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
Summary
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Male.
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
Locations and Contacts
Mens Health Boston, Brookline, Massachusetts 02445, United States
Additional Information
Starting date: September 2013
Last updated: June 6, 2014
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