Overview

This trial is active, not recruiting.

Conditions sexual dysfunction, hyperlipidemia
Treatments fenofibrate, rosuvastatin, fenofibrate + rosuvastatin
Phase phase 4
Sponsor Second University of Naples
Start date April 2008
End date October 2015
Trial size 300 participants
Trial identifier NCT00923676, DGMM/03/2007

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Fenofibrate pills
fenofibrate
pill 145 mg, 145 mg/day, for 12 months
(Active Comparator)
Rosuvastatin pills
rosuvastatin
pills of 10 mg, 10 mg/day, 12 months
(Active Comparator)
fenofibrate pills + rosuvastatin pills
fenofibrate + rosuvastatin
fenofibrate 145 mg/day + rosuvastatin 10 mg/day for 12 months

Primary Outcomes

Measure
International index of erectile dysfunction (IIEF) in men and Female sexual function index (FSFI) in women
time frame: Baseline, 6 months, 12 months

Secondary Outcomes

Measure
Blood lipids, inflammatory markers
time frame: Baseline, 6 months, 12 months

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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.

Additional Information

Official title Effect of Fenofibrate and Rosuvastatin on Sexual Dysfunction in Hyperlipidemic Patients. A Randomized Trial
Principal investigator Dario Giugliano, MD,PhD
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Second University of Naples.