To see how the medication MED2005 works (i.e. causes an erection) when applied to the penis by male volunteers who normally are unable to obtain an erectio

Phase 1

Active, not recruiting

• Conditions: This study investigates a drug intended for the treatment of male patients self-diagnosed with Erectile Dysfunction; MedDRA version: 18.1Level: PTClassification code 10061461Term: Erectile dysfunctionSystem Organ Class: 10038604 - Reproductive system and breast disorders; Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

• Registration Number: EUCTR2014-005571-89-PL
• Lead Sponsor: Futura Medical Developments Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-03
• Last Update Posted: 28 November 2016

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Male
• Target Recruitment: 192

Inclusion Criteria

1. Subject is a male aged between 18 and 70 years of age inclusive, at screening.
2. Confirmed self-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. The IIEF question 1-5 and 15 will be used to determine pre-screening eligibility for the subject. A score of 25 or less will be acceptable for inclusion to the run-in-period.
4. Subject answers yes” to the question regarding the presence of residual erectile function 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?”
5. Subject has been involved 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. If the male subject's female partner is of childbearing potential from the time of first sexual intercourse attempt during the run-in period until the last administration of study treatment they must agree to use adequate methods of contraception as listed in Protocol
8. Subject and their female partner are capable of understanding and complying with the requirements of the protocol and must have signed the informed consent form prior to participation of any study-related procedures
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 42

Exclusion Criteria

1. Any significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrinological, metabolic, neurological, psychiatric, or other disease.
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.
3. Any presence of a symptomatic, active urinary tract infection diagnosed by the PI or delegate at screening (subjects may be enrolled 7 days after completion of antibiotic therapy with a clinical cure; if a subject develops a urinary tract infection after screening, they may be continued in the study if they receive appropriate antibiotic therapy).
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. 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 with NO donors, such as other GTN products, isosorbide dinitrate and amyl or butyl-nitrite.
12. Any treatment with acetyl cysteine within 6 months.
13. Any treatment with dihydroergotamine within 6 months.
14. Postural hypotension, hypotension or uncorrected hypovolaemia as the use of GTN in such states could produce severe hypotension or shock.
15. Increased intracranial pressure (e.g. head trauma or cerebral haemorrhage) or inadequate cerebral circulation.
16. Any history of migraine or recurrent headache.
17. Aortic or mitral stenosis.
18. Hypertrophic obstructive cardiomyopathy.
19. Constrictive pericarditis or pericardial tamponade.
20. Marked anaemia within 6 months.
21. Closed-angle glaucoma.
22. Subjects with nursing partners, known pregnant partners or wish to become pregnant during the course of the study.

Please refer to Protocol for detailed list of exclusion criterias.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified