Treatment of Hyperlipidemia and Sexual Dysfunction

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Second University of Naples.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Second University of Naples
ClinicalTrials.gov Identifier:
NCT00923676
First received: June 15, 2009
Last updated: June 17, 2009
Last verified: June 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Blood lipids, inflammatory markers [ Time Frame: Baseline, 6 months, 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 300
Study Start Date: April 2008
Estimated Study Completion Date: November 2009
Estimated Primary Completion Date: October 2009 (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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00923676

Locations
Italy
Department of Geriatrics and Metabolic Diseases
Naples, Italy, 80138
Sponsors and Collaborators
Second University of Naples
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, Department of Geriatrics and Metabolic Diseases SUN, Naples Italy
ClinicalTrials.gov Identifier: NCT00923676     History of Changes
Other Study ID Numbers: DGMM/03/2007
Study First Received: June 15, 2009
Last Updated: June 17, 2009
Health Authority: Italy: Ethics Committee

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

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Mental Disorders
Fenofibrate
Rosuvastatin
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014