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

Primary Purpose

Hypogonadism

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
ARD-0403
Sponsored by
Ardana Bioscience Ltd
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypogonadism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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%

Sites / Locations

  • Medical Affiliated Research Center, Inc
  • Stanford University
  • Los Angeles Biomedical Research Institute at Harbor-UCLA
  • Northwestern University
  • Johns Hopkins University
  • Massachusetts General Hospital
  • Duke University Medical Center
  • Oregon Health and Science University
  • Hospital of the University of Pennsylvania
  • Michael E. Debakey VAMC
  • dgd Research
  • VA Puget Sound Health Care System

Outcomes

Primary Outcome Measures

Pharmacokinetic

Secondary Outcome Measures

Safety and tolerability

Full Information

First Posted
March 16, 2007
Last Updated
April 17, 2008
Sponsor
Ardana Bioscience Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT00448955
Brief Title
Open-Label Study of ARD-0403 in Testosterone Deficient Men
Official Title
A Phase III Open-Label Study of the Efficacy and Safety of ARD-0403, a Testosterone Cream, in Testosterone Deficient Men
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ardana Bioscience Ltd

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ARD-0403
Intervention Description
ARD-0403
Primary Outcome Measure Information:
Title
Pharmacokinetic
Secondary Outcome Measure Information:
Title
Safety and tolerability

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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%
Facility Information:
Facility Name
Medical Affiliated Research Center, Inc
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5826
Country
United States
Facility Name
Los Angeles Biomedical Research Institute at Harbor-UCLA
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-3008
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27706
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Michael E. Debakey VAMC
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
dgd Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-4801
Country
United States
Facility Name
VA Puget Sound Health Care System
City
Seattle
State/Province
Washington
ZIP/Postal Code
98493
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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