CompletedPhase 4

Statin Lowering Testosterone and Sexual Function

Taiwan151 participantsStarted 2013-07

Plain-language summary

Statins may decrease serum testosterone levels via decreasing cholesterol. This longitudinal study detected the effects of rosuvastatin on free testosterone levels and sexual function in men with type 2 diabetes. Methods: Investigator enroll 150 men with type 2 diabetes and hypercholesterolemia. Biochemical assessments include serum total cholesterol (TC), low-density lipoprotein (LDL), high-density lipoprotein, triglyceride, prolactin, thyroid-stimulating hormone, luteinizing hormone, follicle stimulating hormone, total testosterone and serum sex hormone binding globulin (SHBG). All parameters are measured before statin treatment, after 6 months of statin treatment and 6 months after discontinuing statin treatment. Scores of the sexual health inventory for men (SHIM) are also evaluated.

Who can participate

Age range18 Years – 75 Years

SexMALE

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Inclusion criteria

✓. Type2 diabetes mellitus for more than 2 year.
✓. Male subjects
✓. Not received statin therapy for more than 1 year
✓. Normal sexual activity
✓. No hypogonadism history.

Exclusion criteria

✕. Type 1 diabetes mellitus
✕. Duration of diabetes less than 2 years and more than 10 years
✕. Renal function impairment (creatinine level \> 1.4 mg/dl)
✕. Cancer or organic disease associated with hypogonadism,
✕. With testosterone on antiandrogen drug therapy

What they're measuring

serum testosterone

Timeframe: up to 24 weeks

Trial details

NCT IDNCT02612714

SponsorChang Gung Memorial Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-11

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