Effect of Fenofibrate and Rosuvastatin on Sexual Dysfunction in Hyperlipidemic Patients. A Randomized Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- International index of erectile dysfunction (IIEF) in men and Female sexual function index (FSFI) in women
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Pregnancy or less than 8 weeks postpartum.
- •Diabetes mellitus (fasting glucose > 126 mg/dl.
- •Multiple sclerosis.
- •Chronic alcoholism (intake of ≥ 500g/wk).
- •Psychiatric problems.
- •Symptomatic cardiovascular disease.
- •Gynecological surgery.
- •Pelvic trauma.
- •Polycystic ovarian syndrome.
- •Abnormal thyroid function.
研究组 & 干预措施
Fenofibrate
Fenofibrate pills
干预措施: fenofibrate (Drug)
Rosuvastatin
Rosuvastatin pills
干预措施: Rosuvastatin (Drug)
fenofibrate + rosuvastatin
fenofibrate pills + rosuvastatin pills
干预措施: fenofibrate + rosuvastatin (Drug)
结局指标
主要结局
International index of erectile dysfunction (IIEF) in men and Female sexual function index (FSFI) in women
时间窗: Baseline, 6 months, 12 months
次要结局
- Blood lipids, inflammatory markers(Baseline, 6 months, 12 months)
研究者
Dario Giugliano
Prof of Endocrinology
University of Campania "Luigi Vanvitelli"