Plain English Summary
http://www.nres.npsa.nhs.uk/researchsummaries/?entryid29=20579&q=0%c2%ac08%2fH0301%2f74%c2%ac
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RHF0001
Study information
Scientific title
Erectile dysfunction: a randomised controlled trial of lipid lowering with simvastatin (EDS trial)
Acronym
EDS trial
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
On 05/07/2011 the overall trial end date was changed from 30/11/2009 to 30/09/2011.
Ethics approval
Essex 1 Research Ethics Committee, 06/08/2008, ref: 08/H0301/74
Study design
Randomised double-blind placebo-controlled parallel-group multicentre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
01/10/2008
Overall trial end date
30/09/2011
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
170
Participant 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
Recruitment start date
01/10/2008
Recruitment end date
28/07/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Hertfordshire
Hatfield
AL10 9AB
United Kingdom
Sponsor information
Organisation
University of Hertfordshire (UK)
Sponsor details
c/o Prof John Senior
College Lane
Hatfield
AL10 9AB
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR), Research for Patient Benefit (RfPB) (UK) (ref: PB-PG-0107-11391)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21371242
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/22686292
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24593269
Publication citations
-
Protocol
Trivedi D, Kirby M, Norman F, Przybytniak I, Ali S, Wellsted DM, Can simvastatin improve erectile function and health-related quality of life in men aged >40 years with erectile dysfunction? Rationale and design of the Erectile Dysfunction and Statins (EDS) Trial [ISRCTN66772971](1)., BJU Int., 2011, 108, 11, 1850-1854, doi: 10.1111/j.1464-410X.2011.10122.x.
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Results
Trivedi D, Kirby M, Wellsted DM, Ali S, Hackett G, O'Connor B, van Os S, Can simvastatin improve erectile function and health-related quality of life in men aged ≥40 years with erectile dysfunction? Results of the Erectile Dysfunction and Statins Trial [ISRCTN66772971]., BJU Int., 2013, 111, 2, 324-333, doi: 10.1111/j.1464-410X.2012.11241.x.
-
Results
Trivedi D, Wellsted DM, Collard JB, Kirby M, Simvastatin improves the sexual health-related quality of life in men aged 40 years and over with erectile dysfunction: additional data from the erectile dysfunction and statin trial., BMC Urol, 2014, 14, 24, doi: 10.1186/1471-2490-14-24.