Pharmacokinetic Study of Testosterone Enanthate

Hypogonadism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01887418
• Other study ID #: QST-13-002
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 17, 2013
• Last updated: December 13, 2017
• Start date: September 2013
• Est. completion date: January 2014

Study information

• Verified date: December 2017
• Source: Antares Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypogonadism

Intervention

Drug:
• QuickShot™ - 50 mg Treatment B
QuickShot™ for the delivery of testosterone
• QuickShot™ - 100 mg Treatment A
QuickShot™ for the delivery of testosterone
• Delatestryl 200 mg IM Treatment C
Standard of care

Locations

Country	Name	City	State
United States	Mens Health Boston	Brookline	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Antares Pharma Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of Testosterone Enanthate Formulations 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
Primary	The Maximum Plasma Concentration [Cmax] of Testosterone Enanthate Formulations 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
Primary	The Average Concentration [Cavg] of Testosterone Enanthate Formulations 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	Number of Patients in the PK Parameter Category	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