Erectile dysfunction and statins: a randomised controlled trial (RCT)

ISRCTN ISRCTN66772971
DOI https://doi.org/10.1186/ISRCTN66772971
Protocol serial number RHF0001
Sponsor University of Hertfordshire (UK)
Funder National Institute for Health Research (NIHR), Research for Patient Benefit (RfPB) (UK) (ref: PB-PG-0107-11391)
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

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

Study information

Primary study designInterventional
Study designRandomised double-blind placebo-controlled parallel-group multicentre trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleErectile dysfunction: a randomised controlled trial of lipid lowering with simvastatin (EDS trial)
Study acronymEDS trial
Study objectivesPrimary 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) studiedErectile dysfunction caused by vascular impairment
InterventionSimvastatin one 40 mg tablet orally daily at bedtime for 6 months or matched placebo one tablet orally daily at bedtime.
Intervention typeDrug
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Simvastatin
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.

Key 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.

Completion date30/09/2011

Eligibility

Participant type(s)Patient
Age groupAdult
SexMale
Target sample size at registration170
Key inclusion criteria1. 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 criteria1. 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 enrolment01/10/2008
Date of final enrolment28/07/2011

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

University of Hertfordshire
Hatfield
AL10 9AB
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/02/2013 Yes No
Results article results 05/03/2014 Yes No
Protocol article protocol 01/12/2011 Yes No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
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