Treatment for Hypogonadism
Treatment for testosterone deficiency caused by a medical condition involves hormone replacement therapy. Methods of delivery include transdermal, mucoadhesive, and intramuscular injection, depending in part on the age of the man and the duration of deficiency. Oral testosterone (methyltestosterone, Testred) is associated with liver toxicity and liver tumors and so is prescribed sparingly.
In adult men, treatment for low T is aimed at maintaining secondary sex characteristics; improving energy, strength, mood, and feelings of well-being; and preventing bone degeneration.
In November 2013, the results of a study suggesting a possible link between testosterone treatments and an increased risk for heart attacks, strokes, and death in older men with other health problems were published in the Journal of the American Medical Association.
More research is needed to further evaluate this potential link, but in January 2014, the U.S. Food and Drug Administration (FDA) announced that prescription products are approved only to treat low T caused by certain medical conditions. The benefits and safety of testosterone replacement therapy to treat of testosterone deficiency caused by aging have not been established, even if the condition causes symptoms.
Also in 2014 (June), the FDA announced that all approved testosterone products must carry a warning about an increased risk for blood clots (venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism. Men should discuss their treatment and possible risks with their health care provider.
Transdermal delivery (i.e., through the skin) with a testosterone patch is becoming the most common method of treatment for testosterone deficiency in adults. It establishes and maintains adequate serum levels in as many as 92 percent of men treated, without causing significant side effects.
A patch is worn, either on the scrotum or elsewhere on the body, and testosterone is released through the skin at controlled intervals. Patches are typically worn for 12 or 24 hours and can be worn during exercise, bathing, and strenuous activity. Two transdermal patches that are available are Androderm (nonscrotal) and Testoderm (scrotal).
The Androderm patch is applied to the abdomen, lower back, thigh, or upper arm and should be applied at the same time every evening between 8 p.m. and midnight. If the patch falls off before noon, replace it with a fresh patch until it is time to reapply a new patch that evening. If the patch falls off after noon, do not replace it until you reapply a new patch that evening.
The most common side effects associated with transdermal patch therapy include itching, discomfort, and irritation at the site of application. Some men may experience fluid retention, acne, and temporary abnormal breast development (gynecosmastia).
AndroGel and Testim are transdermal gels that are applied once daily to the clean dry skin of the upper arms or abdomen. When used properly, these gels deliver testosterone for 24 hours. The gel must be allowed to dry on the skin before dressing and must be applied at least 6 hours before showering or swimming. Gels cannot be applied to the genitals.
AndroGel is available in a metered-dose pump, which allows physicians to adjust the dosage of the medication. Side effects of transdermal gels include adverse reactions at the site of application, acne, headache, and hair loss (alopecia).
Striant (testosterone buccal system) mucoadhesive CIII is a hormone-replacement treatment that delivers testosterone twice daily through a tablet-like buccal system that adheres to the gum or cheek. It is placed in the mouth where the gum meets the upper lip and dissolves into a gel that remains in place for 12 hours. As the product absorbs moisture, it gradually releases testosterone directly into the bloodstream, bypassing the gastrointestinal tract and the liver. In clinical trials, approximately 87% of patients obtained normal testosterone levels using Striant.
Side effects are usually mild and transient (i.e., come and go) and resolve within 2 weeks. They include gum or mouth irritation, pain, and swelling (edema); bitter taste, and headache. Abnormal breast development (gynecomastia) may also occur. Patients should report persistent gum abnormalities to their physician.
Striant should not be used in men with prostate or breast cancer and should be used with caution in patients with chronic heart, kidney, liver, or lung disease. It may cause edema, congestive heart failure, and sleep apnea, and may increase the risk for enlarged prostate and prostate cancer. Patients taking the medication must undergo regular digital rectal examinations (DRE) and prostate-specific antigen (PSA) tests to monitor for signs of the disease.
Intramuscular injection (IM) is used less frequently because it is associated with erratic testosterone levels. The primary adverse effect associated with injected testosterone involves fluctuating mood, energy level, and libido caused by testosterone levels that rise rapidly upon injection and then fall too low before the next dose.
Kallmann's syndrome may be treated with chorionic gonadotropin, which can correct undescended testicles (cryptorchidism) and infertility. Gonoadotropin releasing hormone (GnRH) therapy can trigger secretion of testosterone and other sex steroids, initiate virilization, and may establish fertility.
Children and adolescents with low testosterone and delayed puberty may be treated with low doses of testosterone through intramuscular injection to induce puberty. Adolescents may receive gradually increasing doses that last longer in the body, because, with age, there is less risk for affecting normal growth patterns.