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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone and Men's Health Articles
Sub-q Testosterone Autoinjector is a safe and effective alternative method for TRT
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<blockquote data-quote="madman" data-source="post: 191032" data-attributes="member: 13851"><p><strong>Introduction</strong>: <em><span style="color: rgb(184, 49, 47)">Xyosted® is a subcutaneous testosterone enanthate-autoinjector (SCTE-AI) which was approved by the Food and Drug Administration in 2018 for patient-administered weekly testosterone replacement therapy (TRT).</span></em></p><p></p><p><strong>Objective</strong>: <span style="color: rgb(44, 130, 201)"><em>This is the largest non-industry sponsored post-market study to evaluate the safety and efficacy profile of SCTE-AI in outpatient urology clinics.</em></span></p><p></p><p><strong>Methods: </strong>From January to October 2019, 110 hypogonadal men were treated with SCTE-AI at a two-institutions. Patients were assessed in a pre-therapy visit prior to receiving SCTE-AI and re-assessed at 6-weeks after treatment initiation. Patients with a history of prostate cancer were excluded. Trough serum total testosterone (TT), estradiol, prostate-specific antigen (PSA), and hematocrit (HCT) levels were collected at clinic visits. Therapeutic phlebotomy was recommended for HCT<u>></u>54%, and treatment was discontinued for significant increases in PSA and for significant treatment-related adverse events. Values from each visit were compared with univariate analysis.</p><p></p><p><strong>Results</strong>:<em><span style="color: rgb(44, 130, 201)"> 110 patients completed the 6 weeks of observation with a mean age of 40.3 ± 10.5. TT significantly rose from 246.6 ± 113.3 ng/dL pretherapy to 538.4 ± 209.3 ng/dL at 6 weeks, p<0.001. Post-therapy, 101/110 (91.8%) of patients had TT>300 ng/dL (Table). No patients had HCT <u>></u> 54%. 74 patients (70.5%) had PSA increase with only 3 (2.9%) experiencing an increase <u>></u>1.0. There was a significant increase in mean PSA from 1.07 ± 0.8 pretherapy to 1.18 ± 0.9 at 6 weeks, p= 0.01. One patient had immediate treatment cessation following the discovery of prostate cancer.</span></em></p><p></p><p><strong>Conclusions</strong>: <strong><span style="color: rgb(184, 49, 47)"><em>This is the largest non-industry sponsored safety and efficacy profile of SCTE-AI application in urology clinics. </em></span><em><span style="color: rgb(44, 130, 201)">After 6 weeks of observation, TT levels increased significantly. SCTE-AI is a safe and effective alternative method for TRT.</span></em></strong></p><p><strong></strong></p><p><strong></strong></p><p><strong></strong></p><p><strong>Table: Total Testosterone (TT) ranges before and after 6 weeks of SCTE-AI therapy</strong></p><table class='post-table ' style='width: 100%'><tr><td></td><td></td><td></td><td></td><td></td></tr><tr><td></td><td ><p>Pre-Therapy</p></td><td ><p>6 weeks</p></td><td></td><td></td></tr><tr><td ><p>TT (ng/dL)</p></td><td ><p>n</p></td><td ><p>%</p></td><td ><p>n</p></td><td ><p>%</p></td></tr><tr><td ><p>0-300</p></td><td ><p>96</p></td><td ><p>87.3%</p></td><td ><p>9</p></td><td ><p>8.2%</p></td></tr><tr><td ><p>300-1000</p></td><td ><p>14</p></td><td ><p>12.7%</p></td><td ><p>97</p></td><td ><p>88.2%</p></td></tr><tr><td ><p>>1000</p></td><td ><p>0</p></td><td ><p>0.0%</p></td><td ><p>4</p></td><td ><p>3.6%</p></td></tr></table></blockquote><p></p>
[QUOTE="madman, post: 191032, member: 13851"] [B]Introduction[/B]: [I][COLOR=rgb(184, 49, 47)]Xyosted® is a subcutaneous testosterone enanthate-autoinjector (SCTE-AI) which was approved by the Food and Drug Administration in 2018 for patient-administered weekly testosterone replacement therapy (TRT).[/COLOR][/I] [B]Objective[/B]: [COLOR=rgb(44, 130, 201)][I]This is the largest non-industry sponsored post-market study to evaluate the safety and efficacy profile of SCTE-AI in outpatient urology clinics.[/I][/COLOR] [B]Methods: [/B]From January to October 2019, 110 hypogonadal men were treated with SCTE-AI at a two-institutions. Patients were assessed in a pre-therapy visit prior to receiving SCTE-AI and re-assessed at 6-weeks after treatment initiation. Patients with a history of prostate cancer were excluded. Trough serum total testosterone (TT), estradiol, prostate-specific antigen (PSA), and hematocrit (HCT) levels were collected at clinic visits. Therapeutic phlebotomy was recommended for HCT[U]>[/U]54%, and treatment was discontinued for significant increases in PSA and for significant treatment-related adverse events. Values from each visit were compared with univariate analysis. [B]Results[/B]:[I][COLOR=rgb(44, 130, 201)] 110 patients completed the 6 weeks of observation with a mean age of 40.3 ± 10.5. TT significantly rose from 246.6 ± 113.3 ng/dL pretherapy to 538.4 ± 209.3 ng/dL at 6 weeks, p<0.001. Post-therapy, 101/110 (91.8%) of patients had TT>300 ng/dL (Table). No patients had HCT [U]>[/U] 54%. 74 patients (70.5%) had PSA increase with only 3 (2.9%) experiencing an increase [U]>[/U]1.0. There was a significant increase in mean PSA from 1.07 ± 0.8 pretherapy to 1.18 ± 0.9 at 6 weeks, p= 0.01. One patient had immediate treatment cessation following the discovery of prostate cancer.[/COLOR][/I] [B]Conclusions[/B]: [B][COLOR=rgb(184, 49, 47)][I]This is the largest non-industry sponsored safety and efficacy profile of SCTE-AI application in urology clinics. [/I][/COLOR][I][COLOR=rgb(44, 130, 201)]After 6 weeks of observation, TT levels increased significantly. SCTE-AI is a safe and effective alternative method for TRT.[/COLOR][/I] Table: Total Testosterone (TT) ranges before and after 6 weeks of SCTE-AI therapy[/B] [TABLE][TR][TD] [/TD] [TD] [/TD] [TD] [/TD] [TD] [/TD] [TD] [/TD][/TR] [TR][TD] [/TD] [TD] Pre-Therapy [/TD] [TD] 6 weeks [/TD] [TD] [/TD] [TD] [/TD][/TR] [TR][TD] TT (ng/dL) [/TD] [TD] n [/TD] [TD] % [/TD] [TD] n [/TD] [TD] % [/TD][/TR] [TR][TD] 0-300 [/TD] [TD] 96 [/TD] [TD] 87.3% [/TD] [TD] 9 [/TD] [TD] 8.2% [/TD][/TR] [TR][TD] 300-1000 [/TD] [TD] 14 [/TD] [TD] 12.7% [/TD] [TD] 97 [/TD] [TD] 88.2% [/TD][/TR] [TR][TD] >1000 [/TD] [TD] 0 [/TD] [TD] 0.0% [/TD] [TD] 4 [/TD] [TD] 3.6% [/TD][/TR][/TABLE] [/QUOTE]
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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone and Men's Health Articles
Sub-q Testosterone Autoinjector is a safe and effective alternative method for TRT
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