52 Week Study + 24-Month Long-Term Extension of Safety, PK, & Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents With Hypogonadism (NCT06689085)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Children's Hospital Los Angeles — Los Angeles, California
Age range: 12 Years to 17 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (20 Sites)
- Children's Hospital Los Angeles — Los Angeles, California
- Rady Children's Hospital - San Diego — San Diego, California
- University of California San Francisco — San Francisco, California
- Children's Hospital Colorado — Aurora, Colorado
- Nemours Children's Specialty Care - Jacksonville — Jacksonville, Florida
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois
- Boston Children's Hospital — Boston, Massachusetts
- University of Massachusetts Memorial Medical Center — Worcester, Massachusetts
- M Health Fairview U Minnesota — Minneapolis, Minnesota
- Washington University School of Medicine in St. Louis — St Louis, Missouri
- The DOCS — Las Vegas, Nevada
- Children's Hospital at Montefiore — The Bronx, New York
- OUHSC Pediatric Diabetes & Endocrinology — Oklahoma City, Oklahoma
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania
- Prisma Health Children's Hospital - Midlands — Columbia, South Carolina
- MedResearch — El Paso, Texas
- Texas Children's Hospital — Houston, Texas
- Primary Children's Hospital — Salt Lake City, Utah
- Seattle Children's Hospital — Seattle, Washington
- MultiCare Institute for Research & Innovation — Tacoma, Washington
📞 Contact the Study Coordinator
Phone: (609) 331-1670
Email: jbitsura@halozyme.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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Explore by condition: All Hypogonadism, Male clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.