Treatment of Hyperlipidemia and Sexual Dysfunction

Phase 4

• Conditions: Sexual Dysfunction; Hyperlipidemia
• Interventions: Drug: fenofibrate + rosuvastatin; Drug: fenofibrate; Drug: Rosuvastatin

• Registration Number: NCT00923676
• Lead Sponsor: University of Campania "Luigi Vanvitelli"

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2009-06-15
• Study First Submitted QC: 2009-06-17
• Study First Posted: 2009-06-18
• Primary Completion: 2015-10
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-17
• Last Update Posted: 2015-11-18
• Study Completion: 2016-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Low-density lipoprotein (LDL)-cholesterol levels > 160 mg/dL, high-density lipoprotein (HDL)-cholesterol levels < 50 mg/dL (for women) and < 40 mg/dl (for men), or triglyceride levels > 150 mg/dL.
• Stable heterosexual partner relationship for the preceding 6 months.

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Exclusion Criteria

• Pregnancy or less than 8 weeks postpartum.
• Diabetes mellitus (fasting glucose > 126 mg/dl.
• Uremia.
• Multiple sclerosis.
• Chronic alcoholism (intake of ≥ 500g/wk).
• Cancer.
• Psychiatric problems.
• Symptomatic cardiovascular disease.
• Gynecological surgery.
• Pelvic trauma.
• Polycystic ovarian syndrome.
• Abnormal thyroid function.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
fenofibrate + rosuvastatin	fenofibrate + rosuvastatin	fenofibrate pills + rosuvastatin pills
Fenofibrate	fenofibrate	Fenofibrate pills
Rosuvastatin	Rosuvastatin	Rosuvastatin pills

Primary Outcome Measures

Name	Time	Method
International index of erectile dysfunction (IIEF) in men and Female sexual function index (FSFI) in women	Baseline, 6 months, 12 months

Secondary Outcome Measures

Name	Time	Method
Blood lipids, inflammatory markers	Baseline, 6 months, 12 months

Trial Locations

Locations (1)

Department of Geriatrics and Metabolic Diseases; 🇮🇹 Naples, Italy