XYOSTED for Adolescent Male Hypogonadism

This study is testing XYOSTED, a testosterone replacement therapy, in adolescent males aged 12 to 17 who have hypogonadism (when the body doesn't produce enough testosterone). The study will last for 52 weeks, with a possible 24-month extension to continue looking at safety. Researchers want to see how well XYOSTED helps with puberty, what the right dose is, and how safe it is. To join, you must have been diagnosed with hypogonadism. The study is currently recruiting about 100 participants, but its overall status is unclear.

Study design
This is a Phase 3/4, open-label, single-arm study involving approximately 100 participants. There is no comparison group receiving a different treatment.
What's involved
Participants will have a screening period, then receive XYOSTED with dose adjustments based on weight and puberty stage. Blood tests will be done regularly to check testosterone levels.
Compensation
Not stated in the trial record.
Follow-up
The primary goal is to evaluate testosterone levels from enrollment through the end of study assessments at Week 53, with a potential 24-month long-term safety extension.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06689085

52 Week Study + 24-Month Long-Term Extension of Safety, PK, & Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents With Hypogonadism

Recruiting
PHASE3Ages 12–17InterventionalTreatment
Halozyme Therapeutics
~100 participants
Updated 2026-02-18 on ClinicalTrials.gov
What's tested:Testosterone enanthate

At a glance

Recruiting sites
20 of 20 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Increase in testosterone, as evaluated using PK parameters
Measured over From Enrollment through End of Study Assessments at Week 53
Hypogonadism, Male
20 sites across 15 states
California3
Massachusetts2
Texas2
Washington2
Colorado1
Florida1
Illinois1
Minnesota1
Director Clinical Operations, MPH, CPM
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  • Increase in testosterone, as evaluated using PK parametersFrom Enrollment through End of Study Assessments at Week 53