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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fenofibrate | Active Comparator | Fenofibrate pills |
|
| Rosuvastatin | Active Comparator | Rosuvastatin pills |
|
| fenofibrate + rosuvastatin | Active Comparator | fenofibrate pills + rosuvastatin pills |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fenofibrate | Drug | pill 145 mg, 145 mg/day, for 12 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| International index of erectile dysfunction (IIEF) in men and Female sexual function index (FSFI) in women | Baseline, 6 months, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Blood lipids, inflammatory markers | Baseline, 6 months, 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dario Giugliano, MD,PhD | Department of Geriatrics and Metabolic Diseases, Second University of Naples, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Geriatrics and Metabolic Diseases | Naples | 80138 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19453904 | Background | 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. |
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| ID | Term |
|---|---|
| D012735 | Sexual Dysfunction, Physiological |
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
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| ID | Term |
|---|---|
| D011345 | Fenofibrate |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D058607 | Fibric Acids |
| D058610 | Isobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| Rosuvastatin |
| Drug |
pills of 10 mg, 10 mg/day, 12 months |
|
| fenofibrate + rosuvastatin | Drug | fenofibrate 145 mg/day + rosuvastatin 10 mg/day for 12 months |
|
| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D001577 | Benzophenones |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D007659 | Ketones |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |