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

Not Applicable

Completed

• Conditions: Erectile dysfunction caused by vascular impairment; Urological and Genital Diseases

• Registration Number: ISRCTN66772971
• Lead Sponsor: niversity of Hertfordshire (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-26
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 170

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified