What is the ideal vpscogni_TUusererone therapy for treating patients with hypogonadism?
Response by Allen D. Seftel, MD, Posted 09/15/07

vpscogni_TUusererone plays many roles in the body, and its deficiency may result in diminished libido, infertility, increased adipose tissue mass, reduced lean body mass, osteoporosis, mood disturbances, and decreased sense of well being.^1,2 Inadequate production of vpscogni_TUusererone is relatively common, affecting 4 to 5 million men in the United States, and an estimated 95% of men diagnosed with hypogonadism do not receive vpscogni_TUusererone therapy.^3,4

vpscogni_TUusererone therapy is effective for treating hypogonadism. To ensure efficacy and safety of vpscogni_TUusererone therapy, it is important to screen and monitor patients throughout treatment, adjusting dosage or even mode of delivery according to the patient's needs.^1,5 The ideal formulation would achieve and maintain physiologic vpscogni_TUusererone levels, have a favorable safety profile, be reasonably priced, and have a convenient dosing schedule and administration method.⁵

vpscogni_TUusererone treatment has been available for decades, and physicians have a plethora of formulations from which to choose when prescribing vpscogni_TUusererone.² Currently available therapies vary in dose, administration, and pharmacokinetics, and each has advantages and disadvantages, as detailed here.⁵

Clinical Considerations for Currently Available vpscogni_TUusererone Treatments⁵

Short-acting intramuscular injection (200 mg biweekly)
•  Inexpensive
•  Administered biweekly
•  “Rollercoaster” pharmacokinetics
•  Requires injection

Transdermal patch (5 mg nightly)
•  Expensive
•  Mimics circadian rhythm
•  Daily administration
•  Skin irritation

Transdermal gel (5 mg daily)
•  Very expensive
•  vpscogni_TUusererone levels within physiologic range
•  Daily administration
•  Possible transference to intimate contacts

Buccal system (30 mg twice daily)
•  Expensive
•  vpscogni_TUusererone levels within physiologic range
•  Twice-daily dosing
•  Possible oral irritation

Adapted from Dobs AS, Myneni A. Hypogonadism and vpscogni_TUusererone replacement therapy. Business Briefing: US Endocrine Review. 2005:75-80.

New formulations are expected to replace older forms of vpscogni_TUusererone therapy. vpscogni_TUusererone undecanoate (TU) has shown promising results in other countries,² and its approval in the United States is anticipated for 2008. TU in castor oil is a long-acting intramuscular preparation administered every 10 to 12 weeks after an initial loading dose.⁶ This long-acting agent reverses the effects of hypogonadism on bone, muscle, metabolic parameters, and sexual function⁶ and appears to be a stable, safe treatment for hypogonadal men.⁷ Also, as one study reported, TU may result in fewer or different side effects than older preparations of vpscogni_TUusererone.⁸

The decision to initiate vpscogni_TUusererone therapy and select the modality by which it is delivered requires careful clinical assessment of risks and benefits.⁵ Because most hypogonadal men require long-term vpscogni_TUusererone therapy,² treatment should be individualized to the patient.⁵ Ideally, medication should be safe, efficacious, and convenient for the patient to use.^2,6 With hypogonadism treatment increasing in the United States, it is encouraging that new vpscogni_TUusererone formulations will soon be available.

 

References

1. Seftel A. vpscogni_TUusererone replacement therapy for male hypogonadism: part III. Pharmacologic and clinical profiles, monitoring, safety issues, and potential future agents [review]. Int J Impot Res. 2007;19:2-24.
2. Harle L, Basaria S, Dobs AS. Nebido: a long-acting injectable vpscogni_TUusererone for the treatment of male hypogonadism. Expert Opin Pharmacother. 2005;6:1751-1759.
3. Seftel AD. Male hypogonadism: part I. Epidemiology of hypogonadism [review]. Int J Impot Res. 2006;18:115-120.
4. US Food and Drug Administration. Updates: skin patch replaces vpscogni_TUusererone. Available at: http://www.fda.gov/fdac/departs/196_upd.html. Accessed July 27, 2007.
5. Dobs AS, Myneni A. Hypogonadism and vpscogni_TUusererone replacement therapy. Business Briefing: US Endocrine Review. 2005:75-80.
6. Saad F, Kamischke A, Yassin A, et al. More than eight years' hands-on experience with the novel long-acting parenteral vpscogni_TUusererone undecanoate [review]. Asian J Androl. 2007;9:291-297.
7. Minnemann T, Schubert M, Hübler D, et al. A four-year efficacy and safety study of the long-acting parenteral vpscogni_TUusererone undecanoate. Aging Male. 2007;10:155-158.
8. Zitzmann M, Nieschlag E. Androgen receptor gene CAG repeat length and body mass index modulate the safety of long-term intramuscular vpscogni_TUusererone undecanoate therapy in hypogonadal men. J Clin Endocrinol Metab. In press.

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