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Clinical Trial Using Topically Applied Glyceryl Trinitrate (GTN) for the Treatment of Erectile Dysfunction

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ClinicalTrials.gov Identifier: NCT03813992
Recruitment Status : Recruiting
First Posted : January 23, 2019
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
Futura Medical Developments Ltd.

Brief Summary:
To demonstrate the efficacy of various doses of MED2005 versus placebo in male patients with clinically diagnosed erectile dysfunction, and to evaluate the long-term efficacy and safety (12 months) of MED2005.

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Drug: MED2005 Phase 3

Detailed Description:
A phase III, dose-ranging, multi-centre, randomised, double-blind, placebo controlled , home-use, parallel group clinical trial of topically applied glyceryl trinitrate for the treatment of erectile dysfunction with an open label extension

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Dose Ranging, Multi-centre, Randomised, Double Blind, Placebo Controlled, Home Use, Parallel Group Clinical Trial of Topically-applied Glyceryl Trinitrate for the Treatment of Erectile Dysfunction, With an Open Label Extension
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : October 7, 2019
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: MED2005 0.2%
MED2005 0.2% w/w gel to deliver 0.6 mg dose of GTN applied topically prior to a sexual intercourse attempt
Drug: MED2005
Topical Product
Other Name: Glyceryl Trinitrate

Active Comparator: MED2005 0.4%
MED2005 0.4% w/w gel to deliver 1.2 mg dose of GTN applied topically prior to a sexual intercourse attempt
Drug: MED2005
Topical Product
Other Name: Glyceryl Trinitrate

Active Comparator: MED2005 0.6%
MED2005 0.6% w/w gel to deliver 1.8 mg dose of GTN applied topically prior to a sexual intercourse attempt
Drug: MED2005
Topical Product
Other Name: Glyceryl Trinitrate

Placebo Comparator: Placebo vehicle
Placebo vehicle applied topically prior to a sexual intercourse attempt
Drug: MED2005
Topical Product
Other Name: Glyceryl Trinitrate




Primary Outcome Measures :
  1. International Index for Erectile Function (IIEF) Questionnaire [ Time Frame: Up to Week 64 of the study ]
    A questionnaire containing 15 questions divided into 5 domains; erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction.

  2. Sexual Encounter Profile (SEP) Questionnaire (Question 2) [ Time Frame: Up to Week 64 of the study ]
    A questionnaire consisting of 5 items assessing the sexual events a patient experiences during sexual intercourse.

  3. Sexual Encounter Profile (SEP) Questionnaire (Question 3) [ Time Frame: Up to Week 64 of the study ]
    A questionnaire consisting of 5 items assessing the sexual events a patient experiences during sexual intercourse.


Secondary Outcome Measures :
  1. Self-Esteem and Relationship (SEAR) Questionnaire [ Time Frame: Up to Week 12 of the study. ]
    A questionnaire to support the validity and reliability for measuring sexual relationship satisfaction, satisfaction, confidence, and self-esteem in men with erectile dysfunction.

  2. Global Assessment Questionnaire (GAQ) [ Time Frame: Up to Week 12 of the study. ]
    A questionnaire that allows patients and their partners to rate (yes or no) an improvement in erectile function.

  3. International Index for Erectile Function (IIEF) Questionnaire (additional domains) [ Time Frame: Up to Week 64 weeks of the study. ]
    A questionnaire containing 15 questions divided into 5 domains; erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction.

  4. Sexual Encounter Profile (SEP) Questionnaire (Questions 1, 4 & 5) [ Time Frame: Up to Week 64 of the study. ]
    A questionnaire consisting of 5 items assessing the sexual events a patient experiences during sexual intercourse.

  5. Sexual Encounter Profile (SEP) Questionnaire [ Time Frame: Up to Week 64 of the study ]
    A questionnaire consisting of 5 items assessing the sexual events a patient experiences during sexual intercourse.

  6. Patient Global Impression of Severity (PGI-S) [ Time Frame: Up to Week 12 of the study. ]
    A one item questionnaire to rate the severity of a patient's erectile dysfunction. This is a single-state 5-point categorical scale.

  7. Patient Global Impression of Change (PGI-C) [ Time Frame: Up to Week 12 of the study ]
    A one item questionnaire to rate a perceived change in a patient's erectile function. This is a transitional 7-point categorical scale.

  8. Onset and duration of action (erection) and erection hardness [ Time Frame: Up to Week 12 of the study ]
    A questionnaire asking both the patient and the patient's partner about the onset and duration of action of the patient's erection.

  9. Usage and application [ Time Frame: Up to Week 12 of the study ]
    A questionnaire has 5 items to assess the usage and application of the investigation product.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male patients must have been in a heterosexual relationship with a female partner for a minimum of 6 months
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is a male aged between 18 and 70 years inclusive, at screening
  2. Confirmed clinical diagnosis of ED for more than 3 months according to the NIH Consensus Statement ('the inability to achieve or maintain penile erection sufficient for satisfactory sexual performance at least once')
  3. Subject answers 'yes' to the question regarding the presence of residual EF over the past 3 months: 'At home over the past 3 months, have you experienced at least some growth of your penis in response to: (1) mechanical stimulation by yourself or your partner, or (2) visual stimulation?'
  4. Subject has been involved in a continuous heterosexual relationship for at least 6 months prior to screening
  5. Documented written informed consent from both subject and his female partner
  6. If the male subject's female partner is of childbearing potential from the time of first sexual intercourse attempt during the screening period until the last administration of study treatment, then the couple must have been using a medically acceptable form of contraception for at least 3 months prior to entering the study, and agree to continue such use for at least 1 month after the last study drug administration. Subjects who are or wish to become pregnant will not be included in the study.
  7. Subject and his female partner are capable of understanding and complying with the requirements of the protocol and must have signed the ICF prior to participation in any study related procedures
  8. Low IIEF-EF scores (≤ 25) during the screening period

To continue in the open-label extension phase of the study, subjects must meet the following inclusion criteria at the follow-up visit of the double-blind phase (Visit 6):

  1. Subject and his female partner complete the double-blind phase
  2. Subject and his female partner were compliant to study procedures during the double blind phase
  3. Documented written informed consent from both subject and his female partner
  4. If the male subject's female partner is of childbearing potential from the time of first sexual intercourse attempt during the screening period until the last administration of study treatment, then the couple must have been using a medically acceptable form of contraception for at least 3 months prior to entering the study, and agree to continue such use for at least 1 month after the last study drug administration. Subjects who are or wish to become pregnant will not be included in the study.

Exclusion Criteria:

  1. Any significant or serious cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrinological, metabolic, neurological or psychiatric disease which, in the opinion of the PI, renders the subject unfit to take part in the study
  2. Subject has 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 Certain concomitant medications; e.g. other vasodilators, calcium channel blockers, angiotensin converting enzyme (ACE) inhibitors, beta blockers, diuretics, anti hypertensives, tricyclic anti depressants and major tranquillisers, as well as the consumption of alcohol, may potentiate the BP lowering effects of MED2005; therefore, the PI must consider this carefully and include subjects at their discretion
  3. Any presence of a symptomatic, active urinary tract infection diagnosed by the PI or their delegate at screening or during the study
  4. Any presence of chronic indwelling urethral catheterisation or penile anatomical abnormalities (e.g. penile fibrosis) that would significantly impair EF
  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 BP
  10. Hypersensitivity to GTN or to any of the excipients, or idiosyncratic reactions to other organic nitrates
  11. Concomitant treatment with sildenafil citrate, tadalafil, vardenafil and other PDE 5 inhibitors
  12. Subjects taking Alpha blockers
  13. Subjects receiving testosterone pellets
  14. Any penile surgery except circumcision
  15. Any treatment with acetyl cysteine within 6 months
  16. Any treatment with dihydroergotamine within 6 months
  17. Postural hypotension, hypotension or uncorrected hypovolaemia, as the use of GTN in such states could produce severe hypotension or shock
  18. Increased intracranial pressure (e.g. head trauma or cerebral haemorrhage) or inadequate cerebral circulation
  19. Any history of migraine or recurrent headache
  20. Aortic or mitral stenosis
  21. Hypertrophic obstructive cardiomyopathy
  22. Constrictive pericarditis or pericardial tamponade
  23. Closed-angle glaucoma
  24. Subjects with nursing partners, known pregnant partners or with partners who wish to become pregnant during the course of the study
  25. Confirmed positive results from urine drug screen (amphetamines, benzodiazepines, cocaine, cannabinoids, opiates, barbiturates, tricyclic antidepressants and methadone) or from the alcohol breath test at screening (for clarification, any positive result from the urine drug screen or alcohol breath tests at screening will mean the subject will be excluded from the study). In the instance that a subject is using medication which may give a positive result, exclusion will be at the PI's discretion
  26. Subject has recent (last 12 months) clinical evidence of alcoholism or drug abuse.
  27. Subject has a positive screen for hepatitis B, consisting of hepatitis B surface antigen (HBsAG), hepatitis C antibody, and human immunodeficiency virus (HIV)
  28. Any clinically significant abnormal laboratory, vital signs or other safety findings as determined by medical history, physical examination or other evaluations conducted at screening or on admission
  29. Subjects unwilling to cease use of vacuum devices, intracavernosal injections, PDE-5s or other therapy for ED for the entire course of the study
  30. Unwillingness of the subject or their partner to agree to make the required attempts at sexual intercourse during treatment period
  31. Any history of unresponsiveness to PDE 5 treatment or significant side effects, excluding visual disturbances, with PDE 5s
  32. Fewer than four attempts at sexual intercourse during the screening period
  33. Subjects or their partners who are illiterate or are unable to understand the language in which the questionnaires are available
  34. Subject has received any investigational product during the 90 days prior to dosing for this study
  35. Subject or his partner cannot communicate reliably with the PI
  36. Subjects with severe premature ejaculation (little or no control of ejaculation at the time of penetration)

Subjects are prohibited from participating in the open-label extension phase of the study if they meet any of the following exclusion criteria at the follow-up visit of the double-blind phase (Visit 6):

  1. Subsequent to recruitment into the double-blind phase of the study, the development of any significant or serious cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrinological, metabolic, neurological or psychiatric disease which, in the opinion of the PI, renders the subject unfit to continue in the open-label extension phase of the study
  2. Subject using any medication that, in the opinion of the PI, is likely to affect the subject's ability to complete or participate in the open-label phase of the study.

    NB The concomitant medications listed as exclusion criteria for the study apply to the open-label extension phase. Certain concomitant medications; e.g. other vasodilators, calcium channel blockers, ACE inhibitors, beta blockers, diuretics, anti hypertensives, tricyclic anti depressants and major tranquillisers, as well as the consumption of alcohol, may potentiate the BP lowering effects of MED2005; therefore, the PI must consider this carefully and include subjects at their discretion

  3. Any presence of a symptomatic, active urinary tract infection diagnosed by the PI or their delegate at the start of the open-label extension phase
  4. Subsequent to recruitment into the double-blind phase of the study, the development of postural hypotension, hypotension or uncorrected hypovolaemia, increased intracranial pressure or inadequate cerebral circulation, any clinically significant vital signs or other safety findings as determined by medical history, physical examination or other evaluations conducted at Visit 6 prior to recruitment to the open-label phase

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): NCT03813992


Contacts
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Contact: Tim J Holland, MBA +44 (0)1483 685683 ext 5683 tim.holland@futuramedical.com
Contact: Andy GB Graham, BSc (Hons) +44 (0)1483 685682 ext 5682 andy.graham@futuramedical.com

  Show 64 Study Locations
Sponsors and Collaborators
Futura Medical Developments Ltd.
Investigators
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Study Director: Tim J Holland, MBA Clinical Development Director
  Study Documents (Full-Text)

Documents provided by Futura Medical Developments Ltd.:
Study Protocol  [PDF] July 27, 2018


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Responsible Party: Futura Medical Developments Ltd.
ClinicalTrials.gov Identifier: NCT03813992     History of Changes
Other Study ID Numbers: FM57
First Posted: January 23, 2019    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Nitroglycerin
Vasodilator Agents