Treatment of Hyperlipidemia and Sexual Dysfunction

Study Overview
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Brief Summary
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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.

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

Conditions
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Sexual Dysfunction, Hyperlipidemia

Intervention / Treatment
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* Drug: fenofibrate
* Drug: Rosuvastatin
* Drug: fenofibrate + rosuvastatin


Participation Criteria
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Eligibility Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fenofibrate<br>Fenofibrate pills | Drug: fenofibrate<br>* pill 145 mg, 145 mg/day, for 12 months<br>|
| Active Comparator: Rosuvastatin<br>Rosuvastatin pills | Drug: Rosuvastatin<br>* pills of 10 mg, 10 mg/day, 12 months<br>|
| Active Comparator: fenofibrate + rosuvastatin<br>fenofibrate pills + rosuvastatin pills | Drug: fenofibrate + rosuvastatin<br>* fenofibrate 145 mg/day + rosuvastatin 10 mg/day for 12 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International index of erectile dysfunction (IIEF) in men and Female sexual function index (FSFI) in women |  | Baseline, 6 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood lipids, inflammatory markers |  | Baseline, 6 months, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyperlipidemia, LDL-cholesterol, HDL-cholesterol, triglycerides, IIEF, FSFI, Male and female sexual dysfunctions