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Pharmacokinetic Study of Testosterone Enanthate

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01887418
First Posted: June 26, 2013
Last Update Posted: October 21, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Antares Pharma Inc.
  Purpose
Relative Bioavailability and Safety comparison of 3 formulations of Testosterone Enanthate.

Condition Intervention 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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Antares Pharma Inc.:

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 [ 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

  • 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

  • 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:
  • 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


Enrollment: 39
Study Start Date: September 2013
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
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
United States, Massachusetts
Mens Health Boston
Brookline, Massachusetts, United States, 02445
Sponsors and Collaborators
Antares Pharma Inc.
Investigators
Principal Investigator: Gary Bedel, MD Prestige Clinical Research
  More Information

Responsible Party: Antares Pharma Inc.
ClinicalTrials.gov Identifier: NCT01887418     History of Changes
Other Study ID Numbers: QST-13-002
First Submitted: June 17, 2013
First Posted: June 26, 2013
Results First Submitted: July 20, 2015
Results First Posted: October 21, 2015
Last Update Posted: October 21, 2015
Last Verified: September 2015

Keywords provided by Antares Pharma Inc.:
Hypogonadism
Testosterone enanthate

Additional relevant MeSH terms:
Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents