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Compounded Testosterone Gels: A Guide for Clinicians and Pharmacists

Author(s):  Cutter Christopher B

Issue:  Nov/Dec 2000 - Compounding for Hormone Replacement Therapy
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Page(s):  432-437

Compounded Testosterone Gels: A Guide for Clinicians and Pharmacists Page 1
Compounded Testosterone Gels: A Guide for Clinicians and Pharmacists Page 2
Compounded Testosterone Gels: A Guide for Clinicians and Pharmacists Page 3
Compounded Testosterone Gels: A Guide for Clinicians and Pharmacists Page 4
Compounded Testosterone Gels: A Guide for Clinicians and Pharmacists Page 5
Compounded Testosterone Gels: A Guide for Clinicians and Pharmacists Page 6

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Abstract:  In this article, the author reviews the basic pathophysiological mechanisms of hypogonadism, emphasizing the role of the compounding pharmacist in the case of these special patients. Regarding compounding gels, he reports on a clinical study involving 10 men that he conducted in 1988 showing that compounded testosterone gels (Pluronic lecithin organogel) or an alcohol-based gel was highly effective and met with high patient acceptance. Patients were withdrawn from their previous testosterone therapy and had baseline levels of hormones measured 2-4 weeks later. Therapy was initiated with testosterone Pluronic lecithin organogel at low doses (1% to 1.5%, 1 to 2 mL) applied at bedtime. Serum levels of total and free testosterone were drawn at weekly intervals, and the amount or concentration of the testosterone gel was then increased as needed. Although some begin to exhibit therapeutic levels of testosterone at the initial dose, most required much higher concentrations (up to 10%). After doses had been titrated upward for 2 weeks, all subjects exhibited adequate therapeutic levels of total androgens. However, results demonstrated great intra- and interpatient variation in response to therapy, so monitoring serum hormone levels was essential for proper titration of the dose. An estimated absorption efficiency of the gels was from 6% to 50% of the applied amount. The author also discusses percutaneous therapy, application site and patient monitoring. He concludes that testosterone gels are effective when properly used and that monitoring the levels of androgens and estrogen enables the physician to determine the effectiveness of the prescribed dosage and application site. Compounded preparations have the advantages of providing dosing flexibility and being priced very reasonably. Tables provide information regarding causes of primary and secondary hypogonadism, disease states associated with hypogonadism, medication and factors associated with hypogonadism, symptoms and

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