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

March 28, 2008 updated by: Ardana Bioscience Ltd

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Medical Affiliated Research Center, Inc
    • California
      • Stanford, California, United States, 94305-5826
        • Stanford University
      • Torrance, California, United States, 90502
        • Harbor-UCLA Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60611-3008
        • Northwestern University
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • North Carolina
      • Durham, North Carolina, United States, 27706
        • Duke University Medical Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • San Antonio, Texas, United States, 78229-4801
        • DGD Research
    • Washington
      • Seattle, Washington, United States, 98493
        • VA Puget Sound Health Care System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy
Time Frame: Study Duration
Study Duration

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety and Tolerability
Time Frame: Study Duration
Study Duration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ardana Bioscience Ltd

Investigators

  • Principal Investigator: R Swerdloff, University of California, Los Angeles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Study Completion (Anticipated)

June 1, 2008

Study Registration Dates

First Submitted

November 21, 2007

First Submitted That Met QC Criteria

November 21, 2007

First Posted (Estimate)

November 22, 2007

Study Record Updates

Last Update Posted (Estimate)

April 1, 2008

Last Update Submitted That Met QC Criteria

March 28, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARD-0403-010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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