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NCT00562731 Clinical Trial

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

Hypogonadism Clinical Trial

— ARD-0403-010  

Official title:
A Phase III, Open-Label Follow-on Study for Long-Term Safety and Efficacy of Testosterone Cream, in Testosterone Deficinet Men Completing Study ARD-0403-004

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00562731
Other study ID # ARD-0403-010
Secondary ID
Status Terminated
Phase Phase 3
First received November 21, 2007
Last updated March 28, 2008
Start date October 2007
Est. completion date June 2008

Study information
Verified date March 2008
Source Ardana Bioscience Ltd
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 150
Est. completion date June 2008
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Testosterone deficiency

- Completed study ARD-0403-004

Exclusion Criteria:

- Previous treatment with testosterone replacement therapy within 4 weeks

- Moderate-severe benign prostatic hypertrophy or prostatic cancer

- Haematocrit >50%

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• ARD-0403
Daily transdermal ARD-0403

Locations
Country Name City State
United States Johns Hopkins University Baltimore Maryland
United States Massachusetts General Hospital Boston Massachusetts
United States Northwestern University Chicago Illinois
United States Duke University Medical Center Durham North Carolina
United States Baylor College of Medicine Houston Texas
United States Medical Affiliated Research Center, Inc Huntsville Alabama
United States Hospital of the University of Pennsylvania Philadelphia Pennsylvania
United States Oregon Health and Science University Portland Oregon
United States dgd Research San Antonio Texas
United States VA Puget Sound Health Care System Seattle Washington
United States Stanford University Stanford California
United States Harbor-UCLA Medical Center Torrance California

Sponsors (1)
Lead Sponsor Collaborator
Ardana Bioscience Ltd

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Efficacy Study Duration
Secondary Safety and Tolerability Study Duration
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