Treatment of Hyperlipidemia and Sexual Dysfunction

Hyperlipidemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00923676
• Other study ID #: DGMM/03/2007
• Status: Active, not recruiting
• Phase: Phase 4
• First received: June 15, 2009
• Last updated: November 17, 2015
• Start date: April 2008
• Est. completion date: April 2016

Study information

• Verified date: November 2015
• Source: Second University of Naples
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: April 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias
• Sexual Dysfunction

Intervention

Drug:
• fenofibrate
pill 145 mg, 145 mg/day, for 12 months
• Rosuvastatin
pills of 10 mg, 10 mg/day, 12 months
• fenofibrate + rosuvastatin
fenofibrate 145 mg/day + rosuvastatin 10 mg/day for 12 months

Locations

Country	Name	City	State
Italy	Department of Geriatrics and Metabolic Diseases	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Second University of Naples

Country where clinical trial is conducted

Italy, 

References & 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):1696-703. doi: 10.1111/j.1743-6109.2009.01284.x. Epub 2009 Apr 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	International index of erectile dysfunction (IIEF) in men and Female sexual function index (FSFI) in women		Baseline, 6 months, 12 months	Yes
Secondary	Blood lipids, inflammatory markers		Baseline, 6 months, 12 months	Yes