- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00923676
Treatment of Hyperlipidemia and Sexual Dysfunction
Effect of Fenofibrate and Rosuvastatin on Sexual Dysfunction in Hyperlipidemic Patients. A Randomized Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Naples, Italy, 80138
- Department of Geriatrics and Metabolic Diseases
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Fenofibrate
Fenofibrate pills
|
pill 145 mg, 145 mg/day, for 12 months
|
Active Comparator: Rosuvastatin
Rosuvastatin pills
|
pills of 10 mg, 10 mg/day, 12 months
|
Active Comparator: fenofibrate + rosuvastatin
fenofibrate pills + rosuvastatin pills
|
fenofibrate 145 mg/day + rosuvastatin 10 mg/day for 12 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
International index of erectile dysfunction (IIEF) in men and Female sexual function index (FSFI) in women
Time Frame: Baseline, 6 months, 12 months
|
Baseline, 6 months, 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Blood lipids, inflammatory markers
Time Frame: Baseline, 6 months, 12 months
|
Baseline, 6 months, 12 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Dario Giugliano, MD,PhD, Department of Geriatrics and Metabolic Diseases, Second University of Naples, Italy
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Metabolic Diseases
- Lipid Metabolism Disorders
- Dyslipidemias
- Hyperlipidemias
- Hyperlipoproteinemias
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Rosuvastatin Calcium
- Fenofibrate
Other Study ID Numbers
- DGMM/03/2007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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