Open-Label Study of ARD-0403 in Testosterone Deficient Men
Public ClinicalTrials.gov record NCT00448955. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III Open-Label Study of the Efficacy and Safety of ARD-0403, a Testosterone Cream, in Testosterone Deficient Men
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00448955
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 150 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 30, 2007
- Primary completion
- Jan 31, 2008
- Completion
- Jan 31, 2008
- Last update posted
- Apr 17, 2008
2007 – 2008
United States locations
- U.S. sites
- 12
- U.S. states
- 10
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Medical Affiliated Research Center, Inc | Huntsville | Alabama | 35801 | — |
| Stanford University | Stanford | California | 94305-5826 | — |
| Los Angeles Biomedical Research Institute at Harbor-UCLA | Torrance | California | 90502 | — |
| Northwestern University | Chicago | Illinois | 60611-3008 | — |
| Johns Hopkins University | Baltimore | Maryland | 21287 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Duke University Medical Center | Durham | North Carolina | 27706 | — |
| Oregon Health and Science University | Portland | Oregon | 97239 | — |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Michael E. Debakey VAMC | Houston | Texas | 77030 | — |
| dgd Research | San Antonio | Texas | 78229-4801 | — |
| VA Puget Sound Health Care System | Seattle | Washington | 98493 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00448955, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 17, 2008 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00448955 live on ClinicalTrials.gov.