Study Details
Testing the Drug XYOSTED for Testosterone Replacement in Male Adolescents
(IRB#: IRB_00186047)
This study will test a drug called XYOSTED for testosterone (hormone) replacement in males aged 12 to 18 years old. The study wants to see if the drug will help this specific male age group with the condition and is safe. People in the study will be treated with one of two specific doses of XYOSTED. Being in the study requires up to 23 study visits over 52 weeks. Medical tests will be done during the study to track the health of participants.
- Male Only
- Over 7 years old
- Volunteers with special conditions
- In Person
- Paid
Who can participate?
Gender: Male Only
Age: Over 7 years old
Volunteers: Volunteers with special conditions
Location: In Person
Inclusion Criteria
- Any prior testosterone treatment being received must be at a stable dose for at least 12 weeks before participation
- Must receive chronic pharmacologic support for the initiation and/or continuation of pubertal maturation
- Specific body mass requirements
- Must use 2 specific forms of highly effective birth control during the study and for 30 days after the last treatment
- Able to attend in person visits at the study clinic
Exclusion Criteria
- Suspected or known constitutional growth delay in growth and puberty (CDGP)
- Evidence of a possible nutritional or gastrointestinal disorder that may impact growth such as abrupt weight loss within the 3 months prior to screening, unmanaged celiac disease, inflammatory bowel disease
- Currently receiving testosterone through a transdermal patch or gel in the 12 weeks before participation
- Allergy to foods or products containing sesame seeds or sesame oil
- Currently receiving antipsychotic and/or selective serotonin reuptake inhibitor (SSRI) medications
Will I be paid for my time?
Yes
IRB#: IRB_00186047
PI: Zoe Raleigh
Department: PEDIATRIC EDUCATION
Approval Date: 2025-10-08 06:00:00
Specialties: Pediatric Endocrinology & Metabolism
I am Interested