E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Classification code | 10061461 |
|
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 |
The primary objective of this study is to test the hypothesis that on-demand therapy with tadalafil, as measured by the spontaneity domain of the PAIRS questionnaire, increases the possibility to spontaneous sexual activity in ED patients, compared with any other previous oral ED treatment. |
|
E.2.2 | Secondary objectives of the trial |
1. Estimate the level of quality of life in treated ED patients in order to be able to compare it with existing data on the quality of life of the general population and patients suffering from other diseases and symptoms. The quality of life will be measured using the 15D and LiSat-11 scales. 2. Estimate whether the response to on-demand therapy with tadalafil, in comparison with previous oral ED treatment, has additional beneficial effect on the psychological/interpersonal aspects in sexual function and the patients general quality of life measured by the sexual self-confidence and time concerns scores of the domains of the PAIRS scale, the 15D scale, teh LiSat-11 scale and the global treatment satisfaction assessment questions
|
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Have a history of erectile dysfunction of at least 3 months duration. 2. Have been using any oral prescription medication, but not tadalafil, for erectile dysfunction for a minimum period of 3 months immediately before Visit 1. 3. Men at least 18 years of age at Visit 1. 4. Provide signed informed consent. 5. Have responded to previous erectile dysfunction medication, as assessed by the investigator. 6. Agree not to use any other erectile dysfunction treatment during the study. 7. Agree to make at least one (1) sexual intercourse attempt each week during the study. 8. Report having had at least one intercourse attempt / week during last four weeks before entering the trial. 9. Have completed the PAIRS, LiSat-11, and 15D questionnaires on Visit 1.
|
|
E.4 | Principal exclusion criteria |
1. Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry. 2. Have previously completed or withdrawn from this study or any other study investigating tadalafil or has been prescribed tadalafil. 3. Exhibit evidence of clinically significant hepatobiliary disease (including jaundice) at Visit 1. 4. Have a history of chronic stable angina that was treated with long- or short-acting nitrates within 3 months before Visit 1. 5. Experienced angina during sexual intercourse within 6 months before Visit 1. 6. Experienced unstable angina within 6 months before Visit 1. 7. Experienced myocardial infarction within 90 days before Visit 1. 8. Have coronary artery bypass graft surgery within 90 days before Visit 1. 9. Have percutaneous coronary intervention (for example, angioplasty or stent placement) within 90 days before Visit 1. 10. Have a supraventricular arrhythmia with a ventricular response >100 bpm at rest despite medical or device therapy. 11. Have a history of refractory spontaneous or induced sustained ventricular tachycardia (heart rate >100 bpm for ³30 sec) or fibrillation. 12. Have an automatic internal cardioverter-defibrillator. 13. Have a history of sudden cardiac arrest. 14. Have congestive heart failure (NYHA Class 2 or above) within 6 months before Visit 1. 15. Have had a known new and significant conduction defect, or had a known new conduction defect that was not evaluated with regard to significance, within 90 days before Visit 1. 16. Have systolic blood pressure <90 mm Hg or diastolic blood pressure <50 mm Hg at screening. 17. Have a history of stroke within the last 6 months. 18. Receiving treatment with cancer chemotherapy.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Change in the score and profiles of the questionnaires PAIRS 23, LiSAt-11 and 15D. |
|
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 | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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 | Information not present in EudraCT |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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.8.5 | The trial involves multiple Member States | No |
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 | 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
|
Visit 3 completed or if patient or investigator decides that the patient will not continue untiel visit 3 completed. |
|
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 | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |