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

Completed · Phase 3

Conditions studied: Hypogonadism

In brief

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

Key facts

Study ID

NCT02159469

Run by

Antares Pharma Inc.

People needed

150

Starts

2014-07-01

Expected to finish

2015-11-01

Last updated by the study team

2018-02-07

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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