Appendix D: Testosterone Therapy And The Risk Of Major Adverse Cardiac Events
Given the conflicting nature of the evidence, the Panel cannot definitively state that there is an association between testosterone therapy and subsequent MACE events nor can it be stated definitely that testosterone therapy is associated with reduced incidence of MACE. However, the FDA added a warning to testosterone product labeling after reviewing five observational studies and two meta-analyses of RCTs that examined the effects of testosterone therapy on MACE. Two of the trials and one meta-analysis pointed to an increased risk of cardiovascular events,363, 364, 366 two revealed no cardiovascular risk,233, 367 and one was neutral with respect to risk.373 The Corona meta-analysis,372 which showed that there was no increased risk of cardiovascular events, was not officially reviewed but was taken into consideration in the final analysis. Although the committee reviewing the evidence concluded that there was not enough data to definitively state that testosterone therapy posed a significant cardiovascular risk, the FDA nonetheless required testosterone product manufacturers to add information to the labeling about a possible increased risk of myocardial infarction and cerebrovascular accidents in patients using testosterone therapy.
Testing For Testosterone Deficiency In Men
Serum total testosterone is the initial test of choice. Specimens must be collected in the morning,8 preferably before 10AM, or within 3 hours of waking, and preferably in a fasting state.5, 9 Testing should occur when the sleep-wake pattern is stable . Testing of serum total testosterone should be performed when patients are clinically well do not test during acute illness or hospitalization.
If the total testosterone level is below the lab-specific lower limit of normal , and 6 nmol/L in older men ),1013 and a diagnostic question remains, cBAT can be used to confirm or rule out hypogonadism.
For men, total testosterone levels may be low but the cBAT normal when the SHBG concentration is decreased. Total testosterone levels may be normal but cBAT low when SHBG concentration is increased. Idiopathic elevations in SHBG are well known as are other conditions that are associated with mild to marked changes in the SHBG concentration. Refer to Appendix C: Conditions Associated with Altered SHBG Concentrations in Men and Women .
Note that testosterone is characterized by episodic secretion: 30% of men with mildly hypogonadal serum testosterone levels will have a normal level on retesting.
Blood Tests For Low Testosterone
Measuring testosterone levels can be a bit challenging. Testosterone is not only affected by age, but it can also change within an individual from week or week or from morning until night. It is generally recommended to have blood drawn around 8 a.m. when levels are the highest. Medications, illness, glucose intake, and activity can also affect testosterone levels. For these reasons, you may need to have your levels checked more than once.
The majority of testosterone in the body is bound to a protein, and the small percentage that is not bound is considered free or biologically active. This distinction plays a role in two of the blood tests that are used to measure testosterone levels:
Total testosterone: This is the most commonly used test. Using a small sample of blood that is drawn from a vein, the total amount of testosterone will be measured. Normal males will have 300 to 1,000 ng/dL of testosterone, though this can vary based on the laboratory. Levels under 300 ng/dL are generally classified as low.
Free or bioavailable testosterone: Some doctors may opt for this test as well, under the assumption that free or bioavailable testosterone is what easily enters into the cells and is therefore more significant.
What Causes Testosterone Deficiency
Testosterone deficiency can be caused by normal ageing. However, there are many other different causes of testosterone deficiency. Some causes of testosterone deficiency can be inherited. Testosterone deficiency may be present at birth or it may develop later in life.
Being significantly overweight or obese at any age may be linked to testosterone deficiency.
Temporary testosterone deficiency may be caused by a physical illness, surgery or emotional stress. The testosterone level will go back to normal once the underlying problem has been treated.
About Low Testosterone Screening
Testosterone production in men occurs in the testes, following signals that come from the pituitary gland.1 In contrast to its reputation for making men oversized, aggressive, and angry, testosterone has other important functions in the body. It is critical to the production of red blood cells, bone and muscle development, sex drive, sperm production, and the changes to a boy’s body that naturally occur during puberty. Women even have testosterone in their bodies, where it also plays a role in red blood cell production, bone strength, and sex drive.
Too much testosterone production is rare because the body does such a good job of regulating production. Abuse of testosterone by those hoping to build muscle quickly can have adverse side effects such as acne, liver disease, cancer, headaches, blood clots, and stunted growth in adolescents.1
Testosterone test results can fluctuate significantly, even on the same day. Your doctor, who knows you and is familiar with your overall physical condition, is the most qualified to diagnose you with low testosterone. Not only do normal testosterone levels vary by age, but for men, testosterone production starts declining at about age 30. Some medical conditions and treatments can cause low testosterone, such as cancer, radiation, chemotherapy, infection, injury to the testes, and autoimmune conditions.
Testing For Hyperandrogenism In Women
Serum total testosterone is frequently normal in women with mild clinical hyperandrogenism . cBAT testing has a better diagnostic yield for testosterone excess in women.19 Repeat serum testosterone testing is not indicated if cBAT is normal. Testing of other androgens is dependent on clinical findings and is beyond the scope of this protocol for more information refer to the BC Guideline.caHormone Testing – Indications and Appropriate Use. For women who have regular menstrual cycles, collection should be performed in the morning on day 410.18
What Is A Testosterone Levels Test
Testosterone is the main sex hormone in males. During a boy’s puberty, testosterone causes the growth of body hair, muscle development, and deepening of the voice. In adult men, it controls sex drive, maintains muscle mass, and helps make sperm. Women also have testosterone in their bodies, but in much smaller amounts.
This test measures the levels of testosterone in your blood. Most of the testosterone in the blood is attached to proteins. Testosterone that is not attached to a protein is called free testosterone. There are two main types of testosterone tests:
- Total testosterone, which measures both attached and free testosterone.
- Free testosterone, which measures just free testosterone. Free testosterone can give more information about certain medical conditions.
Testosterone levels that are too low or too high can cause health problems in both men and women.
Other names: serum testosterone, total testosterone, free testosterone, bioavailable testosterone
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When Is It Ordered
In men, the test may be ordered when infertility is suspected or when you have a decreased sex drive or erectile dysfunction. Some other symptoms of low testosterone include lack of beard and body hair, very small testicles, decreased muscle mass, and development of breast tissue .
In boys with delayed or slowly progressing puberty, or very early puberty, the test is often ordered with the FSH and LH tests. Although there are differences among boys as to when puberty begins, it is generally between ages 9 and 14. Testing may be ordered when these common physical signs of puberty in boys developer early or later:
- Increase in muscle mass
- Growth of body hair and pubic hair
- Growth of testicles and penis
In females, testosterone testing may be ordered when you have irregular or no menstrual periods , are having difficulty getting pregnant, or appear to have masculine features, such as excess facial and body hair, male pattern baldness, and/or a low voice.
In infants, testosterone testing may be ordered when the genitals are not clearly male or female.
Get Some Sun Or Take A Vitamin D Supplement
Vitamin D is quickly becoming one of the worlds most popular vitamins.
Research has shown that it has various health benefits, and may also work as a natural testosterone booster .
Despite its importance, nearly half of the US population is deficient in vitamin D, and an even higher percentage has sub-optimal levels .
A 12-month study found that supplementing with around 3,000 IU of vitamin D3 per day increased testosterone levels by around 25% .
In the elderly, vitamin D and calcium also optimized testosterone levels, which led to a reduced risk of falling .
To boost testosterone and reap the other benefits of vitamin D, try to get regular exposure to sunlight or take around 3,000 IU of a vitamin D3 supplement daily.
If youd like to try supplements, has a good selection available.
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Are The Testosterone Tests Reliable
The blood tests for low testosterone are reliable when they are done properly, and the individual follows all guidelines for the testing such as fasting before the blood specimen is drawn. This is what helps provide an accurate reading.
One of the most important markers checked is the results of the testosterone total test. This will measure the amount of testosterone that is bound to proteins in the blood and that which is not bound. Bioavailable and free testosterone levels are also checked. The free levels are important because that is what helps with muscle tone, energy, memory and concentration, and of course sex drive and performance.
In addition to the blood test for low testosterone, the doctor will also check IGF-1 levels for growth hormone deficiency, thyroid functions, complete blood counts, cholesterol and triglycerides, and other crucial markers to ensure that an accurate reading and understanding of the persons medical condition is determined.
Are The Home Testing Kits Accurate And Reliable
If you are wondering if the home testing kits used to test for testosterone levels at home are accurate and reliable, the answer is yes. There is substantial evidence from research conducted on the use of saliva to test testosterone levels that shows that this bodily fluid can accurately measure testosterone levels.
Another benefit of using home testing kits for this purpose is that you dont have to draw blood. These kits are less invasive and testing saliva is easier compared to testing blood to measure testosterone levels in women.
Whats even more important is that it is less stressful and painful to collect a sample of saliva than it is to draw blood.
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How To Find A Doctor That Will Prescribe Testosterone
One of the biggest concerns many people have is how to find a doctor that will prescribe testosterone treatment that will work. Most general practitioners have little to no training in this area and feel uncomfortable prescribing testosterone injections or creams to their patients. A doctor that has specific training in hormone replacement therapy is the best person to determine the course of action that will work to restore the bodys testosterone levels safely and effectively. At Kingsberg Medical, our doctors are specialists in this field and work with both men and women across the US to bring balance and rejuvenation back into their lives. You can put your trust in our highly trained medical team to guide you in the right direction. For more information about how best treatment for low testosterone can benefit you, simply fill out the contact form on this page or call our phone number today.
When And How Should A Low Testosterone Be Treated
Testosterone replacement shouldn’t be used to treat a naturally occurring, age-related decline in this hormone or simply for a low T number, says Dr. Bhasin, but if a man has a testosterone deficiency or classical hypogonadism, the benefits of treating the condition with testosterone is favorable and outweighs any risks.
According to Dr. Bhasin, over the last two to three years there has been greater availability of high quality lab providing good results for testosterone levels, which until recently has been a problematic when trying to make a firm diagnosis.
To confirm the existence of low testosterone requiring treatment, the patient should have two separate blood tests on nonconsecutive days in the early morning that are analyzed by reliable laboratories certified by the Centers for Disease Control and Prevention, Dr. Bhasin told EndocrineWeb.
A normal range for testosterone levels is 300 ng/dL to 1,000 ng/dL, with the Endocrine Society considering low testosterone below 263 ng/dL, says Dr. Bhasin.
Your doctors should also determine if you shows signs or symptoms of a testosterone deficiency. One problem with the symptoms for testosterone deficiency is many are incredibly nonspecific Dr. Mulhall cautions, which is why getting accurate testosterone levels is vital.
Is Testosterone Replacement Therapy Safe
Testosterone replacement therapy is generally a safe treatment modality. However, there are both benefits and risks associated with treating low testosterone. The figure below provides information on TRTs impact on various health conditions that could be impacted by your course of treatment.
Figure source: Canadian Medical Association Journal: Diagnosis and management of testosterone deficiency syndrome in men: clinical practice guideline. 2015.
How Much Does A Testosterone Test Cost
The cost of a testosterone test depends on a number of factorsâlike whether youâre getting tested at a clinic or at home.
If you get tested at a clinic or lab, prices can range from about $80 to several hundred dollars.
The Everlywell at-home Testosterone Test is $49âincluding shipping. There are no hidden fees: weâre committed to transparent pricing for all tests we offer. Plus, we can provide itemized receipts for the test you orderâwhich you can submit to your HSA/FSA benefits coordinator for reimbursement.
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Ask A Laboratory Scientist
This form enables patients to ask specific questions about lab tests. Your questions will be answered by a laboratory scientist as part of a voluntary service provided by one of our partners, American Society for Clinical Laboratory Science. Please allow 2-3 business days for an email response from one of the volunteers on the Consumer Information Response Team.
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The Everlywell Testosterone Level Test Helps You Check Your Free Testosterone From The Convenience Of Home
This testosterone panel is affordable and reliable. It is a first step in understanding why you may be experiencing symptoms of high or low testosterone. Both younger and older men and women can check free testosterone levels with this at-home test .
Your results will provide detailed information on whether your testosterone level is normal, low, or high compared to reference ranges in your age group. If youâre experiencing signs and symptoms of low hormone levels, sharing your test results with your health care provider can help them recommend possible next steps to take.
Your results from this testosterone level test will include evidence-based guidance about lifestyle changes you can make that can positively impact your testosterone andâmore importantlyâyour health. It’s always a great idea to share your results with your doctor, and this testosterone panel gives you a head start.
Evaluation And Management Of Testosterone Deficiency
To cite this guideline:Mulhall JP, Trost LW, Brannigan RE et al: Evaluation and management of testosterone deficiency: AUA guideline. J Urol 2018 200: 423.
The Evaluation and Management of Testosterone Deficiency AUA Guideline provides guidance to the practicing clinician on how to diagnose, treat and monitor the adult male with testosterone deficiency. The care of testosterone deficient patients should focus on accurate assessment of testosterone levels, symptoms and signs as well as proper on-treatment monitoring to ensure therapeutic testosterone levels are reached and symptoms are ameliorated. Guidance is also given on the management of patients with cardiovascular disease, men who are interested in preserving their fertility and men who are at risk for or have prostate cancer.
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When To Get Tested
- For males, when you may be infertile or are unable to get or maintain an erection
- For females, when your voice is lower in quality or you have excess body hair, when you have abnormal uterine bleeding, do not menstruate , or cannot get pregnant
- When a child has signs of delayed or early puberty, or has genitals that are not clearly male or female
Who Shouldn’t Take Testosterone Replacement Therapy
Testosterone replacement therapy may cause the prostate to grow. If a man has early prostate cancer, there is concern that testosterone may stimulate the cancer’s growth. Therefore, men who have prostate cancer should not take testosterone replacement therapy. It is important for all men considering testosterone replacement therapy to undergo prostate screening before starting this therapy.
Other men who should not take testosterone replacement therapy include those who have:
- An enlarged prostate resulting in urinary symptoms
- A lump on their prostate that has not been evaluated
- A PSA measurement above 4
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