Treatment of Hyperlipidemia and Sexual Dysfunction

University of Campania "Luigi Vanvitelli"

Status and phase: Unknown; Phase 4

Conditions: Hyperlipidemia; Sexual Dysfunction

Treatments: Drug: Rosuvastatin; Drug: fenofibrate; Drug: fenofibrate + rosuvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00923676

DGMM/03/2007

Details and patient eligibility

About

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.

Enrollment: 300 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 3 patient groups

Fenofibrate

Active Comparator group

Description:

Fenofibrate pills

Treatment:

Drug: fenofibrate

Rosuvastatin

Active Comparator group

Description:

Rosuvastatin pills

Treatment:

Drug: Rosuvastatin

fenofibrate + rosuvastatin

Active Comparator group

Description:

fenofibrate pills + rosuvastatin pills

Treatment:

Drug: fenofibrate + rosuvastatin