Got Testosterone?

[Heavy Metal]

Blood doesn't make blood.


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[WillBrink]

I assume it's in my blood but not in my other parts...

I recommend you get clarification on that from the doc as it's not adding up.

[30 cal slut]

Thought you'd all would be interested in a key upcoming date to keep an eye on .

September 17, 2014: FDA’s Drug Safety and Risk Management Advisory Committee meeting jointly with the Bone, Reproductive, and Urologic Drugs Advisory Committee

Topic: Review of testosterone replacement therapy

Background:

http://www.fda.gov/Drugs/DrugSafety/...erone-products

http://www.fda.gov/Drugs/DrugSafety/...erone-products

Safety Announcement

[01-31-2014] The U.S. Food and Drug Administration (FDA) is investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products. We have been monitoring this risk and decided to reassess this safety issue based on the recent publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy. We are providing this alert while we continue to evaluate the information from these studies and other available data, and will communicate our final conclusions and recommendations when the evaluation is complete.

At this time, FDA has not concluded that FDA-approved testosterone treatment increases the risk of stroke, heart attack, or death. Patients should not stop taking prescribed testosterone products without first discussing any questions or concerns with their health care professionals. Health care professionals should consider whether the benefits of FDA-approved testosterone treatment is likely to exceed the potential risks of treatment. The prescribing information in the drug labels of FDA-approved testosterone products should be followed.

Testosterone is a hormone essential to the development of male growth and masculine characteristics. Testosterone products are FDA-approved only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition. Examples of these conditions include failure of the testicles to produce testosterone because of reasons such as genetic problems or chemotherapy. Other examples include problems with brain structures, called the hypothalamus and pituitary, that control the production of testosterone by the testicles.

None of the FDA-approved testosterone products are approved for use in men with low testosterone levels who lack an associated medical condition. FDA-approved testosterone formulations include the topical gel, transdermal patch, buccal system (applied to upper gum or inner cheek), and injection.

The first publication that prompted FDA to reassess the cardiovascular safety of testosterone therapy was an observational study of older men in the U.S. Veteran Affairs health system published in the Journal of the American Medical Association (JAMA) in November 2013.1 The men included in this study had low serum testosterone and were undergoing imaging of the blood vessels of the heart, called coronary angiography, to assess for coronary artery disease. Some of the men received testosterone treatment while others did not. On average, the men who entered the study were about 60 years old, and many had underlying cardiovascular disease. This study suggested a 30 percent increased risk of stroke, heart attack, and death in the group that had been prescribed testosterone therapy.

A second observational study reported an increased risk of heart attack in older men, as well as in younger men with pre-existing heart disease, who filled a prescription for testosterone therapy.2 The study reported a two-fold increase in the risk of heart attack among men aged 65 years and older in the first 90 days following the first prescription. Among younger men less than 65 years old with a pre-existing history of heart disease, the study reported a two- to three-fold increased risk of heart attack in the first 90 days following a first prescription. Younger men without a history of heart disease who filled a prescription for testosterone, however, did not have an increased risk of heart attack.

We urge health care professionals and patients to report side effects involving prescription testosterone products to the FDA MedWatch program, using the information in the "Contact FDA" box at the bottom of the page.

[WillBrink]

Thought you'd all would be interested in a key upcoming date to keep an eye on .

September 17, 2014: FDA’s Drug Safety and Risk Management Advisory Committee meeting jointly with the Bone, Reproductive, and Urologic Drugs Advisory Committee

Topic: Review of testosterone replacement therapy

Background:

http://www.fda.gov/Drugs/DrugSafety/...erone-products

On paper, I don't think it's unreasonable for the FDA to take an enhanced look at TRT due to these studies and the current "Low T" push by pharma. Although the vast majority of data to date shows either no increased risk of heart attack, or even a decreased risk, with TRT (see OP for example), it would be irresponsible for the FDA to simply ignore those studies, which do have a number of flaws to them. As always, there's no free lunch in human biology. Risk/benefit applies, and the data strongly supports the benefits of TRT in those that have low T, far exceeds the risks. Nothing, not air, nor water, is risk free.

[WillBrink]

More info that T is a hormone that has protective effects in women also:

NEW YORK (Reuters Health) – The incidence of breast cancer in women prescribed testosterone implant treatment for symptoms of androgen deficiency is lower than in several comparison groups, according to a prospective study.

“This hormone therapy should be further investigated for the prevention and treatment of breast cancer,” the researchers suggest in their report in Maturitas online September 10.

The authors note that testosterone therapy is being prescribed increasingly for hormone deficiency in pre- and post-menopausal women, and there is evidence that androgens are breast protective.

To investigate the impact on breast cancer risk, Dr. Rebecca L. Glaser, with Wright State University Boonshoft School of Medicine in Dayton, Ohio and Dr. Constantine Dimitrakakis, at Athens University Medical School in Greece, initiated a 10-year prospective study beginning in 2008. The current report is an interim 5-year analysis of the findings.

So far, 1388 women have been accrued to the study. They were seen at the Millennium Wellness Center in Dayton, Ohio for a variety of symptoms of relative androgen deficiency, such as hot flashes, depressive mood, pre-menstrual syndrome, menstrual or migraine headaches, sexual problems, and bone loss. They received subcutaneous pellet implants of testosterone or testosterone combined with anastrozole designed to last 3 months.

The interim analysis includes 1268 participants who received more than one implant. There have been 8 cases of invasive breast cancer in this group, which translates to an incidence of 142 cases per 100,000 person-years. Among women who were consistently adherent to implant therapy, the incidence equated to 73 cases per 100,000 person-years, according to the report.

The authors compare these rates of breast cancer to age-specific SEER incidence rates (293/100,000), incidence in the placebo arm of the Women’s Health Initiative (300/100,000) and in the Million Women Study (325/100,000).

Regarding side effect, Drs. Glaser and Dimitrakakis report no adverse events attributed to testosterone therapy other than expected androgenic effects, which were reversible with lowering the dose.

They conclude, “subcutaneous T (testosterone), and subsequently, T + A (testosterone + anastrozole), has a protective effect in the breast, and prevented cancer occurrence in some cases.”

Furthermore they suggest, “It is possible that continuous, subcutaneous T + A could help prevent breast cancer in high-risk women, and recurrences in breast cancer survivors.”

SOURCE: Reduced breast cancer incidence in women treated with subcutaneous testosterone, or testosterone with anastrozole
Maturitas 2013.

- See more at: http://www.thedoctorschannel.com/vie....w1zwocwV.dpuf

[WillBrink]

Average T levels have been dropping for decades in all sexes, and why that is, remains unclear. I suspect it's no one cause, but this recent study suggests one possible cause:

Reduced Testosterone Tied To Phthalates

Men, women and children exposed to high levels of phthalates tended to have reduced levels of testosterone in their blood compared to those with lower chemical exposure, according to a new paper in the Endocrine Society's Journal of Clinical Endocrinology&Metabolism.

Testosterone is the main sex hormone in men. It contributes to a variety of functions in both sexes, including physical growth and strength, brain function, bone density and cardiovascular health. In the last 50 years, research has identified a trend of declining testosterone in men and a rise in related health conditions, including reduced semen quality in men and genital malformations in newborn boys.

Some animal and cellular studies have found that some phthalates block the effects of testosterone on the body's organs and tissues. Researchers set out to examine whether these chemicals, which are widely used in flexible PVC plastics and personal care products, had a similar effect in humans.

"We found evidence reduced levels of circulating testosterone were associated with increased phthalate exposure in several key populations, including boys ages 6-12, and men and women ages 40-60," said one of the study's authors, John D. Meeker, MS, ScD, of the University of Michigan School of Public Health in Ann Arbor, MI. "This may have important public health implications, since low testosterone levels in young boys can negatively impact reproductive development, and in middle age can impair sexual function, libido, energy, cognitive function and bone health in men and women."

The cross-sectional study examined phthalate exposure and testosterone levels in 2,208 people who participated in the U.S. National Health and Nutrition Examination Survey, 2011-2012. Researchers analyzed urine samples to measure concentrations of 13 substances left after the body metabolizes phthalates. Each participant's testosterone level was measured using a blood sample.

Researchers found an inverse relationship between phthalate exposure and testosterone levels at various life stages. In women ages 40-60, for example, increased phthalate concentrations were associated with a 10.8 to 24 percent decline in testosterone levels. Among boys ages 6-12, increased concentrations of metabolites of a phthalate called di-(2-ethylhexyl) phthalate, or DEHP, was linked to a 24 to 34.1 percent drop in testosterone levels.

"While the study's cross-sectional design limit the conclusions we can draw, our results support the hypothesis that environmental exposure to endocrine-disrupting chemicals such as phthalates could be contributing to the trend of declining testosterone and related disorders," Meeker said. "With mounting evidence for adverse health effects, individuals and policymakers alike may want to take steps to limit human exposure to the degree possible."

CONT:

http://www.science20.com/news_articl...halates-142625

For those interested in the actual study:

Meeker JD, Ferguson KK. Urinary Phthalate Metabolites Are Associated With Decreased Serum Testosterone in Men, Women, and Children From NHANES 2011-2012. J Clin Endocrinol Metab. http://press.endocrine.org/doi/abs/10.1210/jc.2014-2555

Context: There is evidence of declining trends in T levels among men in recent decades, as well as trends in related conditions at multiple life stages and in both sexes. There is also animal and limited human evidence that exposure to phthalates, chemicals found in plastics and personal care products, is associated with reduced androgen levels and associated disorders.

Objective: To explore relationships between urinary concentrations of 13 phthalate metabolites and serum total T levels among men, women, and children when adjusting for important confounders and stratifying by sex and age (6-12, 12-20, 20-40, 40-60, and 60-80 y).

Design: A cross-sectional study. Setting: US National Health and Nutrition Examination Survey, 2011-2012. Patients or Other Participants: US general population.

Interventions: None

Main Outcome Measures: Serum total T measured by isotope dilution-liquid chromatography-tandem mass spectrometry.

Results: Multiple phthalates were associated with significantly reduced T in both sexes and in differing age groups. In females, the strongest and most consistent inverse relationships were found among women ages 40-60 years. In boys 6-12 years old, an interquartile range increase in metabolites of di-2-ethylhexyl phthalate was associated with a 29% (95% confidence interval, 6, 47) reduction in T. In adult men, the only significant or suggestive inverse associations between phthalates (metabolites of di-2-ethylhexyl phthalate and dibutyl phthalate) and T were observed among men ages 40-60 years.

Conclusions: Because T plays an important role in all life stages for both sexes, future efforts should focus on better defining these relationships and their broader impacts.

[WillBrink]

Another "T Booster" supplement bites the dust:

TRIBULUS THE "T BOOSTER"...NOT

Recent study found: "Tribulus terrestris was not more effective than placebo on improving symptoms of erectile dysfunction or serum total testosterone."

This is my shocked face....

Tribulus terrestris versus placebo in the treatment of erectile dysfunction: A prospective, randomized, double blind study.
Actas Urol Esp. 2014 May;38(4):244-8.

Abstract
OBJECTIVES:

To evaluate the possible effects of Tribulus terrestris herbal medicine in the erectile dysfunction treatment and to quantify its potential impact on serum testosterone levels.
DESIGN AND METHODS:

Prospective, randomized, double-blind and placebo-controlled study including thirty healthy men selected from 100 patients who presented themselves spontaneously complaining of erectile dysfunction, ≥ 40 years of age, nonsmokers, not undergoing treatment for prostate cancer or erectile dysfunction, no dyslipidemia, no phosphodiesterase inhibitor use, no hormonal manipulation and, if present hypertension and/or diabetes mellitus should be controlled. International Index of Erectile Function (IIEF-5) and serum testosterone were obtained before randomization and after 30 days of study. Patients were randomized into two groups of fifteen subjects each. The study group received 800 mg of Tribulus terrestris, divided into two doses per day for thirty days and the control group received placebo administered in the same way.

RESULTS:

The groups were statistically equivalent in all aspects evaluated. The mean (SD) age was 60 (9.4) and 62.9 (7.9), P = .36 for intervention and placebo groups, respectively. Before treatment, the intervention group showed mean IIEF-5 of 13.2 (5-21) and mean total testosterone 417.1 ng/dl (270.7-548.4 ng/dl); the placebo group showed mean IIEF-5 of 11.6 (6-21) and mean total testosterone 442.7 ng/dl (301-609.1 ng/dl). After treatment, the intervention group showed mean IIEF-5 of 15.3 (5-21) and mean total testosterone 409.3 ng/dl (216.9-760.8 ng/dl); the placebo group showed mean IIEF-5 of 13.7 (6-21) and mean total testosterone 466.3 ng/dl (264.3-934.3 ng/dl). The time factor caused statistically significant changes in both groups for IIEF-5 only (P = .0004), however, there was no difference between the two groups (P = .7914).

CONCLUSIONS:

At the dose and interval studied, Tribulus terrestris was not more effective than placebo on improving symptoms of erectile dysfunction or serum total testosterone.

http://www.ncbi.nlm.nih.gov/pubmed/24630840

[WillBrink]

Testosterone Treatment and Heart Attack Risk – New study shows testosterone treatment can actually be beneficial
by Monica Mollica

Testosterone therapy has been in use for more than 70 years for the treatment of hypogonadism, also called testosterone deficiency.[1] In the past 30 years there has been a growing body of scientific research demonstrating that testosterone deficiency is associated with increased body weight/adiposity/waist circumference, insulin resistance, type 2 diabetes, hypertension, inflammation, atherosclerosis and cardiovascular disease, erectile dysfunction (ED) and increased risk of mortality [2, 3]. In line with the detrimental health outcomes seen with testosterone deficiency, testosterone therapy has been shown to confer beneficial effects on multiple risk factors and risk biomarkers related to these clinical conditions.[4]

Despite these well-documented health benefits, testosterone therapy is still controversial, in large part due to a few flawed studies about potential elevated heart attack (myocardial infarction) risk with testosterone therapy. On July 2, 2014, a new study was published, demonstrating that testosterone therapy is not associated with an increased risk of heart attack, and may actually confer protection against heart attack…[5]

KEY POINTS

* Testosterone deficiency is associated with increased body weight/adiposity/waist circumference, insulin resistance, type 2 diabetes, hypertension, inflammation, atherosclerosis and cardiovascular disease, erectile dysfunction (ED) and increased risk of mortality [2].

* Testosterone therapy beneficially impacts multiple risk factors and risk biomarkers related to highly prevalent clinical conditions that are associated with testosterone deficiency.[4]

* The most recent study reported reported below demonstrates that testosterone therapy does not increase risk of heart attack, and that it actually may protect against heart attack in high-risk population.[5] This is in line with a large body of research showing beneficial effects of testosterone therapy in hypogonadal men.[4]

* Three large meta-analyses specifically focusing on identifying potential adverse effects of testosterone treatment report no significant increases in cardiovascular risk.[6-8]

* A review of all testosterone trials up to 2012 found that testosterone therapy in patients with preexisting cardiovascular conditions, the effect on disease markers has typically been either neutral or beneficial, and does not increase the incidence of cardiovascular events.[9]

Cont HERE

[30 cal slut]

FDA memorandum just out ahead of September 17 Adcom meeting.

http://www.fda.gov/downloads/Advisor.../UCM412536.pdf

[WillBrink]

There's focus on the benefits of testosterone replacement (TRT) in those who are deficient, but what are the adverse health effects of being deficient? This latest article from Monica M covers that topic.

Adverse health effects of testosterone deficiency, aka hypogonadism, in men

Testosterone deficiency, also known as hypogonadism, is a state with sub-optimal circulating levels of testosterone concomitant with clinical signs and symptoms attributed to low physiological testosterone levels.[1-3]

Sexual dysfunction is the most commonly recognized symptom of testosterone deficiency. However, testosterone also plays a broader role in men’s health. A growing body of evidence has established associations between low testosterone levels and multiple risk factors and diseases including the metabolic syndrome, obesity, type 2 diabetes, sarcopenia, frailty, mobility limitations, osteoporosis, cognitive impairment, depression, cardiovascular disease, and reduced longevity.[3-12]

In this article I provide an overview of the detrimental impact of testosterone deficiency on a wide range of health outcomes.[13]

KEY POINTS

Cont:

http://www.brinkzone.com/anti-aging-...nadism-in-men/