Statin Lowering Testosterone and Sexual Function

NCT02612714 | Completed Phase 4

• 1 other identifier: 103-2005C
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

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.

Conditions

Sexual Dysfunction

Keywords

diabetes; hypercholesterolemia; sexual dysfunction; statin; testosterone

Outcome Measures

Primary Outcomes (1)

• serum testosterone

  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

  up to 24 weeks

Secondary Outcomes (1)

• sexual function evaluation

  up to 24 weeks

Study Arms (1)

medication status

OTHER

Rosuvastatin 5 mg qd for 6 months, Quitted rosuvastatin for 6 months, Re-administrated rosuvastatin for 6 months

Drug: Rosuvastatin

Interventions

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.

Also known as: Cresto

medication status

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung

Kaohsiung City, Kaohsiung, 83349, Taiwan

Location

MeSH Terms

Conditions

Sexual Dysfunction, Physiological; Diabetes Mellitus; Hypercholesterolemia

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ching Jung Hsieh

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of General Internal Medicine

Study Record Dates

• First Submitted: November 7, 2015
• First Posted: November 24, 2015
• Study Start: July 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 24, 2015

Record last verified: 2015-11

Locations

TW (1)