Nelson Vergel
Founder, ExcelMale.com
This autoinjector will be approved by the end of 2017 in the U.S.
The double-blind, multicenter Subcutaneous Testosterone Efficacy and Safety in Adult Men Diagnosed with Hypogonadism (STEADY) trial of a novel, pre-filled auto injector enrolled 150 hypogonadal adult men with two baseline testosterone (T) levels of <300 ng/dL. Patients received 75 mg of testosterone enanthate administered via the auto injector once-weekly for 6 weeks. At week 7 blinded dose adjustments were based on week-6, pre-dose blood levels in the patients. Full pharmacokinetic (PK) profiles were obtained at week 12.
"A starting dose of 75 mg testosterone enanthate via auto injector, followed by a week-6 dose adjustment if necessary, was shown to achieve normal T levels when dosed weekly for 12 weeks in men with hypogonadism," Kaminetsky wrote. "The treatment was well tolerated and the safety profile was consistent with the class."
Read more: http://www.nasdaq.com/press-release...n-annual-meeting-20170516-00315#ixzz4hFuPBVcp
The double-blind, multicenter Subcutaneous Testosterone Efficacy and Safety in Adult Men Diagnosed with Hypogonadism (STEADY) trial of a novel, pre-filled auto injector enrolled 150 hypogonadal adult men with two baseline testosterone (T) levels of <300 ng/dL. Patients received 75 mg of testosterone enanthate administered via the auto injector once-weekly for 6 weeks. At week 7 blinded dose adjustments were based on week-6, pre-dose blood levels in the patients. Full pharmacokinetic (PK) profiles were obtained at week 12.
"A starting dose of 75 mg testosterone enanthate via auto injector, followed by a week-6 dose adjustment if necessary, was shown to achieve normal T levels when dosed weekly for 12 weeks in men with hypogonadism," Kaminetsky wrote. "The treatment was well tolerated and the safety profile was consistent with the class."
Read more: http://www.nasdaq.com/press-release...n-annual-meeting-20170516-00315#ixzz4hFuPBVcp