Condition category
Urological and Genital Diseases
Date applied
12/08/2008
Date assigned
26/09/2008
Last edited
12/06/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Daksha Trivedi

ORCID ID

Contact details

Centre for Research in Primary and Community Care (CRIPACC)
Room 3F416
University of Hertfordshire
Hatfield
AL10 9AB
United Kingdom

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 measures

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

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

http://www.herts.ac.uk

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes