NCT01887418

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2013

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 26, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

October 21, 2015

Completed
Last Updated

January 11, 2018

Status Verified

December 1, 2017

Enrollment Period

4 months

First QC Date

June 17, 2013

Results QC Date

July 20, 2015

Last Update Submit

December 13, 2017

Conditions

Hypogonadism

Keywords

HypogonadismTestosterone enanthate

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (1)

  • Number of Patients in the PK Parameter Category

    6 weeks

Study Arms (3)

QuickShot™ - 100 mg Treatment A

EXPERIMENTAL

QuickShot™Testosterone - Auto-injector device for SC use

Drug: QuickShot™ - 100 mg Treatment A

QuickShot™ - 50 mg Treatment B

EXPERIMENTAL

QuickShot™Testosterone- Auto-injector device for SC use

Drug: QuickShot™ - 50 mg Treatment B

Delatestryl 200 mg IM Treatment C

ACTIVE COMPARATOR

Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference

Drug: Delatestryl 200 mg IM Treatment C

Interventions

QuickShot™ - 50 mg Treatment BDRUG

QuickShot™ for the delivery of testosterone

Also known as: Testosterone, Testosterone enanthate
QuickShot™ - 50 mg Treatment B
QuickShot™ - 100 mg Treatment ADRUG

QuickShot™ for the delivery of testosterone

Also known as: Testosterone, Testosterone enanthate
QuickShot™ - 100 mg Treatment A
Delatestryl 200 mg IM Treatment CDRUG

Standard of care

Also known as: Testosterone, Testosterone enanthate
Delatestryl 200 mg IM Treatment C

Eligibility Criteria

Age18 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult males aged 18 to 75 with a documented diagnosis of hypogonadism

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mens Health Boston

Brookline, Massachusetts, 02445, United States

Location

MeSH Terms

Conditions

Hypogonadism

Interventions

Testosteronetestosterone enanthate

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

AndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsTestosterone CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

Title
Jonathan Jaffe, MD; Vice President Clinical Development
Organization
Antares Pharma Inc.
jjaffe@antarespharma.com
609-329-3020

Study Officials

  • Gary Bedel, MD

    Prestige Clinical Research

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2013

First Posted

June 26, 2013

Study Start

September 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

January 11, 2018

Results First Posted

October 21, 2015

Record last verified: 2017-12

Locations

US(1)