E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 demonstrate that in patients with erectile dysfunction ED , who are found to have low 8 nmol/L or 231 ng/dL or borderline 12 nmol/L or 346 ng/dL baseline total testosterone levels, Testim Gel significantly improves the patient response to tadalafil using the International Index of Erectile Function IIEF scale. |
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E.2.2 | Secondary objectives of the trial |
To assess the safety of co-administering Testim Gel and tadalafil in the targeted patient population. To identify putative predictive factors of Testim Gel efficacy in the target population such as baseline total testosterone levels, bioavailable testosterone levels and androgen receptor Cystine Alanine Guanine CAG repeat number. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Have ED defined as a score 26 in the erectile function module of the IIEF scale 2. Have a score 8804; 3 sometimes to both question 3 successful penetration and question 4 successful maintenance of erection after penetration of the IIEF scale 3. Have a serum total testosterone level 12 nmol/L 346 ng/dL assayed on two samples drawn between 7 and 10 am on two separate days - one at V1 visit performed by central lab - one 10 to 14 days before V2 performed by central lab. 4. Have not been treated with testosterone since the selection visit 5. Have not been treated with PDE5 Inhibitors since the selection visit 6. Have kept the same female partner since the selection visit. |
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E.4 | Principal exclusion criteria |
1. Patients having any contra-indication to tadalafil treatment - stroke within the last 6 months - myocardial infarction within the last 90 days - unstable angina or angina occurring during sexual intercourse - New York Heart Association Class 2 or greater heart failure in the last 6 months - uncontrolled arrhythmias, hypotension 90/50 mm Hg or uncontrolled hypertension 170/100mmHg - clinically significant renal creatinine clearance 30 mL/min or hepatic insufficiency Child-Pugh Class C - patients receiving organic nitrates. 2. Patients having any contra-indication to testosterone therapy - Breast carcinoma - Prostate carcinoma - Suspected prostate carcinoma Prostate Specific Antigen PSA 4 ng/mL - Abnormal findings at the Digital Rectal Examination DRE 3. Patients with known hypersensitivity to tadalafil, testosterone or other drug with a similar chemical structure or any of the excipients 4. Patients having drug induced ED 5. Patients having poorly controlled diabetes defined by Glycosylated Haemoglobin HbA1c 10 6. Patients having history of non-arteritic anterior ischaemic optic neuropathy 7. Patients having received any unlicensed drug within the previous 30 days 8. Patients requiring treatment during the study with drugs that are not permitted by the study protocol see Section 8.7 9. Patients trying to have a baby or planning to in the study period. Requirement for using of adequate contraception such as contraceptive pill, intra uterine device, diaphragm or barrier method such as barrier contraceptive 10. Patients having history of, or known current, problems with alcohol abuse 11. Any mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude, unless the disease under study is such that the subject presents with such symptoms and the consent of a legal guardian or carer must be sought providing the latter is permitted by the local legislation 12. Any other condition that, in the opinion of the investigator, might increase the risk to the subject or decrease the chance of obtaining satisfactory data needed to achieve the objective s of the study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Percentage of patients with a response of 4 most times or 5 almost always/always to both question 3 successful penetration and question 4 successful maintenance of erection after penetration of the IIEF at week 12 or at endpoint. |
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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 | Information not present in EudraCT |
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 | Information not present in EudraCT |
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) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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 | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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 | 5 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |