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CompletedNCT00448955Updated Apr 18, 2008

Open-Label Study of ARD-0403 in Testosterone Deficient Men

A Phase 3 interventional study of ARD-0403 in Hypogonadism, sponsored by Ardana Bioscience Ltd. Completed at 12 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-04-18.

Sponsored by Ardana Bioscience Ltd · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
150
Allocation
Non-randomized
Ages
18 Years and older
Sex
Male
01

Study summary

Male hypogonadism, a disorder associated with testosterone deficiency, is frequently seen in clinical practice and has significant effects on patient wellbeing. The purpose of this study is to investigate the efficacy and safety of ARD-0403 as a testosterone replacement therapy in testosterone deficient men.

02

Conditions studied

  • Hypogonadism

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03

In context

Hypogonadism

345 studies on the registry are indexed under Hypogonadism; 43 are open to participants now.

This study's planned enrollment of 150 is above the median of 56 across 260 interventional studies indexed under Hypogonadism.

Browse Hypogonadism studies →

Lead sponsor

Ardana Bioscience Ltd is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • Testosterone deficiency

Exclusion criteria

Exclusion Criteria:

  • Previous treatment with testosterone replacement therapy within 4 weeks
  • Moderate-severe benign prostatic hypertrophy, or prostatic cancer
  • Haematocrit >50%
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants (estimated)

Interventions

  • DrugARD-0403

    ARD-0403

06

What researchers measure

Primary outcomes

  1. Pharmacokinetic

Secondary outcomes

  1. Safety and tolerability

07

Study locations

12 sites
  • Medical Affiliated Research Center, Inc
    Huntsville, Alabama 35801, United States
  • Stanford University
    Stanford, California 94305-5826, United States
  • Los Angeles Biomedical Research Institute at Harbor-UCLA
    Torrance, California 90502, United States
  • Northwestern University
    Chicago, Illinois 60611-3008, United States
  • Johns Hopkins University
    Baltimore, Maryland 21287, United States
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • Duke University Medical Center
    Durham, North Carolina 27706, United States
  • Oregon Health and Science University
    Portland, Oregon 97239, United States
  • Hospital of the University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
  • Michael E. Debakey VAMC
    Houston, Texas 77030, United States
  • dgd Research
    San Antonio, Texas 78229-4801, United States
  • VA Puget Sound Health Care System
    Seattle, Washington 98493, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00448955
Lead sponsor
Ardana Bioscience Ltd
First posted
Mar 19, 2007
Start date
May 2007
Primary completion
Feb 2008
Completion
Feb 2008
Last update
Apr 18, 2008
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2008. You cannot join it, but the record below documents what was studied.

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