NCT02159469 (STEADY) is a Phase 3 clinical trial of Testosterone enanthate auto-injector in Hypogonadism, sponsored by Antares Pharma Inc..

Who is sponsoring NCT02159469?

NCT02159469 is sponsored by Antares Pharma Inc..

What drugs are being tested in NCT02159469?

Interventions in NCT02159469: Testosterone enanthate auto-injector.

What condition does NCT02159469 study?

NCT02159469 studies Hypogonadism.

Is NCT02159469 still recruiting?

NCT02159469 is currently completed. Last updated 11 January 2018.

Are results published for NCT02159469?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-01-11 · How we verify

NCT02159469: STEADY

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Multiple-dose, 52-week Study to Evaluate the Efficacy and Safety of Testosterone Enanthate Administered Subcutaneously Once Each Week to Adult Males With Hypogonadism

Completed Phase 3 Results posted Last updated 11 January 2018

What this trial tests

Phase 3 trial testing Testosterone enanthate auto-injector in Hypogonadism in 150 participants. Completed in 1 November 2015.

Timeline

1 July 2014

Primary endpoint
1 February 2015

1 November 2015

Quick facts

Lead sponsor	Antares Pharma Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	150
Start date	1 July 2014
Primary completion	1 February 2015
Estimated completion	1 November 2015
Sites	28 locations across United States

Drugs / interventions tested

Testosterone enanthate auto-injector

Conditions studied

Hypogonadism — all drugs for Hypogonadism →

Sponsor

Antares Pharma Inc. — full company profile →

Who can join

18 and older, male only, with Hypogonadism. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Percentage of Patients With Total Testosterone Cavg(0-168h) Serum Concentrations Within the Normal Range (300-1100 ng/dL)
Time frame: 12 weeks
The primary objective of this study was to demonstrate the efficacy of QST (QuickShot Testosterone) administered subcutaneously once each week to adult males with hypogonadism.

Sponsor's own description

Evaluation of efficacy and safety of testosterone enanthate administered subcutaneously using an auto-injector

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

MON-212 Genetic Spectrum Of A Canadian Cohort Of Sporadic Pheochromocytomas And Paragangliomas: Higher Prevalence Of Germline Mutations In PGL And NGS Assay With A Multigene Panel Increases The Mutation Rate
Salle S, Dumas N, Jolin J, Nolet S, et al · · 2020
SUN-928 Adrenal Plasmacytoma in Multiple Myeloma Patient-An Unusual Presentation
Mathew J, Lubitz S, Zaidan J. · · 2020
SAT-037 Effect of Weight on Serum Testosterone with Subcutaneous Testosterone Enanthate in Men with Testosterone Deficiency
Bhattacharya R, Tursi J, Jaffe J. · · 2020

Verify or expand the search:

Other recruiting trials for Hypogonadism

Currently open trials in the same condition.

NCT06455969 — Adaptions and Resiliency to Multi-Stressor OpeRations · Phase 4 · recruiting
NCT06280807 — Observation of Environment and Reproductive-Endocrine Effects · recruiting
NCT04460872 — Locomotor Training With Testosterone to Promote Bone and Muscle Health After Spinal Cord Injury · Phase 2 · recruiting
NCT04731376 — Perioperative Testosterone Replacement Therapy for the Improvement of Post-Operative Outcomes in Patients With Low Testo · Phase 1 · active not recruiting
NCT03887936 — Testosterone Therapy and Bone Quality in Men With Diabetes and Hypogonadism · Phase 4 · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02159469 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Antares Pharma Inc.
Last refreshed: 11 January 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02159469.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing