A Study of XYOSTED® for Testosterone Replacement in Male Adolescents With Conditions Associated with Deficiency or Absence of Endogenous Test

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)

Phase 3/4, open-label, multicenter study in approximately 100 males 12 to <18 years of age with primary or secondary hypogonadism (congenital or acquired)

Study Goal(s):

• 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 of XYOSTED Q4W, Q2W and Q1W in males 12 to < 18 years of age
• To evaluate XYOSTED for both induction and continuation of puberty in pediatric males 12 to <18 years of age with primary or secondary hypogonadism

Eligibility Criteria:

• Deficiency or absence of endogenous testosterone due to primary or secondary hypogonadism of a known etiology. Children with combined hormone deficiencies ok to enroll, if already receiving treatment for concomitant hormonal deficiencies
• Participants on prior testosterone treatment must be receiving a stable dose for ≥12 weeks prior to Screening. Treatment-naïve participants permitted to enroll.
• Parent(s) or a legal guardian will voluntarily provide written informed consent for child to participate & child willing to provide assent 
• Male 12 to < 18 years of age at the time of consent/assent
• Parent(s) or a legal guardian able to understand and comply with all study procedures as outlined in the protocol
• Requires chronic pharmacologic support for initiation and/or continuation of pubertal maturation
• BMI-for-age > the 5th percentile and weigh ≥ 30 kg
• Agrees to practice true abstinence (including 30 days after the last Xyosted administration, or use 2 adequate forms of highly effective contraception (one should be a physical barrier) during the study and for 30 days after the last Xyosted administration (If sexually active with a female partner of child-bearing potential)