Open-Label, Multiple-Dose, 52-Week Study + 24-Month Long-Term Safety Extension to Evaluate the Safety, PK, & Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents With Deficiency or Absence of Endogenous Testosterone Due to Primary or Secondary Hypogonadism
Halozyme Therapeutics
Summary
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.
Description
This is a 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). Each participant will be screened for eligibility within 28 days before receiving his first dose of study drug on Day 1. During the Screening period, each participant will have a full clinical examination with pubertal staging, including 2 separate serum total testosterone (TT) measurements obtained in the early morning, where the average (Cavg) will be considered baseline value. Each participant will be categorized as having pr…
Eligibility
- Age range
- 12–17 years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: 1. Diagnosed with a deficiency or absence of endogenous testosterone due to primary or secondary hypogonadism of a known etiology. Children with combined hormone deficiencies are permitted to enroll (but the child must already be receiving treatment for concomitant hormonal deficiencies) 2. Participants receiving prior testosterone treatment must be receiving a stable dose for at least 12 weeks prior to Screening. Treatment naive participants are permitted to enroll. 3. Have parent(s) or a legal guardian who will voluntarily provide written informed consent for the child t…
Interventions
- Combination ProductTestosterone enanthate
XYOSTED 25 mg / 0.5 mL; XYOSTED 50 mg / 0.5 mL; XYOSTED 75 mg / 0.5 mL; XYOSTED 100 mg / 0.5 mL
Locations (20)
- Children's Hospital Los AngelesLos Angeles, California
- Rady Children's Hospital - San DiegoSan Diego, California
- University of California San FranciscoSan Francisco, California
- Children's Hospital ColoradoAurora, Colorado
- Nemours Children's Specialty Care - JacksonvilleJacksonville, Florida
- Ann & Robert H. Lurie Children's Hospital of ChicagoChicago, Illinois