Erectile dysfunction and statins: a randomised controlled trial (RCT)
| ISRCTN | ISRCTN66772971 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66772971 |
| Secondary identifying numbers | RHF0001 |
- Submission date
- 12/08/2008
- Registration date
- 26/09/2008
- Last edited
- 12/06/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
http://www.nres.npsa.nhs.uk/researchsummaries/?entryid29=20579&q=0%c2%ac08%2fH0301%2f74%c2%ac
Contact information
Dr Daksha Trivedi
Scientific
Scientific
Centre for Research in Primary and Community Care (CRIPACC)
Room 3F416
University of Hertfordshire
Hatfield
AL10 9AB
United Kingdom
Study information
| Study design | Randomised double-blind placebo-controlled parallel-group multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Erectile dysfunction: a randomised controlled trial of lipid lowering with simvastatin (EDS trial) |
| Study acronym | EDS trial |
| Study objectives | 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 On 05/07/2011 the overall trial end date was changed from 30/11/2009 to 30/09/2011. |
| Ethics approval(s) | Essex 1 Research Ethics Committee, 06/08/2008, ref: 08/H0301/74 |
| Health condition(s) or problem(s) studied | Erectile dysfunction caused by vascular impairment |
| Intervention | Simvastatin one 40 mg tablet orally daily at bedtime for 6 months or matched placebo one tablet orally daily at bedtime. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Simvastatin |
| Primary outcome measure | 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 measures | 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. |
| Overall study start date | 01/10/2008 |
| Completion date | 30/09/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 170 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/10/2008 |
| Date of final enrolment | 28/07/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Hertfordshire
Hatfield
AL10 9AB
United Kingdom
AL10 9AB
United Kingdom
Sponsor information
University of Hertfordshire (UK)
University/education
University/education
c/o Prof John Senior
College Lane
Hatfield
AL10 9AB
England
United Kingdom
| Website | http://www.herts.ac.uk |
|---|---|
"ROR" |
https://ror.org/0267vjk41 |
Funders
Funder type
Government
National Institute for Health Research (NIHR), Research for Patient Benefit (RfPB) (UK) (ref: PB-PG-0107-11391)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/12/2011 | Yes | No | |
| Results article | results | 01/02/2013 | Yes | No | |
| Results article | results | 05/03/2014 | Yes | No |
