Phase 3 N=133 Treatment

Subcutaneous Testosterone Enanthate Safety in Adult Men Diagnosed With Hypogonadism

Hypogonadism

Bottom Line

View on ClinicalTrials.gov: NCT02504541 ↗

Enrolled (actual)

133

Serious AEs

3.0%

Results posted

Mar 2018

Primary outcome: Primary: Incidence of Adverse Events as a Measure of Safety of QuickShot™ Testosterone (QST) Administered Subcutaneously (SC) Once Each Week to Adult Males With Hypogonadism — 87; 34; 4; 8 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Testosterone enanthate auto-injector (Combination_product)
Age: Adult, Older Adult · 18+ yrs
Sex: Male
Sponsor: Antares Pharma Inc.
Primary completion: Jun 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Incidence of Adverse Events as a Measure of Safety of QuickShot™ Testosterone (QST) Administered Subcutaneously (SC) Once Each Week to Adult Males With Hypogonadism	87; 34; 4; 8; 4	—

Summary

Evaluation of safety of a concentration controlled testosterone enanthate QuickShot Testosterone regimen administered subcutaneously once each week to adult males with hypogonadism.

Eligibility Criteria

Inclusion Criteria

Adult men ≥18 and ≤75 years of age with a documented history of hypogonadism
Total testosterone levels 50 mL of blood or plasma within 3 months of screening.
Donation of plasma or blood during study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02504541). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.