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A Harvard Specialist shares his thoughts on testosterone-replacement therapy

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

As time passes, the "machinery" which makes testosterone slowly becomes less powerful, and testosterone levels start to drop, by approximately 1% per year, starting in the 40s. As men get in their 50s, 60s, and beyond, they may start 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 called hypogonadism ("hypo" significance low working and"gonadism" referring to the testicles). Yet it is an underdiagnosed issue, with only about 5 percent of those affected undergoing therapy.

But little consensus exists about what constitutes low testosterone, when testosterone supplementation makes sense, or what risks patients face. 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 ailments and male reproductive and sexual difficulties. He's developed particular experience in treating low testosterone levels. In this interview, Dr. Morgentaler shares his perspectives on current controversies, the treatment strategies he uses with his patients, and he believes experts should reconsider the potential link between testosterone-replacement treatment and prostate cancer.

Symptoms and diagnosis

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

As a urologist, I have a tendency to observe men since they have sexual complaints. The primary hallmark of reduced testosterone is low sexual libido or desire, but another may be erectile dysfunction, and any guy who complains of erectile dysfunction should possess his testosterone level checked. Men can experience other symptoms, such as more trouble achieving an orgasm, less-intense orgasms, a 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're often treatable and reversible by normalizing testosterone levels.

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

Not precisely. There are quite a few drugs that may reduce libido, including the BPH drugs finasteride (Proscar) and dutasteride (Avodart). Those drugs may also reduce the amount of the ejaculatory fluid, no question. But a decrease in orgasm intensity normally 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 struggle to get a good erection.

How can you decide if or not a man is a candidate for testosterone-replacement therapy?

There are just 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 perfect. Generally men with the lowest testosterone have the most symptoms and men with maximum testosterone have the least. But there are some men who have reduced levels of testosterone in their blood and have no signs.

Looking purely at the biochemical numbers, The Endocrine Society* believes low testosterone for a entire testosterone level of less than 300 ng/dl, and I believe that is a reasonable guide. But no one quite agrees on a number. It's not like diabetes, where if your fasting glucose is above a certain level, they'll say,"Okay, you've got it." With testosterone, that break point is not quite as clear.

*Notice: The Endocrine Society recommends clinical practice guidelines with recommendations for who should and should not receive testosterone treatment. For a complete copy of visit homepage the read this guidelines, log 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 do not think that it's as confusing as it is apparently from the literature. When most physicians learned about testosterone in medical school, they heard about overall testosterone, or all the testosterone in the body. However, about half of the testosterone that's circulating in the bloodstream is not available to the cells. It's tightly bound to a carrier molecule called sex hormone--binding globulin, which we abbreviate as SHBG.

The available part of total testosterone is called free testosterone, and it is readily available to cells. Though it's only a small fraction of this overall, the free testosterone level is a fairly good indicator of low testosterone. It's not ideal, but the significance is greater compared to total testosterone.

Endocrine Society recommendations outlined

This professional organization recommends testosterone therapy for men who have

Therapy Isn't Suggested for men who have

  • Prostate or breast cancer
  • a nodule on the prostate which may be felt during a DRE
  • a PSA greater 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 elements influence testosterone levels?

For years, the recommendation has been to receive a testosterone value early in the morning because 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 the day. One reported no change in average testosterone till after 2 Between 6 and 2 p.m., it went down by 13%, a small sum, and probably not enough to affect identification. Most guidelines still say it is important to perform the test in the morning, however for men 40 and above, it probably does not matter much, as long as they get their blood drawn before 6 or 5 p.m.

There are some rather interesting findings about dietary supplements. For example, it seems 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 therapy refers to the treatment of hypogonadism with adrenal gland -- testosterone that is manufactured outside the body. Based on the formula, treatment can lead to skin irritation, breast enlargement and tenderness, sleep apnea, acne, reduced sperm count, increased red blood cell count, along with other side effects.

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

Since clomiphene citrate is not accepted by the FDA for use in males, little information exists about the long-term ramifications of carrying it (including the risk of developing prostate cancer) or if it's more effective at boosting testosterone compared to exogenous formulas. But unlike exogenous testosterone, clomiphene citrate preserves -- and potentially enriches -- sperm production. That makes drugs such as clomiphene citrate one of just a few choices for men with low testosterone who wish to father children.

What kinds of testosterone-replacement treatment are available? *

The oldest form is the injection, which we use since it is inexpensive and because we reliably become fantastic testosterone levels in almost everybody. The disadvantage is that a man should come in every couple of weeks to find a shot. A roller-coaster effect may also occur as blood testosterone levels peak and then return to research.

Topical treatments help preserve a more uniform level of blood testosterone. The first form of topical therapy has been a patch, but it has a quite large rate of skin irritation. In 1 study, as many as 40% of men who 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 -- is a topical gel. There are just two brands: AndroGel and Testim. The gel comes in miniature tubes or in a special dispenser, and you rub it on your shoulders or upper arms once a day. Based on my experience, it tends to be consumed to great degrees in about 80% to 85 percent of guys, but leaves a substantial number who don't absorb enough for it to have a positive effect. [For specifics on various formulations, see table below.]

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

Men who start using the gels have to come back in to have their testosterone levels measured again to make sure they're absorbing the right quantity. Our goal is that the mid to upper assortment of normal, which generally means approximately 500 to 600 ng/dl. The concentration of testosterone in blood actually goes up quite quickly, within a few doses. I normally measure it after 2 weeks, even although symptoms may not alter for a month or two.

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