drugset / Trial / NCT06689085
52 Week Study + 24-Month Long-Term Extension of Safety, PK, & Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents With Hypogonadism
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2025-03-07
- Primary completion
- 2028-03
- Completion
- 2030-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Testosterone Enanthate | Small molecule | 25 mg | — |
| Subject | Testosterone Enanthate | Small molecule | 50 mg | — |
| Subject | Testosterone Enanthate | Small molecule | 75 mg | — |
| Subject | Testosterone Enanthate | Small molecule | 100 mg | — |