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Statin Lowering Testosterone and Sexual Function

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ClinicalTrials.gov Identifier: NCT02612714
Recruitment Status : Completed
First Posted : November 24, 2015
Last Update Posted : November 24, 2015
Sponsor:
Information provided by (Responsible Party):
Ching Jung Hsieh, Chang Gung Memorial Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Sexual Dysfunction Drug: Rosuvastatin Phase 4

Detailed Description:

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:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 151 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Statin Therapy is Associated With Low Testosterone and Sexual Function in Men With Type 2 Diabetes
Study Start Date : July 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
medication status
Rosuvastatin 5 mg qd for 6 months, Quitted rosuvastatin for 6 months, Re-administrated rosuvastatin for 6 months
Drug: Rosuvastatin
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 Name: Cresto




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02612714


Locations
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Taiwan
Chang Gung
Kaohsiung, Taiwan, 83349
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: Ching Jung Hsieh Chang Gung Memorial Hospital

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Responsible Party: Ching Jung Hsieh, Chief of General Internal Medicine, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02612714     History of Changes
Other Study ID Numbers: 103-2005C
First Posted: November 24, 2015    Key Record Dates
Last Update Posted: November 24, 2015
Last Verified: November 2015
Keywords provided by Ching Jung Hsieh, Chang Gung Memorial Hospital:
diabetes
hypercholesterolemia
sexual dysfunction
statin
testosterone
Additional relevant MeSH terms:
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Methyltestosterone
Rosuvastatin Calcium
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Enzyme Inhibitors
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents