Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 3

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

NCT06689085 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 100 participants
Start Date 2025-03-07
Est. Completion 2030-03
Phase Phase 3

Sponsor

Halozyme Therapeutics

13 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06689085

The ClinicalTrials.gov registry entry for NCT06689085 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Halozyme Therapeutics, which has 13 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06689085 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, Massachusetts, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06689085?

The interventions under investigation include: Testosterone enanthate (COMBINATION_PRODUCT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06689085?

This trial is sponsored by Halozyme Therapeutics, which has 13 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial