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

Brief 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.

Condition or disease Intervention/treatment Phase
Hypogonadism Drug: ARD-0403 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : October 2007
Estimated Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Drug: ARD-0403
    Daily transdermal ARD-0403

Primary Outcome Measures :
  1. Efficacy [ Time Frame: Study Duration ]

Secondary Outcome Measures :
  1. Safety and Tolerability [ Time Frame: Study Duration ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00562731

United States, Alabama
Medical Affiliated Research Center, Inc
Huntsville, Alabama, United States, 35801
United States, California
Stanford University
Stanford, California, United States, 94305-5826
Harbor-UCLA Medical Center
Torrance, California, United States, 90502
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611-3008
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27706
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
dgd Research
San Antonio, Texas, United States, 78229-4801
United States, Washington
VA Puget Sound Health Care System
Seattle, Washington, United States, 98493
Sponsors and Collaborators
Ardana Bioscience Ltd
Principal Investigator: R Swerdloff University of California, Los Angeles Identifier: NCT00562731     History of Changes
Other Study ID Numbers: ARD-0403-010
First Posted: November 22, 2007    Key Record Dates
Last Update Posted: April 1, 2008
Last Verified: March 2008

Additional relevant MeSH terms:
Gonadal Disorders
Endocrine System Diseases
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents