E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
This study investigates a drug intended for the treatment of male patients self-diagnosed with Erectile Dysfunction |
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E.1.1.1 | Medical condition in easily understood language |
Inability to get and maintain an erection |
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E.1.1.2 | Therapeutic area | Body processes [G] - Reproductive physiologi cal processes [G08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061461 |
E.1.2 | Term | Erectile dysfunction |
E.1.2 | System Organ Class | 10038604 - Reproductive system and breast disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the efficacy of MED2005 in male subjects self-diagnosed with ED using the erectile function domain of the International Index for Erectile Function (IIEF) |
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E.2.2 | Secondary objectives of the trial |
- To evaluate the efficacy of MED2005 in male subjects using validated questionnaires: The other domains of the IIEF questionnaire, the Sexual Encounter Profile (SEP) questionnaire, the Global Assessment Questionnaire (GAQ), as well as subjective measures of the time of onset of action, time to peak effect and offset of action
- To assess the safety and acceptability of MED2005 in ED sufferers and their partners including the subject’s preference |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Efficacy
The efficacy of MED2005 will be assessed using the experience of male volunteers and their female partners based on the validated questionnaires [International Index for Erectile Function (IIEF) questionnaire (male volunteers only), the Sexual Encounter Profile (SEP) questionnaire, Global Assessment Questionnaire (GAQ)], Onset/Offset of Action questions, and an overall volunteer preference question, by comparing the active drug to placebo arm within each subject. |
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E.5.2 | Secondary end point(s) |
Safety analysis
Safety will be evaluated using standard clinical laboratory safety tests (haematology, biochemistry, coagulation and urinalysis), vital signs (temperature, blood pressure [BP] and heart rate [HR]), physical examinations, 12 lead ECG, and AE monitoring before and after each treatment period. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 4 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |