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

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ClinicalTrials.gov Identifier: NCT02504541
Recruitment Status : Completed
First Posted : July 22, 2015
Last Update Posted : August 8, 2017
Information provided by (Responsible Party):
Antares Pharma Inc.

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

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

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 133 participants
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 6-Month Safety Study of QuickShot™ Testosterone Administered Subcutaneously Once Each Week to Adult Males With Hypogonadism
Study Start Date : July 2015
Primary Completion Date : June 2016
Study Completion Date : June 2016

Arm Intervention/treatment
Experimental: Testosterone enanthate auto-injector
Testosterone enanthate administered subcutaneously once each week with possible titration to a higher or lower dose at scheduled intervals during study. Three dose strengths are available: 100 mg, 75 mg, and 50 mg
Drug: Testosterone enanthate auto-injector
Dose Adjustment 100 mg / 75 mg / 50 mg
Other Names:
  • Testosterone
  • Testosterone enanthate
  • QuickShot® Testosterone (QST)

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Change from baseline in follicle stimulating hormone (FSH) at end of Week 12 and Week 26 [ Time Frame: 26 weeks ]
  3. Change from baseline in luteinizing hormone (LH) at end of Week 12 and Week 26 [ Time Frame: 26 weeks ]
  4. Change from baseline in sex hormone-binding globulin (SHBG) at end of Week 12 and Week 26 [ Time Frame: 26 weeks ]
  5. 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 ]
  6. 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 ]
  7. 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 ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult men ≥18 and ≤75 years of age with a documented history 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 prostate-specific antigen (PSA) for age.
  • Abnormal digital rectal examination (DRE)
  • Unstable psychiatric illnesses
  • Obstructive uropathy of prostatic origin
  • Poorly controlled diabetes
  • Congestive heart failure
  • Within 6 months of screening, myocardial infarction (MI), unstable angina leading to hospitalization, percutaneous coronary intervention, coronary artery bypass graft, uncontrolled cardiac arrhythmia, stroke transient ischemia attack, carotid revascularization, endovascular procedure, or surgical intervention for peripheral vascular disease.
  • History or current treatment of thromboembolic disease.
  • Use of adrenocorticotropic hormone (ACTH) 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, gonadotropin-releasing hormone (GnRH) or growth hormone within 12 months of screening.
  • Use of other androgens (DHEA), anabolic steroids, other sex hormones) or other substances/supplements know to affect the pharmacokinetics (PK) 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): NCT02504541

United States, Alabama
Birmingham, Alabama, United States
Mobile, Alabama, United States
United States, Arizona
Tucson, Arizona, United States
United States, California
San Diego, California, United States
United States, Florida
Aventura, Florida, United States
Brandon, Florida, United States
Jacksonville, Florida, United States
United States, Louisiana
Shreveport, Louisiana, United States
United States, Maryland
Elkridge, Maryland, United States
United States, New York
Garden City, New York, United States
New York, New York, United States
United States, Ohio
Columbus, Ohio, United States
Franklin, Ohio, United States
United States, Oregon
Medford, Oregon, United States
United States, South Carolina
Charleston, South Carolina, United States
Greer, South Carolina, United States
United States, Texas
Hurst, Texas, United States
United States, Utah
West Valley City, Utah, United States
United States, Washington
Olympia, Washington, United States
Renton, Washington, United States
Sponsors and Collaborators
Antares Pharma Inc.
Principal Investigator: Gary Bedel, MD Prestige Clinical Research

Responsible Party: Antares Pharma Inc.
ClinicalTrials.gov Identifier: NCT02504541     History of Changes
Other Study ID Numbers: QST-15-005
First Posted: July 22, 2015    Key Record Dates
Last Update Posted: August 8, 2017
Last Verified: August 2017

Keywords provided by Antares Pharma Inc.:
Testosterone enanthate

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