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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Basics & Questions
Testosterone 1326 ng/dl at trough - 100mg cypionate, 1.75mg anastrozole (weekly)
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<blockquote data-quote="madman" data-source="post: 193843" data-attributes="member: 13851"><p>Although we tend to wait 6 weeks to have blood work done I would not fret over testing at week 5.</p><p></p><p></p><p></p><p></p><p><strong>Pharmacokinetic Profile of Subcutaneous Testosterone Enanthate Delivered via a Novel, Prefilled Single-Use Autoinjector: A Phase II Study (2015)</strong></p><p><strong></strong></p><p><strong></strong></p><p><strong>PK Profile Assessment</strong></p><p><u>Seven-day PK profiles were collected for each patient in the SC TE treatment arms at weeks 1 and 5 and the full PK profile following the sixth dose</u>. <u>Pre-dose trough and 24 hours post-dose samples were collected at each of the 6 weekly treatment visits</u>. For patients in the IM TE group, a PK profile was collected through week 4.</p><p></p><p></p><p><strong>Laboratory Tests, Biomarker Analyses, and Safety Analyses</strong></p><p><u>Sensitive and specific liquid chromatography– tandem mass spectrometry (LC-MS/MS) assays for the quantification of T</u>, dihydrotestosterone (DHT), and estradiol was developed, validated, and performed by Medpace Bioanalytical Laboratories (Cincinnati, OH, USA) [28,29].</p><p></p><p></p><p><strong>PK Profile for T</strong></p><p><u><strong>Figure 2 shows pre-dose and 24 hours post-dose TT levels collected during the dosing interval</strong></u><strong>.</strong> Patients achieved mean TT levels within the predetermined reference range (300–1,100 ng/dL) within 24 hours following the first dose with either 50 or 100 mg of TE delivered via the self-administration system. The 50 mg dose of SC TE provided a temporary increase to T levels, which fell to baseline between doses (Figure 2). PK curves in the 50 mg SC group were similar between weeks 1, 5, and 6 (Figure 3A). Unlike the 50-mg group, T levels rose following the first three doses of 100 mg SC TE. <u><strong>Pre-dose and 24 hours post-dose concentration ranges overlapped at week 4 and beyond, which is consistent with having approached steady-state exposure (Figure 2)</strong></u><strong>.</strong> <strong><u>At weeks 5 and 6, PK curves for the 100-mg group overlapped and provided greater T exposure than the exposure observed at week 1 (Figure 3B)</u>.</strong></p><p></p><p></p><p></p><p></p><p></p><p><em><strong><u>Pre-dose and 24 hours post-dose concentration ranges overlapped at week 4 and beyond,</u></strong></em><strong><u> which is consistent with </u><em><u>having approached steady-state exposure</u> </em>(Figure 2).</strong></p><p>[ATTACH=full]12442[/ATTACH]</p><p><strong>Figure 2 Mean pre-dose and 24 hours post-dose total testosterone concentration. Mean total testosterone (TT) concentrations for 50 (open circles) and 100 (closed squares) mg subcutaneous (SC) testosterone enanthate (TE) measured pre-dose (0 hours) and 24 hours post-dose at weeks 1–6. SD = standard deviation</strong></p><p><strong></strong></p><p><strong></strong></p><p><strong></strong></p><p><strong></strong></p><p><strong>Discussion</strong></p><p>Although there have been only a few reports in the literature, these previous studies suggest that the SC route of administration achieves therapeutic T levels and is a viable alternative to IM administration [30–32]. Our article reports the results from a multicenter, multiple-dose, phase II PK study and demonstrates that TE in oil-administered SC via a prefilled single-use disposable autoinjector was able to achieve serum T reliably within the reference ranges over a 1-week dosing interval. <strong><u>Normal T levels were achieved within hours after the first dose and steady-state was approached after the third dose</u>. </strong>SC TE minimized variation in exposure relative to a chronic 200 mg IM TE dosing cohort. Mean steady-state Cavg and Cmax T levels were in the reference range with both doses of SC TE. In the IM TE cohort, Cavg and Cmax were higher than normal in the week after dosing. The supraphysiologic levels of T following 200 mg IM TE is consistent with prior reports [21,22].</p><p></p><p><strong><u>The 50-mg dose exhibited no accumulation between doses. A similar result at this dose was demonstrated in healthy men, suggesting that clearance exceeds exposure by the end of the dosing interval [33]</u>.</strong> The 100 mg SC TE dose achieved approximately twice the T exposure as the 50 mg dose; thus demonstrating dose proportionality. Accordingly, DHT and E2 levels increased with the TE dose. The ratio of DHT to T was similar across the groups, suggesting a similar rate of metabolism. <strong><u>Overall, the results presented here suggest that an intermediate dose of 75 mg weekly will provide optimal T exposure in most patients</u>.</strong></p></blockquote><p></p>
[QUOTE="madman, post: 193843, member: 13851"] Although we tend to wait 6 weeks to have blood work done I would not fret over testing at week 5. [B]Pharmacokinetic Profile of Subcutaneous Testosterone Enanthate Delivered via a Novel, Prefilled Single-Use Autoinjector: A Phase II Study (2015) PK Profile Assessment[/B] [U]Seven-day PK profiles were collected for each patient in the SC TE treatment arms at weeks 1 and 5 and the full PK profile following the sixth dose[/U]. [U]Pre-dose trough and 24 hours post-dose samples were collected at each of the 6 weekly treatment visits[/U]. For patients in the IM TE group, a PK profile was collected through week 4. [B]Laboratory Tests, Biomarker Analyses, and Safety Analyses[/B] [U]Sensitive and specific liquid chromatography– tandem mass spectrometry (LC-MS/MS) assays for the quantification of T[/U], dihydrotestosterone (DHT), and estradiol was developed, validated, and performed by Medpace Bioanalytical Laboratories (Cincinnati, OH, USA) [28,29]. [B]PK Profile for T[/B] [U][B]Figure 2 shows pre-dose and 24 hours post-dose TT levels collected during the dosing interval[/B][/U][B].[/B] Patients achieved mean TT levels within the predetermined reference range (300–1,100 ng/dL) within 24 hours following the first dose with either 50 or 100 mg of TE delivered via the self-administration system. The 50 mg dose of SC TE provided a temporary increase to T levels, which fell to baseline between doses (Figure 2). PK curves in the 50 mg SC group were similar between weeks 1, 5, and 6 (Figure 3A). Unlike the 50-mg group, T levels rose following the first three doses of 100 mg SC TE. [U][B]Pre-dose and 24 hours post-dose concentration ranges overlapped at week 4 and beyond, which is consistent with having approached steady-state exposure (Figure 2)[/B][/U][B].[/B] [B][U]At weeks 5 and 6, PK curves for the 100-mg group overlapped and provided greater T exposure than the exposure observed at week 1 (Figure 3B)[/U].[/B] [I][B][U]Pre-dose and 24 hours post-dose concentration ranges overlapped at week 4 and beyond,[/U][/B][/I][B][U] which is consistent with [/U][I][U]having approached steady-state exposure[/U] [/I](Figure 2).[/B] [ATTACH type="full" alt="Screenshot (3194).png"]12442[/ATTACH] [B]Figure 2 Mean pre-dose and 24 hours post-dose total testosterone concentration. Mean total testosterone (TT) concentrations for 50 (open circles) and 100 (closed squares) mg subcutaneous (SC) testosterone enanthate (TE) measured pre-dose (0 hours) and 24 hours post-dose at weeks 1–6. SD = standard deviation Discussion[/B] Although there have been only a few reports in the literature, these previous studies suggest that the SC route of administration achieves therapeutic T levels and is a viable alternative to IM administration [30–32]. Our article reports the results from a multicenter, multiple-dose, phase II PK study and demonstrates that TE in oil-administered SC via a prefilled single-use disposable autoinjector was able to achieve serum T reliably within the reference ranges over a 1-week dosing interval. [B][U]Normal T levels were achieved within hours after the first dose and steady-state was approached after the third dose[/U]. [/B]SC TE minimized variation in exposure relative to a chronic 200 mg IM TE dosing cohort. Mean steady-state Cavg and Cmax T levels were in the reference range with both doses of SC TE. In the IM TE cohort, Cavg and Cmax were higher than normal in the week after dosing. The supraphysiologic levels of T following 200 mg IM TE is consistent with prior reports [21,22]. [B][U]The 50-mg dose exhibited no accumulation between doses. A similar result at this dose was demonstrated in healthy men, suggesting that clearance exceeds exposure by the end of the dosing interval [33][/U].[/B] The 100 mg SC TE dose achieved approximately twice the T exposure as the 50 mg dose; thus demonstrating dose proportionality. Accordingly, DHT and E2 levels increased with the TE dose. The ratio of DHT to T was similar across the groups, suggesting a similar rate of metabolism. [B][U]Overall, the results presented here suggest that an intermediate dose of 75 mg weekly will provide optimal T exposure in most patients[/U].[/B] [/QUOTE]
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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Basics & Questions
Testosterone 1326 ng/dl at trough - 100mg cypionate, 1.75mg anastrozole (weekly)
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