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NCT06689085 · ClinicalTrials.gov registry record · Phase 3
52 Week Study + 24-Month Long-Term Extension of Safety, PK, & Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents With Hypogonadism
A Phase 3 study of Hypogonadism, Male, sponsored by Halozyme Therapeutics.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 100
- Enrollment target
- 20
- Study locations
NCT06689085: Recruiting Phase 3 study of Hypogonadism, Male, sponsored by Halozyme Therapeutics.
NCT06689085 is a Phase 3 study of Hypogonadism, Male that is actively recruiting participants, run by Halozyme Therapeutics. The registered enrollment target is 100 participants, roughly in line with the 104-participant average among 12 other Hypogonadism, Male trials with a reported enrollment target. The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06689085, a Phase 3 study of Hypogonadism, Male, is actively recruiting participants, sponsored by Halozyme Therapeutics.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 100 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- COMBINATION_PRODUCT Testosterone enanthate
Study Locations (20)
California
- Children's Hospital Los Angeles - Los Angeles
- Rady Children's Hospital - San Diego - San Diego
- University of California San Francisco - San Francisco
Massachusetts
- Boston Children's Hospital - Boston
- University of Massachusetts Memorial Medical Center - Worcester
Texas
- MedResearch - El Paso
- Texas Children's Hospital - Houston
Washington
- Seattle Children's Hospital - Seattle
- MultiCare Institute for Research & Innovation - Tacoma
Colorado
- Children's Hospital Colorado - Aurora
Florida
- Nemours Children's Specialty Care - Jacksonville - Jacksonville
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
Minnesota
- M Health Fairview U Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2025-03-07 |
| Est. Completion | 2030-03 |
| Phase | Phase 3 |
What NCT06689085 shows while recruiting
NCT06689085 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 104-participant average among 12 other Hypogonadism, Male trials with a reported enrollment target.
The record links to 1 condition, with Hypogonadism, Male appearing as the primary indexed condition, and to 1 intervention - of which Testosterone enanthate is the first listed.
NCT06689085 names 20 study sites across 15 states, led by California, Massachusetts, Texas.
Frequently Asked Questions
What is clinical trial NCT06689085 about?
NCT06689085 is a clinical study titled "52 Week Study + 24-Month Long-Term Extension of Safety, PK, & Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents With Hypogonadism". 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 con...
What is the current status of trial NCT06689085?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 100 participants. The study started on 2025-03-07. Estimated completion is 2030-03.
What conditions does trial NCT06689085 study?
This clinical trial studies the following conditions: Hypogonadism, Male.
What interventions are being tested in trial NCT06689085?
The interventions under investigation include: Testosterone enanthate (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT06689085?
This trial is sponsored by Halozyme Therapeutics, which has 31 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06689085 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hypogonadism, Male
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06689085's enrollment target sits among peer trials
100 7th of 12 higher than 6 of 12 other Hypogonadism, Male trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypogonadism, Male trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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