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

Hypogonadism Clinical Trial

— STEADY  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02159469
• Other study ID #: QST-13-003
• Status: Completed
• Phase: Phase 3
• First received: June 6, 2014
• Last updated: January 11, 2018
• Start date: July 2014
• Est. completion date: November 2015

Study information

• Verified date: January 2018
• Source: Antares Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: November 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypogonadism

Intervention

Combination Product:
• Testosterone enanthate auto-injector
Dose Adjustment to 50 mg or 75 mg or 100 mg based upon Testosterone levels

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Antares Pharma Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients With Total Testosterone Cavg(0-168h) Serum Concentrations Within the Normal Range (300-1100 ng/dL)	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.	12 weeks
Secondary	Safety and Tolerability	Incidence of adverse events throughout the study; Incidence and severity of injection site reactions throughout the study	52 weeks