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A Harvard Specialist shares his Ideas on testosterone-replacement therapy

It could be stated that testosterone is the thing that makes guys, men. It gives them their characteristic deep voices, large 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 production of red blood cells, boosts mood, and assists cognition.

As time passes, the "machinery" that produces testosterone gradually becomes less effective, and testosterone levels begin to drop, by about 1 percent per year, beginning in the 40s. As guys get in their 50s, 60s, and beyond, they may begin to have symptoms and signs of low testosterone such as lower libido and sense of vitality, erectile dysfunction, diminished energy, decreased muscle mass and bone density, and anemia. Taken together, these symptoms and signs are often referred to as hypogonadism ("hypo" meaning low working and"gonadism" speaking to the testicles). Yet it's an underdiagnosed problem, with only about 5 percent of these affected receiving treatment.

Studies have revealed that testosterone-replacement therapy may provide a vast range of advantages for men with hypogonadism, such as enhanced libido, mood, cognition, muscle mass, bone density, and red blood cell production. Much of the current debate focuses on the long-held belief that testosterone may 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 difficulties. He's developed particular experience in treating low testosterone levels. In this interview, Dr. Morgentaler shares his views on current controversies, the treatment plans he uses with his patients, and he thinks specialists should rethink the possible connection between testosterone-replacement therapy and prostate cancer.

Symptoms and diagnosis

What symptoms and signs of low testosterone prompt the typical person to see a physician?

As a urologist, I tend to observe guys because they have sexual complaints. The main hallmark of reduced testosterone is low sexual libido or desire, but another can be erectile dysfunction, and any guy who complains of erectile dysfunction should get his testosterone level checked. Men can experience other symptoms, like more trouble achieving an orgasm, less-intense orgasms, a much lesser amount of fluid from ejaculation, and a sense of numbness in the penis when they see or experience something that would usually be arousing.

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

Are not those the same symptoms that guys have when they are treated for benign prostatic hyperplasia, or BPH?

Not exactly. 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 normally doesn't go together with treatment for BPH. Erectile dysfunction does not usually go along with it , though certainly if somebody has less sex drive or less interest, it is more of a struggle to get a good erection.

How can you decide if a man is a candidate for testosterone-replacement therapy?

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

Looking purely 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 sensible guide. However, no one really agrees on a few. It is similar to diabetes, in which if your fasting sugar is over a certain level, they will say,"Okay, you've got it." With testosterone, that break point isn't quite as apparent.

*Notice: The Endocrine Society recommends clinical practice guidelines with recommendations for who should and should not receive testosterone treatment. For a complete copy of these see post instructions, log click for more info on to www.endo-society.org.

Is total testosterone the right thing to be measuring? Or should we be measuring something else?

Well, this is another area of confusion and great debate, but I don't think it's as confusing as it appears to be in the literature. When most doctors learned about testosterone in medical school, they heard about overall testosterone, or all of the testosterone in the body. But about half of the testosterone that's circulating in the bloodstream isn't readily available to cells. It's closely bound to a carrier molecule known as sex hormone--binding globulin, which we abbreviate as SHBG.

The available portion of overall testosterone is known as free testosterone, and it is readily available to the cells. Almost every lab has a blood test to measure free testosterone. Even though it's just a little portion of this total, the free testosterone level is a pretty good indicator of low testosterone. It's not ideal, but the significance is greater compared to total testosterone.

This professional organization urges testosterone therapy for men who have both

Reduced levels of testosterone in the blood (less than 300 ng/dl)
symptoms of low testosterone.

Therapy Isn't Suggested for men who have

Prostate or breast cancer
a nodule on the prostate that may be felt during a DRE
that a PSA greater than 3 ng/ml without further analysis
that a hematocrit greater than 50% 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 elements affect testosterone levels?

For years, the recommendation was to get a testosterone value early in the morning since levels begin to drop after 10 or 11 a.m.. However, the data behind that recommendation were attracted to healthy young men. Two recent studies demonstrated little change in blood testosterone levels in men 40 and mature 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 percent, a modest sum, and probably not enough to influence identification. Most guidelines still say it is important to perform the evaluation in the morning, but for men 40 and above, it likely doesn't matter much, provided that they get their blood drawn before 6 or 5 p.m.

There are some rather interesting findings about diet. By way of 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 treatment refers to the treatment of hypogonadism with exogenous testosterone -- testosterone that is produced outside the body. Depending upon the formulation, therapy can cause skin irritation, breast tenderness and enlargement, sleep apnea, acne, reduced sperm count, increased red blood cell count, along with other side effects.

Within four to six weeks, each one the guys had heightened levels of testosteronenone reported any side effects throughout the year they were followed.

Since clomiphene citrate isn't approved by the FDA for use in males, little information exists regarding the long-term effects of taking it (such as the risk of developing prostate cancer) or whether it's more capable of boosting testosterone than exogenous formulations. But unlike adrenal gland, clomiphene citrate preserves -- and possibly enriches -- sperm production. This makes drugs like clomiphene citrate one of just a few options for men with low testosterone who want to father children.

What kinds of testosterone-replacement therapy are available? *

The oldest form is the injection, which we use since it's inexpensive and because we faithfully become fantastic testosterone levels in nearly everybody. The disadvantage is that a man should come in every couple of weeks to find a shot. A roller-coaster effect can also occur as blood testosterone levels peak and then return to baseline. [Watch"Exogenous vs. endogenous testosterone," above.]

Topical treatments help preserve a more uniform amount of blood glucose. The first form 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 restricts 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. According to my experience, it tends to be absorbed to good levels in about 80% to 85% of men, but that leaves a significant number who do not consume sufficient for it to have a positive impact. [For details on several different formulations, see table ]

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

Men who begin using the implants need to return in to have their testosterone levels measured again to make sure they're absorbing the right amount. Our target is the mid to upper range of normal, which usually means approximately 500 to 600 ng/dl. The concentration of testosterone in blood actually goes up quite quickly, within a few doses. I usually measure it after two weeks, even although symptoms may not alter for a month or two.

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