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Testosterone Replacement, Low T, HCG, & Beyond
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Cycling TRT
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<blockquote data-quote="madman" data-source="post: 206192" data-attributes="member: 13851"><p>Unfortunately, this long-term study (52 weeks) never had a fighting chance.....0 participants!</p><p></p><p></p><p>[URL unfurl="true"]https://clinicaltrials.gov/ct2/show/NCT01417364[/URL]</p><p></p><p></p><p><strong>Recruitment Status:</strong> <em><strong>Withdrawn (<u>Unable to identify any qualifying subjects willing to enroll in this study</u>.)</strong></em></p><p></p><p><strong>First Posted:</strong> August 16, 2011</p><p></p><p><strong>Last Update Posted: </strong>October 2, 2015</p><p></p><p></p><p></p><p><strong>Brief Summary:</strong></p><p></p><p><em><strong>The general hypothesis is that administration of testosterone to healthy, older men for 52 weeks (1 year)</strong> <strong>following a cycle of 4 weeks of testosterone administration and 4 weeks without testosterone (i.e., monthly cycled regimen)</strong> will provide the same gains in muscle strength, muscle mass, and bone density as the standard of care (SOC), continuous administration of testosterone for 52 weeks.</em></p><p></p><p></p><p><strong>Detailed Description:</strong></p><p></p><p><em><strong>The hypothesis is based on data from our current <u>NIA-funded R01 protocol</u>. The investigators treated older men with weekly intramuscular injections of testosterone enanthate (100 mg) for 4 weeks followed by 4 weeks of placebo injections. <u>This 4-week-on, 4-week-off cycled treatment regimen was repeated for 5 cycles (20 weeks)</u>.</strong> This group was compared with a group of older men who received SOC weekly intramuscular injections of testosterone enanthate (100 mg) for 20 weeks and another group who received placebo injections. Our preliminary data showed equal gains over placebo in muscle strength and lean body mass in those who received testosterone for 20 weeks, whether SOC continuous or cycled. Moreover, both groups showed greater bone density and markers of bone formation over placebo. In terms of the anabolic actions of testosterone on skeletal muscle in older men, the investigators found that continuous and cycled administration of testosterone primarily stimulated muscle protein synthesis for the 20 weeks of the study. Cycled testosterone administration enhanced muscle protein synthesis throughout the full 5 cycles of 20 weeks, with no significant loss in muscle protein synthesis during the off-cycle weeks. Additionally, cycled and continuous testosterone administration reduced serum markers of bone resorption compared with placebo. These exciting findings of the benefits of a cycled testosterone regimen in older men represent a novel therapeutic paradigm over the existing SOC approach of continuous administration. <strong>The investigators believe the cycled regimen offers a more safe and efficacious approach to combat sarcopenia and osteoporosis with equal anabolic benefit to muscle and bone with only half the dose of testosterone.</strong> </em><strong><em><u>Critical to the application of this significant paradigm shift in testosterone administration is to determine whether these effects at 20 weeks can persist for the 52 weeks proposed in this study, which represents a treatment duration applicable to the traditional SOC approach</u>.</em></strong></p><p><strong></strong></p><p><strong></strong></p><p><strong></strong></p><p><strong></strong></p><p><strong>Primary Outcome Measures:</strong></p><ol> <li data-xf-list-type="ol"><em>Muscle Strength [ Time Frame: 1 year ]<br /> Muscle strength will be measured using a Biodex 4. All strength measures will be normalized by dividing absolute strength by lean muscle mass.</em></li> <li data-xf-list-type="ol"><em>Lean Body Mass and Muscle Volume [ Time Frame: 1 year ]<br /> Lean body mass will be determined by DEXA and muscle volume by MRI.</em></li> <li data-xf-list-type="ol"><em>Bone density [ Time Frame: 1 year ]<br /> Bone density will be determined by DEXA.</em></li> </ol><p></p><p><strong>Secondary Outcome Measures:</strong></p><ol> <li data-xf-list-type="ol"><em>Assessment of risk factors [ Time Frame: 1 year ]<br /> Prostate health Complete Blood Count (CBC)/hypertension Serum estradiol Bone fracture risk.</em></li> <li data-xf-list-type="ol"><em>Assessment of Physical Performance [ Time Frame: 1 year ]<br /> Subjects will complete a timed 400 Molecular Weight (400MWT) at each study session to assess changes in gait speed as a proxy for physical function.<strong> In addition, subjects will complete Patient-Reported Outcomes Information System (PROMIS®) <u>Short Forms addressing questions related to general health, fatigue, and physical functioning</u></strong></em></li> <li data-xf-list-type="ol"><em>Assessment of muscle signaling [ Time Frame: 1 year ]<br /> Testosterone can alter skeletal muscle cell signaling. We will measure changes in key signaling proteins in skeletal muscle tissue. We anticipate that testosterone treatment will increase levels of anabolic signaling proteins and suppress levels of catabolic signaling proteins</em></li> <li data-xf-list-type="ol"><em>Assessment of bone metabolism. [ Time Frame: 1 year ]<br /> Testosterone can decrease rates of bone turnover (net increase of bone formation). We will measure changes in serum markers of bone formation and bone resorption.</em></li> <li data-xf-list-type="ol"><em>Assessment of Inflammation [ Time Frame: 1 year ]<br /> Testosterone is protective against inflammation. We will measure concentrations of cytokines in blood and muscle tissue.</em></li> <li data-xf-list-type="ol"><em>Assessment of cardiac stiffness [ Time Frame: 1 year ]<br /> Cardiac stiffness and relaxation will be assessed using echocardiography.</em></li> </ol></blockquote><p></p>
[QUOTE="madman, post: 206192, member: 13851"] Unfortunately, this long-term study (52 weeks) never had a fighting chance.....0 participants! [URL unfurl="true"]https://clinicaltrials.gov/ct2/show/NCT01417364[/URL] [B]Recruitment Status:[/B] [I][B]Withdrawn ([U]Unable to identify any qualifying subjects willing to enroll in this study[/U].)[/B][/I] [B]First Posted:[/B] August 16, 2011 [B]Last Update Posted: [/B]October 2, 2015 [B]Brief Summary:[/B] [I][B]The general hypothesis is that administration of testosterone to healthy, older men for 52 weeks (1 year)[/B] [B]following a cycle of 4 weeks of testosterone administration and 4 weeks without testosterone (i.e., monthly cycled regimen)[/B] will provide the same gains in muscle strength, muscle mass, and bone density as the standard of care (SOC), continuous administration of testosterone for 52 weeks.[/I] [B]Detailed Description:[/B] [I][B]The hypothesis is based on data from our current [U]NIA-funded R01 protocol[/U]. The investigators treated older men with weekly intramuscular injections of testosterone enanthate (100 mg) for 4 weeks followed by 4 weeks of placebo injections. [U]This 4-week-on, 4-week-off cycled treatment regimen was repeated for 5 cycles (20 weeks)[/U].[/B] This group was compared with a group of older men who received SOC weekly intramuscular injections of testosterone enanthate (100 mg) for 20 weeks and another group who received placebo injections. Our preliminary data showed equal gains over placebo in muscle strength and lean body mass in those who received testosterone for 20 weeks, whether SOC continuous or cycled. Moreover, both groups showed greater bone density and markers of bone formation over placebo. In terms of the anabolic actions of testosterone on skeletal muscle in older men, the investigators found that continuous and cycled administration of testosterone primarily stimulated muscle protein synthesis for the 20 weeks of the study. Cycled testosterone administration enhanced muscle protein synthesis throughout the full 5 cycles of 20 weeks, with no significant loss in muscle protein synthesis during the off-cycle weeks. Additionally, cycled and continuous testosterone administration reduced serum markers of bone resorption compared with placebo. These exciting findings of the benefits of a cycled testosterone regimen in older men represent a novel therapeutic paradigm over the existing SOC approach of continuous administration. [B]The investigators believe the cycled regimen offers a more safe and efficacious approach to combat sarcopenia and osteoporosis with equal anabolic benefit to muscle and bone with only half the dose of testosterone.[/B] [/I][B][I][U]Critical to the application of this significant paradigm shift in testosterone administration is to determine whether these effects at 20 weeks can persist for the 52 weeks proposed in this study, which represents a treatment duration applicable to the traditional SOC approach[/U].[/I] Primary Outcome Measures:[/B] [LIST=1] [*][I]Muscle Strength [ Time Frame: 1 year ] Muscle strength will be measured using a Biodex 4. All strength measures will be normalized by dividing absolute strength by lean muscle mass.[/I] [*][I]Lean Body Mass and Muscle Volume [ Time Frame: 1 year ] Lean body mass will be determined by DEXA and muscle volume by MRI.[/I] [*][I]Bone density [ Time Frame: 1 year ] Bone density will be determined by DEXA.[/I] [/LIST] [B]Secondary Outcome Measures:[/B] [LIST=1] [*][I]Assessment of risk factors [ Time Frame: 1 year ] Prostate health Complete Blood Count (CBC)/hypertension Serum estradiol Bone fracture risk.[/I] [*][I]Assessment of Physical Performance [ Time Frame: 1 year ] Subjects will complete a timed 400 Molecular Weight (400MWT) at each study session to assess changes in gait speed as a proxy for physical function.[B] In addition, subjects will complete Patient-Reported Outcomes Information System (PROMIS®) [U]Short Forms addressing questions related to general health, fatigue, and physical functioning[/U][/B][/I] [*][I]Assessment of muscle signaling [ Time Frame: 1 year ] Testosterone can alter skeletal muscle cell signaling. We will measure changes in key signaling proteins in skeletal muscle tissue. We anticipate that testosterone treatment will increase levels of anabolic signaling proteins and suppress levels of catabolic signaling proteins[/I] [*][I]Assessment of bone metabolism. [ Time Frame: 1 year ] Testosterone can decrease rates of bone turnover (net increase of bone formation). We will measure changes in serum markers of bone formation and bone resorption.[/I] [*][I]Assessment of Inflammation [ Time Frame: 1 year ] Testosterone is protective against inflammation. We will measure concentrations of cytokines in blood and muscle tissue.[/I] [*][I]Assessment of cardiac stiffness [ Time Frame: 1 year ] Cardiac stiffness and relaxation will be assessed using echocardiography.[/I] [/LIST] [/QUOTE]
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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Basics & Questions
Cycling TRT
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