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<blockquote data-quote="madman" data-source="post: 207203" data-attributes="member: 13851"><p><strong>A 52-Week Study of Dose-Adjusted Subcutaneous Testosterone Enanthate in Oil Self-Administered via Disposable Auto-injector (2018)</strong></p><p><strong></strong></p><p><strong></strong></p><p><strong>Abstract </strong></p><p><strong></strong></p><p><strong>Purpose:</strong> <em>This open-label, single-arm, dose-blinded,<strong> 52-week</strong>, registration-phase study <strong>evaluated the efficacy and safety of subcutaneous testosterone enanthate auto-injector (SCTE-AI) administered weekly to men with hypogonadism.</strong></em></p><p></p><p><strong>Methods:</strong> <em><u><strong>Patients (N=150)</strong></u> were initiated on 75 mg SCTE-AI self-administered weekly. Dose adjustments were made at week 7 to 50, 75, or 100 mg testosterone enanthate (TE) based on week 6 total testosterone (TT) trough concentration. If required, dose adjustments continued through the extended treatment phase. <strong>Pharmacokinetic (PK) and clinical laboratory parameters, treatment-emergent adverse events (TEAEs), and injection site reactions were captured.</strong></em></p><p></p><p><strong>Results: </strong><em><strong>The primary endpoint was met: 92.7% of patients achieved an average TT concentration of 300– 1100 ng/dL (553.3 ± 127.29 ng/dL, mean ± SD) at week 12.</strong> A Cmax of <1500 ng/dL was achieved by 91.3% of patients, and no patients had levels >1800 ng/dL at week 12. </em><strong><em>Mean TT Ctrough was <u>487.2 ± 153.33 ng/dL at week 52</u>.</em></strong><em> Most patients (>95%) reported no injection-related pain. The most frequently reported TEAEs were increased hematocrit, hypertension, and increased prostate-specific antigen, which led to discontinuation in 30 men. There was no study of drug-related serious AEs. </em></p><p></p><p><strong>Discussion: <em><u>Dose-adjusted SCTE-AI demonstrated a steady serum TT PK profile, with small peak and trough fluctuations</u>. SCTE-AI was safe, well-tolerated, and virtually painless, indicating that SCTE-AI offers a testosterone delivery system that is a convenient weekly option for the treatment of testosterone deficiency.</em></strong></p><p></p><p></p><p></p><p></p><p><em><strong>The subcutaneous testosterone enanthate auto-injector (SCTE-AI) is a novel disposable drug-device combination that allows patients to self-administer a single, premeasured TE dose once weekly through a ⅝-inch, 27-gauge needle.12 <u>Previously, treatment with SCTE-AI was found to provide T levels within the reference range (300–1100 ng/dL) over a one-week dosing interval, with steady-state T levels approached by weeks 5–6</u>.12</strong></em></p><p><em><strong></strong></em></p><p><em><strong>*In this study, we assess the<u> long-term efficacy and safety</u> of dose-adjusted SCTE-AI in patients with HG to maintain TT within the reference range.</strong></em></p><p></p><p></p><p></p><p></p><p><strong>Pharmacokinetics</strong></p><p><strong></strong></p><p><strong><em>The primary endpoint was met as <u>92.7% (139/150) of patients overall and 100% (25/25), 90.4% (94/104), and 95.2% (20/21) of those titrated to 50, 75, and 100 mg, respectively, achieved mean TT Cavg0–168h within range at week</u> 12.</em></strong><em> Secondary endpoints were also met as 91.3% (137/150) of patients achieved Cmax <1500 ng/dL and no patients had a measured Cmax exceeding 1500 ng/dL. Of the 150 patients, 13 (8.7%) had missing Cmax values (11 from the 75-mg and 2 from the 100-mg group).</em> <em><strong>Baseline Ctrough (SD) was 231.6 (94.77) ng/dL and <u>remained steady and above 300 ng/dL through one year; 501.9 (172.70) ng/dL by week 6 and 487.2 (153.33) ng/dL at week 52</u> (Figure 2A).</strong></em></p><p></p><p></p><p><strong>Treatment Adherence and Questionnaire Results</strong></p><p></p><p><em>During the 12-week treatment titration phase, patients received a mean of 11.7 injections, with a mean exposure of 81.3 days. During the extended treatment phase, patients received an average of 33.2 injections, with a mean exposure of 235.3 days. Overall, mean compliance (calculated as 100 × number of injections/weeks of treatment) was 98.5%. <strong>Patients indicated satisfaction with self-injection (Supplementary Figure 6), and the <u>PDQ demonstrated significant improvements in several areas, at both week 12 and week 26</u> (Supplementary Figure 7)</strong></em></p><p></p><p></p><p></p><p></p><p><strong>DISCUSSION</strong></p><p><strong></strong></p><p><strong><em>SC delivery of TE through an auto-injector resulted in a <u>steady PK profile at week 12, without the higher peaks and troughs commonly associated with intramuscular T injection</u>-. The peak-to-trough ratio in this study was 1.813. </em><u>Most patients (92.7%) stayed within the physiologic T range for the entire dosing interval</u>; no patients had measured T levels >1500 ng/dL. <u>Ctrough also remained constant during the 52-week study</u>. <em>As fluctuations in T levels affect tolerability of T treatment used to alleviate symptoms of TD and have been associated with more side effects such as acne and mood disturbance, the steady <u>PK profile of SCTE-AI may lead to better control of symptoms</u>.16 </em></strong></p><p><strong><em></em></strong></p><p><strong><em>*<u>Although symptom resolution was not a primary endpoint in this study, improvements in the PDQ were observed</u>. As expected, DHT and E2 increased from baseline to week 12; DHT remained within normal range, and E2 remained close to the upper limit of normal.</em></strong></p><p></p><p></p><p></p><p></p><p>Again....although symptom resolution was not a primary endpoint in this study significant improvements in PDQ were observed.</p><p></p><p>Even then do you really believe <strong><u>N=139</u></strong> would stick with the once-weekly protocol injecting strictly sub-q for 52 weeks.....basically 1 year of their precious time if there was absolutely no improvement in low-t symptoms/overall well-being?</p><p></p><p>LMFAO!</p><p></p><p>As I have stated numerous times on the forum.....yes some men may not do well when injecting sub-q.</p><p></p><p>It is far from common that one would not be able to achieve a healthy let alone high-end T level on such.</p><p></p><p>Again there should be no difference in the absorption/effectiveness of T when injecting strictly sub-q.</p><p></p><p>Are there outliers that may not achieve good numbers.....sure but again far from F**KING COMMON!</p><p></p><p>The men that lurk/live on the forums represent a small slice of men on trt/hrt!</p><p></p><p>You claim that <u>sub-q is inferior to IM</u> let alone make it sound as if everyone and their brother is having a bad experience on such and to make matters worse claim that the <u>absorption/effectiveness is subpar compared to IM injections</u>.....LMFAO!</p><p></p><p></p><p></p><p>The mean TT Ctrough @6, 12, 18, 26, 38....52 weeks in!</p><p></p><p>Ctrough remained constant during the 52-week study.</p><p></p><p><em>Who the F**K knew..... </em><strong><em>Mean TT Ctrough was <u>487.2 ± 153.33 ng/dL at week 52</u>.</em></strong><em> </em></p><p><em>[ATTACH=full]16235[/ATTACH]</em></p><p></p><p></p><p></p><p><strong><em>*The primary endpoint was met as <u>92.7% (139/150) of patients overall and 100% (25/25), 90.4% (94/104), and 95.2% (20/21) of those titrated to 50, 75, and 100 mg, respectively, achieved mean TT Cavg0–168h within range at week</u> 12.</em></strong></p><p><strong></strong></p><p><strong>*<em>The primary endpoint was met:<u> 92.7% of patients achieved an average TT concentration of 300– 1100 ng/dL (553.3 ± 127.29 ng/dL, mean ± SD) at week 12</u>.</em></strong></p><p><strong><em></em></strong></p><p><strong><em>*Mean TT Ctrough was <u>487.2 ± 153.33 ng/dL at week 52</u>.</em></strong></p><p><strong><em></em></strong></p><p><strong><em>*SC delivery of TE through an auto-injector resulted in a <u>steady PK profile at week 12, without the higher peaks and troughs commonly associated with intramuscular T injection</u>-. The peak-to-trough ratio in this study was 1.813. </em><u>Most patients (92.7%) stayed within the physiologic T range for the entire dosing interval</u>; no patients had measured T levels >1500 ng/dL. <u>Ctrough also remained constant during the 52-week study</u>.</strong></p><p><strong></strong></p><p><strong><em>*Patients may face barriers to adherence to TR, including inconvenience and discomfort. <u>In this study, patients were highly adherent to the dosing regimen, indicated a virtually pain-free experience, and demonstrated a high degree of satisfaction with SCTE-AI, as measured by the SIAQ</u>.</em></strong></p><p></p><p></p><p></p><p></p><p><em><strong>Conclusions </strong></em></p><p></p><p><strong><em>Overall, this study demonstrates the steady PK profile and safety of SCTE-AI. SCTE-AI dosing guided by TT Ctrough reduces peak and trough fluctuations, making SCTE-AI a convenient additional option for the treatment of TD.</em></strong></p></blockquote><p></p>
[QUOTE="madman, post: 207203, member: 13851"] [B]A 52-Week Study of Dose-Adjusted Subcutaneous Testosterone Enanthate in Oil Self-Administered via Disposable Auto-injector (2018) Abstract Purpose:[/B] [I]This open-label, single-arm, dose-blinded,[B] 52-week[/B], registration-phase study [B]evaluated the efficacy and safety of subcutaneous testosterone enanthate auto-injector (SCTE-AI) administered weekly to men with hypogonadism.[/B][/I] [B]Methods:[/B] [I][U][B]Patients (N=150)[/B][/U] were initiated on 75 mg SCTE-AI self-administered weekly. Dose adjustments were made at week 7 to 50, 75, or 100 mg testosterone enanthate (TE) based on week 6 total testosterone (TT) trough concentration. If required, dose adjustments continued through the extended treatment phase. [B]Pharmacokinetic (PK) and clinical laboratory parameters, treatment-emergent adverse events (TEAEs), and injection site reactions were captured.[/B][/I] [B]Results: [/B][I][B]The primary endpoint was met: 92.7% of patients achieved an average TT concentration of 300– 1100 ng/dL (553.3 ± 127.29 ng/dL, mean ± SD) at week 12.[/B] A Cmax of <1500 ng/dL was achieved by 91.3% of patients, and no patients had levels >1800 ng/dL at week 12. [/I][B][I]Mean TT Ctrough was [U]487.2 ± 153.33 ng/dL at week 52[/U].[/I][/B][I] Most patients (>95%) reported no injection-related pain. The most frequently reported TEAEs were increased hematocrit, hypertension, and increased prostate-specific antigen, which led to discontinuation in 30 men. There was no study of drug-related serious AEs. [/I] [B]Discussion: [I][U]Dose-adjusted SCTE-AI demonstrated a steady serum TT PK profile, with small peak and trough fluctuations[/U]. SCTE-AI was safe, well-tolerated, and virtually painless, indicating that SCTE-AI offers a testosterone delivery system that is a convenient weekly option for the treatment of testosterone deficiency.[/I][/B] [I][B]The subcutaneous testosterone enanthate auto-injector (SCTE-AI) is a novel disposable drug-device combination that allows patients to self-administer a single, premeasured TE dose once weekly through a ⅝-inch, 27-gauge needle.12 [U]Previously, treatment with SCTE-AI was found to provide T levels within the reference range (300–1100 ng/dL) over a one-week dosing interval, with steady-state T levels approached by weeks 5–6[/U].12 *In this study, we assess the[U] long-term efficacy and safety[/U] of dose-adjusted SCTE-AI in patients with HG to maintain TT within the reference range.[/B][/I] [B]Pharmacokinetics [I]The primary endpoint was met as [U]92.7% (139/150) of patients overall and 100% (25/25), 90.4% (94/104), and 95.2% (20/21) of those titrated to 50, 75, and 100 mg, respectively, achieved mean TT Cavg0–168h within range at week[/U] 12.[/I][/B][I] Secondary endpoints were also met as 91.3% (137/150) of patients achieved Cmax <1500 ng/dL and no patients had a measured Cmax exceeding 1500 ng/dL. Of the 150 patients, 13 (8.7%) had missing Cmax values (11 from the 75-mg and 2 from the 100-mg group).[/I] [I][B]Baseline Ctrough (SD) was 231.6 (94.77) ng/dL and [U]remained steady and above 300 ng/dL through one year; 501.9 (172.70) ng/dL by week 6 and 487.2 (153.33) ng/dL at week 52[/U] (Figure 2A).[/B][/I] [B]Treatment Adherence and Questionnaire Results[/B] [I]During the 12-week treatment titration phase, patients received a mean of 11.7 injections, with a mean exposure of 81.3 days. During the extended treatment phase, patients received an average of 33.2 injections, with a mean exposure of 235.3 days. Overall, mean compliance (calculated as 100 × number of injections/weeks of treatment) was 98.5%. [B]Patients indicated satisfaction with self-injection (Supplementary Figure 6), and the [U]PDQ demonstrated significant improvements in several areas, at both week 12 and week 26[/U] (Supplementary Figure 7)[/B][/I] [B]DISCUSSION [I]SC delivery of TE through an auto-injector resulted in a [U]steady PK profile at week 12, without the higher peaks and troughs commonly associated with intramuscular T injection[/U]-. The peak-to-trough ratio in this study was 1.813. [/I][U]Most patients (92.7%) stayed within the physiologic T range for the entire dosing interval[/U]; no patients had measured T levels >1500 ng/dL. [U]Ctrough also remained constant during the 52-week study[/U]. [I]As fluctuations in T levels affect tolerability of T treatment used to alleviate symptoms of TD and have been associated with more side effects such as acne and mood disturbance, the steady [U]PK profile of SCTE-AI may lead to better control of symptoms[/U].16 *[U]Although symptom resolution was not a primary endpoint in this study, improvements in the PDQ were observed[/U]. As expected, DHT and E2 increased from baseline to week 12; DHT remained within normal range, and E2 remained close to the upper limit of normal.[/I][/B] Again....although symptom resolution was not a primary endpoint in this study significant improvements in PDQ were observed. Even then do you really believe [B][U]N=139[/U][/B] would stick with the once-weekly protocol injecting strictly sub-q for 52 weeks.....basically 1 year of their precious time if there was absolutely no improvement in low-t symptoms/overall well-being? LMFAO! As I have stated numerous times on the forum.....yes some men may not do well when injecting sub-q. It is far from common that one would not be able to achieve a healthy let alone high-end T level on such. Again there should be no difference in the absorption/effectiveness of T when injecting strictly sub-q. Are there outliers that may not achieve good numbers.....sure but again far from F**KING COMMON! The men that lurk/live on the forums represent a small slice of men on trt/hrt! You claim that [U]sub-q is inferior to IM[/U] let alone make it sound as if everyone and their brother is having a bad experience on such and to make matters worse claim that the [U]absorption/effectiveness is subpar compared to IM injections[/U].....LMFAO! The mean TT Ctrough @6, 12, 18, 26, 38....52 weeks in! Ctrough remained constant during the 52-week study. [I]Who the F**K knew..... [/I][B][I]Mean TT Ctrough was [U]487.2 ± 153.33 ng/dL at week 52[/U].[/I][/B][I] [ATTACH type="full" alt="Screenshot (6868).png"]16235[/ATTACH][/I] [B][I]*The primary endpoint was met as [U]92.7% (139/150) of patients overall and 100% (25/25), 90.4% (94/104), and 95.2% (20/21) of those titrated to 50, 75, and 100 mg, respectively, achieved mean TT Cavg0–168h within range at week[/U] 12.[/I] *[I]The primary endpoint was met:[U] 92.7% of patients achieved an average TT concentration of 300– 1100 ng/dL (553.3 ± 127.29 ng/dL, mean ± SD) at week 12[/U]. *Mean TT Ctrough was [U]487.2 ± 153.33 ng/dL at week 52[/U]. *SC delivery of TE through an auto-injector resulted in a [U]steady PK profile at week 12, without the higher peaks and troughs commonly associated with intramuscular T injection[/U]-. The peak-to-trough ratio in this study was 1.813. [/I][U]Most patients (92.7%) stayed within the physiologic T range for the entire dosing interval[/U]; no patients had measured T levels >1500 ng/dL. [U]Ctrough also remained constant during the 52-week study[/U]. [I]*Patients may face barriers to adherence to TR, including inconvenience and discomfort. [U]In this study, patients were highly adherent to the dosing regimen, indicated a virtually pain-free experience, and demonstrated a high degree of satisfaction with SCTE-AI, as measured by the SIAQ[/U].[/I][/B] [I][B]Conclusions [/B][/I] [B][I]Overall, this study demonstrates the steady PK profile and safety of SCTE-AI. SCTE-AI dosing guided by TT Ctrough reduces peak and trough fluctuations, making SCTE-AI a convenient additional option for the treatment of TD.[/I][/B] [/QUOTE]
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