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A Harvard expert shares his Ideas on testosterone-replacement therapy

A meeting with Abraham Morgentaler, M.D.

It could be stated that testosterone is the thing that makes men, guys. 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 at puberty, 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 aids cognition.

As time passes, the testicular"machinery" that makes testosterone gradually becomes less powerful, and testosterone levels begin to drop, by approximately 1% a year, starting in the 40s. As guys get in their 50s, 60s, and beyond, they may begin to have signs and symptoms of low testosterone like lower libido and sense of energy, erectile dysfunction, diminished energy, decreased muscle mass and bone density, and nausea. Taken together, these symptoms and signs are often referred to as hypogonadism ("hypo" meaning low working and"gonadism" referring to the testicles). Yet it is an underdiagnosed issue, with just about 5 percent of these affected undergoing therapy.

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 patients, and why he believes 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 typical man to find a physician?

As a urologist, I tend to observe men since they have sexual complaints. The main hallmark of low testosterone is low sexual libido or desire, but another may be erectile dysfunction, and some other man who complains of erectile dysfunction must possess his testosterone level checked. Men may experience different symptoms, such as more difficulty achieving an orgasm, less-intense orgasms, a smaller amount 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 the symptoms there are, the more likely it is that a man has low testosterone. Many physicians tend to discount 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 men have when they are treated for benign prostatic hyperplasia, or BPH?

Not exactly. There are quite a few drugs which may reduce libido, including the BPH medication finasteride (Proscar) and dutasteride (Avodart). Those drugs can also decrease the amount of the ejaculatory fluid, no question. However a decrease in orgasm intensity usually does not go along 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's more of a challenge to have a good erection.

How do you decide if a person is a candidate for testosterone-replacement therapy?

There are two ways we determine whether someone 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 perfect. Normally men with the lowest testosterone have the most symptoms and men with highest testosterone possess the least. However, there are some men who have reduced levels of testosterone in their blood and have no symptoms.

Looking purely 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's a reasonable guide. But no one really agrees on a number. It's not like diabetes, where 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 clear.

*Notice: The Endocrine Society recommends clinical practice guidelines with recommendations for who should and shouldn't receive testosterone treatment.

Is complete testosterone the ideal 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 that it's as confusing as it appears to be in the literature. When most physicians learned about testosterone in medical school, they learned about total testosterone, or all the testosterone in the body. But about half of their testosterone that is circulating in the bloodstream isn't readily available to the cells.

The available portion of overall testosterone is called free testosterone, and it is readily available to cells. Though it's just a little fraction of this overall, the free testosterone level is a pretty good indicator of low testosterone. It's not ideal, but the correlation is greater than with testosterone.

Endocrine Society recommendations outlined

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 recommended for men who've

  • Prostate or breast cancer
  • a nodule on the prostate that may be felt during a DRE
  • a PSA higher than 3 ng/ml without further analysis
  • that a hematocrit greater than 50 percent or thick, viscous blood
  • untreated obstructive sleep apnea
  • severe lower urinary tract infections
  • class III or view IV heart failure.

    Do time of day, diet, or other elements affect testosterone levels?

    For years, the recommendation has been to get a testosterone value early in the morning because levels begin to fall after 10 or even 11 a.m.. But the information behind that recommendation were attracted to healthy young men. Two recent studies showed little change in blood glucose levels in men 40 and older over the course of this day. One reported no change in average testosterone until after 2 p.m. Between 2 and 6 p.m., it went down by 13 percent, a modest amount, and probably insufficient to influence diagnosis. Most guidelines nevertheless say it's important to perform the test in the morning, but for men 40 and over, it probably does not matter much, provided that they get their blood drawn before 5 or 6 p.m.

    There are some rather interesting findings about dietary supplements. By way of instance, it seems that those who have a diet low in protein have lower testosterone levels than males who eat more protein. But diet hasn't been studied thoroughly enough to make any clear recommendations.

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

    Within four to six months, each one of the men had increased levels of testosteronenone reported some side effects throughout the entire year they had been followed.

    Since clomiphene citrate is not accepted 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 whether it is more capable of boosting testosterone compared to exogenous formulas. But unlike exogenous testosterone, clomiphene citrate preserves -- and possibly enriches -- sperm production. This makes drugs such as clomiphene citrate one of just a few choices for men with low testosterone who want to father children.

    What forms of testosterone-replacement treatment can be found? *

    The earliest form is an injection, which we use since it is inexpensive and since we reliably become good testosterone levels in nearly everybody. The disadvantage is that a person should come in every couple of weeks to find a shot. A roller-coaster effect may also happen as blood glucose levels peak and return to baseline. [See"Exogenous vs. endogenous testosterone," above.]

    Topical treatments help preserve a more uniform amount of blood glucose. The first kind of topical therapy was a patch, but it has a quite large rate of skin irritation. In 1 study, as many as 40 percent of men who 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 begin almost everyone off with -- is a topical gel. The gel comes from miniature tubes or within a special dispenser, and you rub it on your shoulders or upper arms once a day. According to my experience, it has a tendency to be absorbed to good levels in about 80% to 85% of guys, but leaves a significant number who do not absorb enough for it to have a positive effect. [For specifics on various formulations, see table below.]

    Are there any drawbacks to using dyes? How much time does it take for them to work?

    Men who start using the implants need to come back in to have their own testosterone levels measured again to be certain they are absorbing the proper quantity. Our goal is the mid to upper assortment of normal, which usually means approximately 500 to 600 ng/dl. The concentration of testosterone in the blood actually goes up quite fast, in just 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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