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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone and Men's Health Articles
Antares Pharma Reports on Their Study Using Testosterone Subcutaneous Injections
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<blockquote data-quote="Nelson Vergel" data-source="post: 9663" data-attributes="member: 3"><p><img src="https://www.marketwatch.com/story/antares-pharma-announces-first-patient-dosed-in-phase-3-quickshotstudy-evaluating-testosterone-deficient-adult-males-2014-07-22/RenderImage?guid=2a9b66999833465483d735d88d104896&imageID=201" class="bbImage" alt="" data-url="https://www.marketwatch.com/story/antares-pharma-announces-first-patient-dosed-in-phase-3-quickshotstudy-evaluating-testosterone-deficient-adult-males-2014-07-22/RenderImage?guid=2a9b66999833465483d735d88d104896&imageID=201" style="" /></p><p></p><p>EWING, N.J., Jul 22, 2014 (BUSINESS WIRE) -- Antares Pharma, Inc. today announced that the first patient has been dosed in a double-blind, multiple-dose, phase 3 study to evaluate the efficacy and safety of QuickShot® Testosterone (QS T) administered subcutaneously once each week to testosterone-deficient adult males. Patients enrolled in this study must have a documented diagnosis of hypogonadism, or testosterone deficiency defined as having testosterone levels below 300 ng/dL. The study will include a screening phase, a treatment titration and efficacy phase and an extended treatment phase.</p><p></p><p>Eamonn P. Hobbs, President and Chief Executive Officer, stated, “We are very excited to announce that the first patient has been dosed in the phase 3 QS T study of testosterone-deficient adult males. The QS T delivery system could potentially fill a patient need for a more precise and convenient dosing regimen in the growing testosterone replacement market.” Mr. Hobbs continued, “Our proprietary QuickShot system is designed for pain-free subcutaneous administration of a weekly fixed dose of testosterone through a fine gauge needle in a matter of seconds. We look forward to working closely with the U.S. <a href="http://www.marketwatch.com/organizations/Food_and_Drug_Administration?lc=int_mb_1001" target="_blank">Food and Drug Administration</a> to bring this novel product to an expanding market.”</p><p></p><p>Approximately 150 patients will be enrolled in this study. Patients meeting all eligibility criteria will be assigned to receive a starting dose of QS T once weekly for six weeks. Adjustments to dose may be made at week seven based upon the week six pre-dose blood level. The efficacy of QS T and dose adjustment to regulate testosterone levels will be evaluated after 12 weeks of treatment. Upon completion of this phase, patients may remain on their optimized QS T dose and will be followed for an additional 40 weeks. Approximately 100 patients will be needed to complete collection of 26 weeks of safety data, and approximately 50 patients will be needed to complete collection of 52 weeks of safety data.</p></blockquote><p></p>
[QUOTE="Nelson Vergel, post: 9663, member: 3"] [IMG]https://www.marketwatch.com/story/antares-pharma-announces-first-patient-dosed-in-phase-3-quickshotstudy-evaluating-testosterone-deficient-adult-males-2014-07-22/RenderImage?guid=2a9b66999833465483d735d88d104896&imageID=201[/IMG] EWING, N.J., Jul 22, 2014 (BUSINESS WIRE) -- Antares Pharma, Inc. today announced that the first patient has been dosed in a double-blind, multiple-dose, phase 3 study to evaluate the efficacy and safety of QuickShot® Testosterone (QS T) administered subcutaneously once each week to testosterone-deficient adult males. Patients enrolled in this study must have a documented diagnosis of hypogonadism, or testosterone deficiency defined as having testosterone levels below 300 ng/dL. The study will include a screening phase, a treatment titration and efficacy phase and an extended treatment phase. Eamonn P. Hobbs, President and Chief Executive Officer, stated, “We are very excited to announce that the first patient has been dosed in the phase 3 QS T study of testosterone-deficient adult males. The QS T delivery system could potentially fill a patient need for a more precise and convenient dosing regimen in the growing testosterone replacement market.” Mr. Hobbs continued, “Our proprietary QuickShot system is designed for pain-free subcutaneous administration of a weekly fixed dose of testosterone through a fine gauge needle in a matter of seconds. We look forward to working closely with the U.S. [URL="http://www.marketwatch.com/organizations/Food_and_Drug_Administration?lc=int_mb_1001"]Food and Drug Administration[/URL] to bring this novel product to an expanding market.” Approximately 150 patients will be enrolled in this study. Patients meeting all eligibility criteria will be assigned to receive a starting dose of QS T once weekly for six weeks. Adjustments to dose may be made at week seven based upon the week six pre-dose blood level. The efficacy of QS T and dose adjustment to regulate testosterone levels will be evaluated after 12 weeks of treatment. Upon completion of this phase, patients may remain on their optimized QS T dose and will be followed for an additional 40 weeks. Approximately 100 patients will be needed to complete collection of 26 weeks of safety data, and approximately 50 patients will be needed to complete collection of 52 weeks of safety data. [/QUOTE]
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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone and Men's Health Articles
Antares Pharma Reports on Their Study Using Testosterone Subcutaneous Injections
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