Subcutaneous Testosterone Enanthate Safety in Adult Men Diagnosed With Hypogonadism

NCT ID: NCT02504541

Last Updated: 2018-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 133 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2016-06-30

Brief Summary

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

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.

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 50 mg or 75 mg or 100 mg based upon Testosterone levels

Interventions

Testosterone enanthate auto-injector

Dose Adjustment 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 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Antares Pharma Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gary Bedel, MD

Role: PRINCIPAL_INVESTIGATOR

Prestige Clinical Research

Locations

Birmingham, Alabama, United States

Mobile, Alabama, United States

Tucson, Arizona, United States

San Diego, California, United States

Aventura, Florida, United States

Brandon, Florida, United States

Jacksonville, Florida, United States

Shreveport, Louisiana, United States

Elkridge, Maryland, United States

Garden City, New York, United States

New York, New York, United States

Columbus, Ohio, United States

Franklin, Ohio, United States

Medford, Oregon, United States

Charleston, South Carolina, United States

Greer, South Carolina, United States

Hurst, Texas, United States

West Valley City, Utah, United States

Olympia, Washington, United States

Renton, Washington, United States

Countries

United States

References

Gittelman M, Jaffe JS, Kaminetsky JC. Safety of a New Subcutaneous Testosterone Enanthate Auto-Injector: Results of a 26-Week Study. J Sex Med. 2019 Nov;16(11):1741-1748. doi: 10.1016/j.jsxm.2019.08.013. Epub 2019 Sep 21.

Reference Type: DERIVED

PMID: 31551193 (View on PubMed)

Other Identifiers

QST-15-005

Identifier Type: -

Identifier Source: org_study_id