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Treatment of Hyperlipidemia and Sexual Dysfunction

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2015 by Dario Giugliano, Second University of Naples.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00923676
First Posted: June 18, 2009
Last Update Posted: November 18, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dario Giugliano, Second University of Naples
  Purpose

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00923676


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

Publications:
Responsible Party: Dario Giugliano, Prof of Endocrinology, Second University of Naples
ClinicalTrials.gov Identifier: NCT00923676     History of Changes
Other Study ID Numbers: DGMM/03/2007
First Submitted: June 15, 2009
First Posted: June 18, 2009
Last Update Posted: November 18, 2015
Last Verified: November 2015

Keywords provided by Dario Giugliano, Second University of Naples:
Hyperlipidemia
LDL-cholesterol
HDL-cholesterol
triglycerides
IIEF
FSFI
Male and female sexual dysfunctions

Additional relevant MeSH terms:
Hyperlipidemias
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Rosuvastatin Calcium
Fenofibrate
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors