Open-Label Study of ARD-0403 in Testosterone Deficient Men
- Conditions
- Hypogonadism
- Registration Number
- NCT00448955
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 150
- Testosterone deficiency
- 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 Pharmacokinetic
- Secondary Outcome Measures
Name Time Method Safety and tolerability
Trial Locations
- Locations (12)
Medical Affiliated Research Center, Inc
🇺🇸Huntsville, Alabama, United States
Stanford University
🇺🇸Stanford, California, United States
Los Angeles Biomedical Research Institute at Harbor-UCLA
🇺🇸Torrance, California, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Michael E. Debakey VAMC
🇺🇸Houston, Texas, United States
Scroll for more (2 remaining)Medical Affiliated Research Center, Inc🇺🇸Huntsville, Alabama, United States