Actively Recruiting
52 Week Study + 24-Month Long-Term Extension of Safety, PK, & Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents With Hypogonadism
Led by Halozyme Therapeutics · Updated on 2026-02-18
100
Participants Needed
20
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
52 Week Study + 24-Month Long-Term Extension of Safety, PK, & Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents With Hypogonadism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with primary or secondary hypogonadism causing testosterone deficiency
- Stable testosterone treatment for at least 12 weeks prior to screening or treatment-naive
- Male aged 12 to under 18 years at time of consent/assent
- Parent or legal guardian able to provide written informed consent
- Willing to provide assent for study participation
- Requires ongoing pharmacologic support for pubertal maturation
- BMI-for-age above the 5th percentile and weight of at least 30 kg
- If sexually active with female partner of child-bearing potential, agrees to abstinence or use two effective contraception methods during study and 30 days after last dose
- Legally authorized representative able to understand and comply with study procedures
You will not qualify if you...
- Abnormal thyroid function tests at screening
- Suspected or known constitutional delay of growth and puberty
- Nutritional or gastrointestinal disorders affecting growth
- Allergy or hypersensitivity to XYOSTED or its ingredients including sesame oil
- Prior testosterone treatment not stable for at least 12 weeks before screening
- Allergy to sesame seeds or sesame oil
- Stage 1 hypertension or high blood pressure above defined limits
- Significant abnormal lab results including high hematocrit
- History of deep vein thrombosis or pulmonary embolism
- Significant ECG abnormalities
- Suspected or diagnosed pituitary tumors except certain stable cysts or microadenomas
- Active or recent malignancy treatment within 12 months
- Current use of antipsychotic or SSRI medications
- Use of medications or conditions interfering with study safety or evaluation
- History or recent suicidal behavior or ideation
- Use of supraphysiologic systemic glucocorticoids for over 3 weeks
- Recent investigational drug use within one month or five half-lives
- Recent use or need for certain hormone treatments within 12 months
- Use of CYP3A4 or P-gp inhibitors/inducers or substrates within 30 days
- History of alcohol or drug abuse
- Significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, or other conditions
- Chronic urticaria or dermatographism
- Low vitamin D blood level below 20 ng/mL without supplementation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 20 locations
1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
2
Rady Children's Hospital - San Diego
San Diego, California, United States, 92123
Actively Recruiting
3
University of California San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
4
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
5
Nemours Children's Specialty Care - Jacksonville
Jacksonville, Florida, United States, 32207
Actively Recruiting
6
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
7
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
8
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States, 01655
Actively Recruiting
9
M Health Fairview U Minnesota
Minneapolis, Minnesota, United States, 55454
Actively Recruiting
10
Washington University School of Medicine in St. Louis
St Louis, Missouri, United States, 63110
Actively Recruiting
11
The DOCS
Las Vegas, Nevada, United States, 89113
Actively Recruiting
12
Children's Hospital at Montefiore
The Bronx, New York, United States, 10467
Actively Recruiting
13
OUHSC Pediatric Diabetes & Endocrinology
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
14
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
15
Prisma Health Children's Hospital - Midlands
Columbia, South Carolina, United States, 29203
Actively Recruiting
16
MedResearch
El Paso, Texas, United States, 79902
Actively Recruiting
17
Texas Children's Hospital
Houston, Texas, United States, 77030
Actively Recruiting
18
Primary Children's Hospital
Salt Lake City, Utah, United States, 84112
Actively Recruiting
19
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
20
MultiCare Institute for Research & Innovation
Tacoma, Washington, United States, 98405
Actively Recruiting
Research Team
D
Director Clinical Operations, MPH, CPM
CONTACT
C
Chief Medical Officer, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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