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.
52 Week Study + 24-Month Long-Term Extension of Safety, PK, & Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents With Hypogonadism
At a glance
Conditions
Where it's being run
20 sites across 15 statesWho to contact
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What this trial measures
- Increase in testosterone, as evaluated using PK parametersFrom Enrollment through End of Study Assessments at Week 53