Erectile dysfunction Classification code 10061461
Conditions
Interventions
Trade Name: Cialis (tadalafil)
Product Name: Cialis (tadalafil)
Product Code: IC351 (LY450190)
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: tadalafil
Concentration number: 10-mg
Trade
Sponsors
Oy Eli Lilly Finland Ab
Eligibility
Sex/Gender
Male
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 Have previously completed or withdrawn from this study or any other study investigating tadalafil or has been prescribed tadalafil. 3.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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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 ;Primary end point(s): Change in the score and profiles of the questionnaires PAIRS 23, LiSAt-11 and 15D. | — |
Countries
Finland
Outcome results
None listed