Low-dose sex hormone testosterone gel treatment to boost sexual libido in men suffering from hypogonadism may increase heart disease risks, according to a new study.
The study using the low dose testosterone gel Testim in 209 volunteers, with an average age of 74, analysed the effectiveness of the sex hormone therapy in men who already had mobility problems such as difficulty walking two blocks or climbing 10 stairs.
The men who received testosterone gel, sold under the brand name Testim by Auxilium Pharmaceuticals, became better at walking up stairs and performing chest- and leg-press exercises.
However, the study conducted in Massachusetts had to stop at six months because the men using the sex hormone gel were found developing so many heart, breathing and skin problems compared to patients applying a placebo gel to their shoulders or upper arms every day, according to a report.
After six months of the study, 23 patients who were administered the sex hormone testosterone gel Testim complained of a bad side effect such as fainting, chest pain or heart attack and one man in the testosterone group died of a suspected heart attack.
Meanwhile only small portion –five of them — in the placebo group of the patients reported such bad side-effects
According to the researchers, men receiving testosterone had more serious side effects and more side effects considered to be life-threatening lasting for three months after the trial ended.
Even though these numbers were too small to be statistically significant and the side effects could due to a lot of other pre-existing conditions, researchers have arrived at the conclusion that the sex hormone testosterone gel Testim could have played a role in the outcome.
“I think the study raises important questions about the safety of giving testosterone to older individuals,” stated Dr. Shalender Bhasin of the Boston University School of Medicine.
Testosterone is not currently approved for older men with age-related decline or mobility problems. However it is approved by the U.S. Food and Drug Administration for other patients.
Testim, which contains testosterone 1% as active ingredient in a gel form. Testim provides continuous transdermal delivery of testosterone for 24 hours, following a single application to intact, clean, dry skin of the shoulders and upper arms.
One 5 g or two 5 g tubes of Testim contains 50 mg or 100 mg of testosterone, respectively, to be applied daily to the skin’s surface.
Approximately 10% of the applied testosterone dose is absorbed across skin of average permeability during a 24-hour period.
Testosterone is responsible for normal growth and development of the male sex organs and for maintenance of secondary sex
characteristics. These effects include the growth and maturation of the prostate, seminal vesicles, penis, and scrotum; the development of male hair distribution, such as facial, pubic, chest, and axillary hair; laryngeal enlargement; vocal cord thickening; alterations in body musculature; and fat distribution.
Male hypogonadism results from insufficient secretion of testosterone and is characterized by low serum testosterone concentrations.
Symptoms associated with male hypogonadism include decreased sexual desire with or without impotence, fatigue and loss of energy, mood depression, regression of secondary sexual characteristics, and osteoporosis.
Hypogonadism is a risk factor for osteoporosis in men.