Back to resultsPharmacokinetic Study of Testosterone Enanthate
Primary Purpose
Hypogonadism
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
QuickShot™ - 50 mg Treatment B
QuickShot™ - 100 mg Treatment A
Delatestryl 200 mg IM Treatment C
Sponsored by
About this trial
This is an interventional treatment trial for Hypogonadism focused on measuring Hypogonadism, Testosterone enanthate
Eligibility Criteria
Inclusion Criteria:
- Adult males aged 18 to 75 with a documented diagnosis of hypogonadism
Exclusion Criteria:
- Normal testosterone levels
- 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
Sites / Locations
- Mens Health Boston
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
QuickShot™ - 100 mg Treatment A
QuickShot™ - 50 mg Treatment B
Delatestryl 200 mg IM Treatment C
Arm Description
QuickShot™Testosterone - Auto-injector device for SC use
QuickShot™Testosterone- Auto-injector device for SC use
Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference
Outcomes
Primary Outcome Measures
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
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
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
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01887418
Brief Title
Pharmacokinetic Study of Testosterone Enanthate
Official Title
3 Arm Open-label Randomized Multidose Study of Pharmacokinetics, Safety & Tolerability of Testosterone Enanthate Administered Subcutaneously Via an Auto-injector Device or Intramuscular Testosterone Enanthate in Hypogonadal Adult Males
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Antares Pharma Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Relative Bioavailability and Safety comparison of 3 formulations of Testosterone Enanthate.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadism
Keywords
Hypogonadism, Testosterone enanthate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
QuickShot™ - 100 mg Treatment A
Arm Type
Experimental
Arm Description
QuickShot™Testosterone - Auto-injector device for SC use
Arm Title
QuickShot™ - 50 mg Treatment B
Arm Type
Experimental
Arm Description
QuickShot™Testosterone- Auto-injector device for SC use
Arm Title
Delatestryl 200 mg IM Treatment C
Arm Type
Active Comparator
Arm Description
Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference
Intervention Type
Drug
Intervention Name(s)
QuickShot™ - 50 mg Treatment B
Other Intervention Name(s)
Testosterone, Testosterone enanthate
Intervention Description
QuickShot™ for the delivery of testosterone
Intervention Type
Drug
Intervention Name(s)
QuickShot™ - 100 mg Treatment A
Other Intervention Name(s)
Testosterone, Testosterone enanthate
Intervention Description
QuickShot™ for the delivery of testosterone
Intervention Type
Drug
Intervention Name(s)
Delatestryl 200 mg IM Treatment C
Other Intervention Name(s)
Testosterone, Testosterone enanthate
Intervention Description
Standard of care
Primary Outcome Measure Information:
Title
The Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of Testosterone Enanthate Formulations at 6 Weeks
Description
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
Time Frame
0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks
Title
The Maximum Plasma Concentration [Cmax] of Testosterone Enanthate Formulations at 6 Weeks
Description
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
Time Frame
0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks
Title
The Average Concentration [Cavg] of Testosterone Enanthate Formulations at 6 Weeks
Description
The average concentration [Cavg] of TE administered by SC injection once weekly at doses of 50 mg and 100 mg via the QST
Time Frame
0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks
Secondary Outcome Measure Information:
Title
Number of Patients in the PK Parameter Category
Description
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
Time Frame
6 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult males aged 18 to 75 with a documented diagnosis of hypogonadism
Exclusion Criteria:
Normal testosterone levels
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Bedel, MD
Organizational Affiliation
Prestige Clinical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mens Health Boston
City
Brookline
State/Province
Massachusetts
ZIP/Postal Code
02445
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pharmacokinetic Study of Testosterone Enanthate
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