Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-02-20 @ 6:39 PM
Study NCT ID:
NCT02159469
Status:
COMPLETED
Last Update Posted:
2018-02-07
First Post:
2014-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Subcutaneous Testosterone Replacement Efficacy and Safety in Adult Men Diagnosed With Hypogonadism
Sponsor:
Antares Pharma Inc.
Organization:
Study Overview
Official Title:
A Multiple-dose, 52-week Study to Evaluate the Efficacy and Safety of Testosterone Enanthate Administered Subcutaneously Once Each Week to Adult Males With Hypogonadism
Status:
COMPLETED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STEADY
Brief Summary:
Evaluation of efficacy and safety of testosterone enanthate administered subcutaneously using an auto-injector
Detailed Description:
This study will evaluate, if testosterone enanthate administered subcutaneously once each week by an auto-injector to men with low testosterone, can raise their levels into the normal range.
The study will investigate the ability to adjust testosterone enanthate dose levels using single point blood concentrations.
Safety and tolerability of testosterone administration will be evaluated along with the patient's ability to use the auto-injector and follow the instructions for auto-injector use.
The study will investigate the ability to adjust testosterone enanthate dose levels using single point blood concentrations.
Safety and tolerability of testosterone administration will be evaluated along with the patient's ability to use the auto-injector and follow the instructions for auto-injector use.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: