Hypogonadism
Conditions
Keywords
Hypogonadism, Testosterone enanthate
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.
Interventions
COMBINATION_PRODUCTTestosterone enanthate auto-injector
Dose Adjustment 50 mg or 75 mg or 100 mg based upon Testosterone levels
Sponsors
Antares Pharma Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events as a Measure of Safety of QuickShot™ Testosterone (QST) Administered Subcutaneously (SC) Once Each Week to Adult Males With Hypogonadism | 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) |
Countries
United States
Participant flow
Recruitment details
133 patients were enrolled in this study. 113 (85.0%) patients completed the study (through the Follow-up Visit) and 20 (15.0%) patients prematurely withdrew from the study.
Pre-assignment details
Although 21 sites participated in the study, only 19 sites enrolled patients in the United States. This study was intended to collect additional safety and exposure data, to ensure compliance and accuracy.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 133 |
| Total | 133 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 4 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Met Stopping Criteria | 1 |
| Overall Study | Multiple | 5 |
| Overall Study | Other | 2 |
| Overall Study | Protocol Violation | 2 |
| Overall Study | Termination by Sponsor | 1 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Testosterone Enanthate Auto-injector |
|---|---|
| Age, Continuous | 54.5 years STANDARD_DEVIATION 10.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 116 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 113 Participants |
| Region of Enrollment United States | 133 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 133 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 133 |
| other Total, other adverse events | 68 / 133 |
| serious Total, serious adverse events | 4 / 133 |
Outcome results
Primary
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)
Time frame: 26 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Testosterone Enanthate Auto-injector | Incidence of Adverse Events as a Measure of Safety of QuickShot™ Testosterone (QST) Administered Subcutaneously (SC) Once Each Week to Adult Males With Hypogonadism | Patients with any TEAE | 87 Participants |
| Testosterone Enanthate Auto-injector | Incidence of Adverse Events as a Measure of Safety of QuickShot™ Testosterone (QST) Administered Subcutaneously (SC) Once Each Week to Adult Males With Hypogonadism | Patients with any TEAE related to QST | 34 Participants |
| Testosterone Enanthate Auto-injector | Incidence of Adverse Events as a Measure of Safety of QuickShot™ Testosterone (QST) Administered Subcutaneously (SC) Once Each Week to Adult Males With Hypogonadism | Patients with SAE | 4 Participants |
| Testosterone Enanthate Auto-injector | Incidence of Adverse Events as a Measure of Safety of QuickShot™ Testosterone (QST) Administered Subcutaneously (SC) Once Each Week to Adult Males With Hypogonadism | Patients with TEAE leading to Discontinuation | 8 Participants |
| Testosterone Enanthate Auto-injector | Incidence of Adverse Events as a Measure of Safety of QuickShot™ Testosterone (QST) Administered Subcutaneously (SC) Once Each Week to Adult Males With Hypogonadism | Patients with QST related TEAE and discontinuation | 4 Participants |