E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Erectile dysfunction in patients who are naive to PDE5 inhibitors |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10061461 |
E.1.2 | Term | Erectile dysfunction |
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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 tadalafil 5mg (with possible down-titration to 2.5mg) compared with placebo, when taken orally once a day over 12 weeks, in improving erectile function in men with ED who are naive to PDE5 inhibitors To assess the safety of tadalafil 5mg (with possible down-titration to 2.5mg) administered once a day compared with placebo in men with ED who are naive to PDE5 inhibitors |
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E.2.2 | Secondary objectives of the trial |
To evaluate the efficacy of tadalafil compared with placebo as measured by other variables, including other IIEF domains, other SEP questions, and responses to the Global Assessment Question (GAQ) 1 and 2 To characterize the endothelium dysfunction profile in men with ED To evaluate the effect of tadalafil compared with placebo on endothelial dysfunction in men with ED To evaluate the relationship between endothelium dysfunction changes and erectile function changes, assessed by the efficacy measures, including NPT assessments and morning erections chenges To evaluate the effect of tadalafil compared with placebo on the NPT pattern |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male and aged at least 18 years Able to read, understand and provide signed informed consent Have a history of ED (defined as the consistent inability to achieve and/or maintain an erection sufficient to permit satisfactory sexual intercourse) of at least 3 months duration Anticipate having the same adult female sexual partner during the study. (if a qualifying participant has more than one female partner during the study the participant will not be excluded fromthe trial; however the participant will be required to respond to questionnaires based on his sexual interactions with only one of these partners) Agree to make at least four sexual intercourse attempts with the female sexual study partner during the 4-weeks run-in period without medication (Subjects who do not make at least four sexual attempts during the run-in period will not be enrolled in the study; these subjects will be considered screen failures) Agree not to use any other treatment for ED, including herbal and over-the-counter (OTC) medications, during the study (Visit 1 through Visit 6). (Subjects who take any of these medications during the 4 weeks run-in period will not be enrolled in the study; these subjects will be considered screen failure) Agree to participate in recording respones to questionnaires and other instruments used in this study If currently receiving statins , angiotensin-converting enzyme (ACE)inhibitors or angiotensin receptor blockers, have been on a stable dose for at least 3 months before Visit 1 with no anticipated change in dose during the study If currently receiving calcium channel blocker medication: (a)are currently receiving a once daily regimen of calcium channel blocker at the time of entry to the study (Visit1), with no anticipated change during the study; or (b)it is considered acceptable to adjust their medicationto a once daily formulation during the run-in period, such that they are able and willing to receive a once daily formulation from Visit 2 through Visit 6 |
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E.4 | Principal exclusion criteria |
Previous or current treatment with tadalafil or any other PDE5 inhibitor Have ED caused by other primary sexual disorders including premature ejaculation or ED caused by untreated or inadequately treated endocrine disease (for example, hypopituitarism, hypogonadism, or uncorrected hypothyroidism). The subject may be included if, in the opinion of the investigator, the ED persists after adequate treatment of the underlying endocrine disease. Have a history of radical prostatectomy or other pelvic surgery with subsequent failure to achieve any erection. Have a history of penile implant. Have a clinically significant penile deformity in the opinion of the investigator. Have communicable skin or sexually transmitted diseases, or have any rash or lesions on the penis or surrounding area. Exhibit evidence of clinically significant renal insufficiency as determined by the investigator. Exhibit clinical evidence of severe hepatic impairment at Visit 1. Exhibit hemoglobin A1c >11% at Visit 1. Present with chronic stable angina treated with long-acting nitrates, or with chronic stable angina requiring short-acting nitrates in the last 90 days, or with angina occurring during sexual intercourse in the last 6 months. Have met the criteria for unstable angina (Attachment LVHX.3) within 6 months before Visit 1, or have a history of myocardial infarction or coronary artery bypass graft surgery within 90 days before Visit 1, or percutaneous coronary intervention (for example, angioplasty or stent placement) within 90 days before Visit 1. (see protocol page n.30) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Efficacy and safety of tadalafil 5mg (or 2.5mg) taken once a day in men with erectile dysfunction who are naive to PDE5 inhibitors |
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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 | Yes |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | Yes |
E.8.1.6 | Cross over | No |
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 | Yes |
E.8.2.3.1 | Comparator description |
- same IMP used at different dosage |
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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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 25 |
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 | 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 | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
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 | 3 |