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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Basics & Questions
Natesto: large shards UPDATE- batch is all bad.
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<blockquote data-quote="madman" data-source="post: 277207" data-attributes="member: 13851"><p><strong><em>*I would say more like 6 months to obtain peak benefits!</em></strong></p><p></p><p></p><p>Peak benefits meaning overall relief/improvement of low-T symptoms including any beneficial effects when it comes to body composition.</p><p></p><p>If anything I would say 3-6 months without any deviation from the protocol (dosed 2-3 times daily).</p><p></p><p>We are not just talking about the median here!</p><p></p><p>Look over any of the Natesto stuides, sure the mean (SD)/median Cavg is nothing to brag about.</p><p></p><p>Peaks are stellar for most and even though they are short-lived far from common you are crashing back to baseline immediately.</p><p></p><p><strong>*</strong><em><strong>A maximal peak of testosterone appears at about 1 hour, followed by a return to endogenous, pre-dose levels 4 to 6 hours later (half-life ∼1 hour) </strong></em></p><p></p><p></p><p></p><p>[ATTACH=full]42236[/ATTACH]</p><p></p><p></p><p></p><p></p><p><em>*The pharmacokinetic (PK) profile of TNG of different concentrations has been studied in a series of single and multidose PK studies, including in women, healthy volunteers with allergic rhinitis, and men with TDS [15]. <strong>The 24-hour PK profile of testosterone for patients receiving TNG treatment has two or three discrete peaks (“pulses”) of testosterone provoked by LH secretions that occur, on average, every 2 hours. <u>A maximal peak of testosterone appears at about 1 hour, followed by a return to endogenous, predose levels 4 to 6 hours later (half-life ∼1 hour)</u> [4].</strong> The nadir (trough) between doses correlates well with pretreatment endogenous levels at diagnosis.</em></p><p><em></em></p><p><em></em></p><p><em><strong>*In fact, the observed PK profile after a TNG dose is a sum of all sources of testosterone [20, 21]; exogenous and endogenous sources were not independently quantifiable in this study.</strong> <strong><u>When exogenous testosterone was administered, there was a suppression of LH and testosterone production. Endogenous testosterone levels decreased as a result of ongoing elimination and reduced or halted production</u>. <u>Later (>1 hour after administration), as the exogenous testosterone absorption rate was reduced and elimination predominated, resulting in a drop in exogenous testosterone, the HPG recovered, reinitiating endogenous testosterone production</u> (Fig. 6a). The degree of HPG suppression appeared to be proportional to the initial baseline TT. For patients with less severe hypogonadism with a supposedly more active HPG and higher baseline TT level, there was more endogenous testosterone suppression during each dose than for a patient with more severe hypogonadism with less HPG axis potential (Fig. 6b). This model is supported by the larger decreases in LH in patients with higher baseline TT concentration seen in this study. <u>It should be noted that in the Rogol et al. study [15], administration of TNG to healthy men with a predose TT baseline of 534 ng/dL (18.4 nmol/L) also showed Cmax peak levels in the same range as seen in this study and again a return to predose baseline nearly 6 hours after a dose</u>.</strong></em></p><p></p><p></p><p></p><p></p><p></p><p></p><p></p><p><strong><em>In the case of testosterone nasal gel, <u>90% of hypogonadal subjects in the fixed-dose arm and 68% of subjects in the titration arm (ITT) were in the eugonadal range (300–1050 ng/dL) after 90 days of treatment with testosterone nasal gel</u>. <u>Subject's mean total testosterone Cavg level after 90 days was 415 ng/dL when taking the b.i.d. dose and 428 ng/dL when receiving the t.i.d. dose</u>. These levels are consistent with the mean Cavg (418 ng/dL) reported for a large, population-based epidemiological survey of healthy adult males aged 30–79 years (Litman et al., 2006). <u>After considering the protocol violations, the PP percentage of subjects achieving normal serum testosterone is 91% in the fixed-dose arm and 71% in the titration arm</u>.</em></strong> <em><strong><u>Protocol violations included failure to up-titrate subjects upon direction of physician or at patient request (b.i.d. being adequate for symptoms) despite estimated Cavg values <300 ng/dL</u>. Notably, the percentage of PP subjects in the normal range on the b.i.d. dose of the titration arm was 75% (95% CI, 66–83%).</strong></em></p><p><em><strong></strong></em></p><p><em><strong><u>Each individual dose of nasal gel provides a reproducible short-acting peak that returns near to baseline by the time of the next dose</u>. <u>While there are up to three peaks per profile, <em>C</em>max values were consistently below 1500 mg/d and only 3.3% of subjects had values of 1800–2500 ng/dL</u>. While one subject showed a <em>C</em>max >2500 ng/dL (3570 ng/dL); this subject would appear to have violated the protocol by continuing finasteride treatment. No safety concerns were identified for this subject.</strong></em></p><p></p><p><strong><em><u>The peaks-and-troughs PK profile did not appear to have a negative impact on symptomatology</u>. <u>There were statistically significant improvements because of treatment in mean values for the erectile function and mood, and positive trends in improvement for body composition and BMD when compared to pre-treatment baseline values</u>.</em></strong></p></blockquote><p></p>
[QUOTE="madman, post: 277207, member: 13851"] [B][I]*I would say more like 6 months to obtain peak benefits![/I][/B] Peak benefits meaning overall relief/improvement of low-T symptoms including any beneficial effects when it comes to body composition. If anything I would say 3-6 months without any deviation from the protocol (dosed 2-3 times daily). We are not just talking about the median here! Look over any of the Natesto stuides, sure the mean (SD)/median Cavg is nothing to brag about. Peaks are stellar for most and even though they are short-lived far from common you are crashing back to baseline immediately. [B]*[/B][I][B]A maximal peak of testosterone appears at about 1 hour, followed by a return to endogenous, pre-dose levels 4 to 6 hours later (half-life ∼1 hour) [/B][/I] [ATTACH type="full" alt="1709951134829.png"]42236[/ATTACH] [I]*The pharmacokinetic (PK) profile of TNG of different concentrations has been studied in a series of single and multidose PK studies, including in women, healthy volunteers with allergic rhinitis, and men with TDS [15]. [B]The 24-hour PK profile of testosterone for patients receiving TNG treatment has two or three discrete peaks (“pulses”) of testosterone provoked by LH secretions that occur, on average, every 2 hours. [U]A maximal peak of testosterone appears at about 1 hour, followed by a return to endogenous, predose levels 4 to 6 hours later (half-life ∼1 hour)[/U] [4].[/B] The nadir (trough) between doses correlates well with pretreatment endogenous levels at diagnosis. [B]*In fact, the observed PK profile after a TNG dose is a sum of all sources of testosterone [20, 21]; exogenous and endogenous sources were not independently quantifiable in this study.[/B] [B][U]When exogenous testosterone was administered, there was a suppression of LH and testosterone production. Endogenous testosterone levels decreased as a result of ongoing elimination and reduced or halted production[/U]. [U]Later (>1 hour after administration), as the exogenous testosterone absorption rate was reduced and elimination predominated, resulting in a drop in exogenous testosterone, the HPG recovered, reinitiating endogenous testosterone production[/U] (Fig. 6a). The degree of HPG suppression appeared to be proportional to the initial baseline TT. For patients with less severe hypogonadism with a supposedly more active HPG and higher baseline TT level, there was more endogenous testosterone suppression during each dose than for a patient with more severe hypogonadism with less HPG axis potential (Fig. 6b). This model is supported by the larger decreases in LH in patients with higher baseline TT concentration seen in this study. [U]It should be noted that in the Rogol et al. study [15], administration of TNG to healthy men with a predose TT baseline of 534 ng/dL (18.4 nmol/L) also showed Cmax peak levels in the same range as seen in this study and again a return to predose baseline nearly 6 hours after a dose[/U].[/B][/I] [B][I]In the case of testosterone nasal gel, [U]90% of hypogonadal subjects in the fixed-dose arm and 68% of subjects in the titration arm (ITT) were in the eugonadal range (300–1050 ng/dL) after 90 days of treatment with testosterone nasal gel[/U]. [U]Subject's mean total testosterone Cavg level after 90 days was 415 ng/dL when taking the b.i.d. dose and 428 ng/dL when receiving the t.i.d. dose[/U]. These levels are consistent with the mean Cavg (418 ng/dL) reported for a large, population-based epidemiological survey of healthy adult males aged 30–79 years (Litman et al., 2006). [U]After considering the protocol violations, the PP percentage of subjects achieving normal serum testosterone is 91% in the fixed-dose arm and 71% in the titration arm[/U].[/I][/B] [I][B][U]Protocol violations included failure to up-titrate subjects upon direction of physician or at patient request (b.i.d. being adequate for symptoms) despite estimated Cavg values <300 ng/dL[/U]. Notably, the percentage of PP subjects in the normal range on the b.i.d. dose of the titration arm was 75% (95% CI, 66–83%). [U]Each individual dose of nasal gel provides a reproducible short-acting peak that returns near to baseline by the time of the next dose[/U]. [U]While there are up to three peaks per profile, [I]C[/I]max values were consistently below 1500 mg/d and only 3.3% of subjects had values of 1800–2500 ng/dL[/U]. While one subject showed a [I]C[/I]max >2500 ng/dL (3570 ng/dL); this subject would appear to have violated the protocol by continuing finasteride treatment. No safety concerns were identified for this subject.[/B][/I] [B][I][U]The peaks-and-troughs PK profile did not appear to have a negative impact on symptomatology[/U]. [U]There were statistically significant improvements because of treatment in mean values for the erectile function and mood, and positive trends in improvement for body composition and BMD when compared to pre-treatment baseline values[/U].[/I][/B] [/QUOTE]
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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Basics & Questions
Natesto: large shards UPDATE- batch is all bad.
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