E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Erectile dysfunction (ED) |
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MedDRA Classification |
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 characterise patients with ED secondary to a traumatic SCI lasting more than 6 months who respond to therapy with vardenafil in terms of electrophysiologic, urodynamic and clinical (ASIA scale) tests. Definition of responder: Patients with rigidity > 70% measured with RigiScan, during at least 5 minutes after withdrawing the vibrator
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E.2.2 | Secondary objectives of the trial |
- To study whether or not there is a difference in the time that an erection lasts with rigidity >70% between placebo and a 10 mg dose of vardenafil. - To study whether or not there is a difference in the time that an erection lasts with a rigidity >70% between a 10mg and a 20mg dose of vardenafil. - Assessment of the quality of the erection by the patient on a VAS scale between the best possible erection and the worst. - Tolerance of vardenafil in patients with ED due to a traumatic spinal cord injury.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Men who have had erectile dysfunction for at least six months according to the National Institutes of Health (NIH) Consensus Conference December 7-9, 1992
2. History of Spinal Cord Injury of at least 6 months.
3. Stable heterosexual relationship
4. Written informed consent obtained.
5. Medical sexual history at inclusion should record at least four attempts at sexual intercourse on four separate days during the untreated screening period (according to the answer to the following question in the patient diary: “Was sexual activity initiated with the intention of intercourse?”). At least 50% of them during the untreated screening period must be unsuccessful, according to the following questions from the patient diary (at least one question should be answered “No”): “Were you able to achieve at least partial erection (some enlargement of the penis)?”(SEP1); “Were you able to insert your penis in the partner’s vagina?”(SEP2); ”Did your erection last long enough for you to have successful intercourse?” (SEP3).
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E.4 | Principal exclusion criteria |
1. Any unstable medical, psychiatric, or substance abuse disorder that in the opinion of the Investigator is likely to affect the patient’s ability to complete the study or precludes the patient’s participation in the study 2. Patients who have received any investigational drug (including placebo) within 30 days of Visit 1. 3. Use of any treatment for erectile dysfunction within 7 days of the selection visit or during the study, including oral medications, vacuum devices, constrictive devices, injections or urethral suppositories 4. Patients unwilling to cease use of vacuum devices, intracavernosal injections, Viagraâ, Cialisâ or other therapy for erectile dysfunction during the study. 5. Unwillingness of the patient or his partner to make 4 attempts at sexual intercourse on four separate days during the untreated screening period. 6. Known hypersensitivity to any component of the investigational medication. 7. Patients who are illiterate or unable to understand the questionnaires or who are not prepared to complete the patient diary. 8. And those of de technical information of product.
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E.5 End points |
E.5.1 | Primary end point(s) |
Characteristics of responders and non-responder with respect to the electrophysiologic tests (skin sympathetic response, bulbocavernosus reflex and somatosensory and pudendal evoked potential), urodynamic and clinical (ASIA scale) tests of each patient upon starting the trial. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | Information not present in EudraCT |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Information not present in EudraCT |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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 | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |