Davisville Guardian Pharmacy > Compounding > Andropause


Androgen deficiency in the aging male (ADAM), also known as Andropause, affects an estimated 1 in 200 men. Symptoms of testosterone deficiency may include:

  • weakness
  • fatigue
  • reduced libido
  • osteoporosis

A man may be considered hypogonadal at any age if total testosterone is less than 200 ng/dl, or bioavailable testosterone is less than 60 ng/dl. Basaria and Dobs of Johns Hopkins University recommend that elderly men with symptoms of hypogonadism and a total testosterone level < 300ng/dl should be started on hormone replacement.

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Testosterone vs. Synthetics

What is the Optimal Form of Testosterone for Replacement Therapy?

Testosterone USP is natural bio-identical testosterone that has been approved by the United States Pharmacopoeia and is available as a bulk chemical. Upon a prescription order, compounding pharmacists can use Testosterone USP to prepare numerous dosage forms.

Natural Testosterone Replacement is Central to the Treatment of All Facets of Andropause. The term “testosterone” is often used generically when referring to numerous synthetic derivatives, as well as natural bio-identical testosterone. Confusion is responsible for conflicting data in the medical literature about the benefits and risks of testosterone therapy. Studies must be reviewed carefully to determine the form of testosterone that was used. Natural testosterone must not be confused with synthetic derivatives or “anabolic steroids,” which when used by athletes and bodybuilders have caused disastrous effects. For example, administration of synthetic non-aromatizable androgens, like stanozolol or methyltestosterone, causes profound decreases in HDL-C (“good cholesterol”) and significant increases in LDL-C (“bad cholesterol”). Yet, hormone replacement with aromatizable androgens, such as testosterone, results in lower total cholesterol and LDL cholesterol levels while having little to no impact on serum HDL cholesterol levels. Proper monitoring of laboratory values and clinical response are essential when prescribing testosterone replacement therapy.

The only absolute contraindications to androgen replacement therapy are the presence of prostate or breast cancer. “Although it is known that the clinical course of prostate cancer is accelerated by testosterone, its incidence is not increased by [testosterone] administration… There is even no clear evidence that testosterone replacement accelerates the development of BPH.”

Drugs & Aging 1999 Aug;15(2):131-42

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Goals of Therapy

Goals of Testosterone Replacement Therapy in Adult Hypogonadal Men (age 50 or older)

  • Improvement in psychological well-being and mood
  • Improvement in erectile dysfunction
  • Improvement in libido
  • Increased muscle mass
  • Increased strength and stature
  • Preservation of bone mass
  • Possible decrease in cardiovascular risk

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Supporting Literature

Administration of transdermal testosterone (T) gel formulation to hypogonadal men provided dose-proportional increases in serum T levels to the normal adult male range. Testosterone 1% gel (50 or 100 mg/day) was compared to the permeation-enhanced T patch. After 180 days, skin irritation was reported in 5.5% of subjects treated with T gel and in 66% of subjects in the permeation-enhanced T patch group. This research at UCLA concluded that T gel replacement improved sexual function and mood, increased lean mass and muscle strength (principally in the legs), and decreased fat mass in hypogonadal men with less skin irritation and discontinuation compared with the recommended dose of the permeation-enhanced T patch.

J Clin Endocrinol Metab. 2000 Aug;85(8):2839-53
Transdermal testosterone gel improves sexual function, mood, muscle strength, and body composition parameters in hypogonadal men. Testosterone Gel Study Group.

Wang C, Swedloff RS, Iranmanesh A, Dobs A, Snyder PJ, Cunningham G, Matsumoto AM, Weber T, Berman N.
Department of Medicine, Harbor-University of California-Los Angeles Medical Center and Research and Education Institute, Torrance 90509, USA.

Click here to access the PubMed abstract of this article

The following study concluded that replacing testosterone in hypogonadal men increases bone mineral density of the spine and hip, fat-free mass, prostate volume, erythropoiesis, energy, and sexual function. The full effect of testosterone on bone mineral density took 24 months, but the full effects on the other tissues took only 3-6 months.

J Clin Endocrinol Metab 2000 Aug;85(8):2670-7
Effects of testosterone replacement in hypogonadal men.

Snyder PJ, Peachey H, Berlin JA, Hannoush P, Haddad G, Dlewati A, Santanna J, Loh L, Lenrow DA, Holmes JH, Kapoor SC, Atkinson LE, Strom BL.
Department of Medicine, University of Pennsylvania School of Medicine, Philadelphia 19104, USA.

Click here to access the PubMed abstract of this article

Am J Med 2001 May;110(7):563-72
Hypogonadism and androgen replacement therapy in elderly men.

Basaria S, Dobs AS.
Division of Endocrinology and Metabolism, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.

Click here to access the PubMed abstract of this article

Drugs Aging 1999 Aug;15(2):131-42
Risks versus benefits of testosterone therapy in elderly men.

Basaria S, Dobs AS.
Division of Endocrinology and Metabolism, Johns Hopkins University, Baltimore, Maryland 21287, USA.

Click here to access the PubMed abstract of this article

The findings below suggest that low levels of testosterone and SHBG play some role in the development of insulin resistance and subsequent type 2 diabetes.

Diabetes Care 2000 Apr;23(4):490-4
Testosterone, sex hormone-binding globulin, and the development of type 2 diabetes in middle-aged men: prospective results from the Massachusetts male aging study.

Stellato RK, Feldman HA, Hamdy O, Horton ES, McKinlay JB.
New England Research Institutes, Watertown, Massachusetts, USA.

Click here to access the PubMed abstract of this article

Manifestations of testosterone deficiency have included depression, anxiety, irritability, insomnia, weakness, diminished libido, impotence, poor memory, reduced muscle and bone mass, and diminished sexual body hair. Although testosterone levels decline with age, there is great interindividual variability.

Am J Psychiatry 1998 Oct;155(10):1310-8
Age-associated testosterone decline in men: clinical issues for psychiatry.

Sternbach H.
Department of Psychiatry, UCLA-Neuropsychiatric Institute, Los Angeles, USA.

Click here to access the PubMed abstract of this article

Massive obesity in males is associated with decreased total and free testosterone levels as well as elevated estradiol levels.

Med Hypotheses 1999 Jan;52(1):49-51
The hypogonadal-obesity cycle: role of aromatase in modulating the testosterone-estradiol shunt-a major factor in the genesis of morbid obesity.

Cohen PG.

Click here to access the PubMed abstract of this article

These results suggest that testosterone treatment might improve depressed mood in older men who have low levels of bioavailable testosterone.

J Clin Endocrinol Metab 1999 Feb;84(2):573-7
Bioavailable testosterone and depressed mood in older men: the Rancho Bernardo Study.

Barrett-Connor E, Von Muhlen DG, Kritz-Silverstein D.
Department of Family and Preventive Medicine, School of Medicine, University of California, San Diego, La Jolla, CA 92093-0607

Click here to access the PubMed abstract of this article

The following results suggest that until the age of 60 years, the mean serum level of DHEAS is lower in patients with ED than in healthy volunteers.

Urology 2000 May;55(5):755-8
Serum dehydroepiandrosterone sulfate concentrations in men with erectile dysfunction.

Reiter WJ, Pycha A, Schatzl G, Klingler HC, Mark I, Auterith A, Marberger M.
Department of Urology, University of Vienna, Vienna, Austria.

Click here to assess the PubMed abstract of this article.

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