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| [ ...Back to search results ] | [ Print-friendly version ] |
| Erectile dysfunction and statins: a randomised controlled trial (RCT) |
| ISRCTN | ISRCTN66772971 |
| ClinicalTrials.gov identifier | |
| Public title | Erectile dysfunction and statins: a randomised controlled trial (RCT) |
| Scientific title | Erectile dysfunction: a randomised controlled trial of lipid lowering with simvastatin (EDS trial) |
| Acronym | EDS trial |
| Serial number at source | RHF0001 |
| Study hypothesis |
Primary hypothesis:
In men with untreated erectile dysfunction (ED) but no other cardiovascular risk factors, not currently receiving lipid lowering treatment, treatment with simvastatin improves erectile function. Secondary hypotheses: 1. The improvement in erectile function leads to an improvement in sexual health related quality of life 2. The improvement in erectile function is related to a reduction in low-density lipoprotein (LDL) cholesterol and improvement in endothelial function 3. Treatment of ED with simvastatin is cost effective |
| Lay summary | http://www.nres.npsa.nhs.uk/researchsummaries/?entryid29=20579&q=0%c2%ac08%2fH0301%2f74%c2%ac |
| Ethics approval | Essex 1 Research Ethics Committee on 06/08/2008 (ref: 08/H0301/74) |
| Study design | Randomised, double-blind, placebo-controlled, parallel-group, multicentre trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Erectile dysfunction caused by vascular impairment |
| Participants - inclusion criteria |
1. Men aged 40 years and over
2. In a stable heterosexual relationship for at least 6 months 3. No clinically overt cardiovascular risk factors other than raised cholesterol 4. Not currently on lipid or erectile dysfunction therapy 5. Untreated erectile dysfunction defined as score <22 on the International Index of Erectile Function 5 item questionnaire |
| Participants - exclusion criteria |
1. Diabetes, past history of myocardial infarction, hospitalised angina or stroke
2. Hypertension - systolic blood pressure >=170 mmHg, diastolic >=100 mmHg 3. Ratio total:high-density lipoproteins (HDL) cholesterol >=6 4. Total cardiovascular risk >= 20% over next 10 years 5. Current lipid lowering therapy 6. Erectile dysfunction therapy in the last 3 months 7. Hypogonadism 8. Chronic liver disease or abnormal liver function 9. Severe renal disease or evidence of impaired renal function 10. Inflammatory muscle disease or evidence of muscle problems 11. Concomitant administration of contra-indicated drugs: itraconazole, ketoconazole, HIV protease inhibitors, erythromycin, telithromycin and nefazodone 12. Concomitant administration of other drugs associated with increased risk of myopathy/rhabdomyolysis: ciclosporin, danazol and fusidic acid 13. Galactose intolerance, Lapp lactase deficiency or glocose-galactose malabsorption |
| Anticipated start date | 01/10/2008 |
| Anticipated end date | 30/09/2011 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 170 (recruitment complete as of 28/07/2011) |
| Interventions |
Simvastatin one 40 mg tablet orally daily at bedtime for 6 months or matched placebo one tablet orally daily at bedtime.
As of 05/07/2011 the anticipated end date for this trial has been updated from 30/11/2009 to 30/09/2011. The study was granted an extension from the RFPB. |
| Primary outcome measure(s) |
Erectile dysfunction measured by the 5 item version of the International Index of Erectile Function (IIEF-5)
All primary and secondary outcomes will be assessed at baseline and 6 months. |
| Secondary outcome measure(s) |
1. Erectile function as measured by the Sexual Encounter Profile diaries
2. Quality of life (QOL), assessed by the Male Erectile Dysfunction specific questionnaire (MED-QOL) and euroqol EQ-5D 3. Total LDL, HDL cholesterol in fasting blood samples 4. Use of health services and cost of statins 5. Endothelial function measured by pulse wave analysis in a 10% sub-sample All primary and secondary outcomes will be assessed at baseline and 6 months. |
| Sources of funding | National Institute for Health Research (NIHR), Research for Patient Benefit (RfPB) (UK) (ref: PB-PG-0107-11391) |
| Trial website | |
| Publications | 1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21371242 |
| Contact name | Dr Daksha Trivedi |
| Address |
Co-ordinator & Co-Investigator
ED Trial Centre for Research in Primary and Community Care (CRIPACC) Room 3F416 University of Hertfordshire |
| City/town | Hatfield |
| Zip/Postcode | AL10 9AB |
| Country | United Kingdom |
| Sponsor | University of Hertfordshire (UK) |
| Address |
c/o Prof John Senior
College Lane |
| City/town | Hatfield |
| Zip/Postcode | AL10 9AB |
| Country | United Kingdom |
| Sponsor website: | http://www.herts.ac.uk |
| Date applied | 12/08/2008 |
| Last edited | 03/01/2012 |
| Date ISRCTN assigned | 26/09/2008 |
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