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Completed

NCT Number: NCT01887418

Pharmacokinetic Study of Testosterone Enanthate

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

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Key information

Conditions

Hypogonadism Endocrine System Diseases Gonadal Disorders

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Mens Health Boston

Brookline, Massachusetts, 02445, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

QuickShot™ - 50 mg Treatment B

Drug

QuickShot™ for the delivery of testosterone

Other names: Testosterone, Testosterone enanthate

QuickShot™ - 100 mg Treatment A

Drug

QuickShot™ for the delivery of testosterone

Other names: Testosterone, Testosterone enanthate

Delatestryl 200 mg IM Treatment C

Drug

Standard of care

Other names: Testosterone, Testosterone enanthate

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Antares Pharma Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 26, 2013
Registry last updated
Jan 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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