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

This study has been terminated.
(Company strategic decision)
Sponsor:
Information provided by:
Ardana Bioscience Ltd
ClinicalTrials.gov Identifier:
NCT00562731
First received: November 21, 2007
Last updated: March 28, 2008
Last verified: March 2008
  Purpose

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 Intervention Phase
Hypogonadism
Drug: ARD-0403
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Ardana Bioscience Ltd:

Primary Outcome Measures:
  • Efficacy [ Time Frame: Study Duration ]

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

Estimated Enrollment: 150
Study Start Date: October 2007
Estimated Study Completion Date: June 2008
Intervention Details:
    Drug: ARD-0403
    Daily transdermal ARD-0403
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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%
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00562731

Locations
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
Investigators
Principal Investigator: R Swerdloff University of California, Los Angeles
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00562731     History of Changes
Other Study ID Numbers: ARD-0403-010
Study First Received: November 21, 2007
Last Updated: March 28, 2008
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 27, 2014