New Member Question Re "Standard Range=86.98 - 780.10 ng/dL"?

[Mr. Clark]

I'm 58 years old, generally in good shape. I used to work and run regularly (3-4 times per week) but I've been somewhat limited for about a year due to COVID. I still work out at home with dumbells and run and use a stationary bike several days per week, but these are relatively short workouts/runs/bike sessions. I'm 6'0" about 190 lbs. My weight right now is probably about 10 lbs above my average for the past 20 years (my weight has tended to be quite steady right around 180 lbs).

I have very little sex drive, and I've felt significant fatigue/lethargy the past several years, and difficulty concentrating/staying motivated at work (I'm a lawyer, which requires constant "self starting" to churn through the mountains of documents I face every day). I'd say the decline in sex drive and energy levels started about 6-8 years ago, and it really accelerated the past 2-3 years. I don't really feel depressed, just lethargic. Also, I don't experience the same "runners high" and general sense of well being I used to after running or working out. Now it is just a grind to exercise, and there's little mental boost.

I asked my primary care doctor about a testosterone test, and it came back at 137 ng/dL, with a SHBG of 17.8 nmol/L. Using the Free and Bioavailable T calculator (Free & Bioavailable Testosterone calculator) results in free T of 3.49 ng/dL = 2.55 %, and bioavailable T of 81.8 ng/dL = 59.7 %.

The test results list Standard Ranges of 21.63 - 113.13 nmol/L for SHBG and 86.98 - 780.10 ng/dL for testosterone.

My doctor says he does not prescribe TRT unless someone is outside the "normal range" (i.e. the "Standard Range" listed with the test results). In other words, my T level would need to be below 86.98 ng/dL. I mentioned my symptoms of lethargy and no sex drive, and my doctor offered to refer me to an endocronolgist. My general impression is that he goes strictly by the numbers for everything, perhaps for fear of having his license suspended or revoked.

Based on a few google searches, it appears to me that the "Standard Range" is for a Siemens ADVIA Centaur testosterone test system. The "Standard Range" is the middle 95% determined according to CLSI EP28-A3c of a group of 137 men between the ages 50-89 (see page 10: https://www.accessdata.fda.gov/cdrh_docs/pdf15/K151986.pdf)

First question: does anyone know if this particular Siemens test is accurate? The "Standard Range" seems low*, but it's hard to know if this is because this test produces a lower total T number than other tests, or if the group of 137 men ages 50-89 happened to have lower T on average. Also, it's unclear if there may have been quite a few men near the upper end of the age range, which would push the middle 95% numbers down.

Second question: should I go to an endocronologist, or is this a waste of time?

In general, I just want to get my T back to a middle normal range (hopefully this will help with the lethargy, sex drive, etc.). I've never been able to put on a lot of muscle mass working out, and I'm not trying to pack on a lot of muscle at my age. I could stand to lose 10-15 lbs of fat, but I'm not trying to bulk up.


*For example, one paper lists a range of 215-878 for healthy men ages 50–59 ("Male Testosterone: What is normal?," Barrett-Conor, Clinical Endocrinology 2005;62(3):263–64.)

The American Urological Association "(Evaluation and Management of Testosterone Deficiency (2018)" states: "1. Clinicians should use a total testosterone level below 300 ng/dL as a reasonable cut-off in support of the diagnosis of low testosterone."

 

[madman]

I'm 58 years old, generally in good shape. I used to work and run regularly (3-4 times per week) but I've been somewhat limited for about a year due to COVID. I still work out at home with dumbells and run and use a stationary bike several days per week, but these are relatively short workouts/runs/bike sessions. I'm 6'0" about 190 lbs. My weight right now is probably about 10 lbs above my average for the past 20 years (my weight has tended to be quite steady right around 180 lbs).

I have very little sex drive, and I've felt significant fatigue/lethargy the past several years, and difficulty concentrating/staying motivated at work (I'm a lawyer, which requires constant "self starting" to churn through the mountains of documents I face every day). I'd say the decline in sex drive and energy levels started about 6-8 years ago, and it really accelerated the past 2-3 years. I don't really feel depressed, just lethargic. Also, I don't experience the same "runners high" and general sense of well being I used to after running or working out. Now it is just a grind to exercise, and there's little mental boost.

I asked my primary care doctor about a testosterone test, and it came back at 137 ng/dL, with a SHBG of 17.8 nmol/L. Using the Free and Bioavailable T calculator (Free & Bioavailable Testosterone calculator) results in free T of 3.49 ng/dL = 2.55 %, and bioavailable T of 81.8 ng/dL = 59.7 %.

The test results list Standard Ranges of 21.63 - 113.13 nmol/L for SHBG and 86.98 - 780.10 ng/dL for testosterone.

My doctor says he does not prescribe TRT unless someone is outside the "normal range" (i.e. the "Standard Range" listed with the test results). In other words, my T level would need to be below 86.98 ng/dL. I mentioned my symptoms of lethargy and no sex drive, and my doctor offered to refer me to an endocronolgist. My general impression is that he goes strictly by the numbers for everything, perhaps for fear of having his license suspended or revoked.

Based on a few google searches, it appears to me that the "Standard Range" is for a Siemens ADVIA Centaur testosterone test system. The "Standard Range" is the middle 95% determined according to CLSI EP28-A3c of a group of 137 men between the ages 50-89 (see page 10: https://www.accessdata.fda.gov/cdrh_docs/pdf15/K151986.pdf)

First question: does anyone know if this particular Siemens test is accurate? The "Standard Range" seems low*, but it's hard to know if this is because this test produces a lower total T number than other tests, or if the group of 137 men ages 50-89 happened to have lower T on average. Also, it's unclear if there may have been quite a few men near the upper end of the age range, which would push the middle 95% numbers down.

Second question: should I go to an endocronologist, or is this a waste of time?

In general, I just want to get my T back to a middle normal range (hopefully this will help with the lethargy, sex drive, etc.). I've never been able to put on a lot of muscle mass working out, and I'm not trying to pack on a lot of muscle at my age. I could stand to lose 10-15 lbs of fat, but I'm not trying to bulk up.


*For example, one paper lists a range of 215-878 for healthy men ages 50–59 ("Male Testosterone: What is normal?," Barrett-Conor, Clinical Endocrinology 2005;62(3):263–64.)

The American Urological Association "(Evaluation and Management of Testosterone Deficiency (2018)" states: "1. Clinicians should use a total testosterone level below 300 ng/dL as a reasonable cut-off in support of the diagnosis of low testosterone."

I asked my primary care doctor about a testosterone test, and it came back at 137 ng/dL, with a SHBG of 17.8 nmol/L. Using the Free and Bioavailable T calculator (Free & Bioavailable Testosterone calculator) results in free T of 3.49 ng/dL = 2.55 %, and bioavailable T of 81.8 ng/dL = 59.7 %.

The test results list Standard Ranges of 21.63 - 113.13 nmol/L for SHBG and 86.98 - 780.10 ng/dL for testosterone.


What lab did your doctor send you to for bloodwork as the reference range (bottom end) for TT is horribly low 86.98 - 780.10 ng/dL?

Unreal to say the least!

Most men can experience hypogonadal symptoms with TT in the 300-400 ng/dL range let alone if one has high SHBG they could experience low-t symptoms even having a much higher-end TT.

Although TT is important to know FT is what truly matters as it is the active unbound fraction of testosterone responsible for the positive effects.

When testing TT one needs to know where their FT level truly sits let alone SHBG level.

Regardless of your lowish SHBG 17.8 nmol/L seeing as your TT is horribly low 137 ng/dL your FT will be absurdly low.

Your doctor is an idiot for beating around the bush on this one!


My doctor says he does not prescribe TRT unless someone is outside the "normal range" (i.e. the "Standard Range" listed with the test results). In other words, my T level would need to be below 86.98 ng/dL. I mentioned my symptoms of lethargy and no sex drive, and my doctor offered to refer me to an endocronolgist. My general impression is that he goes strictly by the numbers for everything, perhaps for fear of having his license suspended or revoked.

A stickler for numbers yet it is clear as day that your TT/FT levels are horribly low.

Treating symptoms is what truly matters and reference ranges are used as guidelines as there is also such a thing as too high T level when it comes to trt.

Blood work is critical pre-trt and during therapy.

Ranges are not set in stone and are only used as a guideline and unfortunately, when it comes to the reference ranges for TT they have been lowered over the years and the nail in the coffin is the low-end of the reference range which has been driven down so low that many men experiencing low-t symptoms even with a TT in the 300-400 range would be considered normal let alone men with a much higher TT (due to high SHBG).

At least he is referring you to an endocrinologist and although many lack the understanding of updated protocols when it comes to trt let alone can be sticklers when it comes to numbers and keeping your T levels in some puff the magic dragon range (usually mid-normal) you will definitely be given the option to pursue trt as your TT/FT levels are horribly low let alone you must feel horrendous!

You would be much better served looking into a provider such as Defy or digging deeper and finding a doctor or well know urologist who is specialized in trt.


In general, I just want to get my T back to a middle normal range (hopefully this will help with the lethargy, sex drive, etc.). I've never been able to put on a lot of muscle mass working out, and I'm not trying to pack on a lot of muscle at my age. I could stand to lose 10-15 lbs of fat, but I'm not trying to bulk up.

Forget worrying about where your levels need to be as many men may need higher-end TT levels to achieve a healthy FT.

It comes down to where your SHBG level sits and what TT level would be needed in order to achieve a healthy FT level which would result in relief/improvement of low-t symptoms and increased overall well-being.

The goal of trt is to replace physiological levels of testosterone through the use of exogenous testosterone in order to achieve a healthy TT/FT level which will result in the relief/improvement of low-t symptoms while at the same time minimizing/avoiding any potential side-effects (cosmetic/overall health) while keeping blood markers healthy long-term.

FT level 5-10 ng/dL would be considered low.

FT 16-31 ng/dL would be considered a healthy level.

Most men will do well with FT in the 20-30 ng/dL range and some may choose/need to run slightly higher levels

Again it comes down to the individual as some men will do better running higher TT/FT levels whereas others may feel better running lower levels.

Some men will always struggle with side-effects when running too high an FT level.

 

[Mr. Clark]

What lab did your doctor send you to for bloodwork as the reference range (bottom end) for TT is horribly low 86.98 - 780.10 ng/dL?

Unreal to say the least!


When testing TT one needs to know where their FT level truly sits let alone SHBG level.

Regardless of your lowish SHBG 17.8 nmol/L seeing as your TT is horribly low 137 ng/dL your FT will be absurdly low.

Your doctor is an idiot for beating around the bush on this one!

Treating symptoms is what truly matters and reference ranges are used as guidelines as there is also such a thing as too high T level when it comes to trt.

Blood work is critical pre-trt and during therapy.

Ranges are not set in stone and are only used as a guideline and unfortunately, when it comes to the reference ranges for TT they have been lowered over the years and the nail in the coffin is the low-end of the reference range which has been driven down so low that many men experiencing low-t symptoms even with a TT in the 300-400 range would be considered normal let alone men with a much higher TT (due to high SHBG).

At least he is referring you to an endocrinologist and although many lack the understanding of updated protocols when it comes to trt let alone can be sticklers when it comes to numbers and keeping your T levels in some puff the magic dragon range (usually mid-normal) you will definitely be given the option to pursue trt as your TT/FT levels are horribly low let alone you must feel horrendous!

You would be much better served looking into a provider such as Defy or digging deeper and finding a doctor or well know urologist who is specialized in trt.

Forget worrying about where your levels need to be as many men may need higher-end TT levels to achieve a healthy FT.

It comes down to where your SHBG level sits and what TT level would be needed in order to achieve a healthy FT level which would result in relief/improvement of low-t symptoms and increased overall well-being.

The goal of trt is to replace physiological levels of testosterone through the use of exogenous testosterone in order to achieve a healthy TT/FT level which will result in the relief/improvement of low-t symptoms while at the same time minimizing/avoiding any potential side-effects (cosmetic/overall health) while keeping blood markers healthy long-term.

FT level 5-10 ng/dL would be considered low.

FT 16-31 ng/dL would be considered a healthy level.

Most men will do well with FT in the 20-30 ng/dL range and some may choose/need to run slightly higher levels

Again it comes down to the individual as some men will do better running higher TT/FT levels whereas others may feel better running lower levels.

Some men will always struggle with side-effects when running too high an FT level.

Thanks.

I'm not sure what lab was used. They drew blood at his office a couple weeks ago, and I received the test results in a message on my doctor's website later the same day. It did not specify a lab. Given that the "Standard Range" listed in the message is identical to the results listed in the DHHS's letter of 6/29/16 to Matthew Gee of Siemens concerning the Section 501(k) notice filed by Siemens, I'm assuming the lab used the Siemens test kit.

One thing that strikes me as somewhat odd is that the letter of 6/29/16 from DHHS to Siemens lists a device number of K151986. A letter from the FDA to Siemens dated 9/20/19 for a "re-standardized" ADVIA Centaur Testosterone (II) TSTII) test (K191533)(see https://www.accessdata.fda.gov/cdrh_docs/pdf19/K191533.pdf) includes "New Reference Intervals." It appears to me that the new criteria for Reference Intervals (CLSI guideline EP28-A3c) are based on the middle 90% rather than the middle 95%. The table at page 12 of the FDA letter shows a middle 90% range for men 50 and over of 187.72ng/dL - 684.19ng/dL.

The Conclusions portion of the FDA letter dated 9/22/19 states:

"Based on the results of comparative testing, the re-standardized ADVIA Centaur®Testosterone II (TSTII) is substantially equivalent in principle and performance to the currently-marketed predicate device, the ADVIA Centaur® Testosterone II (TSTII) cleared under 510(k) K151986.

The ADVIA Centaur® SHBG with the new reference intervals in the Instructions for Use (package insert) is substantially equivalent to the currently marketed ADVIA Centaur® SHBG (K151986). The new reference intervals that will replace the current reference intervals in the Instructions for Use (Package Inserts) for the currently marketed assay do not require collection of additional analytical performance data." (emphasis added)

In other words, if my doctor used the new reference intervals for the exact same test with a lower end of 187.72ng/dL I would meet the criteria.

I strongly suspect that the lab uses software to generate the test results, and the lab probably failed to update the reference intervals in the software consistent with the package inserts for the new test kits.

Regardless, I find the situation annoying. I'm not a doctor, but it seems to me a doctor should do more than run tests and base decisions very strictly on whether or not the test results fall in the bottom 2.5% or top 2.5% of a group of 137 men across an age range of 39 years (50-89).

I find myself wondering if this automated approach is due to an honest belief that this is best, or if it's driven by pressure from insurance companies, fear of state medical licensing agencies, or a fear of malpractice liability for deviating from a strict numbers-based approach.

 

[madman]

Thanks.

I'm not sure what lab was used. They drew blood at his office a couple weeks ago, and I received the test results in a message on my doctor's website later the same day. It did not specify a lab. Given that the "Standard Range" listed in the message is identical to the results listed in the DHHS's letter of 6/29/16 to Matthew Gee of Siemens concerning the Section 501(k) notice filed by Siemens, I'm assuming the lab used the Siemens test kit.

One thing that strikes me as somewhat odd is that the letter of 6/29/16 from DHHS to Siemens lists a device number of K151986. A letter from the FDA to Siemens dated 9/20/19 for a "re-standardized" ADVIA Centaur Testosterone (II) TSTII) test (K191533)(see https://www.accessdata.fda.gov/cdrh_docs/pdf19/K191533.pdf) includes "New Reference Intervals." It appears to me that the new criteria for Reference Intervals (CLSI guideline EP28-A3c) are based on the middle 90% rather than the middle 95%. The table at page 12 of the FDA letter shows a middle 90% range for men 50 and over of 187.72ng/dL - 684.19ng/dL.

The Conclusions portion of the FDA letter dated 9/22/19 states:

"Based on the results of comparative testing, the re-standardized ADVIA Centaur®Testosterone II (TSTII) is substantially equivalent in principle and performance to the currently-marketed predicate device, the ADVIA Centaur® Testosterone II (TSTII) cleared under 510(k) K151986.

The ADVIA Centaur® SHBG with the new reference intervals in the Instructions for Use (package insert) is substantially equivalent to the currently marketed ADVIA Centaur® SHBG (K151986). The new reference intervals that will replace the current reference intervals in the Instructions for Use (Package Inserts) for the currently marketed assay do not require collection of additional analytical performance data." (emphasis added)

In other words, if my doctor used the new reference intervals for the exact same test with a lower end of 187.72ng/dL I would meet the criteria.

I strongly suspect that the lab uses software to generate the test results, and the lab probably failed to update the reference intervals in the software consistent with the package inserts for the new test kits.

Regardless, I find the situation annoying. I'm not a doctor, but it seems to me a doctor should do more than run tests and base decisions very strictly on whether or not the test results fall in the bottom 2.5% or top 2.5% of a group of 137 men across an age range of 39 years (50-89).

I find myself wondering if this automated approach is due to an honest belief that this is best, or if it's driven by pressure from insurance companies, fear of state medical licensing agencies, or a fear of malpractice liability for deviating from a strict numbers-based approach.

Most are using two of the biggest labs (Quest, Labcorp) for blood work.

070001: Testosterone, Total, Women, Children, and Hypogonadal Males, LC/MS-MS | Labcorp

Labcorp test details for Testosterone, Total, Women, Children, and Hypogonadal Males, LC/MS-MS

www.labcorp.com

reference range 264-916 ng/dL

Quest Diagnostics: Test Directory

testdirectory.questdiagnostics.com

reference range 250-1100 ng/dL

 

[madman]

Believe it or not, the bottom /top end of the reference range was lowered in 2017 as it used to be 348 ng/dL.

 

[madman]

TT 86.98 - 780.10 ng/dL?

This is ridiculous, to say the least!

 

[madman]

From the 2018 AUA Guideline



Guideline Statements Diagnosis of Testosterone Deficiency

1. Clinicians should use a total testosterone level below 300 ng/dL as a reasonable cut-off in support of the diagnosis of low testosterone. (Moderate Recommendation; Evidence Level: Grade B)

2. The diagnosis of low testosterone should be made only after two total testosterone measurements are taken on separate occasions with both conducted in an early morning fashion. (Strong Recommendation; Evidence Level: Grade A)

3. The clinical diagnosis of testosterone deficiency is only made when patients have low total testosterone levels combined with symptoms and/or signs. (Moderate Recommendation; Evidence Level: Grade B)

4. Clinicians should consider measuring total testosterone in patients with a history of unexplained anemia, bone density loss, diabetes, exposure to chemotherapy, exposure to testicular radiation, HIV/AIDS, chronic narcotic use, male infertility, pituitary dysfunction, and chronic corticosteroid use even in the absence of symptoms or signs associated with testosterone deficiency. (Moderate Recommendation; Evidence Level: Grade B)

5. The use of validated questionnaires is not currently recommended to either define which patients are candidates for testosterone therapy or to monitor symptom response in patients on testosterone therapy. (Conditional Recommendation; Evidence Level: Grade C).





Adjunctive Testing

6. In patients with low testosterone, clinicians should measure serum luteinizing hormone levels. (Strong Recommendation; Evidence Level: Grade A)

7. Serum prolactin levels should be measured in patients with low testosterone levels combined with low or low/ normal luteinizing hormone levels. (Strong Recommendation; Evidence Level: Grade A)

8. Patients with persistently high prolactin levels of unknown etiology should undergo evaluation for endocrine disorders. (Strong Recommendation; Evidence Level: Grade A)

9. Serum estradiol should be measured in testosterone deficient patients who present with breast symptoms or gynecomastia prior to the commencement of testosterone therapy. (Expert Opinion)

10. Men with testosterone deficiency who are interested in fertility should have a reproductive health evaluation performed prior to treatment. (Moderate Recommendation; Evidence Level: Grade B)

11. Prior to offering testosterone therapy, clinicians should measure hemoglobin and hematocrit and inform patients regarding the increased risk of polycythemia. (Strong Recommendation; Evidence Level: Grade A)

12. PSA should be measured in men over 40 years of age prior to commencement of testosterone therapy to exclude a prostate cancer diagnosis. (Clinical Principle)




As you can see what is stated below clearly makes it difficult for many men to get treatment let alone reap any of the beneficial effects of trt by being dead set on keeping you in range LMFAO!

*It was decided that a cut-off value was critical to define testosterone deficiency and that this cut-off be based on at least two total testosterone levels drawn in an early morning fashion at the same laboratory using the same assay. The cut-off of 300 ng/dL was chosen based on the mean total testosterone levels cited in the best available literature with a view to maximizing the potential benefit from prescribing testosterone while minimizing the risks of such treatment.

*The Panel defines success as the achievement of therapeutic testosterone levels to the normal physiologic range of 450 -600 ng/dL (middle tertile of the reference range for most labs) accompanied by symptom/sign improvement/resolution.




Reference Ranges

Well-established reference ranges constitute the essential basis for identifying whether the circulating levels of a particular analyte, testosterone, in this case, are normal or low. Due to the challenges in testosterone methodology, there is considerable variability in testosterone reference ranges.13 The specific reference ranges used to diagnose testosterone deficiency are discussed in more depth later in this document. However, practicing clinicians who review testosterone lab results will commonly face the dilemma of whether to use the reference ranges published by their specific lab or the absolute measure itself.

As an example, a total testosterone value of 250 ng/dL may be considered low based on the current guideline but be marked within the normal range by the laboratory.

This situation commonly occurs as reference laboratories often define a normal value as ranging within the 5th (or 2.5th) and 95th (or 97.5th) percentiles of a sampled population.

However, as the testosterone literature uses absolute values to define low testosterone, the absolute value is ultimately the most important factor to determine whether patients may expect to achieve benefits with testosterone therapy.

In cases of discrepancy between laboratory reference ranges and this guideline, clinicians are recommended to utilize the absolute value with the understanding that all labs (including CDC-certified LCMS) include some degree of variability. Clinicians wishing to identify laboratories meeting CDC standards are encouraged to refer to the list of sites currently meeting CDC requirements listed on the CDC Hormone Standardization Program.



No need to get caught up in the s**t show!

Again find a doctor who specializes in hrt/trt.

 

[Mr. Clark]

From the 2018 AUA Guideline



Guideline Statements Diagnosis of Testosterone Deficiency

1. Clinicians should use a total testosterone level below 300 ng/dL as a reasonable cut-off in support of the diagnosis of low testosterone. (Moderate Recommendation; Evidence Level: Grade B)

2. The diagnosis of low testosterone should be made only after two total testosterone measurements are taken on separate occasions with both conducted in an early morning fashion. (Strong Recommendation; Evidence Level: Grade A)

3. The clinical diagnosis of testosterone deficiency is only made when patients have low total testosterone levels combined with symptoms and/or signs. (Moderate Recommendation; Evidence Level: Grade B)

4. Clinicians should consider measuring total testosterone in patients with a history of unexplained anemia, bone density loss, diabetes, exposure to chemotherapy, exposure to testicular radiation, HIV/AIDS, chronic narcotic use, male infertility, pituitary dysfunction, and chronic corticosteroid use even in the absence of symptoms or signs associated with testosterone deficiency. (Moderate Recommendation; Evidence Level: Grade B)

5. The use of validated questionnaires is not currently recommended to either define which patients are candidates for testosterone therapy or to monitor symptom response in patients on testosterone therapy. (Conditional Recommendation; Evidence Level: Grade C).





Adjunctive Testing

6. In patients with low testosterone, clinicians should measure serum luteinizing hormone levels. (Strong Recommendation; Evidence Level: Grade A)

7. Serum prolactin levels should be measured in patients with low testosterone levels combined with low or low/ normal luteinizing hormone levels. (Strong Recommendation; Evidence Level: Grade A)

8. Patients with persistently high prolactin levels of unknown etiology should undergo evaluation for endocrine disorders. (Strong Recommendation; Evidence Level: Grade A)

9. Serum estradiol should be measured in testosterone deficient patients who present with breast symptoms or gynecomastia prior to the commencement of testosterone therapy. (Expert Opinion)

10. Men with testosterone deficiency who are interested in fertility should have a reproductive health evaluation performed prior to treatment. (Moderate Recommendation; Evidence Level: Grade B)

11. Prior to offering testosterone therapy, clinicians should measure hemoglobin and hematocrit and inform patients regarding the increased risk of polycythemia. (Strong Recommendation; Evidence Level: Grade A)

12. PSA should be measured in men over 40 years of age prior to commencement of testosterone therapy to exclude a prostate cancer diagnosis. (Clinical Principle)




As you can see what is stated below clearly makes it difficult for many men to get treatment let alone reap any of the beneficial effects of trt by being dead set on keeping you in range LMFAO!

*It was decided that a cut-off value was critical to define testosterone deficiency and that this cut-off be based on at least two total testosterone levels drawn in an early morning fashion at the same laboratory using the same assay. The cut-off of 300 ng/dL was chosen based on the mean total testosterone levels cited in the best available literature with a view to maximizing the potential benefit from prescribing testosterone while minimizing the risks of such treatment.

*The Panel defines success as the achievement of therapeutic testosterone levels to the normal physiologic range of 450 -600 ng/dL (middle tertile of the reference range for most labs) accompanied by symptom/sign improvement/resolution.




Reference Ranges

Well-established reference ranges constitute the essential basis for identifying whether the circulating levels of a particular analyte, testosterone, in this case, are normal or low. Due to the challenges in testosterone methodology, there is considerable variability in testosterone reference ranges.13 The specific reference ranges used to diagnose testosterone deficiency are discussed in more depth later in this document. However, practicing clinicians who review testosterone lab results will commonly face the dilemma of whether to use the reference ranges published by their specific lab or the absolute measure itself.

As an example, a total testosterone value of 250 ng/dL may be considered low based on the current guideline but be marked within the normal range by the laboratory.

This situation commonly occurs as reference laboratories often define a normal value as ranging within the 5th (or 2.5th) and 95th (or 97.5th) percentiles of a sampled population.

However, as the testosterone literature uses absolute values to define low testosterone, the absolute value is ultimately the most important factor to determine whether patients may expect to achieve benefits with testosterone therapy.

In cases of discrepancy between laboratory reference ranges and this guideline, clinicians are recommended to utilize the absolute value with the understanding that all labs (including CDC-certified LCMS) include some degree of variability. Clinicians wishing to identify laboratories meeting CDC standards are encouraged to refer to the list of sites currently meeting CDC requirements listed on the CDC Hormone Standardization Program.



No need to get caught up in the s**t show!

Again find a doctor who specializes in hrt/trt.

Thanks again.

I was thinking about pointing out to my doctor that my level is below the lower end of the new middle 90% range used by Siemens, but I suspect it would fall deaf ears:

"Arguments have no chance against petrified training; they wear it as little as the waves wear a cliff." Mark Twain, A Connecticut Yankee in King Arthur's Court

A Connecticut Yankee in King Arthur's Court by Mark Twain: Part 2 Chapter 17 (continued) - The Literature Page

 

[Mr. Clark]

From the 2018 AUA Guideline



Guideline Statements Diagnosis of Testosterone Deficiency

1. Clinicians should use a total testosterone level below 300 ng/dL as a reasonable cut-off in support of the diagnosis of low testosterone. (Moderate Recommendation; Evidence Level: Grade B)

2. The diagnosis of low testosterone should be made only after two total testosterone measurements are taken on separate occasions with both conducted in an early morning fashion. (Strong Recommendation; Evidence Level: Grade A)

3. The clinical diagnosis of testosterone deficiency is only made when patients have low total testosterone levels combined with symptoms and/or signs. (Moderate Recommendation; Evidence Level: Grade B)

4. Clinicians should consider measuring total testosterone in patients with a history of unexplained anemia, bone density loss, diabetes, exposure to chemotherapy, exposure to testicular radiation, HIV/AIDS, chronic narcotic use, male infertility, pituitary dysfunction, and chronic corticosteroid use even in the absence of symptoms or signs associated with testosterone deficiency. (Moderate Recommendation; Evidence Level: Grade B)

5. The use of validated questionnaires is not currently recommended to either define which patients are candidates for testosterone therapy or to monitor symptom response in patients on testosterone therapy. (Conditional Recommendation; Evidence Level: Grade C).





Adjunctive Testing

6. In patients with low testosterone, clinicians should measure serum luteinizing hormone levels. (Strong Recommendation; Evidence Level: Grade A)

7. Serum prolactin levels should be measured in patients with low testosterone levels combined with low or low/ normal luteinizing hormone levels. (Strong Recommendation; Evidence Level: Grade A)

8. Patients with persistently high prolactin levels of unknown etiology should undergo evaluation for endocrine disorders. (Strong Recommendation; Evidence Level: Grade A)

9. Serum estradiol should be measured in testosterone deficient patients who present with breast symptoms or gynecomastia prior to the commencement of testosterone therapy. (Expert Opinion)

10. Men with testosterone deficiency who are interested in fertility should have a reproductive health evaluation performed prior to treatment. (Moderate Recommendation; Evidence Level: Grade B)

11. Prior to offering testosterone therapy, clinicians should measure hemoglobin and hematocrit and inform patients regarding the increased risk of polycythemia. (Strong Recommendation; Evidence Level: Grade A)

12. PSA should be measured in men over 40 years of age prior to commencement of testosterone therapy to exclude a prostate cancer diagnosis. (Clinical Principle)




As you can see what is stated below clearly makes it difficult for many men to get treatment let alone reap any of the beneficial effects of trt by being dead set on keeping you in range LMFAO!

*It was decided that a cut-off value was critical to define testosterone deficiency and that this cut-off be based on at least two total testosterone levels drawn in an early morning fashion at the same laboratory using the same assay. The cut-off of 300 ng/dL was chosen based on the mean total testosterone levels cited in the best available literature with a view to maximizing the potential benefit from prescribing testosterone while minimizing the risks of such treatment.

*The Panel defines success as the achievement of therapeutic testosterone levels to the normal physiologic range of 450 -600 ng/dL (middle tertile of the reference range for most labs) accompanied by symptom/sign improvement/resolution.




Reference Ranges

Well-established reference ranges constitute the essential basis for identifying whether the circulating levels of a particular analyte, testosterone, in this case, are normal or low. Due to the challenges in testosterone methodology, there is considerable variability in testosterone reference ranges.13 The specific reference ranges used to diagnose testosterone deficiency are discussed in more depth later in this document. However, practicing clinicians who review testosterone lab results will commonly face the dilemma of whether to use the reference ranges published by their specific lab or the absolute measure itself.

As an example, a total testosterone value of 250 ng/dL may be considered low based on the current guideline but be marked within the normal range by the laboratory.

This situation commonly occurs as reference laboratories often define a normal value as ranging within the 5th (or 2.5th) and 95th (or 97.5th) percentiles of a sampled population.

However, as the testosterone literature uses absolute values to define low testosterone, the absolute value is ultimately the most important factor to determine whether patients may expect to achieve benefits with testosterone therapy.

In cases of discrepancy between laboratory reference ranges and this guideline, clinicians are recommended to utilize the absolute value with the understanding that all labs (including CDC-certified LCMS) include some degree of variability. Clinicians wishing to identify laboratories meeting CDC standards are encouraged to refer to the list of sites currently meeting CDC requirements listed on the CDC Hormone Standardization Program.



No need to get caught up in the s**t show!

Again find a doctor who specializes in hrt/trt.

From the 2018 AUA Guideline



Guideline Statements Diagnosis of Testosterone Deficiency

1. Clinicians should use a total testosterone level below 300 ng/dL as a reasonable cut-off in support of the diagnosis of low testosterone. (Moderate Recommendation; Evidence Level: Grade B)

2. The diagnosis of low testosterone should be made only after two total testosterone measurements are taken on separate occasions with both conducted in an early morning fashion. (Strong Recommendation; Evidence Level: Grade A)

3. The clinical diagnosis of testosterone deficiency is only made when patients have low total testosterone levels combined with symptoms and/or signs. (Moderate Recommendation; Evidence Level: Grade B)

4. Clinicians should consider measuring total testosterone in patients with a history of unexplained anemia, bone density loss, diabetes, exposure to chemotherapy, exposure to testicular radiation, HIV/AIDS, chronic narcotic use, male infertility, pituitary dysfunction, and chronic corticosteroid use even in the absence of symptoms or signs associated with testosterone deficiency. (Moderate Recommendation; Evidence Level: Grade B)

5. The use of validated questionnaires is not currently recommended to either define which patients are candidates for testosterone therapy or to monitor symptom response in patients on testosterone therapy. (Conditional Recommendation; Evidence Level: Grade C).





Adjunctive Testing

6. In patients with low testosterone, clinicians should measure serum luteinizing hormone levels. (Strong Recommendation; Evidence Level: Grade A)

7. Serum prolactin levels should be measured in patients with low testosterone levels combined with low or low/ normal luteinizing hormone levels. (Strong Recommendation; Evidence Level: Grade A)

8. Patients with persistently high prolactin levels of unknown etiology should undergo evaluation for endocrine disorders. (Strong Recommendation; Evidence Level: Grade A)

9. Serum estradiol should be measured in testosterone deficient patients who present with breast symptoms or gynecomastia prior to the commencement of testosterone therapy. (Expert Opinion)

10. Men with testosterone deficiency who are interested in fertility should have a reproductive health evaluation performed prior to treatment. (Moderate Recommendation; Evidence Level: Grade B)

11. Prior to offering testosterone therapy, clinicians should measure hemoglobin and hematocrit and inform patients regarding the increased risk of polycythemia. (Strong Recommendation; Evidence Level: Grade A)

12. PSA should be measured in men over 40 years of age prior to commencement of testosterone therapy to exclude a prostate cancer diagnosis. (Clinical Principle)




As you can see what is stated below clearly makes it difficult for many men to get treatment let alone reap any of the beneficial effects of trt by being dead set on keeping you in range LMFAO!

*It was decided that a cut-off value was critical to define testosterone deficiency and that this cut-off be based on at least two total testosterone levels drawn in an early morning fashion at the same laboratory using the same assay. The cut-off of 300 ng/dL was chosen based on the mean total testosterone levels cited in the best available literature with a view to maximizing the potential benefit from prescribing testosterone while minimizing the risks of such treatment.

*The Panel defines success as the achievement of therapeutic testosterone levels to the normal physiologic range of 450 -600 ng/dL (middle tertile of the reference range for most labs) accompanied by symptom/sign improvement/resolution.




Reference Ranges

Well-established reference ranges constitute the essential basis for identifying whether the circulating levels of a particular analyte, testosterone, in this case, are normal or low. Due to the challenges in testosterone methodology, there is considerable variability in testosterone reference ranges.13 The specific reference ranges used to diagnose testosterone deficiency are discussed in more depth later in this document. However, practicing clinicians who review testosterone lab results will commonly face the dilemma of whether to use the reference ranges published by their specific lab or the absolute measure itself.

As an example, a total testosterone value of 250 ng/dL may be considered low based on the current guideline but be marked within the normal range by the laboratory.

This situation commonly occurs as reference laboratories often define a normal value as ranging within the 5th (or 2.5th) and 95th (or 97.5th) percentiles of a sampled population.

However, as the testosterone literature uses absolute values to define low testosterone, the absolute value is ultimately the most important factor to determine whether patients may expect to achieve benefits with testosterone therapy.

In cases of discrepancy between laboratory reference ranges and this guideline, clinicians are recommended to utilize the absolute value with the understanding that all labs (including CDC-certified LCMS) include some degree of variability. Clinicians wishing to identify laboratories meeting CDC standards are encouraged to refer to the list of sites currently meeting CDC requirements listed on the CDC Hormone Standardization Program.



No need to get caught up in the s**t show!

Again find a doctor who specializes in hrt/trt.

My doc referred me to an endocronologist. The endo said I needed to get blood drawn in the morning when T is highest (for the prior T test the blood was drawn in the afternoon).

After getting blood drawn in the morning, the T level was somewhat higher. The endo stated: " The total testosterone was 180.50, sex hormone binding globulin 15.50, and albumin 4.3. These calculate to a bioavailable testosterone of 116 (normal 50 to 190) and a free testosterone of 4.93 (normal 3.87 to 14.7). The total testosterone appears low only because the sex hormone binding globulin is low, which is a variant of normal. The bioavailable and free testosterone are normal. Therefore, there is no need to start testosterone therapy at this time."

The numbers still seem a bit low to me, and the normal ranges he lists also seem low. For example, Harvard lists the following for men ages 50-59:

Total testosterone

Free testosterone

Bioavailable testosterone

215–878

4.2–22.2

80–420

Testosterone, aging, and the mind - Harvard Health

Testosterone affects many of the body's functions throughout a man's life. Some studies have attempted to link declining testosterone production in later life to decreased cognitive functio...

www.health.harvard.edu

What strikes me as especially odd is that normal bioavailable and free T ranges cited by the Endo are significantly lower than in the Harvard article.

It appears to me he is using the same numbers as the Mayo Clinic:

TTFB - Overview: Testosterone, Total, Bioavailable, and Free, Serum

Second- or third-order test for evaluating testosterone status (eg, when abnormalities of sex hormone-binding globulin are present)

www.mayocliniclabs.com

I talked to the endo briefly about lethargy, lack of libido, etc. but he seems to think this is just natural aging. I can understand that to a point, but the lack of libido is causing issues with my wife and this has become a quality of life issue for me (admitedly I don't know for sure if low T is causing the lethargy and libido issues).

My Free T4 is 1.09 ng/dL so I doubt that the lethargy is a result of a thyroid problem.

Any thoughts would be appreciated.

 

[madman]

My doc referred me to an endocronologist. The endo said I needed to get blood drawn in the morning when T is highest (for the prior T test the blood was drawn in the afternoon).

After getting blood drawn in the morning, the T level was somewhat higher. The endo stated: " The total testosterone was 180.50, sex hormone binding globulin 15.50, and albumin 4.3. These calculate to a bioavailable testosterone of 116 (normal 50 to 190) and a free testosterone of 4.93 (normal 3.87 to 14.7). The total testosterone appears low only because the sex hormone binding globulin is low, which is a variant of normal. The bioavailable and free testosterone are normal. Therefore, there is no need to start testosterone therapy at this time."

The numbers still seem a bit low to me, and the normal ranges he lists also seem low. For example, Harvard lists the following for men ages 50-59:

Total testosterone

Free testosterone

Bioavailable testosterone

215–878

4.2–22.2

80–420

Testosterone, aging, and the mind - Harvard Health

Testosterone affects many of the body's functions throughout a man's life. Some studies have attempted to link declining testosterone production in later life to decreased cognitive functio...

www.health.harvard.edu

What strikes me as especially odd is that normal bioavailable and free T ranges cited by the Endo are significantly lower than in the Harvard article.

It appears to me he is using the same numbers as the Mayo Clinic:

TTFB - Overview: Testosterone, Total, Bioavailable, and Free, Serum

Second- or third-order test for evaluating testosterone status (eg, when abnormalities of sex hormone-binding globulin are present)

www.mayocliniclabs.com

I talked to the endo briefly about lethargy, lack of libido, etc. but he seems to think this is just natural aging. I can understand that to a point, but the lack of libido is causing issues with my wife and this has become a quality of life issue for me (admitedly I don't know for sure if low T is causing the lethargy and libido issues).

My Free T4 is 1.09 ng/dL so I doubt that the lethargy is a result of a thyroid problem.

Any thoughts would be appreciated.

Again from my reply in post #7

--------------------------------------------------------------------------------------------------
From the 2018 AUA Guideline

Guideline Statements Diagnosis of Testosterone Deficiency

1. Clinicians should use a total testosterone level below 300 ng/dL as a reasonable cut-off in support of the diagnosis of low testosterone. (Moderate Recommendation; Evidence Level: Grade B)

2. The diagnosis of low testosterone should be made only after two total testosterone measurements are taken on separate occasions with both conducted in an early morning fashion. (Strong Recommendation; Evidence Level: Grade A)

3. The clinical diagnosis of testosterone deficiency is only made when patients have low total testosterone levels combined with symptoms and/or signs. (Moderate Recommendation; Evidence Level: Grade B)

4. Clinicians should consider measuring total testosterone in patients with a history of unexplained anemia, bone density loss, diabetes, exposure to chemotherapy, exposure to testicular radiation, HIV/AIDS, chronic narcotic use, male infertility, pituitary dysfunction, and chronic corticosteroid use even in the absence of symptoms or signs associated with testosterone deficiency. (Moderate Recommendation; Evidence Level: Grade B)

5. The use of validated questionnaires is not currently recommended to either define which patients are candidates for testosterone therapy or to monitor symptom response in patients on testosterone therapy. (Conditional Recommendation; Evidence Level: Grade C).




Adjunctive Testing

6. In patients with low testosterone, clinicians should measure serum luteinizing hormone levels. (Strong Recommendation; Evidence Level: Grade A)

7. Serum prolactin levels should be measured in patients with low testosterone levels combined with low or low/ normal luteinizing hormone levels. (Strong Recommendation; Evidence Level: Grade A)

8. Patients with persistently high prolactin levels of unknown etiology should undergo evaluation for endocrine disorders. (Strong Recommendation; Evidence Level: Grade A)

9. Serum estradiol should be measured in testosterone deficient patients who present with breast symptoms or gynecomastia prior to the commencement of testosterone therapy. (Expert Opinion)

10. Men with testosterone deficiency who are interested in fertility should have a reproductive health evaluation performed prior to treatment. (Moderate Recommendation; Evidence Level: Grade B)

11. Prior to offering testosterone therapy, clinicians should measure hemoglobin and hematocrit and inform patients regarding the increased risk of polycythemia. (Strong Recommendation; Evidence Level: Grade A)

12. PSA should be measured in men over 40 years of age prior to commencement of testosterone therapy to exclude a prostate cancer diagnosis. (Clinical Principle)
--------------------------------------------------------------------------------------------------


As you can see what is stated below clearly makes it difficult for many men to get treatment let alone reap any of the beneficial effects of trt by being dead set on keeping you in range LMFAO!

*It was decided that a cut-off value was critical to define testosterone deficiency and that this cut-off be based on at least two total testosterone levels drawn in an early morning fashion at the same laboratory using the same assay. The cut-off of 300 ng/dL was chosen based on the mean total testosterone levels cited in the best available literature with a view to maximizing the potential benefit from prescribing testosterone while minimizing the risks of such treatment.

*The Panel defines success as the achievement of therapeutic testosterone levels to the normal physiologic range of 450 -600 ng/dL (middle tertile of the reference range for most labs) accompanied by symptom/sign improvement/resolution.




Reference Ranges

Well-established reference ranges constitute the essential basis for identifying whether the circulating levels of a particular analyte, testosterone, in this case, are normal or low. Due to the challenges in testosterone methodology, there is considerable variability in testosterone reference ranges.13 The specific reference ranges used to diagnose testosterone deficiency are discussed in more depth later in this document. However, practicing clinicians who review testosterone lab results will commonly face the dilemma of whether to use the reference ranges published by their specific lab or the absolute measure itself.

As an example, a total testosterone value of 250 ng/dL may be considered low based on the current guideline but be marked within the normal range by the laboratory.

This situation commonly occurs as reference laboratories often define a normal value as ranging within the 5th (or 2.5th) and 95th (or 97.5th) percentiles of a sampled population.

However, as the testosterone literature uses absolute values to define low testosterone, the absolute value is ultimately the most important factor to determine whether patients may expect to achieve benefits with testosterone therapy.

In cases of discrepancy between laboratory reference ranges and this guideline, clinicians are recommended to utilize the absolute value with the understanding that all labs (including CDC-certified LCMS) include some degree of variability. Clinicians wishing to identify laboratories meeting CDC standards are encouraged to refer to the list of sites currently meeting CDC requirements listed on the CDC Hormone Standardization Program.


No need to get caught up in the s**t show!

Again find a doctor who specializes in hrt/trt.




The endo said I needed to get blood drawn in the morning when T is highest (for the prior T test the blood was drawn in the afternoon).

True but keep in mind that this can be blunted in older men.

During the 24hr circadian rhythm of a healthy young male testosterone levels will start to increase around 3-4 am reaching a peak between 6-8 am and by 11-12 pm will start to decline late afternoon/early evening reaching a trough between 6-8 pm.

Fluctuations from peak--->trough would be around 20-25%

Natural T levels follow a diurnal 24 hr circadian rhythm and will start to rise gradually around 3 am reaching peak levels around 8 am

Natural endogenous testosterone secretion is pulsatile and diurnal.




The total testosterone was 180.50, sex hormone binding globulin 15.50, and albumin 4.3.

The total testosterone appears low only because the sex hormone binding globulin is low, which is a variant of normal. The bioavailable and free testosterone are normal. Therefore, there is no need to start testosterone therapy at this time."

Your TT is still horribly low and even with a lowish SHBG 15.5 nmol/L your FT will be low!

Even when using the calculated methods available online whether the linear law-of-mass action cFTV or the newer TruT™ (cFTZ) algorithm your FT level would be absurdly low.




My reply from post #2

In general, I just want to get my T back to a middle normal range (hopefully this will help with the lethargy, sex drive, etc.). I've never been able to put on a lot of muscle mass working out, and I'm not trying to pack on a lot of muscle at my age. I could stand to lose 10-15 lbs of fat, but I'm not trying to bulk up.

Forget worrying about where your levels need to be as many men may need higher-end TT levels to achieve a healthy FT.

It comes down to where your SHBG level sits and what TT level would be needed in order to achieve a healthy FT level which would result in relief/improvement of low-t symptoms and increased overall well-being.

The goal of trt is to replace physiological levels of testosterone through the use of exogenous testosterone in order to achieve a healthy TT/FT level which will result in the relief/improvement of low-t symptoms while at the same time minimizing/avoiding any potential side effects (cosmetic/overall health) while keeping blood markers healthy long-term.

FT level 5-10 ng/dL would be considered low.

FT 16-31 ng/dL would be considered a healthy level.

Most men will do well with FT in the 20-30 ng/dL range and some may choose/need to run slightly higher levels

Again it comes down to the individual as some men will do better running higher TT/FT levels whereas others may feel better running lower levels.

Some men will always struggle with side effects when running too high an FT level.

 

[madman]

Forget getting caught up in the age reference ranges.

Your TT 180 ng/dL is absurdly low and FT is sub-par to say the least!

Where your TT/FT level sits as of now is far from where you were at in your prime.


*My doctor says he does not prescribe TRT unless someone is outside the "normal range" (i.e. the "Standard Range" listed with the test results). In other words, my T level would need to be below 86.98 ng/dL. I mentioned my symptoms of lethargy and no sex drive, and my doctor offered to refer me to an endocronolgist. My general impression is that he goes strictly by the numbers for everything, perhaps for fear of having his license suspended or revoked.

*In general, I just want to get my T back to a middle normal range (hopefully this will help with the lethargy, sex drive, etc.). I've never been able to put on a lot of muscle mass working out, and I'm not trying to pack on a lot of muscle at my age. I could stand to lose 10-15 lbs of fat, but I'm not trying to bulk up.

*I talked to the endo briefly about lethargy, lack of libido, etc. but he seems to think this is just natural aging. I can understand that to a point, but the lack of libido is causing issues with my wife and this has become a quality of life issue for me (admitedly I don't know for sure if low T is causing the lethargy and libido issues).

 

[Systemlord]

Mr. Clark your best move is to seek an opinion and/or TRT outside of the sick care system which seems out of touch with sex hormones therapy.