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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Basics & Questions
Is Aveed (Nebido outside the US) Long Acting Testosterone Injection The Answer For Men's Low T?
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<blockquote data-quote="Nelson Vergel" data-source="post: 10508" data-attributes="member: 3"><p><a href="http://onlinelibrary.wiley.com/doi/10.2164/jandrol.109.009597/full" target="_blank"><strong>Pharmacokinetics and Safety of Long-Acting Testosterone Undecanoate (Aveed in the US, Nebido in all other countries) Injections in Hypogonadal Men: An 84-Week Phase III Clinical Trial</strong></a></p><p></p><p></p><p>ABSTRACT: </p><p></p><p>Currently available testosterone (T) injections in the United States are administered at 2&#8211;3 weekly intervals. Less frequent injections with favorable serum T pharmacokinetics would benefit hypogonadal men. The objective of this study is to assess the pharmacokinetics of long-acting testosterone undecanoate (TU) intramuscular (IM) injection in hypogonadal men. An unblinded, multicenter phase 3 clinical trial was conducted in 31 academic centers and contract research organizations. Males (130) more than 18 years of age with serum total T < 300 ng/dL were enrolled and received 750-mg injections of TU at weeks 0 and 4 and every 10 weeks thereafter for 9 injections over 84 weeks. The main outcome variables were serum total T, free T, dihydrotestosterone (DHT), estradiol (E2) levels, and safety parameters. After the first injection, patients maintained average trough T concentrations in the adult male range (300&#8211;1000 ng/dL or 10.4&#8211;34.7 nmol/L) before each injection and at multiple time points measured after the third and fourth injections. Serum free T, DHT, and E2 levels and their ratios to serum T remained relatively consistent once steady state was attained. TU injections were generally well tolerated, with safety profiles similar to other T replacement. We conclude that hypogonadal patients treated for 84 weeks with a 750-mg IM injection of TU every 10 weeks demonstrated average concentrations of T, its metabolites (DHT and E2), and ratios—DHT:T and E2: T—within the adult male reference range at all time points measured. TU injections would be an acceptable alternative to the currently available 2&#8211;3 weekly injectables.</p><p></p><p>**************</p><p></p><p>This was a multicenter, open-label, US-based study of the efficacy and safety of treatment with 750 mg TU in 3 mL of castor oil (250 mg/mL) by deep IM injections administered to the gluteus muscle at week 0 (baseline), week 4, and every 10 weeks thereafter through 9 injections. </p><p></p><p></p><p>Serum free T, DHT, E2, and SHBG concentrations for 10 weeks after the third TU injection are provided in the next graph. Serum free T, DHT, and E2 concentrations after the third 750-mg TU injection followed the same pattern as serum T, with peaks at about 7 days and troughs before the next injection. Serum SHBG showed steady levels, which was not changed throughout the 10 weeks after the TU injection.</p><p></p><p></p><p></p><p>[ATTACH]956[/ATTACH]</p><p></p><p></p><p>The following graph provides the mean concentrations of serum T in 117 men over the 10-week interval after the third and fourth injection of 750 mg TU. The serum T levels peaked at about 7 days after each injection. Then serum T levels gradually decreased to reach a mean serum T level just above 300 ng/dL (10.4 nmol/L) 10 weeks after the injection. The serum T profiles were identical after the third and fourth injections. </p><p></p><p></p><p>[ATTACH]957[/ATTACH]</p><p></p><p>Comment from Nelson Vergel:</p><p></p><p>The current approved injection protocol for Aveed in the US (3 mL (750 mg) to be injected intramuscularly at initiation, at 4 weeks, and every 10 weeks thereafter) does not keep total testosterone blood levels above 500 ng/dl. The cut off used was 300 ng/dL in the studies that got the product approved in the United States. Many men do not feel the benefits of testosterone replacement when their total T blood levels are under 500 ng/dL. So, this protocol may not be successful for many men in the United States.</p></blockquote><p></p>
[QUOTE="Nelson Vergel, post: 10508, member: 3"] [URL="http://onlinelibrary.wiley.com/doi/10.2164/jandrol.109.009597/full"][B]Pharmacokinetics and Safety of Long-Acting Testosterone Undecanoate (Aveed in the US, Nebido in all other countries) Injections in Hypogonadal Men: An 84-Week Phase III Clinical Trial[/B][/URL] ABSTRACT: Currently available testosterone (T) injections in the United States are administered at 2–3 weekly intervals. Less frequent injections with favorable serum T pharmacokinetics would benefit hypogonadal men. The objective of this study is to assess the pharmacokinetics of long-acting testosterone undecanoate (TU) intramuscular (IM) injection in hypogonadal men. An unblinded, multicenter phase 3 clinical trial was conducted in 31 academic centers and contract research organizations. Males (130) more than 18 years of age with serum total T < 300 ng/dL were enrolled and received 750-mg injections of TU at weeks 0 and 4 and every 10 weeks thereafter for 9 injections over 84 weeks. The main outcome variables were serum total T, free T, dihydrotestosterone (DHT), estradiol (E2) levels, and safety parameters. After the first injection, patients maintained average trough T concentrations in the adult male range (300–1000 ng/dL or 10.4–34.7 nmol/L) before each injection and at multiple time points measured after the third and fourth injections. Serum free T, DHT, and E2 levels and their ratios to serum T remained relatively consistent once steady state was attained. TU injections were generally well tolerated, with safety profiles similar to other T replacement. We conclude that hypogonadal patients treated for 84 weeks with a 750-mg IM injection of TU every 10 weeks demonstrated average concentrations of T, its metabolites (DHT and E2), and ratios—DHT:T and E2: T—within the adult male reference range at all time points measured. TU injections would be an acceptable alternative to the currently available 2–3 weekly injectables. ************** This was a multicenter, open-label, US-based study of the efficacy and safety of treatment with 750 mg TU in 3 mL of castor oil (250 mg/mL) by deep IM injections administered to the gluteus muscle at week 0 (baseline), week 4, and every 10 weeks thereafter through 9 injections. Serum free T, DHT, E2, and SHBG concentrations for 10 weeks after the third TU injection are provided in the next graph. Serum free T, DHT, and E2 concentrations after the third 750-mg TU injection followed the same pattern as serum T, with peaks at about 7 days and troughs before the next injection. Serum SHBG showed steady levels, which was not changed throughout the 10 weeks after the TU injection. [ATTACH=CONFIG]956[/ATTACH] The following graph provides the mean concentrations of serum T in 117 men over the 10-week interval after the third and fourth injection of 750 mg TU. The serum T levels peaked at about 7 days after each injection. Then serum T levels gradually decreased to reach a mean serum T level just above 300 ng/dL (10.4 nmol/L) 10 weeks after the injection. The serum T profiles were identical after the third and fourth injections. [ATTACH=CONFIG]957[/ATTACH] Comment from Nelson Vergel: The current approved injection protocol for Aveed in the US (3 mL (750 mg) to be injected intramuscularly at initiation, at 4 weeks, and every 10 weeks thereafter) does not keep total testosterone blood levels above 500 ng/dl. The cut off used was 300 ng/dL in the studies that got the product approved in the United States. Many men do not feel the benefits of testosterone replacement when their total T blood levels are under 500 ng/dL. So, this protocol may not be successful for many men in the United States. [/QUOTE]
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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Basics & Questions
Is Aveed (Nebido outside the US) Long Acting Testosterone Injection The Answer For Men's Low T?
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