Original Query: ALL
Previous Study | Return to List | Next Study

Open-Label Study of ARD-0403 in Testosterone Deficient Men (ARD-0403-010)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00562731
Recruitment Status : Terminated (Company strategic decision)
First Posted : November 22, 2007
Last Update Posted : April 1, 2008
Information provided by:
Ardana Bioscience Ltd

November 21, 2007
November 22, 2007
April 1, 2008
October 2007
Not Provided
Efficacy [ Time Frame: Study Duration ]
Same as current
Complete list of historical versions of study NCT00562731 on Archive Site
Safety and Tolerability [ Time Frame: Study Duration ]
Same as current
Not Provided
Not Provided
Open-Label Study of ARD-0403 in Testosterone Deficient Men
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
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.
Not Provided
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Drug: ARD-0403
Daily transdermal ARD-0403
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2008
Not Provided

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%
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Not Provided
Not Provided
Ardana Bioscience Ltd
Not Provided
Principal Investigator: R Swerdloff University of California, Los Angeles
Ardana Bioscience Ltd
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP