1. Testosterone and Diabetes
Part 3 of 3
Sara Dempsey
Doctor of Pharmacy Candidate
LECOM School of Pharmacy

2. Treating Low Testosterone

3. How can we treat low testosterone
Along with diet, exercise, and diabetes medications, testosterone replacement may be considered in diabetic men
Testosterone replacement options
Topical Gel
Topical Solution
Intramuscular (IM) injection
Testosterone patch
Buccal testosterone
Dosage adjustments should be made based on serum testosterone levels
Correlation between dose of testosterone and rise in levels
"Low Testosterone (Low T)." . MedicineNet, 12 Sept Web. 20 Jan <
Lexicomp OnlineTM, Lexicomp-Drugs Online, Hudson, Ohio:Lexi-comp Inc; 2013 January 20th 2012 Clinical pharmacology

4. Testosterone treatment options
Gel
Androgel®
1% mg applied to the abdomen or to the shoulders and upper arms in the morning
1.62% mg applied to shoulders and upper arms in the morning
Fortesta®
10-70 mg applied to thighs every morning
Testim®
5 -10 grams (contains mg of testosterone) applied to shoulders and upper arms in the morning
Lexicomp OnlineTM, Lexicomp-Drugs Online, Hudson, Ohio:Lexi-comp Inc; 2013 January 20th 2012 Clinical pharmacology

5. Testosterone treatment options continued
Solution
Axiron ® mg
Applied to the underarms
each morning
Lexicomp OnlineTM, Lexicomp-Drugs Online, Hudson, Ohio:Lexi-comp Inc; 2013 January 20th 2012 Clinical pharmacology

6. Testosterone treatment options continued
IM injection
Testosterone enanthate or testosterone cypionate
FDA approved dosing: mg q 2-4 weeks
Buccal
Striant ®
30 mg q 12 h applied to gums
Transdermal
Androderm®
Initially 4- 5 mg daily
news.bbc.co.uk
Lexicomp OnlineTM, Lexicomp-Drugs Online, Hudson, Ohio:Lexi-comp Inc; 2013 January 20th 2013 Clinical pharmacology

7. Results of testosterone replacement therapy
Normal serum testosterone levels can be seen:
Androgel (Gel)
After 30 days of application serum testosterone levels have been seen to be within the normal range
Average of 556 ng/dl for 1% and 792 ng/dl for 1.62% gel
Axiron (Solution)
After 14 days of application steady state concentrations have been seen
Injection
After 7 days since the first injection, testosterone levels should be within the range of ng/dl
Striant (Buccal)
After 7 days of therapy , avg testosterone levels were 550 ng/dl in clinical trials
Androderm (Transdermal)
After 14 days of therapy testosterone levels should be between ng/dl
"Androgel-Prescribing information." . Abbott Laboratories, n.d. Web. 27 Jan <
"Prescribing Information-Axiron." . Lilly USA, n.d. Web. 26 Jan <
Bhasin et al. Guidelines for Testosterone Therapy in Androgen-Deficient Men J Clin Endocrinol Metab, June 2010, 95(6):2536–2559
"Prescribing information-Androderm." . Watson Pharma, n.d. Web. 26 Jan <
"Striant-prescribing information." . Columbia laboratories, n.d. Web. 27 Jan <

8. Results of testosterone replacement therapy
In general, overall results of testosterone replacement therapy
Insulin sensitivity- results may be seen within a few days
Glycemic control- results may be seen in months
Changes in body composition- results may be seen in weeks
Saad, F. "Onset of effects of testosterone treatment and time span until maximum effects are achieved." Eur J Endocrinol (2011): Print.

9. Testosterone replacement therapy benefits in diabetes
Study looked at benefits of testosterone replacement therapy in men 30 years of age or older with type 2 diabetes
Crossover Study: Double blind, placebo controlled
Treatment- 200 mg IM testosterone q 2 weeks versus placebo for 3 months
Conclusion: Benefits of testosterone therapy
Insulin resistance was decreased
Glycemic control was improved
Kapoor, D. "Testosterone replacement therapy improves insulin resistance, glycaemic control, visceral adiposity and hypercholesterolaemia in hypogonadal men with type 2 diabetes." European Journal of Endocrinology (2006): Print.

10. Other benefits of testosterone replacement
Testosterone replacement therapy has the potential to:
Boost energy levels
Increase strength and muscle mass
Improve bone mineral density
Reduction of fat
Bassil, N. "The benefits and risks of testosterone replacement therapy: a review." NCBI. US National Library of Medicine National Insitute of Health, 22 Jun Web. 20 Jan <

11. Risks of testosterone replacement
Possible risks associated with testosterone replacement can include:
Increase risk for prostate cancer
BPH symptoms may worsen
Hepatotoxicity or liver failure
Gynecomastia
Infertility
Development of sleep apnea
Bassil, N. "The benefits and risks of testosterone replacement therapy: a review." NCBI. US National Library of Medicine National Insitute of Health, 22 Jun Web. 20 Jan <

12. Concerns with testosterone replacement therapy
Other Adverse Reactions
Reactions at application site such as itching, burning, or blisters
Increase in hemoglobin and hematocrit (H&H)
Contraindications
Men with prostate cancer
Monitoring parameters
Prior to therapy and then after six months
LFT’s, H&H, and lipids
Serum Testosterone
Lexicomp OnlineTM, Lexicomp-Drugs Online, Hudson, Ohio:Lexi-comp Inc; 2013 January 20th 2013 Clinical pharmacology

13. Concerns with testosterone replacement therapy
Drug interactions
Testosterone may increase the concentration of Cyclosporine
Testosterone may increase the effect of Vitamin K antagonists such as warfarin
Testosterone concentration may decrease with usage of St. Johns wart
Lexicomp OnlineTM, Lexicomp-Drugs Online, Hudson, Ohio:Lexi-comp Inc; 2013 January 20th 2013 Clinical pharmacology

14. What if testosterone replacement doesn’t work
If testosterone replacement fails to increase serum testosterone levels then
Stop testosterone replacement therapy
Investigate other possible causes of low serum testosterone levels
Bassil, N. "The benefits and risks of testosterone replacement therapy: a review." NCBI. US National Library of Medicine National Insitute of Health, 22 Jun Web. 20 Jan <

15. Summary
Testosterone is an important hormone that helps maintain many body systems
Testosterone levels decline with age
Testosterone levels are often decreased in obese men and men with type 2 diabetes
Food, drugs, and exercise can all effect testosterone levels

16. Summary
Testosterone replacement therapy along with diet, exercise, and diabetes medications is an option for men with low testosterone and type 2 diabetes
Testosterone treatment options consist of IM injection, topical, transdermal, and buccal dosage forms
If testosterone levels do not increase after testosterone replacement therapy, then medication should be discontinued and further follow up is needed to determine cause of low testosterone

17. References
Bowen, R. "Gonadotropins: Luteinizing and Follicle Stimulating Hormones." . N.p., 13 May Web. 20 Jan <
"Mayo Clinic." Testosterone therapy: Key to male vitality?. Mayo Foundation for Medical Education and Research, 10 Apr Web. 20 Jan <
"Matsumoto, A. "Fundamental Aspects of Hypogonadism in the Aging Male." Rev Urol.. 5.(Suppl 1) (2003): S3-S10. Print.
"Low Testosterone (Low T)." . MedicineNet, 12 Sept Web. 20 Jan <
Wang, C. "Low Testosterone AssociatedWith Obesity and theMetabolic Syndrome Contributes to Sexual Dysfunction and Cardiovascular Disease Risk inMen With Type 2 Diabetes." Diabetes Care. 34.July (2011): Print.
Dhindsa, S. "Testosterone Concentrations in Diabetic and Nondiabetic Obese Men." Diabetes Care. 33. (2010): Print.
"Testosterone decreases after ingestion of sugar (glucose)." The Endocrine Society. N.p., 12 Jun Web. 20 Jan <
Emanuele, M. "Alcohol and the Male Reproductive System." National Institute on Alcohol Abuse and Alcoholism. National Institutes of Health. Web. 20 Jan <
Armanini, D. "Reduction of Serum Testosterone in Men by Licorice." N Engl J Med (1999): Print.
Goodin , S. "Clinical and biological activity of soy protein powder supplementation in healthy male volunteers.." Cancer Epidemiol Biomarkers Prev (2007): Print.
Maskarinec, G. "Serum prostate-specific antigen but not testosterone levels decrease in a randomized soy intervention among men." European Journal of Clinical Nutrition. 60. (2006): Print.
Drug-induced male sexual dysfunction. Pharmacist's Letter/Prescriber's Letter 2006;22(9):
Oishi, S. "Effects of butylparaben on the male reproductive system in rats." Toxicol Ind Health (2001): n. page. Print.
Oishi, S. "Effects of propyl paraben on the male reproductive system." Food and Chemical Toxicilogy (2002): Print.
Linnamo, V. "Acute hormonal responses to submaximal and maximal heavy resistance and explosive exercises in men and women.." J Strength Cond Res (2005): Abstract.
Zmuda, J. "Exercise increases serum testosterone and sex hormone-binding globulin levels in older men.." Metabolism (1996): Abstract.
Melville, N. "Medscape Medical News." Low Testosterone Levels Can Improve With Weight Loss, Exercise. N.p., 26 Jun Web. 20 Jan <
Lexicomp OnlineTM, Lexicomp-Drugs Online, Hudson, Ohio:Lexi-comp Inc; 2013 January 20th 2013 Clinical pharmacology
"Androgel-Prescribing information." . Abbott Laboratories, n.d. Web. 27 Jan <
"Prescribing Information-Axiron." . Lilly USA, n.d. Web. 26 Jan <
Bhasin et al. Guidelines for Testosterone Therapy in Androgen-Deficient Men J Clin Endocrinol Metab, June 2010, 95(6):2536–2559
"Prescribing information-Androderm." . Watson Pharma, n.d. Web. 26 Jan <
"Striant-prescribing information." . Columbia laboratories, n.d. Web. 27 Jan <
Saad, F. "Onset of effects of testosterone treatment and time span until maximum effects are achieved." Eur J Endocrinol (2011): Print.
Kapoor, D. "Testosterone replacement therapy improves insulin resistance, glycaemic control, visceral adiposity and hypercholesterolaemia in hypogonadal men with type 2 diabetes." European Journal of Endocrinology (2006): Print.
Bassil, N. "The benefits and risks of testosterone replacement therapy: a review." NCBI. US National Library of Medicine National Insitute of Health, 22 Jun Web. 20 Jan <