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Pharmacokinetic Study of Testosterone Enanthate

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ClinicalTrials.gov Identifier: NCT01887418
Recruitment Status : Completed
First Posted : June 26, 2013
Results First Posted : October 21, 2015
Last Update Posted : January 11, 2018
Sponsor:
Information provided by (Responsible Party):
Antares Pharma Inc.

Study Description
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Brief Summary:
Relative Bioavailability and Safety comparison of 3 formulations of Testosterone Enanthate.

Condition or disease Intervention/treatment Phase
Hypogonadism Drug: QuickShot™ - 50 mg Treatment B Drug: QuickShot™ - 100 mg Treatment A Drug: Delatestryl 200 mg IM Treatment C Phase 1 Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: QuickShot™ - 100 mg Treatment A
QuickShot™Testosterone - Auto-injector device for SC use
 Drug: QuickShot™ - 100 mg Treatment A
QuickShot™ for the delivery of testosterone
Other Names:
  • Testosterone
  • Testosterone enanthate
Experimental: QuickShot™ - 50 mg Treatment B
QuickShot™Testosterone- Auto-injector device for SC use
 Drug: QuickShot™ - 50 mg Treatment B
QuickShot™ for the delivery of testosterone
Other Names:
  • Testosterone
  • Testosterone enanthate
Active Comparator: Delatestryl 200 mg IM Treatment C
Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference
 Drug: Delatestryl 200 mg IM Treatment C
Standard of care
Other Names:
  • Testosterone
  • Testosterone enanthate


Outcome Measures
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Primary Outcome Measures :
  1. The Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of Testosterone Enanthate Formulations at 6 Weeks [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, 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

  2. The Maximum Plasma Concentration [Cmax] of Testosterone Enanthate Formulations at 6 Weeks [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, 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

  3. The Average Concentration [Cavg] of Testosterone Enanthate Formulations at 6 Weeks [ Time Frame: 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 TE administered by SC injection once weekly at doses of 50 mg and 100 mg via the QST


Secondary Outcome Measures :
  1. Number of Patients in the PK Parameter Category [ Time Frame: 6 weeks ]
    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


Eligibility Criteria
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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 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
Contacts and Locations
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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): NCT01887418


Locations
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United States, Massachusetts
Mens Health Boston
Brookline, Massachusetts, United States, 02445
Sponsors and Collaborators
Antares Pharma Inc.
Investigators
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Principal Investigator: Gary Bedel, MD Prestige Clinical Research
More Information
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Responsible Party: Antares Pharma Inc.
ClinicalTrials.gov Identifier: NCT01887418    
Other Study ID Numbers: QST-13-002
First Posted: June 26, 2013    Key Record Dates
Results First Posted: October 21, 2015
Last Update Posted: January 11, 2018
Last Verified: December 2017
Keywords provided by Antares Pharma Inc.:
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