Subcutaneous Testosterone Replacement Efficacy and Safety in Adult Men Diagnosed With Hypogonadism (STEADY)

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

Evaluation of efficacy and safety of testosterone enanthate administered subcutaneously using an auto-injector

Study Overview

• Status: Completed
• Conditions: Hypogonadism
• Intervention / Treatment: Combination product: Testosterone enanthate 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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States
    • Huntsville, Alabama, United States
  • Arizona
    • Tucson, Arizona, United States
  • California
    • Burbank, California, United States
    • Torrance, California, United States
    • Upland, California, United States
  • Florida
    • Jacksonville, Florida, United States
    • Oviedo, Florida, United States
  • Kentucky
    • Lexington, Kentucky, United States
  • Louisiana
    • Shreveport, Louisiana, United States
  • Massachusetts
    • Brookline, Massachusetts, United States
    • Methuen, Massachusetts, United States
  • Missouri
    • Kansas City, Missouri, United States
  • New Jersey
    • Lawrenceville, New Jersey, United States
  • New York
    • Albany, New York, United States
    • New York, New York, United States
    • Rochester, New York, United States
  • Ohio
    • Franklin, Ohio, United States
  • Oregon
    • Medford, Oregon, United States
  • Rhode Island
    • Warwick, Rhode Island, United States
  • South Carolina
    • Mount Pleasant, South Carolina, United States
  • Tennessee
    • Nashville, Tennessee, United States
  • Texas
    • San Antonio, Texas, United States
    • Sugar Land, Texas, United States
  • Utah
    • West Valley City, Utah, United States
  • Virginia
    • Norfolk, Virginia, United States
    • Richmond, Virginia, United States
  • Washington
    • Renton, Washington, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Adult males aged ≥ 18 year of age with a documented diagnosis of hypogonadism
• Total testosterone levels < 300 ng/dL at two qualification visits
• Patients in good general health

Exclusion Criteria:

• Allergy to sesame or testosterone products
• BMI ≥ 40 kg/m2
• Hematocrit ≥ 52%
• History or current evidence of breast or prostate cancer
• Elevated PSA (Prostate-Specific Antigen) for age.
• Abnormal DRE (digital rectal examination)
• Obstructive uropathy of prostatic origin
• Poorly controlled diabetes
• Congestive heart failure
• Within 6 months of screening, MI (myocardial ischemia), unstable angina leading to hospitalization, percutaneous coronary intervention, coronary artery bypass graft, uncontrolled cardiac arrhythmia, stroke transient ischemia attack, ceratoid revascularization, endovascular procedure, or surgical intervention for peripheral vascular disease.
• History or current treatment of thromboembolic disease.
• Use of ACTH (adrenocorticotropic hormone) or oral/depot corticosteroids within 6 weeks of screening.
• History of severe, untreated sleep apnea
• Subjects with any clinically significant medical condition which, in the opinion of the investigator, would make the subject an unsuitable candidate for enrollment in the study
• Positive serology for HIV, hepatitis B or hepatitis C
• Current evidence of drug or alcohol abuse.
• Skin conditions in injection site that could confound injection site assessments.
• Administration of other investigational compounds within one month of screening or 5 half-lives of the investigational compound, whichever is longer).
• Use of estrogen, GnRH (gonadotropin-releasing hormone) or growth hormone within 12 months of screening.
• Use of other androgens (DHEA(Dehydroepiandrosterone), anabolic steroids, other sex hormones) or other substances/supplements know to affect the PK (pharmacokinetics) of testosterone enanthate
• Considered or scheduled surgical or dental procedures associated with blood loss ≥500 mL during study.
• Donation of plasma or blood within 56 days of screening or history of donation of > 50 mL of blood or plasma within 3 months of screening.
• Donation of plasma or blood during study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Testosterone enanthate auto-injector; Testosterone enanthate 50 mg / 75 mg / 100 mg administered subcutaneously once each week with possible titration to a higher or lower dose at scheduled intervals during study.	Combination product: Testosterone enanthate auto-injector; Dose Adjustment to 50 mg or 75 mg or 100 mg based upon Testosterone levels; Other Names: Testosterone; Testosterone enanthate; QuickShot® Testosterone (QST)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients With Total Testosterone Cavg(0-168h) Serum Concentrations Within the Normal Range (300-1100 ng/dL)	The primary objective of this study was to demonstrate the efficacy of QST (QuickShot Testosterone) administered subcutaneously once each week to adult males with hypogonadism.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Tolerability	Incidence of adverse events throughout the study; Incidence and severity of injection site reactions throughout the study	52 weeks

Collaborators and Investigators

• Sponsor: Antares Pharma Inc.
• Investigators: Principal Investigator: Jed Kaminetsky, MD, Manhattan Medical Research Practice

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: June 6, 2014
• First Submitted That Met QC Criteria: June 6, 2014
• First Posted (Estimate): June 10, 2014

Study Record Updates

• Last Update Posted (Actual): February 7, 2018
• Last Update Submitted That Met QC Criteria: January 11, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Hypogonadism; Testosterone enanthate
• Additional Relevant MeSH Terms: Endocrine System Diseases; Gonadal Disorders; Hypogonadism; Physiological Effects of Drugs; Antineoplastic Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Androgens; Anabolic Agents; Testosterone; Methyltestosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
• Other Study ID Numbers: QST-13-003