Hypogonadism
Conditions
Keywords
Hypogonadism, Testosterone enanthate
Brief summary
Evaluation of efficacy and safety of testosterone enanthate administered subcutaneously using an auto-injector
Detailed description
This study will evaluate, if testosterone enanthate administered subcutaneously once each week by an auto-injector to men with low testosterone, can raise their levels into the normal range. The study will investigate the ability to adjust testosterone enanthate dose levels using single point blood concentrations. Safety and tolerability of testosterone administration will be evaluated along with the patient's ability to use the auto-injector and follow the instructions for auto-injector use.
Interventions
COMBINATION_PRODUCTTestosterone enanthate auto-injector
Dose Adjustment to 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 No maximum
Healthy volunteers
No
Inclusion criteria
* Adult males aged ≥ 18 year of age with a documented diagnosis 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 PSA (Prostate-Specific Antigen) for age. * Abnormal DRE (digital rectal examination) * Obstructive uropathy of prostatic origin * Poorly controlled diabetes * Congestive heart failure * Within 6 months of screening, MI (myocardial ischemia), unstable angina leading to hospitalization, percutaneous coronary intervention, coronary artery bypass graft, uncontrolled cardiac arrhythmia, stroke transient ischemia attack, ceratoid revascularization, endovascular procedure, or surgical intervention for peripheral vascular disease. * History or current treatment of thromboembolic disease. * Use of ACTH (adrenocorticotropic hormone) 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, GnRH (gonadotropin-releasing hormone) or growth hormone within 12 months of screening. * Use of other androgens (DHEA(Dehydroepiandrosterone), anabolic steroids, other sex hormones) or other substances/supplements know to affect the PK (pharmacokinetics) 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 |
|---|---|---|
| Percentage of Patients With Total Testosterone Cavg(0-168h) Serum Concentrations Within the Normal Range (300-1100 ng/dL) | 12 weeks | The primary objective of this study was to demonstrate the efficacy of QST (QuickShot Testosterone) administered subcutaneously once each week to adult males with hypogonadism. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability | 52 weeks | * Incidence of adverse events throughout the study * Incidence and severity of injection site reactions throughout the study |
Countries
United States
Participant flow
Recruitment details
Approximately 150 patients were enrolled in this study. 128 patients completed through at least Week 26, 98 patients completed through Week 52, and 97 patients completed the full study (through the Follow-up Visit).
Pre-assignment details
The study was designed to ensure a minimum of 100 patients completed a collection of 26 weeks of safety data, and a minimum of 50 patients completed a collection of 52 weeks of safety data. Minimum enrollment goals were exceeded.
Participants by arm
| Arm | Count |
|---|---|
| Testosterone Enanthate Auto-injector Testosterone enanthate administered subcutaneously once each week with possible titration to a higher or lower dose at scheduled intervals during study.
Testosterone enanthate auto-injector Dose Adjustment: 50 mg / 75 mg / 100 mg | 150 |
| Total | 150 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 5 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Met Stopping Criteria | 3 |
| Overall Study | Missing Completion status | 1 |
| Overall Study | Multiple | 29 |
| Overall Study | Non-compliance | 2 |
| Overall Study | Other | 1 |
| Overall Study | Sponsor's request | 2 |
| Overall Study | Withdrawal by Subject | 9 |
Baseline characteristics
| Characteristic | Testosterone Enanthate Auto-injector |
|---|---|
| Age, Continuous | 53.4 years STANDARD_DEVIATION 12.04 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 142 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants |
| Race (NIH/OMB) More than one race | 1 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 | 133 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 150 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 150 |
| other Total, other adverse events | 125 / 150 |
| serious Total, serious adverse events | 3 / 150 |
Outcome results
Primary
Percentage of Patients With Total Testosterone Cavg(0-168h) Serum Concentrations Within the Normal Range (300-1100 ng/dL)
The primary objective of this study was to demonstrate the efficacy of QST (QuickShot Testosterone) administered subcutaneously once each week to adult males with hypogonadism.
Time frame: 12 weeks
Population: The Population consisted of all patients who received at least 1 dose of the investigational product. Percentage was calculated using the number of patients in the column heading as the denominator.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Testosterone Enanthate Auto-injector | Percentage of Patients With Total Testosterone Cavg(0-168h) Serum Concentrations Within the Normal Range (300-1100 ng/dL) | 139 Participants |
Secondary
Safety and Tolerability
* Incidence of adverse events throughout the study * Incidence and severity of injection site reactions throughout the study
Time frame: 52 weeks
Population: TEAE (Treatment-emergent adverse event)s were defined as any event that started on or after the first dosing of IP (Investigational Product), or existed prior to the first dose and worsened in severity or relatedness to IP after dosing. The Population consisted of all patients who received at least 1 dose of the investigational product.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Testosterone Enanthate Auto-injector | Safety and Tolerability | Patients with any TEAE | 125 Participants |
| Testosterone Enanthate Auto-injector | Safety and Tolerability | Patients with any TEAE related to IP | 66 Participants |
| Testosterone Enanthate Auto-injector | Safety and Tolerability | Patients with any SAE | 3 Participants |
| Testosterone Enanthate Auto-injector | Safety and Tolerability | Patients with TEAE leading to discontinuation | 30 Participants |
| Testosterone Enanthate Auto-injector | Safety and Tolerability | Patients discontinued due to IP related TEAE | 1 Participants |
| Testosterone Enanthate Auto-injector | Safety and Tolerability | Patients with any adverse event leading to death | 1 Participants |