Back to resultsSubcutaneous Testosterone Enanthate Safety in Adult Men Diagnosed With Hypogonadism
Primary Purpose
Hypogonadism
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Testosterone enanthate auto-injector
Sponsored by
About this trial
This is an interventional treatment trial for Hypogonadism focused on measuring Hypogonadism, Testosterone enanthate
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Testosterone enanthate auto-injector
Arm Description
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.
Outcomes
Primary Outcome Measures
Incidence of Adverse Events as a Measure of Safety of QuickShot™ Testosterone (QST) Administered Subcutaneously (SC) Once Each Week to Adult Males With Hypogonadism
Number of participants experiencing adverse events that started on or after the first dose of QST, or existed prior to the first dose and woresened in severity or relatedness to QST after dosing, were evaluated in this population.
Although a patient may have had 2 or more TEAEs or SAEs, the patient was counted only once within a SOC category. The same patient may have contributed to 2 or more preferred term categories. (Four patients had a total of 9 SAEs during the study)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02504541
Brief Title
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
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Antares Pharma Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadism
Keywords
Hypogonadism, Testosterone enanthate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
133 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Testosterone enanthate auto-injector
Arm Type
Experimental
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Testosterone enanthate auto-injector
Other Intervention Name(s)
Testosterone, Testosterone enanthate, QuickShot® Testosterone (QST)
Intervention Description
Dose Adjustment 50 mg or 75 mg or 100 mg based upon Testosterone levels
Primary Outcome Measure Information:
Title
Incidence of Adverse Events as a Measure of Safety of QuickShot™ Testosterone (QST) Administered Subcutaneously (SC) Once Each Week to Adult Males With Hypogonadism
Description
Number of participants experiencing adverse events that started on or after the first dose of QST, or existed prior to the first dose and woresened in severity or relatedness to QST after dosing, were evaluated in this population.
Although a patient may have had 2 or more TEAEs or SAEs, the patient was counted only once within a SOC category. The same patient may have contributed to 2 or more preferred term categories. (Four patients had a total of 9 SAEs during the study)
Time Frame
26 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Bedel, MD
Organizational Affiliation
Prestige Clinical Research
Official's Role
Principal Investigator
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Mobile
State/Province
Alabama
Country
United States
City
Tucson
State/Province
Arizona
Country
United States
City
San Diego
State/Province
California
Country
United States
City
Aventura
State/Province
Florida
Country
United States
City
Brandon
State/Province
Florida
Country
United States
City
Jacksonville
State/Province
Florida
Country
United States
City
Shreveport
State/Province
Louisiana
Country
United States
City
Elkridge
State/Province
Maryland
Country
United States
City
Garden City
State/Province
New York
Country
United States
City
New York
State/Province
New York
Country
United States
City
Columbus
State/Province
Ohio
Country
United States
City
Franklin
State/Province
Ohio
Country
United States
City
Medford
State/Province
Oregon
Country
United States
City
Charleston
State/Province
South Carolina
Country
United States
City
Greer
State/Province
South Carolina
Country
United States
City
Hurst
State/Province
Texas
Country
United States
City
West Valley City
State/Province
Utah
Country
United States
City
Olympia
State/Province
Washington
Country
United States
City
Renton
State/Province
Washington
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
31551193
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.
Results Reference
derived
Learn more about this trial
Subcutaneous Testosterone Enanthate Safety in Adult Men Diagnosed With Hypogonadism
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