Clinical trial NCT00923676: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Sexual Dysfunction
Hyperlipidemia
Keywords: Hyperlipidemia
LDL-cholesterol
HDL-cholesterol
triglycerides
IIEF
FSFI
Male and female sexual dysfunctions
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2009-06-18
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: International index of erectile dysfunction (IIEF) in men and Female sexual function index (FSFI) in women
timeFrame: Baseline, 6 months, 12 months
Secondary outcomes:
measure: Blood lipids, inflammatory markers
timeFrame: Baseline, 6 months, 12 months
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Department of Geriatrics and Metabolic Diseases
Study officials:
affiliation: Department of Geriatrics and Metabolic Diseases, Second University of Naples, Italy
name: Dario Giugliano, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.