Pharmacokinetic Study of Testosterone Enanthate

December 13, 2017 updated by: Antares Pharma Inc.

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

Relative Bioavailability and Safety comparison of 3 formulations of Testosterone Enanthate.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Brookline, Massachusetts, United States, 02445
        • Mens Health Boston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
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
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
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
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
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
0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Antares Pharma Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (ACTUAL)

January 1, 2014

Study Completion (ACTUAL)

January 1, 2014

Study Registration Dates

First Submitted

June 17, 2013

First Submitted That Met QC Criteria

June 24, 2013

First Posted (ESTIMATE)

June 26, 2013

Study Record Updates

Last Update Posted (ACTUAL)

January 11, 2018

Last Update Submitted That Met QC Criteria

December 13, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QST-13-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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