Ageless Forever Anti-Aging News Blog

Efficacy and safety of injectable testosterone undecanoate (Aveed or Nebido) for the treatment of hypogonadism

Since its approval in 2004, many clinical studies have been conducted with testosterone undecanoate, the first long-acting injectable form of testosterone.
 
Testosterone undecanoate has been proven to have an excellent safety profile and need only be administered four times annually to produce stable testosterone levels.[1]
 
Long-term studies have validated the clinical efficacy of testosterone undecanoate in maintaining stable therapeutic levels of testosterone and safely conferring the desired benefits of androgen replacement.[1]
 
Here I summarize the results from a comprehensive meta-analysis of all uncontrolled and placebo-controlled randomized clinical trials (RCTs) demonstrating the effect of injectable testosterone undecanoate on multiple clinical outcomes.[2]
 
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Testosterone Levels, Testosterone Therapy and Cardiovascular Risk in Men

Hypogonadism, also known as testosterone deficiency, is increasing in prevalence worldwide. While a rapidly expanding body of research is documenting the detrimental health consequences of hypogonadism, at the same time there is a prevailing concern and misunderstanding about the effects of testosterone therapy on cardiovascular risk.
 
In this article I present a summary of a recently published comprehensive review on the association of hypogonadism with cardiovascular risk factors, and the effect of testosterone therapy on those risk factors.[1]
 
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Is hypogonadism, aka "andropause", the male version of menopause?

Many men who reach middle-age start to experience symptoms that resemble those of menopause; reduced libido, lack of energy, weight gain, fatigue, depression and osteoporosis, to name a few.[1-5]
 
Therefore these conditions are frequently seen as being equivalent, and hypogonadism (which sometimes get the prefix "late onset") has therefore been called "andropause", "male climacteric", "male menopause" or "MANopause.[6, 7] 
 
However, this is very misleading. In this article I will contrast and comment on the differences between hypogonadism, also known as testosterone deficiency, and menopause.[8]
 
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Testosterone in women - is it physiological and clinically important?

Testosterone is popularly known as the "male" hormone. While it is true that men have much higher levels of testosterone than women, and that testosterone contributes to secondary sex characteristics that physiologically distinguish men from women (increased muscle mass and facial/body hair), this does not mean that testosterone isn't important in women.
 
In the same way that men need estrogen, aka the "female" hormone, for optimal health, women need testosterone for optimal health. This article will describe testosterone physiology in women and its importance for women's health, and refute the two prevailing myths that "testosterone is un-physiological in women", and that "there is no research or clinical experience supporting the use of testosterone therapy in women".... you may be surprised...!
 
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Testosterone Deficiency - Prevalence and Treatment Rates

Testosterone deficiency, also known as hypogonadism, is gaining recognition among both clinicians and the general population. This article summarizes the findings from a review on the prevalence of testosterone deficiency, as well as the proportion of hypogonadal men who are receiving testosterone treatment.[1]
 
While testosterone prescribing has increased lately, as you will find out here, the prevalence of testosterone deficiency far exceeds the prescribing rate; i.e. majority of men with low-T are still not being treated with testosterone therapy.
 
You may be surprised to find out that testosterone deficiency is still not well-understood by general practitioners and cardiologists, and that these key clinicians lack knowledge on its deleterious cardiovascular effects. Therefore, even man needs to take control of his own health and don't let any ignorant or old-school doctor deny you a prescription that you may need...
 
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Testosterone Therapy vs. Estrogen Therapy in Surgically Menopausal Women - effectiveness comparison

In a previous article I outlined a study showing the effectiveness of testosterone therapy on menopausal symptoms in pre- and post-menopausal women. Here I will present and comment on an insightful study that compared head-to-head the effectiveness of testosterone therapy and estrogen therapy in surgically menopausal women who had their ovaries removed.[1]
 
STUDY DESIGN:
Before the surgical removal of both ovaries (bilateral ovariectomy) women were randomly assigned to either a testosterone alone, estrogen alone, or placebo groups. There were 10 patients in each group.
 
Mean age of the women was 46 years. They had underwent bilateral ovariectomy due to having uterine fibroids (aka myoma), which are non-cancerous (benign) tumors that develop in the womb (uterus).
 
HORMONE TREATMENTS:
 
The testosterone group received injectable testosterone (enanthate); 200 mg/ml.
 
The estrogen group received injectable estradiol; 10mg/ml.
 
The testosterone/estrogen group received injectable testosterone (enanthate) 150 mg + 8.5 mg estradiol/ml.
 
All groups received 1 ml intramuscular injections every 28 days for 3 months.
 
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Beneficial effects of testosterone therapy on menopause symptoms and quality of life

Testosterone levels in women decline steeply with age during the reproductive years; by the time women reach their late 40, their blood testosterone levels are approximately half what they were in their 20s.[1, 2] 
 
Symptoms of androgen deficiency, including a reduced sense of well-being, dysphoric mood (sadness, depression, anxiety, and irritability), fatigue, decreased libido, hot flashes, bone loss, decreased muscle mass and strength, changes in cognition and memory, and insomnia may occur prior to cessation of menses.[3] Pre-menopausal women frequently report "menopausal symptoms", most of which are not related to estradiol levels.[4]
 
In the past, post-menopausal women with menopausal symptoms have been treated with estrogen, and more recently with bio-identical estrogen. However, new research shows that menopausal symptoms can be treated safely and effectively with testosterone.[5] It has even been shown that testosterone therapy may be more effective than estrogen therapy for treating menopausal symptoms and improving wellbeing.[6] This is great news for women with a family history of breast or emdometrial cancer, who fear taking estrogen.
 
A notable study "Beneficial effects of testosterone therapy in women measured by the validated Menopause Rating Scale" investigated the effectiveness of a 3 month continuous testosterone therapy, delivered by subcutaneous implant, on the relief of somatic, psychological and urogenital symptoms in both pre- and post-menopausal women.[5] This study also investigated long-term efficacy and safety in a sub-group of women who were treated for 2-3 years.
 
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Testing for testosterone deficiency - things to know about the blood draw

The first step (aside from identifying symptoms) in diagnosing testosterone deficiency, aka low-T, is to do a blood test.

Here I cover some important practical things to know about a blood draw for testosterone analysis...

 

 

 

 

 

 

 

 

 

 

 

 


 

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Adverse health effects of testosterone deficiency 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]
 
This summary gives an overview of the detrimental impact of testosterone deficiency on a wide range of health outcomes.[13]
 
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Testosterone Treatment and Heart Attack Risk - new study shows testosterone treatment can even be beneficial

Testosterone therapy has been in use for more than 70 years for the treatment of testosterone deficiency, historically called hypogonadism.[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 and media outcry about potential elevated heart attack risk with testosterone therapy. On July 2, 2014, a study was published which demonstrated that testosterone therapy is not associated with an increased risk of MI, and that is actually may protect against heart attack....[5]
 
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Dr. Pierce's Medical Organization Affiliations

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