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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone and Men's Health Articles
Significant decrease in SHBG with the use of Oral TU (JATENZO)
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<blockquote data-quote="madman" data-source="post: 221581" data-attributes="member: 13851"><p><strong>A New Oral Testosterone Undecanoate Formulation Restores Testosterone to Normal Concentrations in Hypogonadal Men (2020)</strong></p><p><em>Ronald S. Swerdloff, Christina Wang, William B. White, Jed Kaminetsky, Marc C. Gittelman, James A. Longstreth, Robert E. Dudley, and Theodore M. Danoff6</em></p><p></p><p></p><p><strong>Data analyses </strong></p><p><strong></strong></p><p><strong>Efficacy/pharmacokinetic analyses. </strong><em>Efficacy was assessed based on the percentage of treated patients whose T Cavg was in the eugonadal range. The T Cavg was separately summarized for those receiving oral TU and topical T, respectively, without a formal comparison between the treatment groups. The Cavg was calculated by non-compartmental PK methods using actual sample collection times relative to dosing using a modified intent-to-treat population (mITT). In the efficacy analysis, patients who dropped out prior to the final study day due to a possible treatment-related cause (e.g., an AE), were counted as treatment failures, while patients who dropped out for other causes (e.g., site closure not related to study conduct) had their T Cavg imputed using last observation carried forward (LOCF) methodology. A 95% Clopper-Pearson binomial confidence interval (CI) for the proportion was reported along with the estimated proportion.</em></p><p></p><p><strong><em>Standard descriptive PK for the oral TU and topical T, as calculated using non-compartmental methods, were presented for total T, free T (calculated), DHT, and estradiol. <u>In addition, changes from the pretreatment baseline to the end-of-study were presented for the endogenous molecules LH, FSH, and SHBG</u>. </em></strong></p><p><strong></strong></p><p><strong></strong></p><p><strong></strong></p><p><strong></strong></p><p><strong>Changes in calculated free T, SHBG, Estradiol, DHT, LH, and FSH after oral TU </strong></p><p></p><p><em><strong>Effects of oral TU and topical T on calculated free T, DHT, estradiol (E2), LH, FSH, and SHBG are depicted in <u>Fig. 6</u></strong>.<strong> As expected in both treatment groups, T administration caused significant elevations from baseline in free T, DHT, and estradiol and <u>decreases in, LH, FSH, and SHBG</u>. </strong>The magnitude of effects observed in oral TU patients paralleled those seen in patients treated with topical T and the differences in responses between the treatment groups were not statistically different. </em><strong><em>However, there was a trend toward higher free T concentrations in oral TU patients compared to topical T patients and a<u> greater mean decline in SHBG in oral TU patients</u>. The greater increase in free T from baseline for the oral TU group was partly a function of a <u>36% decrease in mean SHBG from 28.6 ± 14.7(SD) to 17.0 ±7.6 nmol/L in the oral TU group</u> compared to essentially no change in the topical T group from 26.8 ± 10 to 26.4 ± 11.7 nmol/L.</em></strong><em> However, both baseline and final mean SHBG concentrations remained within the normal range for eugonadal men (10.8 to 46.6 nmol/L) at the final study visit in both groups.</em></p><p><em></em></p><p><em>Over the course of the study, mean estradiol levels increased to slightly above the upper end of the eugonadal range in both treatment groups [oral TU: 32 ± 14 pg/mL (117 ± 51 pmol/L) and topical T: 33 ± 18 pg/mL (121 ± 66 pmol/L]. Plasma DHT concentrations for the oral TU- and topical T-treated patients were essentially identical at all PK visits and at the final visit [73 ng/dL (2.5 nmol/L) were slightly above the normal upper limit of 65 ng/dL (2.2 nmol/L).<strong> Mean change from baseline in the serum concentrations of LH and FSH at end of the study (AM pre-dose concentration) in the oral TU and topical T patients showed an approximately 70% decrease from mean baseline values.</strong></em></p><p></p><p></p><p><strong>Figure 6. <u>Effect of oral TU and topical T on LH, Free T, DHT, FSH, estradiol, and SHBG over course of T therapy</u>.</strong></p><p><strong>[ATTACH=full]21254[/ATTACH]</strong></p><p><strong>[ATTACH=full]21226[/ATTACH][ATTACH=full]21227[/ATTACH]</strong></p><p><strong></strong></p><p><strong></strong></p><p><strong></strong></p><p><strong><em>My reply from a previous thread:</em></strong></p><p></p><p>Injecting higher doses of androgens would have a larger impact on driving down SHBG but even then it depends on the individual as some may notice a larger drop and others not so drastic.</p><p></p><p>Far from common that one would notice an absurd drop in SHBG using therapeutic doses of T.</p><p></p><p>Depending on dose T used/injection frequency it is not a given that SHBG will be driven down as some will only notice a slight drop or it stays around pre-trt levels.</p><p></p><p>To be honest the c-17 alpha-alkylated orals such as methyltestosterone, oxandrolone, stanozolol, methandrostenolone, fluoxymesterone, and oxymetholone would have the biggest impact on driving down SHBG.</p></blockquote><p></p>
[QUOTE="madman, post: 221581, member: 13851"] [B]A New Oral Testosterone Undecanoate Formulation Restores Testosterone to Normal Concentrations in Hypogonadal Men (2020)[/B] [I]Ronald S. Swerdloff, Christina Wang, William B. White, Jed Kaminetsky, Marc C. Gittelman, James A. Longstreth, Robert E. Dudley, and Theodore M. Danoff6[/I] [B]Data analyses Efficacy/pharmacokinetic analyses. [/B][I]Efficacy was assessed based on the percentage of treated patients whose T Cavg was in the eugonadal range. The T Cavg was separately summarized for those receiving oral TU and topical T, respectively, without a formal comparison between the treatment groups. The Cavg was calculated by non-compartmental PK methods using actual sample collection times relative to dosing using a modified intent-to-treat population (mITT). In the efficacy analysis, patients who dropped out prior to the final study day due to a possible treatment-related cause (e.g., an AE), were counted as treatment failures, while patients who dropped out for other causes (e.g., site closure not related to study conduct) had their T Cavg imputed using last observation carried forward (LOCF) methodology. A 95% Clopper-Pearson binomial confidence interval (CI) for the proportion was reported along with the estimated proportion.[/I] [B][I]Standard descriptive PK for the oral TU and topical T, as calculated using non-compartmental methods, were presented for total T, free T (calculated), DHT, and estradiol. [U]In addition, changes from the pretreatment baseline to the end-of-study were presented for the endogenous molecules LH, FSH, and SHBG[/U]. [/I] Changes in calculated free T, SHBG, Estradiol, DHT, LH, and FSH after oral TU [/B] [I][B]Effects of oral TU and topical T on calculated free T, DHT, estradiol (E2), LH, FSH, and SHBG are depicted in [U]Fig. 6[/U][/B].[B] As expected in both treatment groups, T administration caused significant elevations from baseline in free T, DHT, and estradiol and [U]decreases in, LH, FSH, and SHBG[/U]. [/B]The magnitude of effects observed in oral TU patients paralleled those seen in patients treated with topical T and the differences in responses between the treatment groups were not statistically different. [/I][B][I]However, there was a trend toward higher free T concentrations in oral TU patients compared to topical T patients and a[U] greater mean decline in SHBG in oral TU patients[/U]. The greater increase in free T from baseline for the oral TU group was partly a function of a [U]36% decrease in mean SHBG from 28.6 ± 14.7(SD) to 17.0 ±7.6 nmol/L in the oral TU group[/U] compared to essentially no change in the topical T group from 26.8 ± 10 to 26.4 ± 11.7 nmol/L.[/I][/B][I] However, both baseline and final mean SHBG concentrations remained within the normal range for eugonadal men (10.8 to 46.6 nmol/L) at the final study visit in both groups. Over the course of the study, mean estradiol levels increased to slightly above the upper end of the eugonadal range in both treatment groups [oral TU: 32 ± 14 pg/mL (117 ± 51 pmol/L) and topical T: 33 ± 18 pg/mL (121 ± 66 pmol/L]. Plasma DHT concentrations for the oral TU- and topical T-treated patients were essentially identical at all PK visits and at the final visit [73 ng/dL (2.5 nmol/L) were slightly above the normal upper limit of 65 ng/dL (2.2 nmol/L).[B] Mean change from baseline in the serum concentrations of LH and FSH at end of the study (AM pre-dose concentration) in the oral TU and topical T patients showed an approximately 70% decrease from mean baseline values.[/B][/I] [B]Figure 6. [U]Effect of oral TU and topical T on LH, Free T, DHT, FSH, estradiol, and SHBG over course of T therapy[/U]. [ATTACH type="full"]21254[/ATTACH] [ATTACH type="full" alt="Screenshot (12531).png"]21226[/ATTACH][ATTACH type="full" alt="Screenshot (12532).png"]21227[/ATTACH] [I]My reply from a previous thread:[/I][/B] Injecting higher doses of androgens would have a larger impact on driving down SHBG but even then it depends on the individual as some may notice a larger drop and others not so drastic. Far from common that one would notice an absurd drop in SHBG using therapeutic doses of T. Depending on dose T used/injection frequency it is not a given that SHBG will be driven down as some will only notice a slight drop or it stays around pre-trt levels. To be honest the c-17 alpha-alkylated orals such as methyltestosterone, oxandrolone, stanozolol, methandrostenolone, fluoxymesterone, and oxymetholone would have the biggest impact on driving down SHBG. [/QUOTE]
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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone and Men's Health Articles
Significant decrease in SHBG with the use of Oral TU (JATENZO)
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