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 | 7.1 |
E.1.2 | Level | LLT |
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 study objective is to evaluate the effect that sildenafil citrate has on the hardness of erections in males with erectile dysfunction, based on subject responses to question 5 on the Event Log (hardness of erection) as measured at the end of double blind treatment (week 6). |
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E.2.2 | Secondary objectives of the trial |
Assess the efficacy, treatment satisfaction and quality of life changes of sildenafil citrate in men with erectile dysfunction, based on the following assessments as measured at the end of double blind treatment (week 6) and at the end of open label treatment (week 12):
Responses to the: - Quality of Erection Questionnaire (QEQ). - International Index of Erectile Function (IIEF) Domains (Erectile Function; Orgasmic Function; Sexual Desire; Intercourse Satisfaction; Overall Satisfaction).
· Event Log success rate variables.
Responses to the: - Self Esteem and Relationship (SEAR) Questionnaire (including individual scores for Confidence domain including the sub-domains of Self Esteem and Overall Relationship and the Sexual Relationship domain. - Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire. - Global Efficacy Assessment Questionnaire.
· Safety and tolerability based on adverse events and other safety assessments. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial: 1. Male subjects aged 18-55. 2. Documented clinical diagnosis of erectile dysfunction confirmed by an IIEF-EF Domain score of less than or equal to 25. (If the subject scores greater than 25 on the IIEF-EF Domain, screening procedures should be terminated.) 3. Stable sexual partner for the duration of the study. 4. The investigator must obtain written informed consent prior the conduct of any study related procedures. |
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E.4 | Principal exclusion criteria |
Subjects presenting with any of the following will not be included in the trial: 1. Subjects with resting sitting and/or standing systolic hypotension (BP<90/50mmHg) or hypertension (BP>170/110mmHg). 2. Subjects with significant cardiovascular disease in the last 3 months, including cardiac failure, stroke, myocardial infarction, unstable angina, symptomatic or clinically significant cardiac arrhythmias. 3. Subjects who are currently prescribed, taking and/or likely to be treated with nitrates or nitric oxide donors in any form on either a regular or an intermittent basis. 4. Subjects with any relevant clinically significant abnormalities on the screening physical examination. 5. Subjects who have been treated with more than 6 doses of sildenafil citrate or any other phosphodiesterase type 5 (PDE-5) inhibitor such as vardenafil or tadalafil for erectile dysfunction [Note: subjects should not have taken any PDE-5 inhibitors within 4 weeks prior to the date of screening]. 6. Subjects who have a known hypersensitivity to sildenafil citrate or any component of the study medication; subjects who have had any previous treatment related intolerable side effects to sildenafil citrate. 7. Subjects currently taking any other commercially available drug or non-drug treatments for erectile dysfunction (i.e., intraurethral agents, prostheses, injection therapy, topical applications, herbal or alternative medications, or vacuum-assisted erection devices. Such treatments must be terminated at or before the screening visit and must not be taken at any time during the study. 8. Subjects with severe hepatic impairment, a known history of retinitis pigmentosa or with hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption. 9. Subjects, due to the possible dose of 100 mg sildenafil citrate in this study, who are receiving concomitant treatment with potent CYP3A4 inhibitors such as ritonavir, saquinavir, ketoconazole, itraconazole, erythromycin and cimetidine. 10. Subjects who have received any investigational drug within the six weeks prior to screening or who are taking any other investigational drugs concomitantly. 11. Subjects who have any medical (including known history of major hematological, renal, vascular, or hepatic abnormalities) or psychological condition or social circumstances that would impair their ability to participate reliably in the study, or those who may increase the risk to themselves or others by participating. 12. Subjects, due to the required starting dose of 50 mg sildenafil citrate in this study, who have severe renal impairment. 13. Subjects who have donated blood within 4 weeks prior to screening, or those who intend on donating blood or blood products during the period of the study or within one month following completion of the study. 14. Subjects who, in the opinion of the investigator, abuse alcohol or drugs. 15. Subjects who, in the opinion of the investigator, are not likely to complete the study for whatever reason, including planned elective surgery. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Responses to Question 5 (erectile hardness) of the Event Log |
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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 | No |
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 | 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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
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 | Yes |
E.8.1.7.1 | Other trial design description |
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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.8.3 |
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 | 0 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial months | 6 |