Clinical trial NCT02159469: Subcutaneous Testosterone Replacement Efficacy and Safety in Adult Men Diagnosed With Hypogonadism
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypogonadism
Keywords: Hypogonadism
Testosterone enanthate
Lead sponsor: Antares Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2014-06-10
Enrollment: 150
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of Patients With Total Testosterone Cavg(0-168h) Serum Concentrations Within the Normal Range (300-1100 ng/dL)
timeFrame: 12 weeks
Secondary outcomes:
measure: Safety and Tolerability
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Huntsville
country: United States
state: Alabama
city: Tucson
country: United States
state: Arizona
city: Burbank
country: United States
state: California
city: Torrance
country: United States
state: California
city: Upland
country: United States
state: California
city: Jacksonville
country: United States
state: Florida
city: Oviedo
country: United States
state: Florida
city: Lexington
country: United States
state: Kentucky
city: Shreveport
country: United States
state: Louisiana
city: Brookline
country: United States
state: Massachusetts
city: Methuen
country: United States
state: Massachusetts
city: Kansas City
country: United States
state: Missouri
city: Lawrenceville
country: United States
state: New Jersey
city: Albany
country: United States
state: New York
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Franklin
country: United States
state: Ohio
city: Medford
country: United States
state: Oregon
city: Warwick
country: United States
state: Rhode Island
city: Mount Pleasant
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
city: San Antonio
country: United States
state: Texas
city: Sugar Land
country: United States
state: Texas
city: West Valley City
country: United States
state: Utah
city: Norfolk
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Renton
country: United States
state: Washington
Study officials:
affiliation: Manhattan Medical Research Practice
name: Jed Kaminetsky, MD
role: PRINCIPAL_INVESTIGATOR
References: