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 determine whether, in men with untreated ED but no other cardiovascular risk factors, not currently receiving lipid lowering therapy, treatment with Simvastatin improves erectile function. |
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E.2.2 | Secondary objectives of the trial |
To determine whether: 1) Any improvement in erectile function leads to an improvement in sexual health related quality of life. 2) Any improvement in erectile function is related to: i) reduction in LDL cholesterol; ii) improvement in endothelial function (in sub-study). 3) Treatment of ED with Simvastatin is cost effective
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Erectile Dysfunction and Statins: a RCT - substudy to assess endothelial function. Version 0.4 19.05.08 To determine whether any improvement in erectile function is related toimprovement in endothelial function |
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E.3 | Principal inclusion criteria |
• Men aged 40 years and over • In a stable heterosexual relationship for over 6 months • No clinically overt cardiovascular risk factors other than raised cholesterol • Not currently on lipid or ED therapy • Untreated erectile dysfunction (ED) (score < 22 on the IIEF-5)
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E.4 | Principal exclusion criteria |
• Diabetes, past history of myocardial infarction, hospitalised angina or stroke • Hypertension: systolic blood pressure > 170mmHg, diastolic > 100mmHg • Ratio total:HDL cholesterol > 6. • Total cardiovascular risk > 20% over next ten years • Current lipid lowering therapy • Current (within last 3 months) ED therapy • Hypogonadism (Testosterone<8 nmol/L) • Chronic liver disease • Severe renal disease • Inflammatory muscle disease or evidence of muscle problems • Concomitant administration of contra-indicated drugs • Concomitant administration of other drugs associated with increased risk of myopathy/rhabdomyolysis • Other serious conditions at the discretion of the GP • Unable to read and write in English.
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E.5 End points |
E.5.1 | Primary end point(s) |
Erectile dysfunction (ED) measured by the 5 item version of the International Index of Erectile Function (IIEF-5) This is a validated self-administered questionnaire requiring those completing it to have attempted vaginal sexual intercourse in the preceding four weeks. Each item scores 1 to 5 giving a total from 5 to 25. A score > 21 denotes no ED, 21-17 mild ED, 16-12 moderate ED and 7-5 severe ED. Those with scores < 22 are eligible unless receiving treatment for ED. |
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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 | 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 | 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.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
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 | Yes |
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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Last visit of last subject |
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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 | 2 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |