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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone and Men's Health Articles
Effect of Oral Testosterone Undecanoate on LH and FSH Concentrations
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<blockquote data-quote="madman" data-source="post: 191033" data-attributes="member: 13851"><p><strong>Introduction</strong>: <span style="color: rgb(184, 49, 47)"><em>Treatment of male hypogonadism with testosterone (T), most profoundly with long-acting injections and pellets, has been shown to inhibit the hypogonadal-pituitary-gonadal (HPG) axis<a href="https://www.smsna.org/V1/2020/program/abstracts#_ftn4" target="_blank">[4]</a>. T injections result in a reduction in both luteinizing hormone (LH) and follicle-stimulating hormone (FSH) concentrations to undetectable levels as quickly as 2 weeks following initiation of therapy<a href="https://www.smsna.org/V1/2020/program/abstracts#_ftn5" target="_blank">[5]</a>.</em></span> <span style="color: rgb(44, 130, 201)"><em>The decrease in LH and FSH impairs critical components of spermatogenesis. </em></span><span style="color: rgb(184, 49, 47)"><em><u>In a phase 3 study of an oral testosterone undecanoate (TU) capsule (JATENZO®), complete suppression of LH and FSH concentrations was not observed in all men<a href="https://www.smsna.org/V1/2020/program/abstracts#_ftn6" target="_blank">[6]</a>, although the impact on gonadotropin suppression by age was not studied</u>.</em></span></p><p></p><p><strong>Objectives</strong>: To determine the impact of oral TU administration on LH and FSH concentrations, stratified by age, in hypogonadal men after four months of treatment.</p><p></p><p><strong>Methods</strong>: In the inTUne trial, 166 hypogonadal men (diagnosis by the Endocrine Society guideline criteria of two-morning serum T < 300 ng/dL and signs/symptoms of hypogonadism), age 18 – 65 y/o, were recruited into a 105 day, randomized, open-label, multicenter, dose-titration trial. Full methods have been previously published3. We conducted a post hoc analysis of the LH and FSH levels, stratified by age. The age groups were 18-40, 41-50, and > 50 y/o.</p><p></p><p><strong>Results</strong>: <span style="color: rgb(184, 49, 47)"><em>At study completion, the mean serum equivalent T Cavg for the oral TU group was 489 ± 154.9 ng/dL. When stratified by age, there were 26, 36, and 104 men in the 18 – 40, 40 – 50, and > 50 y/o groups, respectively.</em></span> <span style="color: rgb(44, 130, 201)"><em>Overall, the LH concentrations significantly suppressed ~75%; and the FSH concentrations significantly suppressed ~65% (See Table). While LH and FSH concentrations significantly suppressed for all age groups, the concentrations of FSH remained in the normal range, in all age groups.</em></span><span style="color: rgb(184, 49, 47)"><em> In contrast, the concentration of LH remained in the normal range only for the 18 – 40 y/o group (See table).</em></span></p><p></p><p><strong>Conclusion</strong>: <span style="color: rgb(184, 49, 47)"><em><strong>Oral TU caused reductions in gonadotropins in this cohort of hypogonadal men, but gonadotropin concentrations remained within normal limits in younger men.</strong></em></span> <strong><em><span style="color: rgb(44, 130, 201)"><u>Although the impact of these findings on spermatogenesis and fertility needs additional evaluation, these results suggest that oral TU does not have as significant of a suppressive impact on the HPG axis as some other forms of T replacement, which could potentially result in a reduced suppression of spermatogenesis in men 18-40 yrs</u>.</span></em></strong></p><p><strong></strong></p><p><strong></strong></p><p><strong></strong></p><p><strong></strong></p><p><strong></strong></p><p><strong>Table: <span style="color: rgb(184, 49, 47)">Changes in gonadotropin concentrations, stratified by age</span></strong></p><table class='post-table ' style='width: 100%'><tr><td></td><td ><p>18 – 40 y/o<br /> (n = 26)</p></td><td></td><td ><p>40 – 50 y/o<br /> (n = 36)</p></td><td></td><td ><p>>50 y/o<br /> (n = 103)</p></td><td></td><td ><p>Overall<br /> (N = 165)</p></td><td></td><td></td></tr><tr><td></td><td ><p>BL</p></td><td ><p>4 Mo</p></td><td ><p>BL</p></td><td ><p>4 Mo</p></td><td ><p>BL</p></td><td ><p>4 Mo</p></td><td ><p>BL</p></td><td ><p>4 Mo</p></td><td></td></tr><tr><td ><p>Total T (ng/dL ± SD)</p></td><td ><p>240.5 ± 118.1</p></td><td ><p>444.7 ± 138.0*</p></td><td ><p>242.7 ± 82.3</p></td><td ><p>474.9 ± 149.0*</p></td><td ><p>255.3 ± 97.4</p></td><td ><p>492.7 ± 154.9*</p></td><td ><p>251.3 ± 80.7</p></td><td ><p>489.0 ± 154.9*</p></td><td></td></tr><tr><td ><p>LH (mIU/mL ± SD)</p></td><td ><p>4.58 ± 6.4</p></td><td ><p>1.76 ± 3.7*</p></td><td ><p>3.45 ± 2.5</p></td><td ><p>1.03 ± 2.2*</p></td><td ><p>4.21 ± 3.6</p></td><td ><p>0.87 ± 2.1*</p></td><td ><p>4.10 ± 4.0</p></td><td ><p>1.05 ± 2.4*</p></td><td></td></tr><tr><td ><p>FSH (mIU/mL ± SD)</p></td><td ><p>5.66 ± 9.6</p></td><td ><p>2.63 ± 6.2*</p></td><td ><p>4.09 ± 4.5</p></td><td ><p>1.68 ± 4.9*</p></td><td ><p>5.72 ± 7.1</p></td><td ><p>1.70 ± 5.7*</p></td><td ><p>5.35 ± 7.1</p></td><td ><p>1.84 ± 5.6*</p></td><td></td></tr><tr><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td></tr></table><strong>* Denotes p < 0.001 when compared to the baseline<span style="color: rgb(184, 49, 47)"> (BL) </span>levels.</strong></p><p><strong></strong></p><p><strong></strong></p><p><strong></strong></p><p><strong>Normal ranges for <span style="color: rgb(184, 49, 47)">LH = 1.3 – 8.1 mIU/mL</span> and <span style="color: rgb(184, 49, 47)">FSH = 1.4 – 9.5 mIU/mL</span></strong></p></blockquote><p></p>
[QUOTE="madman, post: 191033, member: 13851"] [B]Introduction[/B]: [COLOR=rgb(184, 49, 47)][I]Treatment of male hypogonadism with testosterone (T), most profoundly with long-acting injections and pellets, has been shown to inhibit the hypogonadal-pituitary-gonadal (HPG) axis[URL='https://www.smsna.org/V1/2020/program/abstracts#_ftn4'][4][/URL]. T injections result in a reduction in both luteinizing hormone (LH) and follicle-stimulating hormone (FSH) concentrations to undetectable levels as quickly as 2 weeks following initiation of therapy[URL='https://www.smsna.org/V1/2020/program/abstracts#_ftn5'][5][/URL].[/I][/COLOR] [COLOR=rgb(44, 130, 201)][I]The decrease in LH and FSH impairs critical components of spermatogenesis. [/I][/COLOR][COLOR=rgb(184, 49, 47)][I][U]In a phase 3 study of an oral testosterone undecanoate (TU) capsule (JATENZO®), complete suppression of LH and FSH concentrations was not observed in all men[URL='https://www.smsna.org/V1/2020/program/abstracts#_ftn6'][6][/URL], although the impact on gonadotropin suppression by age was not studied[/U].[/I][/COLOR] [B]Objectives[/B]: To determine the impact of oral TU administration on LH and FSH concentrations, stratified by age, in hypogonadal men after four months of treatment. [B]Methods[/B]: In the inTUne trial, 166 hypogonadal men (diagnosis by the Endocrine Society guideline criteria of two-morning serum T < 300 ng/dL and signs/symptoms of hypogonadism), age 18 – 65 y/o, were recruited into a 105 day, randomized, open-label, multicenter, dose-titration trial. Full methods have been previously published3. We conducted a post hoc analysis of the LH and FSH levels, stratified by age. The age groups were 18-40, 41-50, and > 50 y/o. [B]Results[/B]: [COLOR=rgb(184, 49, 47)][I]At study completion, the mean serum equivalent T Cavg for the oral TU group was 489 ± 154.9 ng/dL. When stratified by age, there were 26, 36, and 104 men in the 18 – 40, 40 – 50, and > 50 y/o groups, respectively.[/I][/COLOR] [COLOR=rgb(44, 130, 201)][I]Overall, the LH concentrations significantly suppressed ~75%; and the FSH concentrations significantly suppressed ~65% (See Table). While LH and FSH concentrations significantly suppressed for all age groups, the concentrations of FSH remained in the normal range, in all age groups.[/I][/COLOR][COLOR=rgb(184, 49, 47)][I] In contrast, the concentration of LH remained in the normal range only for the 18 – 40 y/o group (See table).[/I][/COLOR] [B]Conclusion[/B]: [COLOR=rgb(184, 49, 47)][I][B]Oral TU caused reductions in gonadotropins in this cohort of hypogonadal men, but gonadotropin concentrations remained within normal limits in younger men.[/B][/I][/COLOR] [B][I][COLOR=rgb(44, 130, 201)][U]Although the impact of these findings on spermatogenesis and fertility needs additional evaluation, these results suggest that oral TU does not have as significant of a suppressive impact on the HPG axis as some other forms of T replacement, which could potentially result in a reduced suppression of spermatogenesis in men 18-40 yrs[/U].[/COLOR][/I] Table: [COLOR=rgb(184, 49, 47)]Changes in gonadotropin concentrations, stratified by age[/COLOR][/B] [TABLE][TR][TD] [/TD] [TD] 18 – 40 y/o (n = 26) [/TD] [TD] [/TD] [TD] 40 – 50 y/o (n = 36) [/TD] [TD] [/TD] [TD] >50 y/o (n = 103) [/TD] [TD] [/TD] [TD] Overall (N = 165) [/TD] [TD] [/TD] [TD] [/TD][/TR] [TR][TD] [/TD] [TD] BL [/TD] [TD] 4 Mo [/TD] [TD] BL [/TD] [TD] 4 Mo [/TD] [TD] BL [/TD] [TD] 4 Mo [/TD] [TD] BL [/TD] [TD] 4 Mo [/TD] [TD] [/TD][/TR] [TR][TD] Total T (ng/dL ± SD) [/TD] [TD] 240.5 ± 118.1 [/TD] [TD] 444.7 ± 138.0* [/TD] [TD] 242.7 ± 82.3 [/TD] [TD] 474.9 ± 149.0* [/TD] [TD] 255.3 ± 97.4 [/TD] [TD] 492.7 ± 154.9* [/TD] [TD] 251.3 ± 80.7 [/TD] [TD] 489.0 ± 154.9* [/TD] [TD] [/TD][/TR] [TR][TD] LH (mIU/mL ± SD) [/TD] [TD] 4.58 ± 6.4 [/TD] [TD] 1.76 ± 3.7* [/TD] [TD] 3.45 ± 2.5 [/TD] [TD] 1.03 ± 2.2* [/TD] [TD] 4.21 ± 3.6 [/TD] [TD] 0.87 ± 2.1* [/TD] [TD] 4.10 ± 4.0 [/TD] [TD] 1.05 ± 2.4* [/TD] [TD] [/TD][/TR] [TR][TD] FSH (mIU/mL ± SD) [/TD] [TD] 5.66 ± 9.6 [/TD] [TD] 2.63 ± 6.2* [/TD] [TD] 4.09 ± 4.5 [/TD] [TD] 1.68 ± 4.9* [/TD] [TD] 5.72 ± 7.1 [/TD] [TD] 1.70 ± 5.7* [/TD] [TD] 5.35 ± 7.1 [/TD] [TD] 1.84 ± 5.6* [/TD] [TD] [/TD][/TR] [TR][TD] [/TD] [TD] [/TD] [TD] [/TD] [TD] [/TD] [TD] [/TD] [TD] [/TD] [TD] [/TD] [TD] [/TD] [TD] [/TD] [TD] [/TD][/TR][/TABLE] [B]* Denotes p < 0.001 when compared to the baseline[COLOR=rgb(184, 49, 47)] (BL) [/COLOR]levels. Normal ranges for [COLOR=rgb(184, 49, 47)]LH = 1.3 – 8.1 mIU/mL[/COLOR] and [COLOR=rgb(184, 49, 47)]FSH = 1.4 – 9.5 mIU/mL[/COLOR][/B] [/QUOTE]
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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone and Men's Health Articles
Effect of Oral Testosterone Undecanoate on LH and FSH Concentrations
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