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A Harvard Specialist shares his Ideas on testosterone-replacement therapy

A meeting with Abraham Morgentaler, M.D.

It could be said that testosterone is what makes men, men. It gives them their characteristic deep voices, large muscles, and facial and body hair, distinguishing them from women. It stimulates the growth of the genitals at puberty, plays a role in sperm production, fuels libido, and contributes to normal erections. It also boosts the creation of red blood cells, boosts mood, and assists cognition.

Over time, the "machinery" which makes testosterone gradually becomes less effective, and testosterone levels begin to drop, by approximately 1 percent per year, starting in the 40s. As guys get in their 50s, 60s, and beyond, they may start to have symptoms and signs of low testosterone such as 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 referred to as hypogonadism ("hypo" meaning low working and"gonadism" speaking to the testicles). Yet it's an underdiagnosed issue, with just about 5 percent of these affected undergoing therapy.

Various studies have shown that testosterone-replacement therapy can provide a wide range of advantages for men with hypogonadism, including 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 sexual and reproductive problems. He's developed particular expertise in treating lower testosterone levels. In this interview, Dr. Morgentaler shares his views on current controversies, the treatment strategies he uses with his patients, and he believes specialists should rethink the potential link between testosterone-replacement therapy and prostate cancer.

Symptoms and diagnosis

What signs and symptoms of low testosterone prompt that the typical man to see a doctor?

As a urologist, I have a tendency to see guys since they have sexual complaints. The main hallmark of reduced testosterone is reduced sexual desire or libido, but another can be erectile dysfunction, and any man who complains of erectile dysfunction should get his testosterone level checked. Men may experience other symptoms, like more difficulty achieving an orgasm, less-intense orgasms, a much lesser quantity of fluid from ejaculation, and a feeling of numbness in the penis when they see or experience something that would normally be arousing.

The more of these symptoms there are, the more likely it is that a man has low testosterone. Many physicians tend to discount those"soft symptoms" as a normal part of aging, however, they are often treatable and reversible by normalizing 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 that may lessen sex drive, including the BPH medication finasteride (Proscar) and dutasteride (Avodart). Those drugs may also reduce the amount of the ejaculatory fluid, no question. But a reduction in orgasm intensity usually does not go along with therapy for BPH. Erectile dysfunction does not ordinarily go together with it either, though certainly if somebody has less sex drive or less attention, it is more of a challenge to get a good erection.

How can you determine if or not a person is a candidate for testosterone-replacement therapy?

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

Looking at the biochemical numbers, The Endocrine Society* believes low testosterone for a total testosterone level of less than 300 ng/dl, and I think that is a reasonable guide. But no one really agrees on a few. It's similar to diabetes, in which if your fasting glucose is over a certain level, they will say,"Okay, you've got it." With testosterone, that break point is not quite as apparent.

*Notice: The Endocrine Society publishes clinical practice guidelines with recommendations for who should and should not receive testosterone therapy. For a complete copy of these instructions, log on to www.endo-society.org.

Is total testosterone the ideal thing to be measuring? Or should we be measuring something different?

This is another area of confusion and good debate, but I don't think that it's as confusing as it appears to be from the literature. When most doctors learned about testosterone in medical school, they learned about overall testosterone, or all the testosterone in the body. But about half of their testosterone that's circulating in the blood is not readily available to cells.

The biologically available portion of total testosterone is known as free testosterone, and it's readily available to cells. Almost every lab has a blood test to measure free testosterone. Though it's only a little fraction of this total, the free testosterone level is a fairly good indicator of low testosterone. It's not ideal, but the correlation is greater compared to total testosterone.

Endocrine Society recommendations outlined

This professional organization recommends testosterone treatment for men who have both

Therapy is not Suggested for men who have

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

    Do time daily, 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 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 this day. One reported no change in average testosterone until after 2 Between 2 and 6 p.m., it went down by 13 percent, a small amount, and probably insufficient to affect diagnosis. Most guidelines still say it's important to perform the evaluation in the morning, but for men 40 and over, it likely does not matter much, as long as they get their blood drawn before 6 or 5 p.m.

    There are a number of very interesting findings about diet. By way of instance, it seems that individuals who have a diet low in protein have lower testosterone levels than males who consume more protein. But diet hasn't been studied thoroughly enough to create any recommendations that are clear.

    Exogenous vs. endogenous testosterone

    Within the following article, testosterone-replacement therapy refers to the treatment of hypogonadism with exogenous testosterone -- testosterone that is produced outside the body. Based on the formulation, treatment can cause skin irritation, breast tenderness and enlargement, sleep apnea, acne, decreased sperm count, increased red blood cell count, along with other side effects.

    In a recent prospective study, 36 hypogonadal men took a daily dose of clomiphene citrate for at least three months. Within four to six weeks, all of the men had heightened levels of testosterone; none reported any side effects during the year they were followed.

    Because clomiphene citrate is not approved by the FDA for use in men, little information exists about the long-term effects of carrying it (such as the probability of developing prostate cancer) or if it is more capable of boosting testosterone compared to exogenous formulas. But unlike adrenal gland, clomiphene citrate preserves -- and potentially enhances -- sperm production. This makes medication such as clomiphene citrate one of only a few options for men with low testosterone who wish to father children.

    What kinds of testosterone-replacement therapy can be found? *

    The earliest form is an injection, which we still use since it's inexpensive and since we faithfully become good 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 return to baseline.

    Topical therapies help preserve a more uniform amount of blood testosterone. The first form of topical treatment has been a patch, but it has a very high rate of skin irritation. In 1 study, as many as 40 percent of people that used the patch developed a red area on their skin. That restricts its usage.

    The most commonly used testosterone preparation in the United States -- and also the one I begin almost everyone off with -- is a topical gel. There are just two brands: AndroGel and Testim. The gel comes in miniature 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 consumed to good levels in about 80% to 85 percent of guys, but that leaves a significant number who do not absorb enough for it to have a favorable effect. [For specifics on several different formulations, see table ]

    Are there any downsides to using dyes? How long does it require them to get the job done?

    Men who start using the gels have to return in to have their testosterone levels measured again to be certain they're absorbing the proper amount. Our goal is that the mid to upper range of normal, which generally means around 500 to 600 ng/dl. The concentration of testosterone in blood actually goes up quite fast, within a few doses. I normally measure it after two weeks, even though symptoms may not alter for a month or two.

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