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Treatment of Hyperlipidemia and Sexual Dysfunction

Primary Purpose

Sexual Dysfunction, Hyperlipidemia

Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
fenofibrate
Rosuvastatin
fenofibrate + rosuvastatin
Sponsored by
University of Campania "Luigi Vanvitelli"
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sexual Dysfunction focused on measuring Hyperlipidemia, LDL-cholesterol, HDL-cholesterol, triglycerides, IIEF, FSFI, Male and female sexual dysfunctions

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Department of Geriatrics and Metabolic Diseases

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Fenofibrate

Rosuvastatin

fenofibrate + rosuvastatin

Arm Description

Fenofibrate pills

Rosuvastatin pills

fenofibrate pills + rosuvastatin pills

Outcomes

Primary Outcome Measures

International index of erectile dysfunction (IIEF) in men and Female sexual function index (FSFI) in women

Secondary Outcome Measures

Blood lipids, inflammatory markers

Full Information

First Posted
June 15, 2009
Last Updated
November 17, 2015
Sponsor
University of Campania "Luigi Vanvitelli"
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1. Study Identification

Unique Protocol Identification Number
NCT00923676
Brief Title
Treatment of Hyperlipidemia and Sexual Dysfunction
Official Title
Effect of Fenofibrate and Rosuvastatin on Sexual Dysfunction in Hyperlipidemic Patients. A Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2008 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
April 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campania "Luigi Vanvitelli"

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexual Dysfunction, Hyperlipidemia
Keywords
Hyperlipidemia, LDL-cholesterol, HDL-cholesterol, triglycerides, IIEF, FSFI, Male and female sexual dysfunctions

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fenofibrate
Arm Type
Active Comparator
Arm Description
Fenofibrate pills
Arm Title
Rosuvastatin
Arm Type
Active Comparator
Arm Description
Rosuvastatin pills
Arm Title
fenofibrate + rosuvastatin
Arm Type
Active Comparator
Arm Description
fenofibrate pills + rosuvastatin pills
Intervention Type
Drug
Intervention Name(s)
fenofibrate
Intervention Description
pill 145 mg, 145 mg/day, for 12 months
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Intervention Description
pills of 10 mg, 10 mg/day, 12 months
Intervention Type
Drug
Intervention Name(s)
fenofibrate + rosuvastatin
Intervention Description
fenofibrate 145 mg/day + rosuvastatin 10 mg/day for 12 months
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Blood lipids, inflammatory markers
Time Frame
Baseline, 6 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dario Giugliano, MD,PhD
Organizational Affiliation
Department of Geriatrics and Metabolic Diseases, Second University of Naples, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Geriatrics and Metabolic Diseases
City
Naples
ZIP/Postal Code
80138
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
19453904
Citation
Esposito K, Ciotola M, Maiorino MI, Giugliano F, Autorino R, De Sio M, Cozzolino D, Saccomanno F, Giugliano D. Hyperlipidemia and sexual function in premenopausal women. J Sex Med. 2009 Jun;6(6):1696-1703. doi: 10.1111/j.1743-6109.2009.01284.x. Epub 2009 Apr 23.
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Treatment of Hyperlipidemia and Sexual Dysfunction

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