E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Unassisted Erectile Function in Subjects Undergoing Bilateral Nerve-Sparing Radical Prostatectomy |
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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 | PT |
E.1.2 | Classification code | 10061461 |
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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 |
The primary objective of this study is to evaluate the efficacy of tadalafil 5 mg once a day (OaD) and tadalafil 20 mg on demand (PRN), compared with placebo, when taken orally over 9 months, in improving unassisted erectile function, as measured by the percentage of subjects with a score of >22 in the Erectile Function (EF) Domain (sum of Questions 1 through 5 and Question 15) of the International Index of Erectile Function (IIEF) after a drug-free washout of 6 weeks. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of this study are as follows (where tadalafil compared with placebo means tadalafil 5 mg OaD versus placebo and tadalafil 20 mg PRN versus placebo): To evaluate the efficacy of tadalafil 5 mg OaD on drug-assisted erectile function when administered to all subjects at the end of the 3-month, open-label period, as measured by the IIEF, Sexual Encounter Profile (SEP) questions, Residual Erectile Function (REF), and Global Assessment Questions (GAQs) 1 and 2. To evaluate the efficacy of tadalafil compared with placebo on drug-assisted erectile function at the end of the 9-month, placebo-controlled period, as measured by the IIEF, SEP questions, REF and GAQs 1 and 2. To evaluate the efficacy of tadalafil compared with placebo on unassisted erectile function at the end of the washout period, as measured by the IIEF, SEP questions and REF. To evaluate the effect of tadalafil compared with placebo on penile length and girth. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Men may be considered for entry to the study if they: are scheduled to undergo BNSRP for organ-confined, non-metastatic prostate cancer; are aged >18 years at Visit 1 and <65 years at time of BNSRP; have a normal preoperative erectile function score (IIEF-EF score >=26 at Visit 1); and develop ED (defined as the consistent inability to achieve and/or maintain an erection sufficient to permit satisfactory sexual intercourse) after surgery. Surgeons performing the surgery must have sufficient prior experience, defined as at least 50 BNSRP surgical procedures performed before Visit 2. Female partners, if willing to participate by answering EPIC partner questions, must be aged >18 years at Visit 4, and anticipate having the same male study subject as her sexual partner during the study. |
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E.4 | Principal exclusion criteria |
[18] Have a history of ED, with or without treatment. 19] Have a history of prostatic surgery or prostatic physical treatments including hyperthermia, microwave therapy, transurethral needle ablation (TUNA), lasers, high intensity focused ultrasound (HIFU) and cryotherapy. [20] Have a history of penile implant. [21] Have a history of drug, alcohol or substance abuse within the previous 6 months, as assessed by the investigator. [22] Have a history of galactose intolerance, lapp lactase deficiency, or glucose-galactose malabsorption. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Percentage of subject with a score of >= 22 in the IIEF-EF Domain after 6 week drug free washout |
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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) | No |
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 | 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 | No |
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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 53 |
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 | 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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ultima visita dell` ultimo paziente |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |