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
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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
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
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, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
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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