52 Week Study + 24-Month Long-Term Extension of Safety, PK, & Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents With Hypogonadism

Part of paid clinical trials in Los Angeles, California.

Sponsor
Halozyme Therapeutics
Study ID
NCT06689085
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Hypogonadism, Male

Eligibility Criteria

Sex
MALE
Age
12 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Testosterone enanthate — COMBINATION_PRODUCT
    XYOSTED 25 mg / 0.5 mL; XYOSTED 50 mg / 0.5 mL; XYOSTED 75 mg / 0.5 mL; XYOSTED 100 mg / 0.5 mL

Study Details

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.

Key Dates

Start date
Mar 7, 2025
Status verified
Feb 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2030

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Participants
    XYOSTED Injection (Testosterone enanthate) 25 mg / 0.5 mL, 50 mg / 0.5 mL, 75 mg / 0.5 mL, 100 mg / 0.5 mL

Primary Outcome Measure

Increase in testosterone, as evaluated using PK parameters [ Time Frame: From Enrollment through End of Study Assessments at Week 53 ]

Central Contacts

Locations (20)

FacilityCityStateZIPSite coordinators
Children's Hospital Los AngelesLos AngelesCalifornia90027-
Rady Children's Hospital - San DiegoSan DiegoCalifornia92123-
University of California San FranciscoSan FranciscoCalifornia94143-
Children's Hospital ColoradoAuroraColorado80045-
Nemours Children's Specialty Care - JacksonvilleJacksonvilleFlorida32207-
Ann & Robert H. Lurie Children's Hospital of ChicagoChicagoIllinois60611-
Boston Children's HospitalBostonMassachusetts02115-
University of Massachusetts Memorial Medical CenterWorcesterMassachusetts01655-
M Health Fairview U MinnesotaMinneapolisMinnesota55454-
Washington University School of Medicine in St. LouisSt LouisMissouri63110-
The DOCSLas VegasNevada89113-
Children's Hospital at MontefioreThe BronxNew York10467-
OUHSC Pediatric Diabetes & EndocrinologyOklahoma CityOklahoma73104-
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-
Prisma Health Children's Hospital - MidlandsColumbiaSouth Carolina29203-
MedResearchEl PasoTexas79902-
Texas Children's HospitalHoustonTexas77030-
Primary Children's HospitalSalt Lake CityUtah84112-
Seattle Children's HospitalSeattleWashington98105-
MultiCare Institute for Research & InnovationTacomaWashington98405-

Find similar trials in Los Angeles, CA

By research site
Children's Hospital Los Angeles· Los Angeles, CARady Children's Hospital - San Diego· San Diego, CAUniversity of California San Francisco· San Francisco, CAChildren's Hospital Colorado· Aurora, CONemours Children's Specialty Care - Jacksonville· Jacksonville, FLAnn & Robert H. Lurie Children's Hospital of Chicago· Chicago, IL

Related Studies