Treatment of Hyperlipidemia and Sexual Dysfunction

November 17, 2015 updated by: Dario Giugliano, University of Campania "Luigi Vanvitelli"

Effect of Fenofibrate and Rosuvastatin on Sexual Dysfunction in Hyperlipidemic Patients. A Randomized Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Naples, Italy, 80138
        • Department of Geriatrics and Metabolic Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood lipids, inflammatory markers
Time Frame: Baseline, 6 months, 12 months
Baseline, 6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campania "Luigi Vanvitelli"

Investigators

  • Principal Investigator: Dario Giugliano, MD,PhD, Department of Geriatrics and Metabolic Diseases, Second University of Naples, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

October 1, 2015

Study Completion (Anticipated)

April 1, 2016

Study Registration Dates

First Submitted

June 15, 2009

First Submitted That Met QC Criteria

June 17, 2009

First Posted (Estimate)

June 18, 2009

Study Record Updates

Last Update Posted (Estimate)

November 18, 2015

Last Update Submitted That Met QC Criteria

November 17, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DGMM/03/2007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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