Status: Recruiting
52 Week Study + 24-Month Long-Term Extension of Safety, PK, & Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents With Hypogonadism
This is a 52-week open label single arm study + 24-Month long-term safety extension to investigate the effects of XYOSTED, as testosterone replacement therapy, on adolescent males with either primary or secondary hypogonadism. The study aims to determine the effectiveness of XYOSTED measured by continuation or induction of puberty in addition to XYOSTED dosage, safety and testosterone levels.
Participants needed: 100
Trial details
Phase: Phase 3Age: 12-17Biological sex: MaleType: InterventionalSponsor: Halozyme TherapeuticsUpdated: Feb 18, 2026Locations: 20
Eligibility criteria
Diagnosed with a deficiency or absence of endogenous testosterone due to primary... [+9]
Has abnormal thyroid function tests at Screening. May supplement per usual clini... [+23]