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NCT Number: NCT02612714

Statin Lowering Testosterone and Sexual Function

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.

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Key information

Conditions

Sexual Dysfunction Diabetes Mellitus Dyslipidemias Endocrine System Diseases Genital Diseases Glucose Metabolism Disorders Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Sexual Dysfunction, Physiological Urogenital Diseases

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Chang Gung

Kaohsiung City, Kaohsiung, 83349, Taiwan

About this study

Autonomic neuropathy and hypogonadism are the cause of impotence in men with diabetes. Hypercholesterolemia is also one of the dominant co-morbidity of diabetes. Many men with diabetes are being treated with statins to low down the serum levels of cholesterol. However, cholesterol is the major substrate for testosterone biosynthesis, statin may decrease serum testosterone levels via decreasing cholesterol level. In previous studies, few longitudinal studies with few enrolled subject were done before and with conflict results. Free testosterone is also not routinely used, so compromised the accuracy. The investigators will analyze the effect of statins on free testosterone levels in a longitudinal study of men with type 2 diabetes and do animal study to realize if the statin will influence the sex organ of rat.

Methods:

Investigator will enroll 150 men with type 2 diabetes and hypercholesterolemia. Clinical and biochemical assessments include blood pressure, HbA1C, lipid profile, height, weight, and waist circumference, luteinizing hormone (LH), follicle stimulating hormone (FSH) and free testosterone , which will be measured before statin treatment, after 3 months of statin treatment and then after quitted statin treatment for 3 months, and also give questionnaire about sex function.

The investigators expect:

  • Statin may potentially lead to hypogonadism or impotence In men with type 2 diabetes.
  • The relationship between blood glucose, lipid profile, blood pressure, anthropometric measures and serum free testosterone levels may also be revealed.
  • If this hypothesis is adverse, statin treatment will not influence gonadal function and has that side effect.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rosuvastatin

Drug

All parameters were 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) were also evaluated.

Other names: Cresto

Primary outcomes

  1. serum testosterone

    Time frame: up to 24 weeks

    The measure is a composite outcome measure consisting of multiple measures. Serum testosterone measured after 24 weeks statin treatment, after quitted statin for 24 weeks and after 24 weeks of re-administrating statin

Secondary outcomes

  1. sexual function evaluation

    Time frame: up to 24 weeks

    The measure is a composite outcome measure consisting of multiple measures. Sexual function measured by questionaire after 24 weeks of statin treatment, after quitted statin for 24 weeks and after 24 weeks of re-administrating statin

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

Statin Therapy is Associated With Low Testosterone and Sexual Function in Men With Type 2 Diabetes

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 24, 2015
Registry last updated
Nov 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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