensitivity to any component of the investigational product.
  20. Subjects who are illiterate or are unable to understand the language in which the online questionnaires are available.
  21. Subject has received any investigational product during the 90 days prior to dosing for this study.
  22. Subject or their partner cannot communicate reliably with the Investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02495467


Contacts
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Contact: Jim P Lees, BSc Med Sci +44 1483 685682 jim.lees@futuramedical.com

Locations
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United Kingdom
Richmond Pharmacology Ltd. Recruiting
Croydon, Surrey, United Kingdom, CR7 7YE
Contact    +44(0)20 8664 5200    volunteer@richmondpharmacology.com   
Principal Investigator: Jörg Täubel, MD FFPM         
Sponsors and Collaborators
Futura Medical Developments Ltd.
Richmond Pharmacology Limited
Investigators
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Study Director: Tim J Holland, MSc Futura Medical Developments Ltd.
Principal Investigator: Jörg Täubel, MD FFPM Richmond Pharmacology Limited

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Responsible Party: Futura Medical Developments Ltd.
ClinicalTrials.gov Identifier: NCT02495467     History of Changes
Other Study ID Numbers: FM53
First Posted: July 13, 2015    Key Record Dates
Last Update Posted: January 26, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Nitroglycerin
Vasodilator Agents