NCT00923676

Treatment of Hyperlipidemia and Sexual Dysfunction

Effect of Fenofibrate and Rosuvastatin on Sexual Dysfunction in Hyperlipidemic Patients. A Randomized Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: University of Campania Luigi Vanvitelli · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Hyperlipidemias are frequently associated with and are considered an important cause of erectile dysfunction in men. This association has been attributed to the impairment of blood flow through endothelium-dependent relaxation in smooth muscle cells of corpus cavernosum. Basic science and human research suggest that the vascular pathophysiology of male and female sexual dysfunction may be similar, as the first phase of the female sexual response is mediated by a combination of vasocongestive and neuro-muscular event which include increased clitoral length and diameter, as well as increased vaginal lubrication, wall engorgement and luminal diameter. The investigators have shown that women with hyperlipidemia had a higher prevalence of sexual dysfunction as compared with age-matched women without hyperlipidemia. The aim of this study was to asses the effect of anti-hyperlipidemic drugs (fenofibrate and rosuvastatin, single or in combination) on validated indices of sexual function in hyperlipidemic men and women with sexual dysfunction at baseline.

Conditions

• Sexual Dysfunction
• Hyperlipidemia

Interventions

Type	Name	Description
DRUG	fenofibrate	pill 145 mg, 145 mg/day, for 12 months
DRUG	Rosuvastatin	pills of 10 mg, 10 mg/day, 12 months
DRUG	fenofibrate + rosuvastatin	fenofibrate 145 mg/day + rosuvastatin 10 mg/day for 12 months

Timeline

• Start date: 2008-04-01
• Primary completion: 2015-10-01
• Completion: 2016-04-01
• First posted: 2009-06-18
• Last updated: 2015-11-18

Locations

1 site across 1 country: Italy