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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone and Men's Health Articles
High hematocrit prevalence with intranasal vs. intramuscular testosterone
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<blockquote data-quote="madman" data-source="post: 183794" data-attributes="member: 13851"><p>This is key:</p><p></p><p><strong><span style="color: rgb(184, 49, 47)">* t</span></strong><span style="color: rgb(184, 49, 47)"><strong>he unique, ultradian, pulsatile nature of TNG </strong></span></p><p><span style="color: rgb(184, 49, 47)"><strong>* limited impact on the HPG axis </strong></span><span style="color: rgb(44, 130, 201)"><strong><u>with significant trough time</u></strong></span></p><p></p><p></p><p></p><p></p><p></p><p></p><p>TNG 4.5% testosterone nasal gel (Natesto® ) is a thixotropic gel that is applied to the nasal cavity. Testosterone levels or symptoms are used to guide titration decisions between either twice daily or three times a day doses used to restore testosterone levels to the normal range. Surprisingly, patients report higher convenience with TNG than once-daily topical gels. The pharmacokinetic (PK) profile of TNG of different concentrations has been studied in a series of single and multidose PK studies, including in women, healthy volunteers with allergic rhinitis, and TDS men. <strong><span style="color: rgb(184, 49, 47)"><u>The 24-hour pharmacokinetic profile</u> of testosterone for patients on TNG treatment has <u>two or three discrete peaks (“pulses”) of testosterone provoked by LH secretions that occur on average every 2 hours</u>. <u>A maximal peak of testosterone appears at about 1h (Tmax) followed by a return to endogenous, pre-dose levels, 4-6 hours later (t1/2 ~1h)</u>. <u>The nadir (trough) between doses correlates well with pre-treatment endogenous levels at diagnosis</u>.</span></strong></p><p></p><p><span style="color: rgb(44, 130, 201)"><strong><u>The</u></strong><u><strong> unique, pulsatile, pharmacokinetic profile</strong></u><strong><u> is believed to have limited impact on the HPG axis with significant trough time </u></strong></span><span style="color: rgb(184, 49, 47)"><strong><u>preserving luteinizing hormone (LH), follicle stimulating hormone (FSH), endogenous testosterone production and sperm counts, </u></strong></span><strong><span style="color: rgb(184, 49, 47)"><u>while also limiting excess RBC production, estradiol, DHT and PSA in clinical trials</u>.</span> </strong>However, it was previously unclear whether TNG was sufficient to produce strong efficacy outcomes when baseline endogenous production was very low, thus the impetus to perform a post-hoc analysis of Phase 3 data with particular attention to pre-study baseline and its effects on the pharmacokinetics and symptomatic efficacy. Of particular interest was the subset of patients who presented with very low baseline endogenous testosterone (<100 ng/dL (3.5 nmol/L)) to determine if TNG is a suitable treatment option for this population.</p><p></p><p></p><p></p><p><strong>Conclusions</strong></p><p><strong></strong></p><p><strong>Testosterone nasal gel treatment restores TT levels <span style="color: rgb(184, 49, 47)"><u>while preserving significant aspects of HPG function, including the continued release of gonadotropins and production of endogenous testosterone, which allows maintenance of baseline levels</u>.</span></strong> <strong>Both modest TDS (TT 250-300 ng/dL; (8.7 – 10.4 nmol/L)) and more severe TDS patients (TT 0-100 ng/dL (0 – 3.5 nmol/L), when treated with TNG, achieve max TT levels around 800 ng/dL (27.7 nmol/L). Efficacy, as measured by erectile function and mood were significantly improved to similar levels in both groups.<span style="color: rgb(44, 130, 201)"> <u>The unique, ultradian, pulsatile nature of TNG, which does not depress endogenous testosterone production </u></span>means that a wide range of testosterone deficient patients can effectively be treated with it.</strong></p></blockquote><p></p>
[QUOTE="madman, post: 183794, member: 13851"] This is key: [B][COLOR=rgb(184, 49, 47)]* t[/COLOR][/B][COLOR=rgb(184, 49, 47)][B]he unique, ultradian, pulsatile nature of TNG * limited impact on the HPG axis [/B][/COLOR][COLOR=rgb(44, 130, 201)][B][U]with significant trough time[/U][/B][/COLOR] TNG 4.5% testosterone nasal gel (Natesto® ) is a thixotropic gel that is applied to the nasal cavity. Testosterone levels or symptoms are used to guide titration decisions between either twice daily or three times a day doses used to restore testosterone levels to the normal range. Surprisingly, patients report higher convenience with TNG than once-daily topical gels. The pharmacokinetic (PK) profile of TNG of different concentrations has been studied in a series of single and multidose PK studies, including in women, healthy volunteers with allergic rhinitis, and TDS men. [B][COLOR=rgb(184, 49, 47)][U]The 24-hour pharmacokinetic profile[/U] of testosterone for patients on TNG treatment has [U]two or three discrete peaks (“pulses”) of testosterone provoked by LH secretions that occur on average every 2 hours[/U]. [U]A maximal peak of testosterone appears at about 1h (Tmax) followed by a return to endogenous, pre-dose levels, 4-6 hours later (t1/2 ~1h)[/U]. [U]The nadir (trough) between doses correlates well with pre-treatment endogenous levels at diagnosis[/U].[/COLOR][/B] [COLOR=rgb(44, 130, 201)][B][U]The[/U][/B][U][B] unique, pulsatile, pharmacokinetic profile[/B][/U][B][U] is believed to have limited impact on the HPG axis with significant trough time [/U][/B][/COLOR][COLOR=rgb(184, 49, 47)][B][U]preserving luteinizing hormone (LH), follicle stimulating hormone (FSH), endogenous testosterone production and sperm counts, [/U][/B][/COLOR][B][COLOR=rgb(184, 49, 47)][U]while also limiting excess RBC production, estradiol, DHT and PSA in clinical trials[/U].[/COLOR] [/B]However, it was previously unclear whether TNG was sufficient to produce strong efficacy outcomes when baseline endogenous production was very low, thus the impetus to perform a post-hoc analysis of Phase 3 data with particular attention to pre-study baseline and its effects on the pharmacokinetics and symptomatic efficacy. Of particular interest was the subset of patients who presented with very low baseline endogenous testosterone (<100 ng/dL (3.5 nmol/L)) to determine if TNG is a suitable treatment option for this population. [B]Conclusions Testosterone nasal gel treatment restores TT levels [COLOR=rgb(184, 49, 47)][U]while preserving significant aspects of HPG function, including the continued release of gonadotropins and production of endogenous testosterone, which allows maintenance of baseline levels[/U].[/COLOR][/B] [B]Both modest TDS (TT 250-300 ng/dL; (8.7 – 10.4 nmol/L)) and more severe TDS patients (TT 0-100 ng/dL (0 – 3.5 nmol/L), when treated with TNG, achieve max TT levels around 800 ng/dL (27.7 nmol/L). Efficacy, as measured by erectile function and mood were significantly improved to similar levels in both groups.[COLOR=rgb(44, 130, 201)] [U]The unique, ultradian, pulsatile nature of TNG, which does not depress endogenous testosterone production [/U][/COLOR]means that a wide range of testosterone deficient patients can effectively be treated with it.[/B] [/QUOTE]
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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone and Men's Health Articles
High hematocrit prevalence with intranasal vs. intramuscular testosterone
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