Clinical Trial: Subcutaneous Testosterone Enanthate Safety in Adult Men Diagnosed With Hypogonadism (STEADY)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A 6-Month Safety Study of QuickShot™ Testosterone Administered Subcutaneously Once Each Week to Adult Males With Hypogonadism

Brief Summary: Evaluation of safety of a concentration controlled testosterone enanthate QuickShot Testosterone regimen administered subcutaneously once each week to adult males with hypogonadism.

Detailed Summary: Safety assessments, including laboratory assessments, adverse events and injection site assessments, will be conducted for all patients at scheduled intervals during the Treatment Titration Period.
Sponsor: Antares Pharma Inc.

Current Primary Outcome: Incidence of adverse events as a measure of Safety of QuickShot™ Testosterone (QST) administered subcutaneously (SC) once each week to adult males with hypogonadism [ Time Frame: 26 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Percentage of patients with Total Testosterone (TT) Ctrough values more than 300 ng/dL and less than or equal to 650 ng/dL at 12 weeks, 18 weeks and 26 weeks [ Time Frame: 26 weeks ]
  • Change from baseline in follicle stimulating hormone (FSH) at end of Week 12 and Week 26 [ Time Frame: 26 weeks ]
  • Change from baseline in luteinizing hormone (LH) at end of Week 12 and Week 26 [ Time Frame: 26 weeks ]
  • Change from baseline in sex hormone-binding globulin (SHBG) at end of Week 12 and Week 26 [ Time Frame: 26 weeks ]
  • Peak plasma concentration (Cmax) for testosterone enanthate (TE), TT and their metabolites dihydrotestosterone (DHT), dihydrotestosterone enanthate (DHTE) and estradiol (E2) for the 75 mg dose of QST at Week 1, Week 6 and Week 12 [ Time Frame: 12 weeks ]
  • Average plasma concentration (Cavg) for TE, TT and their metabolites DHT, DHTE and E2 for the 75 mg dose of QST at Week 1, Week 6 and Week 12 [ Time Frame: 12 weeks ]
  • Area under the plasma concentration versus time curve (AUC) for TE, TT and their metabolites DHT, DHTE and E2 for the 75 mg dose of QST at Week 1, Week 6 and Week 12 [ Time Frame: 12 weeks ]


Original Secondary Outcome: Same as current

Information By: Antares Pharma Inc.

Dates:
Date Received: July 20, 2015
Date Started: July 2015
Date Completion:
Last Updated: August 16, 2016
Last Verified: August 2016