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Treatment of Hyperlipidemia and Sexual Dysfunction

NCT ID: NCT00923676

Last Updated: 2015-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2016-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Sexual Dysfunction Hyperlipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Fenofibrate

Fenofibrate pills

Group Type ACTIVE_COMPARATOR

fenofibrate

Intervention Type DRUG

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

Rosuvastatin

Rosuvastatin pills

Group Type ACTIVE_COMPARATOR

Rosuvastatin

Intervention Type DRUG

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

fenofibrate + rosuvastatin

fenofibrate pills + rosuvastatin pills

Group Type ACTIVE_COMPARATOR

fenofibrate + rosuvastatin

Intervention Type DRUG

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

Interventions

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fenofibrate

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

Intervention Type DRUG

Rosuvastatin

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

Intervention Type DRUG

fenofibrate + rosuvastatin

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Campania Luigi Vanvitelli

OTHER

Sponsor Role lead

Responsible Party

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Dario Giugliano

Prof of Endocrinology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dario Giugliano, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Department of Geriatrics and Metabolic Diseases

Naples, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 19453904 (View on PubMed)

Other Identifiers

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DGMM/03/2007

Identifier Type: -

Identifier Source: org_study_id