Hyperlipidemia, Sexual Dysfunction
Conditions
Keywords
Hyperlipidemia, LDL-cholesterol, HDL-cholesterol, triglycerides, IIEF, FSFI, Male and female sexual dysfunctions
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.
Interventions
DRUGfenofibrate
pill 145 mg, 145 mg/day, for 12 months
DRUGRosuvastatin
pills of 10 mg, 10 mg/day, 12 months
DRUGfenofibrate + rosuvastatin
fenofibrate 145 mg/day + rosuvastatin 10 mg/day for 12 months
Sponsors
University of Campania Luigi Vanvitelli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| International index of erectile dysfunction (IIEF) in men and Female sexual function index (FSFI) in women | Baseline, 6 months, 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Blood lipids, inflammatory markers | Baseline, 6 months, 12 months |
Countries
Italy
Outcome results
None listed