Subcutaneous Testosterone Enanthate Safety in Adult Men Diagnosed With Hypogonadism
A 6-Month Safety Study of QuickShot™ Testosterone Administered Subcutaneously Once Each Week to Adult Males With Hypogonadism
1 other identifier
interventional
133
1 country
20
Brief Summary
Evaluation of safety of a concentration controlled testosterone enanthate QuickShot Testosterone regimen administered subcutaneously once each week to adult males with hypogonadism.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2015
Shorter than P25 for phase_3
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 20, 2015
CompletedFirst Posted
Study publicly available on registry
July 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedResults Posted
Study results publicly available
March 30, 2018
CompletedMarch 30, 2018
March 1, 2018
11 months
July 20, 2015
December 13, 2017
March 29, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
26 weeks
Study Arms (1)
Testosterone enanthate auto-injector
EXPERIMENTALTestosterone 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.
Interventions
Dose Adjustment 50 mg or 75 mg or 100 mg based upon Testosterone levels
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Mobile, Alabama, United States
Unknown Facility
Tucson, Arizona, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
Aventura, Florida, United States
Unknown Facility
Brandon, Florida, United States
Unknown Facility
Jacksonville, Florida, United States
Unknown Facility
Shreveport, Louisiana, United States
Unknown Facility
Elkridge, Maryland, United States
Unknown Facility
Garden City, New York, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Columbus, Ohio, United States
Unknown Facility
Franklin, Ohio, United States
Unknown Facility
Medford, Oregon, United States
Unknown Facility
Charleston, South Carolina, United States
Unknown Facility
Greer, South Carolina, United States
Unknown Facility
Hurst, Texas, United States
Unknown Facility
West Valley City, Utah, United States
Unknown Facility
Olympia, Washington, United States
Unknown Facility
Renton, Washington, United States
Related Publications (1)
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.
PMID: 31551193DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jonathan Jaffe, MD
- Organization
- Antares Pharma, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Gary Bedel, MD
Prestige Clinical Research
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2015
First Posted
July 22, 2015
Study Start
July 1, 2015
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
March 30, 2018
Results First Posted
March 30, 2018
Record last verified: 2018-03