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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: 15880" data-attributes="member: 3"><p><strong>Antares Pharma Announces Positive Top-Line Pharmacokinetic Results From The Quickshot® [Subcutaneous Injection] Phase 3 Study In Testosterone Deficient Men</strong></p><p><a href="http://www.sec.gov/Archives/edgar/data/1016169/000119312515061057/d880836dex991.htm" target="_blank">http://www.sec.gov/Archives/edgar/data/1016169/000119312515061057/d880836dex991.htm</a></p><p></p><p></p><p>Antares Pharma, Inc. (NASDAQ: ATRS) today announced positive top-line pharmacokinetic results that showed that the primary endpoint was achieved in the Company’s ongoing, multi-center, phase 3 clinical study (QST-13-003) evaluating the efficacy and safety of testosterone enanthate administered once-weekly by subcutaneous injection using the QuickShot® auto injector in testosterone deficient adult males.</p><p></p><p></p><p>In the study, 150 adult males with hypogonadism (low testosterone) and testosterone blood levels less than 300 ng/dL received a starting dose of 75 mg of subcutaneously administered testosterone enanthate (QuickShot® Testosterone, or QS T) once weekly for six weeks.</p><p></p><p></p><p>Blinded adjustments to dose were made when necessary at week seven based upon the week six pre-dose blood level, and full pharmacokinetic (PK) profiles were obtained during the 12th week of treatment.</p><p></p><p></p><p>The protocol for the study required that at the week 12 endpoint:</p><p>(i) at least 75% of all patients’ Cavg are within the normal range of 300 to 1100 ng/dL, with a lower limit of a 95% 2-sided confidence interval of greater than or equal to 65%,</p><p>(ii) at least 85% of patients’ Cmax are less than1500 ng/dL and</p><p>(iii) no more than 5% of patients had a Cmax greater than 1800 ng/dL.</p><p></p><p></p><p>The primary endpoint of the population that received one or more doses of QS T was met by 139 out of 150 patients, equating to 92.7% with a 95% confidence interval of 87.3% to 96.3%. Among the 137 patients that completed all 12 weeks of dosing and PK sampling, 98.5% were within the pre-defined range.</p></blockquote><p></p>
[QUOTE="Nelson Vergel, post: 15880, member: 3"] [B]Antares Pharma Announces Positive Top-Line Pharmacokinetic Results From The Quickshot® [Subcutaneous Injection] Phase 3 Study In Testosterone Deficient Men[/B] [URL]http://www.sec.gov/Archives/edgar/data/1016169/000119312515061057/d880836dex991.htm[/URL] Antares Pharma, Inc. (NASDAQ: ATRS) today announced positive top-line pharmacokinetic results that showed that the primary endpoint was achieved in the Company’s ongoing, multi-center, phase 3 clinical study (QST-13-003) evaluating the efficacy and safety of testosterone enanthate administered once-weekly by subcutaneous injection using the QuickShot® auto injector in testosterone deficient adult males. In the study, 150 adult males with hypogonadism (low testosterone) and testosterone blood levels less than 300 ng/dL received a starting dose of 75 mg of subcutaneously administered testosterone enanthate (QuickShot® Testosterone, or QS T) once weekly for six weeks. Blinded adjustments to dose were made when necessary at week seven based upon the week six pre-dose blood level, and full pharmacokinetic (PK) profiles were obtained during the 12th week of treatment. The protocol for the study required that at the week 12 endpoint: (i) at least 75% of all patients’ Cavg are within the normal range of 300 to 1100 ng/dL, with a lower limit of a 95% 2-sided confidence interval of greater than or equal to 65%, (ii) at least 85% of patients’ Cmax are less than1500 ng/dL and (iii) no more than 5% of patients had a Cmax greater than 1800 ng/dL. The primary endpoint of the population that received one or more doses of QS T was met by 139 out of 150 patients, equating to 92.7% with a 95% confidence interval of 87.3% to 96.3%. Among the 137 patients that completed all 12 weeks of dosing and PK sampling, 98.5% were within the pre-defined range. [/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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