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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Side Effect Management
Free Testosterone targets for the best Libido
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<blockquote data-quote="madman" data-source="post: 277603" data-attributes="member: 13851"><p>As I have stated in previous posts no one should be using/relying upon the TruT calculator as it is still in development/needs further validation.</p><p></p><p><strong>*</strong><em><strong>This Phase IIB proposal aims to continue the development of the TruTTM algorithm by validating it in common conditions characterized by altered estradiol (E2), T, and SHBG concentrations and incorporating the interaction of E2 with T for wider commercial adoption in women in whom E2 levels vary greatly across the menstrual cycle and in TGD population</strong></em></p><p></p><p></p><p></p><p></p><p>Everyone should be testing their FT using what would be considered the most accurate assays such as the gold standard Equilibrium Dialysis or Equilibrium Ultrafiltration especially in cases of altered SHBG.</p><p></p><p>If you do not have access to such assays, highly doubtful if you live in the US then you would need to use/rely upon the linear law-of-mass action cFTV.</p><p></p><p>Keep in mind as of now cFTV tends to overestimate slightly when compared against a standardized Equilibrium Dialysis assay.</p><p></p><p>There is no so called optimal trough FT for the best libido!</p><p></p><p>If anything you should be aiming for a healthy trough FT.</p><p></p><p>A healthy trough FT based off a standardized ED assay would be around 16-31 ng/dL.</p><p></p><p>More importantly you need keep the injection frequency/peak--->trough in mind as there is a world of difference between one hitting a high trough FT injecting once weekly vs daily or EOD!</p><p></p><p>Even than it is not a given that having a healthy/high FT will result in having a good/strong sex drive as libido let alone ED are multifactorial.</p><p></p><p>Testosterone is only one piece of the puzzle.</p><p></p><p>Also need to keep in mind that running too high a trough FT level can be just as bad in many ways as running too low a level especially when it comes to libido/erectile function and mood!</p><p></p><p></p><p></p><p></p><p>[URL unfurl="true"]https://www.excelmale.com/threads/calculate-free-testosterone-with-trut-by-fpt.18468/page-8#post-264860[/URL]</p><p></p><p><strong><em>TruTTM (v2.0) algorithm</em></strong></p><p><strong></strong></p><p><strong>ABSTRACT</strong></p><p><strong></strong></p><p><strong>Background: </strong><em>Measurement of free testosterone (T) concentrations is indicated in the diagnosis of androgen disorders, including hypogonadism in men; hirsutism, polycystic ovary syndrome (PCOS), and androgenic alopecia in women; pubertal disorders in boys and management of gender-affirming hormone therapies for transgender and gender diverse (TGD) persons.<strong> This Phase IIB proposal <u>aims to continue the development of the TruTTM algorithm by validating it in common conditions characterized by altered estradiol (E2), T, and SHBG concentrations and incorporating the interaction of E2 with T</u> for wider commercial adoption in women in whom E2 levels vary greatly across the menstrual cycle and in TGD population.</strong></em></p><p></p><p><strong>Approach: </strong><em><strong>This application follows the FDA’s published “<u>Guidance for Industry: Bioanalytical Method Validation</u>”.</strong></em></p><p></p><p><strong><em>The essential parameters to determine the acceptability of a bioanalytical method include its <u>technical performance (accuracy, precision, sensitivity, selectivity, stability, and matrix effects)</u>.</em></strong></p><p><strong><em></em></strong></p><p><strong><em>Reference ranges should be determined in <u>appropriate human samples</u>.</em></strong></p><p><strong><em></em></strong></p><p><strong><em>The <u>analytical method should be validated for the intended use (e.g., determination in conditions of intended use, such as persons with altered E2 and T levels, women with PCOS, TGD persons, etc.)</u>.</em></strong></p><p><strong><em></em></strong></p><p><strong><em>In studies through the Phase II, we demonstrated that the method has superior performance characteristics and extended the validation of TruTTM algorithm in conditions characterized by altered SHBG concentrations.</em></strong></p><p><strong><em></em></strong></p><p><strong><em>*In the proposed Phase IIB studies, we will <u>generate the v2.0 of TruTTM algorithm by incorporating the dynamics of the E2 induced perturbation in free T levels, validate it in men, women, and TGD populations</u> (<u>Aim 1</u>) and deploy HIPAA-compliant, secure integration of the algorithm into electronic medical records (EMR) workflow</em></strong></p><p><strong><em></em></strong></p><p><strong><em>*(<u>Aim 2</u>). <u>Future Directions and Commercialization potential</u>: The phase IIB program will <u>enable the pilot commercial deployment of a HIPAA-compliant (FDA registered) platform for commercializing the TruTTM (v2.0) algorithm embedded into electronic medical record (EMR) for wider clinical adoption</u>.</em></strong></p><p><strong><em></em></strong></p><p><strong><em>These studies will improve clinical care and <u>advance our fundamental understanding of dynamic regulation of T bioavailability</u> in diverse populations including unrepresented sexual and gender minorities</em></strong></p></blockquote><p></p>
[QUOTE="madman, post: 277603, member: 13851"] As I have stated in previous posts no one should be using/relying upon the TruT calculator as it is still in development/needs further validation. [B]*[/B][I][B]This Phase IIB proposal aims to continue the development of the TruTTM algorithm by validating it in common conditions characterized by altered estradiol (E2), T, and SHBG concentrations and incorporating the interaction of E2 with T for wider commercial adoption in women in whom E2 levels vary greatly across the menstrual cycle and in TGD population[/B][/I] Everyone should be testing their FT using what would be considered the most accurate assays such as the gold standard Equilibrium Dialysis or Equilibrium Ultrafiltration especially in cases of altered SHBG. If you do not have access to such assays, highly doubtful if you live in the US then you would need to use/rely upon the linear law-of-mass action cFTV. Keep in mind as of now cFTV tends to overestimate slightly when compared against a standardized Equilibrium Dialysis assay. There is no so called optimal trough FT for the best libido! If anything you should be aiming for a healthy trough FT. A healthy trough FT based off a standardized ED assay would be around 16-31 ng/dL. More importantly you need keep the injection frequency/peak--->trough in mind as there is a world of difference between one hitting a high trough FT injecting once weekly vs daily or EOD! Even than it is not a given that having a healthy/high FT will result in having a good/strong sex drive as libido let alone ED are multifactorial. Testosterone is only one piece of the puzzle. Also need to keep in mind that running too high a trough FT level can be just as bad in many ways as running too low a level especially when it comes to libido/erectile function and mood! [URL unfurl="true"]https://www.excelmale.com/threads/calculate-free-testosterone-with-trut-by-fpt.18468/page-8#post-264860[/URL] [B][I]TruTTM (v2.0) algorithm[/I] ABSTRACT Background: [/B][I]Measurement of free testosterone (T) concentrations is indicated in the diagnosis of androgen disorders, including hypogonadism in men; hirsutism, polycystic ovary syndrome (PCOS), and androgenic alopecia in women; pubertal disorders in boys and management of gender-affirming hormone therapies for transgender and gender diverse (TGD) persons.[B] This Phase IIB proposal [U]aims to continue the development of the TruTTM algorithm by validating it in common conditions characterized by altered estradiol (E2), T, and SHBG concentrations and incorporating the interaction of E2 with T[/U] for wider commercial adoption in women in whom E2 levels vary greatly across the menstrual cycle and in TGD population.[/B][/I] [B]Approach: [/B][I][B]This application follows the FDA’s published “[U]Guidance for Industry: Bioanalytical Method Validation[/U]”.[/B][/I] [B][I]The essential parameters to determine the acceptability of a bioanalytical method include its [U]technical performance (accuracy, precision, sensitivity, selectivity, stability, and matrix effects)[/U]. Reference ranges should be determined in [U]appropriate human samples[/U]. The [U]analytical method should be validated for the intended use (e.g., determination in conditions of intended use, such as persons with altered E2 and T levels, women with PCOS, TGD persons, etc.)[/U]. In studies through the Phase II, we demonstrated that the method has superior performance characteristics and extended the validation of TruTTM algorithm in conditions characterized by altered SHBG concentrations. *In the proposed Phase IIB studies, we will [U]generate the v2.0 of TruTTM algorithm by incorporating the dynamics of the E2 induced perturbation in free T levels, validate it in men, women, and TGD populations[/U] ([U]Aim 1[/U]) and deploy HIPAA-compliant, secure integration of the algorithm into electronic medical records (EMR) workflow *([U]Aim 2[/U]). [U]Future Directions and Commercialization potential[/U]: The phase IIB program will [U]enable the pilot commercial deployment of a HIPAA-compliant (FDA registered) platform for commercializing the TruTTM (v2.0) algorithm embedded into electronic medical record (EMR) for wider clinical adoption[/U]. These studies will improve clinical care and [U]advance our fundamental understanding of dynamic regulation of T bioavailability[/U] in diverse populations including unrepresented sexual and gender minorities[/I][/B] [/QUOTE]
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Testosterone Replacement, Low T, HCG, & Beyond
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Free Testosterone targets for the best Libido
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