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Conditions: Low Testosterone

Testosterone Replacement Therapy Rarely Prescribed for Hypogonadal Men

The Controversy

TRT has been the subject of much debate over the last couple of years, with some researchers finding an association between TRT and elevated risk of cardiovascular events.

However, some scientists have questioned the reliability of these studies, especially the methodologies used. Other studies have found that men are not at higher risk of cardiovascular problems and that TRT might actually be protective.

Earlier this year, the FDA called for testosterone manufacturers to include warnings about these possible risks on all product packaging. The agency also reminded the medical community that it has approved TRT only for men with hypogonadism – low testosterone caused by problems in the testes or brain.

In other words, TRT has not been FDA-approved for age-related hypogonadism, the natural decline in testosterone that men experience as they get older. Such hormonal decreases can make men feel sluggish, depressed, and less interested in sex. Some patients find they feel better with TRT.

It’s unclear whether the controversy has steered some clinicians away from prescribing the therapy. Still, if you think testosterone would benefit your patients, it’s important to understand the pros and cons.

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Conditions: Low Testosterone

Testosterone Controversy Continues

Cardiovascular Risk: No Scientific Basis

The FDA announcement comes after a January 2015 report in Mayo Clinic Proceedings, which found no scientific basis to support a link between testosterone therapy and cardiovascular risk.

The authors, members of The Androgen Study Group, analyzed dozens of studies related to testosterone and cardiovascular health published between 1940 and August 2014. Of all the studies analyzed, only four reported an increase in cardiovascular risk for men on testosterone therapy, including the JAMA study noted above.

However, other studies found that testosterone therapy could actually improve cardiovascular health. For example, low testosterone was associated with atherosclerosis, coronary artery disease, and death from cardiovascular disease. Maintaining normal levels of testosterone could reduce cardiovascular risk factors like obesity, high blood pressure, and poor blood glucose control.

The authors could not definitively say that testosterone therapy was safe in light of cardiovascular risk. More research is needed, they explained.

Still, their review of the literature led them to this conclusion:

 “In summary, we find no scientific basis for the suggestion that [testosterone] therapy increases [cardiovascular] risk. In fact, as of this date, we are unaware of any compelling evidence that [testosterone] therapy is associated with increased [cardiovascular] risk. On the contrary, the weight of evidence accumulated by researchers around the world over several decades clearly indicates that higher levels of [testosterone] are associated with amelioration of [cardiovascular] risk factors and reduced risk of mortality.” (emphasis in original text)

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Conditions: Low Testosterone

Testosterone Concerns

As a healthcare professional, you’ve no doubt heard the buzz about testosterone and “low T.”

Testosterone ConcernsIt’s normal for men’s testosterone levels to decline as they age. This decline leaves some men feeling run down and depressed. They may lose interest in sex and develop erectile problems.

It may be easy to suggest that low testosterone is the culprit. Testosterone is widely marketed and often touted as an elixir that can return youth and vitality to the middle-aged man.

Certainly there are benefits to testosterone therapy. It can improve muscle power and bone mineral density. For some men, mood, libido, and erectile function get better as well.

But testosterone therapy is not appropriate for every man. If your patients are thinking about taking testosterone, several concerns should be addressed:

  • Testosterone therapy may not be needed. Symptoms such as fatigue, decreased sex drive, depression, and erectile dysfunction could very well signal testosterone deficiency. But these symptoms might be explained by other conditions, too. It’s important for patients to have a thorough examination before testosterone is prescribed. Also, some symptoms may be alleviated through lifestyle changes, like improved diet and exercise, making testosterone treatment unnecessary.
  • Testosterone therapy may have risks. At the end of January 2014, the U.S. Food and Drug Administration (FDA) announced its plans to investigate the safety of FDA-approved testosterone products. This decision came after two studies raised the agency’s concern. The first study, published in the Journal of the American Medical Association (JAMA) in November 2013, found increased risk of heart attack, stroke and death among men who took testosterone after coronary angiography. The second, which appeared two months later in PLOS One, found that heart attack risk increased for men aged 65 and older and for men younger than 65 with a history of heart disease. (Younger men with no history of heart disease were not at increased risk.)
  • Study funding may skew results, making them difficult to interpret. In a Medscape slideshow presentation, Dr. Charles Vega of the University of California, Irvine points out that half of the clinical trials examining cardiovascular events and testosterone have been sponsored by the pharmaceutical industry. In sponsored trials, the rate of cardiovascular events is 4%. In non-sponsored trials, the rate is 8%.
  • Men may try over-the-counter testosterone products, which can be risky. Some men feel embarrassed to discuss their symptoms with a physician, especially if they’re having sexual problems. They may see advertisements for testosterone products or hear about them from friends. Ordering such products online or picking them up at the drugstore may seem like a good way to avoid going to the doctor. But over-the-counter products are not always what they seem. They may include ingredients that aren’t listed on the label. These ingredients may cause dangerous interactions with drugs the man is already taking. Over-the-counter supplements are not regulated by the FDA. In the United States, testosterone is a controlled substance and illegal to sell without a prescription. (For more details on the risks of over-the-counter testosterone supplements, please click here.)

So who should take testosterone and how should therapy be managed?

Dr. Vega makes the following suggestions:

Only symptomatic men should be evaluated for possible [testosterone deficiency], and [testosterone deficiency] should not be diagnosed without 2 morning testosterone levels that are unequivocally low. Serum testosterone levels should be reevaluated 3-6 months after the initiation of testosterone treatment, with the goal of achieving serum testosterone levels in the mid-normal range. [Testosterone therapy] should be prescribed only for men who truly need it, and these men require close follow-up to ensure that treatment goals are met and to avoid overtreatment. Caution is warranted in recommending [testosterone therapy] to men at high [cardiovascular] risk.

Testosterone therapy can do a lot of good. But it’s important to consider it in full context.


Print this article or view it as a PDF file here: Testosterone Concerns


Resources

Medscape

Black, Henry, MD

“When Men Want Testosterone, Show Them the Evidence”

(January 24, 2014)

http://www.medscape.com/viewarticle/819393?src=wnl_edit_specol

Vega, Charles P., MD

“Putting the ‘T’rouble in Testosterone Therapy?”

(January 30, 2014)

http://www.medscape.com/viewarticle/819766

Vega, Charles P., MD

“‘T’errific or ‘T’errible? A Review of Testosterone Deficiency”

(Slideshow. February 18, 2014)

http://www.medscape.com/features/slideshow/testosterone-deficiency#1

Sexual Medicine Society of North America

“FDA to Review Safety of Testosterone Therapy”

(February 12, 2014)

http://www.sexhealthmatters.org/news/fda-to-review-safety-of-testosterone-therapy

“Marketing Low Testosterone”

(May 29, 2013)

http://www.sexhealthmatters.org/news/marketing-low-testosterone

“Risks and Realities of OTC Testosterone Supplements”

(April 9, 2013)

http://www.sexhealthmatters.org/sex-health-blog/risks-and-realities-of-otc-testosterone-supplements

Conditions: Low Testosterone

Testosterone Gel and BMI

If your patients or clients include older men, it’s likely that some have low testosterone (also called hypogonadism). Testosterone is an important hormone for men. It’s responsible for secondary sex characteristics like facial hair and a deepening voice. It also contributes much to a man’s sex life.

Testosterone levels naturally decline as men age. Some experts call this andropause and liken it to the estrogen decreases associated with female menopause, although this comparison is not entirely accurate. Testosterone declines for men tend to be more subtle than the estrogen declines in women.

Still, low testosterone can be troublesome. Men may feel fatigued and weak. They may lose muscle mass and gain body fat. And they often develop sexual problems, such as low sex drive and erectile dysfunction.

Some men replenish their testosterone through a prescription testosterone 2% gel. However, the effects of body mass index (BMI) on this type of therapy have not been widely studied.

New Research

In November 2013, the Journal of Sexual Medicine published a study by American researchers who examined the issue. They worked with 149 men between the ages of 18 and 75 who had baseline testosterone levels below 250/300 ng/dL. (According to the U.S. National Institutes of Health, a range of 300 – 1,000 ng/dL is considered normal.)

The men were divided into three groups based on their baseline BMIs. Tertile 1 included men with BMIs less than or equal to 29.1 kg/m2. The BMIs of men in Tertile 2 ranged from 29.2 to 32.4 kg/m2. Men in Tertile 3 had BMIs greater than 32.4 kg/m2).  The mean ages for the men in Tertiles 1, 2, and 3 were 52.9, 54.0, and 54.2, respectively.

Each man used a testosterone 2% gel for 90 days. The gel was applied to the front and inner thigh. If needed, the dosage could be adjusted at specified points during the study.

After 90 days, the researchers found that 79.1% of the men in Tertile 1, 79.5% of the men in Tertile 2, and 73.8% of the men in Tertile 3 had testosterone levels in the normal range. Men with BMIs greater than 32.4 kg/m2 needed higher doses of testosterone to reach this goal, however.

The researchers found that the treatment was generally well tolerated, even for men who had increased doses. The most common adverse events were skin reactions, upper respiratory infections, and sinusitis.

Using Testosterone With Care

If you have a patient considering testosterone gel therapy, here are a few points to keep in mind:

·         Therapy should be conducted under a doctor’s care. Only a qualified physician can determine the proper dose of testosterone for that individual patient. A doctor can also do a thorough examination to determine whether a man’s symptoms are indeed cause by low testosterone or whether other factors are involved.

·         Men should be cautioned about over-the-counter testosterone supplements, which are widely marketed. Again, testosterone therapy should be done under a physician’s guidance. Over-the-counter preparations can be risky. (Click here to learn more about these risks.)

·         Men using a testosterone gel should follow the doctor’s instructions carefully and read the accompanying medication guide. The application area should be covered to avoid transferring the gel to others, especially women and children. This guide, provided by the U.S. Food and Drug Administration, provides more information on the proper use of testosterone gel.

For More Information

We provide comprehensive information on low testosterone here. Your colleagues and managers may also provide details relevant to your particular clinical site.


Print this article or view it as a PDF file here: Testosterone Gel and BMI


Resources

The Journal of Sexual Medicine

Dobs, Adrian, MD, et al.

“Testosterone 2% Gel Can Normalize Testosterone Concentrations in Men with Low Testosterone Regardless of Body Mass Index”

(Full-text. First published online: November 28, 2013)

http://onlinelibrary.wiley.com/doi/10.1111/jsm.12411/full

Medline Plus

“Testosterone”

(Page updated: March 22, 2012)

http://www.nlm.nih.gov/medlineplus/ency/article/003707.htm

Sexual Medicine Society of North America

“Risks and Realities of OTC Testosterone Supplements”

(April 9, 2013)

http://www.sexhealthmatters.org/sex-health-blog/risks-and-realities-of-otc-testosterone-supplements

U.S. Food and Drug Administration

“Testosterone Gel”

(Medication guide. February 2012)

http://www.fda.gov/downloads/drugs/drugsafety/ucm294248.pdf

Conditions: Low Testosterone

PSA Test and Hypogonadism

Can a test used to screen for prostate cancer be used to confirm hypogonadism in men with sexual dysfunction? It’s possible, according to new research published in the Journal of Sexual Medicine in July 2013.

What is Hypogonadism?

Hypogonadism occurs when a man’s body doesn’t produce enough – or any - testosterone. The problem may stem from a problem with the testes, which produce the hormone. Or, it may result from problems in the brain, specifically the hypothalamus or pituitary gland, both of which play a role in testosterone production.

Testosterone is important to men’s health. It has a huge effect on sex drive and is involved with erectile function. It gives men their secondary sex characteristics, like facial hair and a deeper voice. It’s also involved with sperm production, strength, and muscle mass.

When men have hypogonadism, they often feel weaker, fatigued, and moody. Their sex drive decreases and they may have trouble getting erections. Their testicles may get smaller; their breasts may get larger. Low testosterone levels also put them at higher risk for osteoporosis.

It’s natural for men’s testosterone levels to gradually decline as they age. Testosterone therapy may help, but should be done under a doctor’s care.

What is the PSA Test?

PSA stands for prostate-specific antigen. Produced by the prostate gland, PSA is a protein that helps liquefy semen. The PSA test is a common, though controversial, screening tool for prostate cancer. A PSA reading above 4.0 ng/mL usually prompts more screening. However, such readings do not always indicate cancer.

What is the connection between PSA and Hypogonadism?

In this study, Italian researchers were interested in late onset hypogonadism. They noted that past research on the relationship between PSA and testosterone levels was “controversial” and set out to investigate whether PSA could be a useful marker for low testosterone in men with sexual problems.

Their study involved almost 3,000 men seeking treatment for sexual dysfunction. None of the men had had prostate disease before the study. Men with PSA levels above 4 ng/mL were excluded. The participants ranged in age from 18 to 85 years (mean age 52.5).

In addition to taking a variety of measurements, such as waist circumference, total testosterone, testis volume, blood pressure, and HDL cholesterol, the researchers interviewed the men and had them complete questionnaires designed to assess hypogonadism.

The researchers found that after adjusting for age, lower PSA levels were linked to conditions associated with hypogonadism, including delayed puberty, lower testis volume, metabolic syndrome, type 2 diabetes, and cardiovascular disease. Men with lower PSA levels were also more likely to have problems with erections.

While these results did show that low PSA might help confirm a hypogonadism diagnosis, the study authors said the efficacy of PSA testing for this purpose was “modest.”

They explained that the relationship between PSA levels and testosterone was more evident when men’s testosterone levels were below average. The link was not as strong for men with normal testosterone levels. In the research, PSA levels did not rise when testosterone readings were above 8 nmol/L.

Also, the findings were more accurate in younger patients. When men are over a certain age, other factors are more likely to affect PSA. In these cases, using PSA to confirm hypogonadism could be less reliable.

With these points in mind, however, PSA testing could still help clinicians evaluate symptoms of hypogonadism in men with sexual dysfunction.

Resources

International Society for Sexual Medicine

“Serum PSA and Testosterone Levels”

(September 2013)

http://www.issm.info/news/sex-health-headlines/serum-psa-and-testosterone-levels

The Journal of Sexual Medicine

Rastrelli, Giulia, MD, et al.

“Serum PSA as a Predictor of Testosterone Deficiency”

(Full-text. First published online: July 16, 2013)

http://onlinelibrary.wiley.com/doi/10.1111/jsm.12266/abstract

National Cancer Institute

“Prostate-Specific Antigen (PSA) Test”

http://www.cancer.gov/cancertopics/factsheet/detection/PSA

Sexual Medicine Society of North America

“Conditions – Low Testosterone”

http://www.sexhealthmatters.org/low-testosterone/conditions-low-testosterone

“Diagnosing Low Testosterone”

http://www.sexhealthmatters.org/low-testosterone/diagnosing-low-testosterone

“Overview – Low Testosterone”

http://www.sexhealthmatters.org/low-testosterone/overview-low-testosterone

“Prostate Cancer – PSA Test Revisited”

(November 11, 2011)

http://www.sexhealthmatters.org/sex-health-blog/prostate-cancer-psa-test-revisited

Conditions: Low Testosterone

Causes - Low Testosterone

What are the symptoms/conditions of low testosterone?

Decreased testosterone causes a wide variety of clinical findings. The sexual manifestations of low testosterone include diminished sexual desire and sense of vitality as well as erectile dysfunction.

Additionally, men with low testosterone may experience decreased size or firmness of the testicles, breast enlargement and muscle loss. The growth of body hair usually slows, but the voice and size of the penis typically do not change. Hypogonadism also increases the risk of osteoporosis and fractures. Mental and emotional symptoms similar to those of menopause - mood swings, depression, irritability and fatigue may occur. When the onset is rapid, men can experience hot flashes.

Conditions: Low Testosterone

Treating Low Testosterone

Are there testosterone pills available?

Testosterone pills are available, but physicians generally do not recommend them. In this form, testosterone is metabolized quickly and cannot achieve sufficient blood levels to be useful. The use of testosterone in this form has been associated with dangerous side effects in the liver, including benign and malignant tumors.

Reformulation of testosterone undecanoate, an oral testosterone therapy used in Europe that is not associated with significant liver toxicity, is being tested in the United States.

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Conditions: Low Testosterone

Diagnosing Low Testosterone

How are low testosterone levels diagnosed?

If a physician suspects low testosterone based on symptoms and physical examination, the diagnosis must be confirmed by laboratory testing.

Most circulating testosterone is bound to sex hormone-binding globulin and albumin. In young adult men, only about 2 percent of testosterone is unbound (free testosterone). Total testosterone (bound plus free testosterone) is the preferred measure since tests for free-testosterone are not as accurate.

Testosterone levels are best measured early in the morning. This is because testosterone level has a daily pattern (diurnal) where it is most abundant at about 8:00 a.m.

Testing of LH and FSH, other hormones that stimulate the testes, are also performed to determine whether the cause of low testosterone is primary or secondary.

Conditions: Low Testosterone

Overview - Low Testosterone

What is hypogonadism and the role of Testosterone?

Hypogonadism refers to reduced or absent secretion of testosterone. Testosterone is produced primarily by the testes. Testosterone plays an important role in the development and maintenance of many male physical characteristics such as sex drive, sperm production, muscle mass and strength, fat distribution and bone mass.

In primary hypogonadism, the testes themselves do not function properly. Secondary hypogonadism occurs if there are problems in the brain, (hypothalamus or pituitary gland), both of which play important roles in controlling the sex glands.

As a man ages, it is normal for testosterone levels to gradually decline. In America, approximately 2 million to 4 million American men have hypogonadism, but only about five percent currently receive treatment. In 2003, a large VA center survey suggests that the prevalence of men presenting with impaired libido and erectile dysfunction due to low testosterone may actually be much larger than previously thought.

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