Open-Label Study of ARD-0403 in Testosterone Deficient Men
A Phase III Open-Label Study of the Efficacy and Safety of ARD-0403, a Testosterone Cream, in Testosterone Deficient Men
1 other identifier
interventional
150
1 country
12
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2007
Shorter than P25 for phase_3
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 16, 2007
CompletedFirst Posted
Study publicly available on registry
March 19, 2007
CompletedStudy Start
First participant enrolled
May 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedApril 18, 2008
April 1, 2008
9 months
March 16, 2007
April 17, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
Pharmacokinetic
Secondary Outcomes (1)
Safety and tolerability
Interventions
ARD-0403
Eligibility Criteria
You may qualify if:
- Testosterone deficiency
You may not qualify if:
- Previous treatment with testosterone replacement therapy within 4 weeks
- Moderate-severe benign prostatic hypertrophy, or prostatic cancer
- Haematocrit \>50%
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 16, 2007
First Posted
March 19, 2007
Study Start
May 1, 2007
Primary Completion
February 1, 2008
Study Completion
February 1, 2008
Last Updated
April 18, 2008
Record last verified: 2008-04