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A Harvard Specialist shares his thoughts on testosterone-replacement therapy

It could be stated that testosterone is the thing that makes men, men. It gives them their characteristic deep voices, big muscles, and body and facial hair, differentiating them from women. It stimulates the growth of the genitals , plays a role in sperm production, fuels libido, and leads to regular erections. It also fosters the creation of red blood cells, boosts mood, and aids cognition.

Over time, the testicular"machinery" which makes testosterone gradually becomes less powerful, and testosterone levels begin to fall, by approximately 1 percent a year, starting in the 40s. As men get into their 50s, 60s, and beyond, they might start to have signs and symptoms of low testosterone like reduced sex drive and sense of energy, erectile dysfunction, diminished energy, reduced muscle mass and bone density, and nausea. Taken together, these signs and symptoms are often called hypogonadism ("hypo" significance low functioning and"gonadism" speaking to the testicles). Researchers estimate that the illness affects anywhere from two to six million men in the United States. Yet it is an underdiagnosed issue, with only about 5 percent of those affected receiving treatment.

But little consensus exists on what constitutes low testosterone, when testosterone supplementation makes sense, or what dangers patients face. Much of the current debate focuses on the long-held belief that testosterone can stimulate prostate cancer.

Dr. Abraham Morgentaler, an associate professor of surgery at Harvard Medical School and the director of Men's Health Boston, specializes in treating prostate diseases and male reproductive and sexual problems. He has developed specific expertise in treating lower testosterone levels. In this interview, Dr. Morgentaler shares his views on current controversies, the treatment plans he uses with his own patients, and he believes experts should reconsider the possible link between testosterone-replacement treatment and prostate cancer.

Symptoms and diagnosis

What signs and symptoms of low testosterone prompt that the average person to find a doctor?

As a urologist, I have a tendency to see men since they have sexual complaints. The primary hallmark of reduced testosterone is reduced sexual desire or libido, but another may be erectile dysfunction, and any man who complains of erectile dysfunction must possess his testosterone level checked. Men can experience other symptoms, such as more trouble achieving an orgasm, less-intense orgasms, a lesser quantity of fluid from ejaculation, and a sense of numbness in the manhood when they see or experience something that would normally be arousing.

The more of the symptoms there are, the more likely it is that a man has low testosterone. Many physicians often discount these"soft symptoms" as a normal part of aging, but they're often treatable and reversible by decreasing testosterone levels.

Aren't those the same symptoms that guys have when they are treated for benign prostatic hyperplasia, or BPH?

Not precisely. There are a number of drugs which may reduce libido, including the BPH drugs finasteride (Proscar) and dutasteride (Avodart). Those drugs may also reduce the quantity of the ejaculatory fluid, no question. But a decrease in orgasm intensity usually does not go along with therapy for BPH. Erectile dysfunction does not ordinarily go together with it , though certainly if a person has less sex drive or less attention, it is more of a challenge to get a good erection.

How do you decide if or not a person is a candidate for testosterone-replacement therapy?

There are two ways that we determine whether somebody has low testosterone. One is a blood test and the other one is by characteristic signs and symptoms, and the correlation between these two approaches is far from ideal. Generally men with the lowest testosterone have the most symptoms and men with highest testosterone have the least. But there are a number of guys who have reduced levels of testosterone in their blood and have no signs.

Looking at the biochemical numbers, The Endocrine Society* considers low testosterone to be a total testosterone level of less than 300 ng/dl, and I think that's a reasonable guide. However, no one really agrees on a few. It is not like diabetes, where if your fasting glucose is above a certain level, they'll say,"Okay, you've got it." With testosterone, that break point is not quite as clear.

*Note: The Endocrine Society publishes clinical practice guidelines with recommendations for who should and shouldn't receive testosterone therapy. See"Endocrine check that Society recommendations summarized." For a complete copy of useful content the guidelines, log on to www.endo-society.org.

Is complete testosterone the ideal point to be measuring? Or if we are measuring something different?

Well, this is another area of confusion and great debate, but I don't think that it's as confusing as it is apparently from the literature. When most physicians learned about testosterone in medical school, they heard about total testosterone, or all the testosterone in the body. But about half of the testosterone that is circulating in the blood is not available to the cells.

The available portion of overall testosterone is known as free testosterone, and it's readily available to the cells. Almost every laboratory has a blood test to measure free testosterone. Though it's just a small fraction of this overall, the free testosterone level is a pretty good indicator of low testosterone. It is not ideal, but the significance is greater than with total testosterone.

Endocrine Society recommendations summarized

This professional organization recommends testosterone treatment for men who have

Therapy Isn't recommended for men who have

  • Breast or prostate cancer
  • a nodule on the prostate which can be felt during a DRE
  • a PSA higher than 3 ng/ml without additional evaluation
  • that a hematocrit greater than 50 percent or thick, viscous blood
  • untreated obstructive sleep apnea
  • severe lower urinary tract symptoms
  • class III or IV heart failure.

Do time of day, diet, or other factors influence testosterone levels?

For many years, the recommendation has been to receive a testosterone value early in the morning since levels start to fall after 10 or even 11 a.m.. But the information behind that recommendation were drawn from healthy young men. Two recent studies demonstrated little change in blood testosterone levels in men 40 and older within the course of the day. One reported no change in typical testosterone till after 2 p.m. Between 6 and 2 p.m., it went down by 13%, a small amount, and probably not enough to affect diagnosis. Most guidelines nevertheless say it's important to perform the test in the morning, however for men 40 and above, it likely doesn't matter much, as long as they obtain their blood drawn before 5 or 6 p.m.

There are a number of very interesting findings about dietary supplements. For instance, it appears that those who have a diet low in protein have lower testosterone levels than males who consume more protein. But diet has not been studied thoroughly enough to create any clear recommendations.

Exogenous vs. endogenous testosterone

Within this guide, testosterone-replacement therapy refers to the treatment of hypogonadism with adrenal gland -- testosterone that is produced outside the body. Depending upon the formula, treatment can cause skin irritation, breast tenderness and enlargement, sleep apnea, acne, reduced sperm count, increased red blood cell count, and additional side effects.

At a recent prospective study, 36 hypogonadal men took a daily dose of clomiphene citrate for at least three months. Within four to six weeks, each one of the guys had heightened levels of testosterone; none reported some side effects during the entire year they had been followed.

Because clomiphene citrate isn't accepted by the FDA for use in men, little information exists regarding the long-term effects of carrying it (such as the risk of developing prostate cancer) or whether it's more effective at boosting testosterone than exogenous formulas. But unlike adrenal gland, clomiphene citrate preserves -- and potentially enriches -- sperm production. That makes drugs such as clomiphene citrate one of just a few choices for men with low testosterone who want to father children.

What kinds of testosterone-replacement treatment are available? *

The oldest form is an injection, which we use because it is cheap and because we reliably become fantastic testosterone levels in almost everybody. The disadvantage is that a man should come in every couple of weeks to get a shot. A roller-coaster effect can also happen as blood glucose levels peak and return to research.

Topical treatments help preserve a more uniform level of blood glucose. The first kind of topical therapy was a patch, but it has a very high rate of skin irritation. In one study, as many as 40 percent of people that used the patch developed a reddish area in their skin. That limits its use.

The most commonly used testosterone preparation in the United States -- and the one I start almost everyone off with -- is a topical gel. The gel comes from tiny tubes or within a unique dispenser, and you rub it on your shoulders or upper arms once a day. Based on my experience, it tends to be absorbed to good levels in about 80% to 85 percent of guys, but leaves a significant number who do not consume enough for this to have a favorable impact. [For specifics on several different formulations, see table ]

Are there any drawbacks to using gels? How long does it take for them to work?

Men who start using the gels have to come back in to have their testosterone levels measured again to be sure they're absorbing the right amount. Our target is the mid to upper assortment of normal, which generally means approximately 500 to 600 ng/dl. The concentration of testosterone in blood actually goes up quite quickly, within a few doses. I normally measure it after 2 weeks, even though symptoms may not change for a month or two.

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