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

This study has been completed.
Sponsor:
Information provided by:
Ardana Bioscience Ltd
ClinicalTrials.gov Identifier:
NCT00448955
First received: March 16, 2007
Last updated: April 17, 2008
Last verified: April 2008
  Purpose

Male hypogonadism, a disorder associated with testosterone deficiency, is frequently seen in clinical practice and has significant effects on patient wellbeing. 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 Study of the Efficacy and Safety of ARD-0403, a Testosterone Cream, in Testosterone Deficient Men

Resource links provided by NLM:


Further study details as provided by Ardana Bioscience Ltd:

Primary Outcome Measures:
  • Pharmacokinetic

Secondary Outcome Measures:
  • Safety and tolerability

Estimated Enrollment: 150
Study Start Date: May 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: ARD-0403
    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

Exclusion Criteria:

  • Previous treatment with testosterone replacement therapy within 4 weeks
  • Moderate-severe benign prostatic hypertrophy, or prostatic cancer
  • Haematocrit >50%
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00448955

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
Los Angeles Biomedical Research Institute at Harbor-UCLA
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
Michael E. Debakey VAMC
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
  More Information

No publications provided

Responsible Party: Ardana Bioscience Ltd.
ClinicalTrials.gov Identifier: NCT00448955     History of Changes
Other Study ID Numbers: ARD-0403-004
Study First Received: March 16, 2007
Last Updated: April 17, 2008
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 22, 2014