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A Harvard expert shares his Ideas on testosterone-replacement therapy

It might be said that testosterone is the thing that makes guys, men. It gives them their characteristic deep voices, big muscles, and body and facial hair, differentiating them from girls. It stimulates the growth of the genitals , plays a role in sperm production, fuels libido, and leads to normal erections. It also boosts the production of red blood cells, boosts mood, and assists cognition.

As time passes, the testicular"machinery" which produces testosterone gradually becomes less powerful, and testosterone levels begin to fall, by approximately 1 percent a year, starting in the 40s. As guys get into their 50s, 60s, and beyond, they might begin 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 anemia. Taken together, these symptoms and signs are often called hypogonadism ("hypo" meaning low working and"gonadism" speaking to the testicles). Researchers estimate that the condition affects anywhere from two to six million men in the USA. Yet it's an underdiagnosed problem, with only about 5 percent of these affected receiving treatment.

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 ailments and male sexual and reproductive problems. He's developed specific expertise in treating low testosterone levels. In this interview, Dr. Morgentaler shares his views on current controversies, the treatment plans he utilizes his patients, and he thinks experts should reconsider the potential connection between testosterone-replacement treatment and prostate cancer.

Symptoms and diagnosis

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

As a urologist, I have a tendency to see men because 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, such as more difficulty achieving an orgasm, less-intense orgasms, a smaller amount of fluid out of ejaculation, and a sense of numbness in the manhood when they see or experience something which would usually be arousing.

The more of the symptoms you will find, the more probable it is that a man has low testosterone. Many physicians often discount these"soft symptoms" as a normal part of aging, but they are often treatable and reversible by normalizing testosterone levels.

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

Not exactly. There are quite a few medications which may reduce libido, such as 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 normally doesn't go together with therapy for BPH. Erectile dysfunction does not ordinarily go together with it either, though certainly if somebody has less sex drive or less interest, it's more of a struggle to have a fantastic erection.

How can you determine whether or not a man is a candidate for testosterone-replacement therapy?

There are just two ways we determine whether somebody has reduced testosterone. One is a blood test and the other one is by characteristic symptoms and signs, and the correlation between those two methods is far from ideal. Normally men with the lowest testosterone have the most symptoms and men with highest testosterone possess the least. But there are some men who have reduced levels of testosterone in their blood and have no symptoms.

Looking purely at the biochemical amounts, The Endocrine Society* believes low testosterone to be a total testosterone level of less than 300 ng/dl, and I believe that is a reasonable guide. But no one really agrees on a number. 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 shouldn't receive testosterone treatment. For a complete copy of the guidelines, log on to www.endo-society.org.

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

This is another area of confusion and great discussion, 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 heard about total testosterone, or all of the testosterone in the body. However, about half of the testosterone that is circulating in the bloodstream isn't available to cells.

The available portion of total testosterone is known as free testosterone, and it's readily available to cells. Nearly 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 is not ideal, but the correlation is greater compared to total testosterone.

This professional organization urges testosterone treatment for men who have both

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

Therapy is not Suggested for men who have

Prostate or breast cancer
a nodule on the prostate which may be felt during a DRE
a PSA higher than 3 ng/ml without further evaluation
that a hematocrit greater than 50% or thick, viscous blood
untreated obstructive sleep apnea
severe lower urinary tract symptoms

class III or Recommended Site IV heart failure.

Do time daily, diet, or other factors affect testosterone levels?

For many years, the recommendation has been to get a testosterone value early in the morning since levels begin to drop after 10 or 11 a.m.. However, the information behind that recommendation were attracted to 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 till after 2 Between 6 and 2 p.m., it went down by 13 percent, a modest amount, and probably insufficient to affect diagnosis. Most guidelines still say it is important to perform the evaluation in the morning, but for men 40 and over, it probably doesn't matter much, as long as they obtain their blood drawn before 5 or 6 p.m.

There are some very interesting findings about dietary supplements. By way of instance, it appears that individuals who have a diet low in protein have lower testosterone levels than males who eat more protein. But diet has not been studied thoroughly enough to make any recommendations that are clear.

Exogenous vs. endogenous testosterone

In the following guide, testosterone-replacement treatment refers to the treatment of hypogonadism with adrenal gland -- testosterone that's manufactured outside the body. Depending 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 additional side effects.

Preliminary studies have proven that clomiphene citrate (Clomid), a drug generally prescribed to stimulate ovulation in women struggling with infertility, can foster the production of natural testosterone, termed nitric oxide, in men. Within four to six months, each one the men had heightened levels of testosteronenone 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 taking it (including the risk of developing prostate cancer) or whether it is more effective at boosting testosterone than exogenous formulations. But unlike exogenous testosterone, clomiphene citrate preserves -- and possibly enhances -- sperm production. This makes medication such as clomiphene citrate one of just a few options for men with low testosterone that wish to father children.

What forms of testosterone-replacement therapy are available? *

The oldest form is an injection, which we still use because it is cheap and since we faithfully become fantastic testosterone levels in almost everybody. The disadvantage is that a man needs to come in every few weeks to find a shot. A roller-coaster effect may also happen as blood testosterone levels peak and then return to baseline. [Watch"Exogenous vs. endogenous testosterone," above.]

Topical treatments help preserve a more uniform level of blood testosterone. The first form of topical treatment has been 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 red area on their skin. That limits its usage.

The most widely used testosterone preparation from the United States -- and also the one I begin almost everyone off with -- is a topical gel. According to my experience, it has a tendency to be absorbed to great degrees in about 80% to 85% of men, but leaves a substantial number who don't consume enough for it to have a favorable effect. [For specifics on several different formulations, see table below.]

Are there any drawbacks to using dyes? How long does it take for them to get the job done?

Men who start using the implants need to return in to have their testosterone levels measured again to be sure they are absorbing the proper amount. Our goal is 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 several doses. I usually measure it after 2 weeks, even though symptoms may not alter for a month or two.

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