An Open-Label Multiple-Dose, 52-Week Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents (ages: 12 to <18 years) with Conditions Associated with Deficiency or Absence of Endogenous Testosterone Due to Primary or Secondary Hypogonadism (Congenital or Acquired)
Evaluate the Safety, Pharmacokinetics, and Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents (ages: 12 to <18 years) with Conditions Associated with deficiency or Absence of Endogenous Testosterone Due to Primary or Secondary Hypogonadism (Congenital or Acquired)
Why this Research Matters
The objectives of this study are: - To determine the efficacy of XYOSTED administered at an appropriate dose and interval to permanently hypogonadal adolescent males. - To determine the safety and tolerability of XYOSTED for the continuation of puberty in males 12 to < 18 years of age. - To characterize the pharmacokinetics (PK) of XYOSTED Q4W and Q2W in males 12 to < 18 years of age. - To have evaluation of XYOSTED for both induction and continuation of puberty in pediatric males 12 to < 18 years of age with primary or secondary hypogonadism.
Who can Participate
Male Adolescents (ages: 12 to <18 years) with Conditions Associated with Deficiency or Absence of Endogenous Testosterone Due to Primary or Secondary Hypogonadism (Congenital or Acquired)
Study ID
Protocol Number: 24-1937
Meet the Team
Principal Investigator