Clinical trial NCT02504541: Subcutaneous Testosterone Enanthate Safety in Adult Men Diagnosed With Hypogonadism
Official title: A 6-Month Safety Study of QuickShot™ Testosterone 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: 2015-07-22
Enrollment: 133
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Incidence of Adverse Events as a Measure of Safety of QuickShot™ Testosterone (QST) Administered Subcutaneously (SC) Once Each Week to Adult Males With Hypogonadism
timeFrame: 26 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Mobile
country: United States
state: Alabama
city: Tucson
country: United States
state: Arizona
city: San Diego
country: United States
state: California
city: Aventura
country: United States
state: Florida
city: Brandon
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Shreveport
country: United States
state: Louisiana
city: Elkridge
country: United States
state: Maryland
city: Garden City
country: United States
state: New York
city: New York
country: United States
state: New York
city: Columbus
country: United States
state: Ohio
city: Franklin
country: United States
state: Ohio
city: Medford
country: United States
state: Oregon
city: Charleston
country: United States
state: South Carolina
city: Greer
country: United States
state: South Carolina
city: Hurst
country: United States
state: Texas
city: West Valley City
country: United States
state: Utah
city: Olympia
country: United States
state: Washington
city: Renton
country: United States
state: Washington
Study officials:
affiliation: Prestige Clinical Research
name: Gary Bedel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.