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A Harvard Specialist shares his Ideas on testosterone-replacement therapy

It might be said that testosterone is the thing that makes guys, guys. It gives them their characteristic deep voices, large muscles, and body and facial hair, differentiating them from girls. It stimulates the growth of the genitals at puberty, plays a role in sperm production, fuels libido, and leads to regular erections. Additionally, it fosters the production of red blood cells, boosts mood, and aids cognition.

As time passes, the "machinery" which makes testosterone slowly becomes less effective, and testosterone levels start to drop, by approximately 1 percent per year, starting in the 40s. As men get in their 50s, 60s, and beyond, they might start to have symptoms and signs of low testosterone such as lower libido and sense of energy, erectile dysfunction, diminished energy, reduced muscle mass and bone density, and anemia. Taken together, these symptoms and signs are often referred to as hypogonadism ("hypo" significance low functioning and"gonadism" referring to the testicles). Researchers estimate that the illness affects anywhere from two to six million men in the USA. Yet it's an underdiagnosed problem, with just about 5% of those affected undergoing therapy.

Much of the current debate focuses on the long-held belief that testosterone may stimulate prostate cancer.

He's developed specific experience in treating low testosterone levels. In this interview, Dr. Morgentaler shares his perspectives on current controversies, the treatment plans he uses with his own patients, and why he thinks specialists should rethink the potential connection between testosterone-replacement therapy and prostate cancer.

Symptoms and diagnosis

What symptoms and signs of low testosterone prompt that the typical man to find a physician?

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

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

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

Not precisely. There are quite a few medications which may lessen sex drive, such as the BPH drugs finasteride (Proscar) and dutasteride (Avodart). Those drugs may also decrease the amount of the ejaculatory fluid, no question. However a reduction in orgasm intensity normally doesn't go together with therapy for BPH. Erectile dysfunction does not usually go together with it , though certainly if a person has less sex drive or less attention, it's more of a challenge to get a fantastic erection.

How can you decide whether a man is a candidate for testosterone-replacement treatment?

There are just two ways we determine whether someone has low testosterone. One is a blood test and the other is by characteristic signs and symptoms, and the correlation between these two methods is far from perfect. Generally men with the lowest testosterone have the most symptoms and men with maximum testosterone have the least. However, 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 entire testosterone level of less than 300 ng/dl, and I think that is a sensible guide. But no one quite agrees on a number. It is not like diabetes, where if your fasting glucose is over a certain level, they will say,"Okay, you've got it." With testosterone, that break point isn't quite as clear.

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

Is total testosterone the right point to be measuring? Or if we are measuring something else?

Well, this is just another area of confusion and great debate, but I do not 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 total testosterone, or all of the testosterone in the human body. But about half of their testosterone that's circulating in the bloodstream is not readily available to the cells.

The available portion of overall testosterone is called free testosterone, and it is readily available to the cells. Nearly every lab has a blood test to measure free testosterone. Even though it's just a small portion of this overall, the free testosterone level is a pretty good indicator of reduced testosterone. It is not ideal, but the correlation is greater than with 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 Isn't Suggested for men who've

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

class III or IV heart failure.

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

For many years, the recommendation was to receive a testosterone value early in the morning since levels begin to fall after 10 or even 11 a.m.. However, the data behind this recommendation were attracted to healthy young men. Two recent studies demonstrated little change in blood glucose levels in men 40 and mature within the course of the day. One reported no change in average testosterone till after 2 p.m. Between 2 and 6 p.m., it went down by 13%, a modest sum, and probably insufficient to influence identification. Most guidelines still say it's important to perform the test in the morning, however for men 40 and over, it likely does not matter much, provided that they get their blood drawn before 5 or 6 p.m.

There are a number of very interesting findings about diet. For example, it appears that those that have a diet low in protein have lower testosterone levels than men who consume more protein. But diet hasn't been researched thoroughly enough to create any clear recommendations.

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 upon the formulation, treatment can cause skin irritation, breast enlargement and tenderness, sleep apnea, acne, decreased sperm count, increased red blood cell count, along with other side effects.

Preliminary studies have shown that clomiphene citrate (Clomid), a drug generally prescribed to stimulate ovulation in women struggling with infertility, may boost the production of natural testosterone, also known as endogenous testosterone, in men. Within four to six months, all the men had increased levels of testosteronenone reported any side effects throughout the year they were followed.

Since 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 probability of developing prostate cancer) or whether it is more capable of boosting testosterone than exogenous formulas. But unlike adrenal gland, clomiphene citrate maintains -- and potentially 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.

Formulations

What forms of testosterone-replacement therapy are available? *

The oldest form is the injection, which we use because it's inexpensive and since we faithfully become good testosterone levels in nearly everybody. The disadvantage is that a person needs to 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. [See"Exogenous vs. endogenous testosterone," above.]

Topical therapies help preserve a more uniform amount of blood glucose. The first form of topical therapy has been a patch, but it has a quite high rate of skin irritation. In one study, as many as 40 percent of people that used the patch developed a red area in their skin. That restricts its use.

The most commonly used testosterone preparation from the United States -- and also the one I start almost everyone off -- is a topical gel. Based on my experience, it tends to be consumed to good levels in about 80% to 85 percent of men, but that leaves a significant number who don't absorb sufficient for it to have a positive impact. [For specifics on various formulations, see table ]

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 assortment of normal, which usually means around 500 to 600 ng/dl. The concentration of testosterone in blood really goes up quite quickly, within several doses. I usually measure it after 2 weeks, although symptoms may not change for a month or two.

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