Subcutaneous Testosterone Enanthate Safety in Adult Men Diagnosed With Hypogonadism
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| ClinicalTrials.gov Identifier: NCT02504541 |
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Recruitment Status :
Completed
First Posted : July 22, 2015
Results First Posted : March 30, 2018
Last Update Posted : March 30, 2018
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Sponsor:
Antares Pharma Inc.
Information provided by (Responsible Party):
Antares Pharma Inc.
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Brief Summary:
Evaluation of safety of a concentration controlled testosterone enanthate QuickShot Testosterone regimen administered subcutaneously once each week to adult males with hypogonadism.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hypogonadism | Combination Product: Testosterone enanthate auto-injector | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 133 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A 6-Month Safety Study of QuickShot™ Testosterone Administered Subcutaneously Once Each Week to Adult Males With Hypogonadism |
| Study Start Date : | July 2015 |
| Actual Primary Completion Date : | June 2016 |
| Actual Study Completion Date : | June 2016 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Safety
| Arm | Intervention/treatment |
|---|---|
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Experimental: Testosterone enanthate auto-injector
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.
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Combination Product: Testosterone enanthate auto-injector
Dose Adjustment 50 mg or 75 mg or 100 mg based upon Testosterone levels
Other Names:
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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 [ Time Frame: 26 weeks ]
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)
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02504541
Locations
| United States, Alabama | |
| Birmingham, Alabama, United States | |
| Mobile, Alabama, United States | |
| United States, Arizona | |
| Tucson, Arizona, United States | |
| United States, California | |
| San Diego, California, United States | |
| United States, Florida | |
| Aventura, Florida, United States | |
| Brandon, Florida, United States | |
| Jacksonville, Florida, United States | |
| United States, Louisiana | |
| Shreveport, Louisiana, United States | |
| United States, Maryland | |
| Elkridge, Maryland, United States | |
| United States, New York | |
| Garden City, New York, United States | |
| New York, New York, United States | |
| United States, Ohio | |
| Columbus, Ohio, United States | |
| Franklin, Ohio, United States | |
| United States, Oregon | |
| Medford, Oregon, United States | |
| United States, South Carolina | |
| Charleston, South Carolina, United States | |
| Greer, South Carolina, United States | |
| United States, Texas | |
| Hurst, Texas, United States | |
| United States, Utah | |
| West Valley City, Utah, United States | |
| United States, Washington | |
| Olympia, Washington, United States | |
| Renton, Washington, United States | |
Sponsors and Collaborators
Antares Pharma Inc.
Investigators
| Principal Investigator: | Gary Bedel, MD | Prestige Clinical Research |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Antares Pharma Inc. |
| ClinicalTrials.gov Identifier: | NCT02504541 |
| Other Study ID Numbers: |
QST-15-005 |
| First Posted: | July 22, 2015 Key Record Dates |
| Results First Posted: | March 30, 2018 |
| Last Update Posted: | March 30, 2018 |
| Last Verified: | March 2018 |
Keywords provided by Antares Pharma Inc.:
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Hypogonadism Testosterone enanthate |
Additional relevant MeSH terms:
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Hypogonadism Gonadal Disorders Endocrine System Diseases Methyltestosterone Testosterone Testosterone undecanoate Testosterone enanthate Testosterone 17 beta-cypionate |
Androgens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Anabolic Agents |