Open-Label Study of ARD-0403 in Testosterone Deficient Men
- Conditions
- Hypogonadism
- Registration Number
- NCT00562731
- Lead Sponsor
- Ardana Bioscience Ltd
- Brief Summary
Male hypogonadism, a disorder associated with testosterone deficiency, is frequently seen in clinical practice and has significant effects on patient well-being. The purpose of this study is to investigate the efficacy and safety of ARD-0403 as a testosterone replacement therapy in testosterone deficient men.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 150
- Testosterone deficiency
- Completed study ARD-0403-004
- Previous treatment with testosterone replacement therapy within 4 weeks
- Moderate-severe benign prostatic hypertrophy or prostatic cancer
- Haematocrit >50%
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Efficacy Study Duration
- Secondary Outcome Measures
Name Time Method Safety and Tolerability Study Duration
Trial Locations
- Locations (12)
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
VA Puget Sound Health Care System
🇺🇸Seattle, Washington, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Harbor-UCLA Medical Center
🇺🇸Torrance, California, United States
Medical Affiliated Research Center, Inc
🇺🇸Huntsville, Alabama, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Stanford University
🇺🇸Stanford, California, United States
dgd Research
🇺🇸San Antonio, Texas, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States