NCT00923676

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2008

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 15, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 18, 2009

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

November 18, 2015

Status Verified

November 1, 2015

Enrollment Period

7.5 years

First QC Date

June 15, 2009

Last Update Submit

November 17, 2015

Conditions

Sexual DysfunctionHyperlipidemia

Keywords

HyperlipidemiaLDL-cholesterolHDL-cholesteroltriglyceridesIIEFFSFIMale and female sexual dysfunctions

Outcome Measures

Primary Outcomes (1)

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

    Baseline, 6 months, 12 months

Secondary Outcomes (1)

  • Blood lipids, inflammatory markers

    Baseline, 6 months, 12 months

Study Arms (3)

Fenofibrate

ACTIVE COMPARATOR

Fenofibrate pills

Drug: fenofibrate

Rosuvastatin

ACTIVE COMPARATOR

Rosuvastatin pills

Drug: Rosuvastatin

fenofibrate + rosuvastatin

ACTIVE COMPARATOR

fenofibrate pills + rosuvastatin pills

Drug: fenofibrate + rosuvastatin

Interventions

fenofibrateDRUG

pill 145 mg, 145 mg/day, for 12 months

Fenofibrate
RosuvastatinDRUG

pills of 10 mg, 10 mg/day, 12 months

Rosuvastatin
fenofibrate + rosuvastatinDRUG

fenofibrate 145 mg/day + rosuvastatin 10 mg/day for 12 months

fenofibrate + rosuvastatin

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Geriatrics and Metabolic Diseases

Naples, 80138, Italy

Location

Related Publications (1)

  • 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.

    PMID: 19453904BACKGROUND

MeSH Terms

Conditions

Sexual Dysfunction, PhysiologicalHyperlipidemias

Interventions

FenofibrateRosuvastatin Calcium

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Fibric AcidsIsobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPhenyl EthersEthersBenzophenonesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenolsKetonesSulfonamidesAmidesFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Dario Giugliano, MD,PhD

    Department of Geriatrics and Metabolic Diseases, Second University of Naples, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof of Endocrinology

Study Record Dates

First Submitted

June 15, 2009

First Posted

June 18, 2009

Study Start

April 1, 2008

Primary Completion

October 1, 2015

Study Completion

April 1, 2016

Last Updated

November 18, 2015

Record last verified: 2015-11

Locations

IT(1)