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

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ClinicalTrials.gov Identifier: NCT02159469
Recruitment Status : Completed
First Posted : June 10, 2014
Results First Posted : January 9, 2018
Last Update Posted : February 7, 2018
Sponsor:
Information provided by (Responsible Party):
Antares Pharma Inc.

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

Condition or disease Intervention/treatment Phase
Hypogonadism Combination Product: Testosterone enanthate auto-injector Phase 3

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  (Clinical Trial)
Actual Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : July 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : November 2015


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)




Primary Outcome Measures :
  1. Percentage of Patients With Total Testosterone Cavg(0-168h) Serum Concentrations Within the Normal Range (300-1100 ng/dL) [ Time Frame: 12 weeks ]
    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.


Secondary Outcome Measures :
  1. Safety and Tolerability [ Time Frame: 52 weeks ]
    • Incidence of adverse events throughout the study
    • Incidence and severity of injection site reactions throughout the study



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02159469


  Show 28 Study Locations
Sponsors and Collaborators
Antares Pharma Inc.
Investigators
Principal Investigator: Jed Kaminetsky, MD Manhattan Medical Research Practice

Responsible Party: Antares Pharma Inc.
ClinicalTrials.gov Identifier: NCT02159469     History of Changes
Other Study ID Numbers: QST-13-003
First Posted: June 10, 2014    Key Record Dates
Results First Posted: January 9, 2018
Last Update Posted: February 7, 2018
Last Verified: January 2018

Keywords provided by Antares Pharma Inc.:
Hypogonadism
Testosterone enanthate

Additional relevant MeSH terms:
Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents