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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Basics & Questions
Oral TRT without Dose Titration Requirement
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<blockquote data-quote="madman" data-source="post: 191021" data-attributes="member: 13851"><p><strong>Introduction:</strong> <em><span style="color: rgb(184, 49, 47)">Most marketed testosterone replacement therapy (TRT) products require multiple dose adjustment visits to achieve desired eugonadal testosterone (T) levels. For the majority of patients, typical titration of TRT takes 3-6 months with multiple bloods draws and titrations (mostly up titrations) to reach an efficacious dose (e.g., ANDROGEL® 1.62 and JATENZO®). The additional dose adjustment visits are burdensome for patients and physicians. Moreover, a major reason for discontinuation is possibly related to an inadequate therapeutic response within 3-6 months of therapy.</span></em> <span style="color: rgb(44, 130, 201)"><em>The selection of an efficacious dose from the start of therapy with no potential for titration decision errors remains an unmet need. TLANDO<strong>TM </strong>(LPCN 1021, testosterone undecanoate) is an easy to use oral TRT option designed to enable effective T replacement in hypogonadal males from the start of therapy without dose titration requirement. The oral, fixed-dose regimen of TLANDO<strong>TM</strong> may offer additional advantages over most existing TRT options, including an absence of accidental transfer risk, absence of application site reactions or need for self-injections, consistent inter-day performance, no additional clinic/pharmacy visits, favorable liver safety profile, and low hematocrit (HCT) increase. TLANDO<strong>TM</strong> may essentially improve patient adherence and persistence to TRT.</em></span></p><p></p><p><strong>Objective:</strong> <span style="color: rgb(184, 49, 47)"><em>The objective was to assess whether TLANDO<strong>TM</strong>, an oral fixed-dose regimen TRT option, can safely and effectively restore testosterone levels in hypogonadal men without the need for any dose adjustment.</em></span></p><p></p><p><strong>Methods:</strong> A 24 day, open-label, single-arm, multicenter study with TLANDO<strong>TM</strong> in hypogonadal men (NCT03242590) was conducted. Subjects (N=95) received 225 mg testosterone undecanoate orally twice a day. At the end of the study, blood samples were collected over a 24-hour period for pharmacokinetic analysis. The primary endpoint was the percentage of TLANDO-treated subjects who achieved a 24-hour average serum T concentration (T Cavg) within the eugonadal range of 300 to 1080 ng/dL after 24 days of treatment. Key safety endpoints included the incidence of adverse events (AEs), physical examination results, clinical laboratory test results, and changes in HCT and prostate-specific antigen (PSA).</p><p></p><p><strong>Results:</strong> 94 subjects completed the study with a mean age of 56.0 years, mean BMI of 32.8 kg/m2, and baseline T level 202 ± 75 ng/dL. The vast majority, 80% (95% CI 72% - 88%), of hypogonadal subjects achieved T Cavg within the normal range post ~3 weeks of treatment without requiring dose adjustment. T Cavg and the mean peak serum T concentration were 476 ± 174 ng/dL and 1178 ± 484 ng/dL, respectively. The incidence of treatment-emergent adverse events (TEAEs) was 21%. Decrease in lipids was observed (-8.9 mg/dL for triglycerides, and -10.6 mg/dL for total cholesterol). The most frequent TEAEs were blood prolactin increase (6.3%), weight increase (2.1%), headache (2.1%), and musculoskeletal pain (2.1%). Increase in hematocrit (0.9% CBL) and PSA (0.2 μg/L CBL) were observed.</p><p></p><p><strong>Conclusions:</strong> <strong><em><span style="color: rgb(184, 49, 47)">Safety and efficacy of TLANDOTM, a clinically easy to use oral TRT without dose titration requirement, was confirmed.</span></em></strong> <span style="color: rgb(44, 130, 201)"><em><strong>TLANDOTM is well suited to improve persistence rates in TRT therapy.</strong></em></span></p></blockquote><p></p>
[QUOTE="madman, post: 191021, member: 13851"] [B]Introduction:[/B] [I][COLOR=rgb(184, 49, 47)]Most marketed testosterone replacement therapy (TRT) products require multiple dose adjustment visits to achieve desired eugonadal testosterone (T) levels. For the majority of patients, typical titration of TRT takes 3-6 months with multiple bloods draws and titrations (mostly up titrations) to reach an efficacious dose (e.g., ANDROGEL® 1.62 and JATENZO®). The additional dose adjustment visits are burdensome for patients and physicians. Moreover, a major reason for discontinuation is possibly related to an inadequate therapeutic response within 3-6 months of therapy.[/COLOR][/I] [COLOR=rgb(44, 130, 201)][I]The selection of an efficacious dose from the start of therapy with no potential for titration decision errors remains an unmet need. TLANDO[B]TM [/B](LPCN 1021, testosterone undecanoate) is an easy to use oral TRT option designed to enable effective T replacement in hypogonadal males from the start of therapy without dose titration requirement. The oral, fixed-dose regimen of TLANDO[B]TM[/B] may offer additional advantages over most existing TRT options, including an absence of accidental transfer risk, absence of application site reactions or need for self-injections, consistent inter-day performance, no additional clinic/pharmacy visits, favorable liver safety profile, and low hematocrit (HCT) increase. TLANDO[B]TM[/B] may essentially improve patient adherence and persistence to TRT.[/I][/COLOR] [B]Objective:[/B] [COLOR=rgb(184, 49, 47)][I]The objective was to assess whether TLANDO[B]TM[/B], an oral fixed-dose regimen TRT option, can safely and effectively restore testosterone levels in hypogonadal men without the need for any dose adjustment.[/I][/COLOR] [B]Methods:[/B] A 24 day, open-label, single-arm, multicenter study with TLANDO[B]TM[/B] in hypogonadal men (NCT03242590) was conducted. Subjects (N=95) received 225 mg testosterone undecanoate orally twice a day. At the end of the study, blood samples were collected over a 24-hour period for pharmacokinetic analysis. The primary endpoint was the percentage of TLANDO-treated subjects who achieved a 24-hour average serum T concentration (T Cavg) within the eugonadal range of 300 to 1080 ng/dL after 24 days of treatment. Key safety endpoints included the incidence of adverse events (AEs), physical examination results, clinical laboratory test results, and changes in HCT and prostate-specific antigen (PSA). [B]Results:[/B] 94 subjects completed the study with a mean age of 56.0 years, mean BMI of 32.8 kg/m2, and baseline T level 202 ± 75 ng/dL. The vast majority, 80% (95% CI 72% - 88%), of hypogonadal subjects achieved T Cavg within the normal range post ~3 weeks of treatment without requiring dose adjustment. T Cavg and the mean peak serum T concentration were 476 ± 174 ng/dL and 1178 ± 484 ng/dL, respectively. The incidence of treatment-emergent adverse events (TEAEs) was 21%. Decrease in lipids was observed (-8.9 mg/dL for triglycerides, and -10.6 mg/dL for total cholesterol). The most frequent TEAEs were blood prolactin increase (6.3%), weight increase (2.1%), headache (2.1%), and musculoskeletal pain (2.1%). Increase in hematocrit (0.9% CBL) and PSA (0.2 μg/L CBL) were observed. [B]Conclusions:[/B] [B][I][COLOR=rgb(184, 49, 47)]Safety and efficacy of TLANDOTM, a clinically easy to use oral TRT without dose titration requirement, was confirmed.[/COLOR][/I][/B] [COLOR=rgb(44, 130, 201)][I][B]TLANDOTM is well suited to improve persistence rates in TRT therapy.[/B][/I][/COLOR] [/QUOTE]
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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Basics & Questions
Oral TRT without Dose Titration Requirement
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