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Relative Bioavailability and Safety comparison of 3 formulations of Testosterone Enanthate.
Standard Pharmacokinetic (PK) analyses of data for serum testosterone were done. Cmax, Area Under Curve (AUC), and Cavg were used for the comparison of relative bioavailability of the treatments and reference arm.
Safety comparisons were based upon the occurrence, severity and rate of treatment emergent adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QuickShotâ„¢ - 100 mg Treatment A | Experimental | QuickShotâ„¢Testosterone - Auto-injector device for SC use |
|
| QuickShotâ„¢ - 50 mg Treatment B | Experimental | QuickShotâ„¢Testosterone- Auto-injector device for SC use |
|
| Delatestryl 200 mg IM Treatment C | Active Comparator | Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QuickShotâ„¢ - 50 mg Treatment B | Drug | QuickShotâ„¢ for the delivery of testosterone |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of Testosterone Enanthate Formulations at 6 Weeks | The area under the curve from time zero to last quantifiable concentration [AUC (0-t)] of TE administered by SC injection once weekly at doses of 50 mg and 100 mg via the QST | 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks |
| The Maximum Plasma Concentration [Cmax] of Testosterone Enanthate Formulations at 6 Weeks | The maximum observed plasma concentration [Cmax] of TE administered by SC injection once weekly at doses of 50 mg and 100 mg via the QST | 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks |
| The Average Concentration [Cavg] of Testosterone Enanthate Formulations at 6 Weeks | The average concentration [Cavg] of TE administered by SC injection once weekly at doses of 50 mg and 100 mg via the QST | 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients in the PK Parameter Category | The number of TT Cavg (0-168h) values within the normal range (300-1100 ng/dL) following treatment with SC TE administered via QST or IM TE | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gary Bedel, MD | Prestige Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mens Health Boston | Brookline | Massachusetts | 02445 | United States |
Eligible patients were randomized to receive SC 50mg (Treatment B) or SC 100mg (Treatment A) QST and the subject who were on IM testosterone replacement therapy, received IM TE RLD (Treatment C).
Subjects were screened at 10 sites in USA. In total, 39 eligible subjects were enrolled and received study medication (investigational SC QST or IM RLD): 14 subjects in 50 mg SC QST arm, 15 subjects in 100 mg SC QST arm and 10 subjects in 200 mg IM RLD arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | QuickShotâ„¢ - 100 mg Treatment A | QuickShotâ„¢ - Auto-injector device for SC use QuickShotâ„¢ - 100 mg Treatment A: QuickShotâ„¢ for the delivery of testosterone once a week |
| FG001 | QuickShotâ„¢ - 50 mg Treatment B | QuickShotâ„¢ - Auto-injector device for SC use QuickShotâ„¢ - 50 mg Treatment B: QuickShotâ„¢ for the delivery of testosterone once a week. |
| FG002 | Delatestryl 200 mg IM Treatment C | Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference Delatestryl 200 mg IM Treatment C: injected once only |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Safety Population (39 subjects) was all randomized subjects who received at least 1 dose of investigational product.
The PK Population (39 subjects) was all subjects from Safety Population who did not have a major protocol deviation that impacted the integrity of PK data and had at least 1 valid post-dose plasma concentration value.
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| ID | Title | Description |
|---|---|---|
| BG000 | QuickShotâ„¢ - 100 mg Treatment A | QuickShotâ„¢ - Auto-injector device for SC use QuickShotâ„¢ - 100 mg Treatment A: QuickShotâ„¢ for the delivery of testosterone once a week for 6 weeks |
| BG001 | QuickShotâ„¢ - 50 mg Treatment B |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Number of Patients in the PK Parameter Category | The number of TT Cavg (0-168h) values within the normal range (300-1100 ng/dL) following treatment with SC TE administered via QST or IM TE | Posted | Number | participants | 6 weeks |
|
Adverse events were classified as any adverse events that occurred from Day1 (after screening) to a given treatment period until the subject completed the study. The duration of the study participation for subjects was approximately 19 weeks.
The Safety Population was defined as all randomized subjects who received at least 1 dose of investigational product. The safety population was 39 subjects.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | QuickShotâ„¢ - 100 mg Treatment A | QuickShotâ„¢ - Auto-injector device for SC use QuickShotâ„¢ - 100 mg Treatment A: QuickShotâ„¢ for the delivery of testosterone once a week |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Jaffe, MD; Vice President Clinical Development | Antares Pharma Inc. | 609-329-3020 | 324 | jjaffe@antarespharma.com |
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| ID | Term |
|---|---|
| D007006 | Hypogonadism |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D013739 | Testosterone |
| C004648 | testosterone enanthate |
| ID | Term |
|---|---|
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| QuickShotâ„¢ - 100 mg Treatment A | Drug | QuickShotâ„¢ for the delivery of testosterone |
|
|
| Delatestryl 200 mg IM Treatment C | Drug | Standard of care |
|
|
QuickShotâ„¢ - Auto-injector device for SC use
QuickShotâ„¢ - 50 mg Treatment B: QuickShotâ„¢ for the delivery of testosterone once a week for 6 weeks
| BG002 | Delatestryl 200 mg IM Treatment C | Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference Delatestryl 200 mg IM Treatment C: injected once only |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) at screening (kg/m^2) | Mean | Standard Deviation | kg/m^2 |
|
| Baseline Total Testosterone (TT) (ng/dL) | Mean | Standard Deviation | ng/dL |
|
| Delatestryl 200 mg IM Treatment C |
Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference Delatestryl 200 mg IM Treatment C: Standard of care |
|
|
| Primary | The Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of Testosterone Enanthate Formulations at 6 Weeks | The area under the curve from time zero to last quantifiable concentration [AUC (0-t)] of TE administered by SC injection once weekly at doses of 50 mg and 100 mg via the QST | PK profile of TT obtained at Week 6 of treatment by QST | Posted | Mean | Standard Deviation | ng*hr/dL | 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks |
|
|
|
| Primary | The Maximum Plasma Concentration [Cmax] of Testosterone Enanthate Formulations at 6 Weeks | The maximum observed plasma concentration [Cmax] of TE administered by SC injection once weekly at doses of 50 mg and 100 mg via the QST | PK profile of TT obtained at Week 6 of treatment by QST | Posted | Mean | Standard Deviation | ng/dL | 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks |
|
|
|
| Primary | The Average Concentration [Cavg] of Testosterone Enanthate Formulations at 6 Weeks | The average concentration [Cavg] of TE administered by SC injection once weekly at doses of 50 mg and 100 mg via the QST | PK profile of TT obtained at Week 6 of treatment by QST | Posted | Mean | Standard Deviation | ng/dL | 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks |
|
|
|
| 0 |
| 15 |
| 7 |
| 15 |
| EG001 | QuickShotâ„¢ - 50 mg Treatment B | QuickShotâ„¢ - Auto-injector device for SC use QuickShotâ„¢ - 50 mg Treatment B: QuickShotâ„¢ for the delivery of testosterone once a week. | 0 | 14 | 6 | 14 |
| EG002 | Delatestryl 200 mg IM Treatment C | Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference Delatestryl 200 mg IM Treatment C: injected once only | 0 | 10 | 0 | 10 |
| Vessel puncture site hematoma | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Injection site hemorrhage* | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Prostatic specific antigen increased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Paranasal sinus hypersecretion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
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| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |