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Treatment of Hyperlipidemia and Sexual Dysfunction

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Dario Giugliano, Second University of Naples Identifier:
First received: June 15, 2009
Last updated: November 17, 2015
Last verified: November 2015

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.

Condition Intervention Phase
Sexual Dysfunction Hyperlipidemia Drug: fenofibrate Drug: Rosuvastatin Drug: fenofibrate + rosuvastatin Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Fenofibrate and Rosuvastatin on Sexual Dysfunction in Hyperlipidemic Patients. A Randomized Trial

Resource links provided by NLM:

Further study details as provided by Dario Giugliano, Second University of Naples:

Primary Outcome Measures:
  • International index of erectile dysfunction (IIEF) in men and Female sexual function index (FSFI) in women [ Time Frame: Baseline, 6 months, 12 months ]

Secondary Outcome Measures:
  • Blood lipids, inflammatory markers [ Time Frame: Baseline, 6 months, 12 months ]

Enrollment: 300
Study Start Date: April 2008
Estimated Study Completion Date: April 2016
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Fenofibrate
Fenofibrate pills
Drug: fenofibrate
pill 145 mg, 145 mg/day, for 12 months
Active Comparator: Rosuvastatin
Rosuvastatin pills
Drug: Rosuvastatin
pills of 10 mg, 10 mg/day, 12 months
Active Comparator: fenofibrate + rosuvastatin
fenofibrate pills + rosuvastatin pills
Drug: fenofibrate + rosuvastatin
fenofibrate 145 mg/day + rosuvastatin 10 mg/day for 12 months


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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.
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Please refer to this study by its identifier: NCT00923676

Department of Geriatrics and Metabolic Diseases
Naples, Italy, 80138
Sponsors and Collaborators
University of Campania "Luigi Vanvitelli"
Principal Investigator: Dario Giugliano, MD,PhD Department of Geriatrics and Metabolic Diseases, Second University of Naples, Italy
  More Information

Responsible Party: Dario Giugliano, Prof of Endocrinology, Second University of Naples Identifier: NCT00923676     History of Changes
Other Study ID Numbers: DGMM/03/2007
Study First Received: June 15, 2009
Last Updated: November 17, 2015

Keywords provided by Dario Giugliano, Second University of Naples:
Male and female sexual dysfunctions

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Rosuvastatin Calcium
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents processed this record on September 21, 2017