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

NCT ID: NCT02159469

Last Updated: 2018-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2015-11-30

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.

Conditions

Hypogonadism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Testosterone enanthate auto-injector

Intervention Type: COMBINATION_PRODUCT

Dose Adjustment to 50 mg or 75 mg or 100 mg based upon Testosterone levels

Interventions

Testosterone enanthate auto-injector

Dose Adjustment to 50 mg or 75 mg or 100 mg based upon Testosterone levels

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

Testosterone; Testosterone enanthate; QuickShot® Testosterone (QST)

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Antares Pharma Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jed Kaminetsky, MD

Role: PRINCIPAL_INVESTIGATOR

Manhattan Medical Research Practice

Locations

Birmingham, Alabama, United States

Huntsville, Alabama, United States

Tucson, Arizona, United States

Burbank, California, United States

Torrance, California, United States

Upland, California, United States

Jacksonville, Florida, United States

Oviedo, Florida, United States

Lexington, Kentucky, United States

Shreveport, Louisiana, United States

Brookline, Massachusetts, United States

Methuen, Massachusetts, United States

Kansas City, Missouri, United States

Lawrenceville, New Jersey, United States

Albany, New York, United States

New York, New York, United States

Rochester, New York, United States

Franklin, Ohio, United States

Medford, Oregon, United States

Warwick, Rhode Island, United States

Mt. Pleasant, South Carolina, United States

Nashville, Tennessee, United States

San Antonio, Texas, United States

Sugar Land, Texas, United States

West Valley City, Utah, United States

Norfolk, Virginia, United States

Richmond, Virginia, United States

Renton, Washington, United States

Countries

United States

Other Identifiers

QST-13-003

Identifier Type: -

Identifier Source: org_study_id