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Pharmacokinetic Study of Testosterone Enanthate

Information source: Antares Pharma Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypogonadism

Intervention: QuickShot™ and testosterone enanthate- combination B (Drug); QuickShot™ and testosterone enanthate- combination A (Drug); Delatestryl/needle/syringe (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: Antares Pharma Inc.

Official(s) and/or principal investigator(s):
Gary Bedel, MD, Principal Investigator, Affiliation: Prestige Clinical Research


Relative bioavailability and safety comparison of 3 formulations of testosterone enanthate.

Clinical Details

Official title: 3 Arm, Open-label, Randomized, Multidose Parallel Group Study of Pharmacokinetics, Safety, and Tolerability of Two Dose Levels of a Formulation of Testosterone Enanthate in a Device or Needle and Syringe in Hypogonadal Adult Male

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Relative bioavailability of testosterone enanthate formulations

Secondary outcome: Safety and tolerability

Detailed description: Standard pharmacokinetic analyses of blood concentration data for serum testosterone, dihydrotestosterone and estradiol comparing, Cmax, area under the concentration time curve, and average blood concentration to facilitate the comparison of the relative bioavailability of the treatment and control arms. Safety comparisons will be based upon the occurrence, severity and rate of treatment emergent adverse events and measurement of standard safety laboratory parameters, as well as assessment of the frequency and severity of any derangements of laboratory parameters.


Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Male.


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

Locations and Contacts

Mens Health Boston, Brookline, Massachusetts 02445, United States
Additional Information

Starting date: September 2013
Last updated: June 6, 2014

Page last updated: August 23, 2015

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