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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Basics & Questions
IM versus Sub-q T Injections: Effect on TT, hematocrit, E2, and PSA
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<blockquote data-quote="madman" data-source="post: 191164" data-attributes="member: 13851"><p>I would put money on it that injection frequency was once weekly as it is clearly stated <em><span style="color: rgb(44, 130, 201)">Subcutaneous testosterone enanthate-autoinjectors (SCTE-AI).</span></em></p><p></p><p>There is only one FDA-approved autoinjector on the market and that is Xyosted (testosterone enanthate) which is meant for once-weekly subcutaneous injections.</p><p></p><p>It comes in three dosage strengths, 50 mg, 75 mg, and 100 mg.</p><p></p><p>The recommended starting dose is 75 mg/week and many of the studies on Xyosted use the starting dose of 75 mg/week and titrate up or down depending on T level achieved/relief of low-t symptoms or lack thereof.</p><p></p><p>Would make no sense to use different doses let alone injection frequencies (IM vs sub-Q).</p><p></p><p>Even then 75 mg/wk (IM/sub-q) was most likely the dose used in the study and would seem reasonable looking at the TT troughs achieved on both protocols.</p><table class='post-table ' style='width: 100%'><tr><td ><p><strong>IM-TC </strong></p></td><td ><p><strong>SCTE-AI</strong></p></td></tr></table><table class='post-table ' style='width: 100%'><tr><td ><p>n=<span style="color: rgb(44, 130, 201)">188</span></p></td><td ><p>n=<span style="color: rgb(44, 130, 201)">114</span></p></td></tr></table><table class='post-table ' style='width: 100%'><tr><td ><p>mean <span style="color: rgb(184, 49, 47)">(SD)</span></p></td><td ><p>mean <span style="color: rgb(184, 49, 47)">(SD)</span></p></td></tr></table><table class='post-table ' style='width: 100%'><tr><td ><p>536.4<span style="color: rgb(184, 49, 47)"> (295)</span></p></td><td ><p>552.5 <span style="color: rgb(184, 49, 47)">(207)</span></p></td></tr></table>.</p><p></p><p></p><p></p><p>[URL unfurl="true"]https://www.excelmale.com/forum/threads/safety-of-a-new-subcutaneous-testosterone-enanthate-auto-injector-results-of-a-26-week-study.19671/#post-159659[/URL]</p><p></p><p></p><p><strong>Aim</strong></p><p><strong></strong></p><p><strong><span style="color: rgb(184, 49, 47)"><em>The purpose of this study was to confirm the safety and characterize the pharmacokinetic (PK) profile of the subcutaneous TE auto-injector (SCTE-AI) in adult men with TD.</em></span></strong></p><p><strong></strong></p><p><strong></strong></p><p><strong>Methods</strong></p><p></p><p><span style="color: rgb(0, 0, 0)"><em>In this phase III, 26-week study, 133 men 18-75 years of age with symptomatic TD </em></span><span style="color: rgb(44, 130, 201)"><em><strong>self-administered SCTE-AI 75 mg once weekly</strong></em></span><span style="color: rgb(0, 0, 0)"><em> for 6 weeks from July 2015 to June 2016. Dosing was adjusted when indicated to 50 mg or 100 mg to maintain T trough levels between 350 and 650 ng/dL (12.1-22.5 nmol/L).</em></span> <em><span style="color: rgb(184, 49, 47)"><strong>PK data were collected from a subgroup of patients receiving 75 mg SCTE-AI through week 12. </strong></span><span style="color: rgb(0, 0, 0)">Safety, including ambulatory blood pressure monitoring (ABPM), lipid levels, and adverse drug reactions, and PK were assessed.</span></em></p><p></p><p></p><p><strong>PK Population Substudy PKs </strong></p><p></p><p><span style="color: rgb(184, 49, 47)"><strong><em>In the PK substudy population</em></strong><em> <u><strong>(patients who received 75 mg SCTE-AI through week 12)</strong></u><strong>, TT concentrations increased from predose week 1 to week 12 (Figure 3A). </strong></em></span><span style="color: rgb(44, 130, 201)"><em><strong><u>Mean TT Ctrough increased from</u></strong></em></span><span style="color: rgb(184, 49, 47)"><em><strong> 223.7 ng/dL (7.8 nmol/L) at predose week 1, to 373.7 ng/dL (13.0 nmol/L), 478.9 ng/dL (16.6 nmol/L), and</strong></em></span><span style="color: rgb(44, 130, 201)"><em><strong> <u>541.2 ng/dL (18.8 nmol/L) at weeks</u></strong></em></span><span style="color: rgb(184, 49, 47)"><em><strong> 1, 6, and </strong></em></span><span style="color: rgb(44, 130, 201)"><em><strong><u>12</u>,</strong></em></span><span style="color: rgb(184, 49, 47)"><em><strong> respectively. </strong></em></span><em>The majority of the 21 PK substudy patients had TT Cavg0-168h 300-1,100 ng/dL (10.4-38.1 nmol/L): 18 patients (86%), 20 patients (95%), and 21 patients (100%) at weeks 1, 6, and 12, respectively. TE, DHT, and E2 concentrations also increased as anticipated from week 1 to week 12, and from predose to postdose at scheduled time points within each of weeks 1, 6, and 12 (Figure 3BeD). DHTE was undetectable at most time points in most patients. Endocrine parameters of follicle-stimulating hormone, luteinizing hormone, and sex hormone-binding globulin decreased from baseline to weeks 13 and 26/ET (Supplemental Table 4).</em></p><p></p><p>[ATTACH=full]11767[/ATTACH]</p></blockquote><p></p>
[QUOTE="madman, post: 191164, member: 13851"] I would put money on it that injection frequency was once weekly as it is clearly stated [I][COLOR=rgb(44, 130, 201)]Subcutaneous testosterone enanthate-autoinjectors (SCTE-AI).[/COLOR][/I] There is only one FDA-approved autoinjector on the market and that is Xyosted (testosterone enanthate) which is meant for once-weekly subcutaneous injections. It comes in three dosage strengths, 50 mg, 75 mg, and 100 mg. The recommended starting dose is 75 mg/week and many of the studies on Xyosted use the starting dose of 75 mg/week and titrate up or down depending on T level achieved/relief of low-t symptoms or lack thereof. Would make no sense to use different doses let alone injection frequencies (IM vs sub-Q). Even then 75 mg/wk (IM/sub-q) was most likely the dose used in the study and would seem reasonable looking at the TT troughs achieved on both protocols. [TABLE][TR][TD] [B]IM-TC [/B] [/TD] [TD] [B]SCTE-AI[/B] [/TD][/TR][/TABLE] [TABLE][TR][TD] n=[COLOR=rgb(44, 130, 201)]188[/COLOR] [/TD] [TD] n=[COLOR=rgb(44, 130, 201)]114[/COLOR] [/TD][/TR][/TABLE] [TABLE][TR][TD] mean [COLOR=rgb(184, 49, 47)](SD)[/COLOR] [/TD] [TD] mean [COLOR=rgb(184, 49, 47)](SD)[/COLOR] [/TD][/TR][/TABLE] [TABLE][TR][TD] 536.4[COLOR=rgb(184, 49, 47)] (295)[/COLOR] [/TD] [TD] 552.5 [COLOR=rgb(184, 49, 47)](207)[/COLOR] [/TD][/TR][/TABLE] . [URL unfurl="true"]https://www.excelmale.com/forum/threads/safety-of-a-new-subcutaneous-testosterone-enanthate-auto-injector-results-of-a-26-week-study.19671/#post-159659[/URL] [B]Aim [COLOR=rgb(184, 49, 47)][I]The purpose of this study was to confirm the safety and characterize the pharmacokinetic (PK) profile of the subcutaneous TE auto-injector (SCTE-AI) in adult men with TD.[/I][/COLOR] Methods[/B] [COLOR=rgb(0, 0, 0)][I]In this phase III, 26-week study, 133 men 18-75 years of age with symptomatic TD [/I][/COLOR][COLOR=rgb(44, 130, 201)][I][B]self-administered SCTE-AI 75 mg once weekly[/B][/I][/COLOR][COLOR=rgb(0, 0, 0)][I] for 6 weeks from July 2015 to June 2016. Dosing was adjusted when indicated to 50 mg or 100 mg to maintain T trough levels between 350 and 650 ng/dL (12.1-22.5 nmol/L).[/I][/COLOR] [I][COLOR=rgb(184, 49, 47)][B]PK data were collected from a subgroup of patients receiving 75 mg SCTE-AI through week 12. [/B][/COLOR][COLOR=rgb(0, 0, 0)]Safety, including ambulatory blood pressure monitoring (ABPM), lipid levels, and adverse drug reactions, and PK were assessed.[/COLOR][/I] [B]PK Population Substudy PKs [/B] [COLOR=rgb(184, 49, 47)][B][I]In the PK substudy population[/I][/B][I] [U][B](patients who received 75 mg SCTE-AI through week 12)[/B][/U][B], TT concentrations increased from predose week 1 to week 12 (Figure 3A). [/B][/I][/COLOR][COLOR=rgb(44, 130, 201)][I][B][U]Mean TT Ctrough increased from[/U][/B][/I][/COLOR][COLOR=rgb(184, 49, 47)][I][B] 223.7 ng/dL (7.8 nmol/L) at predose week 1, to 373.7 ng/dL (13.0 nmol/L), 478.9 ng/dL (16.6 nmol/L), and[/B][/I][/COLOR][COLOR=rgb(44, 130, 201)][I][B] [U]541.2 ng/dL (18.8 nmol/L) at weeks[/U][/B][/I][/COLOR][COLOR=rgb(184, 49, 47)][I][B] 1, 6, and [/B][/I][/COLOR][COLOR=rgb(44, 130, 201)][I][B][U]12[/U],[/B][/I][/COLOR][COLOR=rgb(184, 49, 47)][I][B] respectively. [/B][/I][/COLOR][I]The majority of the 21 PK substudy patients had TT Cavg0-168h 300-1,100 ng/dL (10.4-38.1 nmol/L): 18 patients (86%), 20 patients (95%), and 21 patients (100%) at weeks 1, 6, and 12, respectively. TE, DHT, and E2 concentrations also increased as anticipated from week 1 to week 12, and from predose to postdose at scheduled time points within each of weeks 1, 6, and 12 (Figure 3BeD). DHTE was undetectable at most time points in most patients. Endocrine parameters of follicle-stimulating hormone, luteinizing hormone, and sex hormone-binding globulin decreased from baseline to weeks 13 and 26/ET (Supplemental Table 4).[/I] [ATTACH type="full" alt="Screenshot (2686).png"]11767[/ATTACH] [/QUOTE]
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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Basics & Questions
IM versus Sub-q T Injections: Effect on TT, hematocrit, E2, and PSA
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