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

NCT ID: NCT00562731

Last Updated: 2008-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hypogonadism

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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ARD-0403

Daily transdermal ARD-0403

Intervention Type DRUG

Eligibility Criteria

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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%
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Ardana Bioscience Ltd

INDUSTRY

Sponsor Role lead

Principal Investigators

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R Swerdloff

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

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Medical Affiliated Research Center, Inc

Huntsville, Alabama, United States

Site Status

Stanford University

Stanford, California, United States

Site Status

Harbor-UCLA Medical Center

Torrance, California, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Oregon Health and Science University

Portland, Oregon, United States

Site Status

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Baylor College of Medicine

Houston, Texas, United States

Site Status

dgd Research

San Antonio, Texas, United States

Site Status

VA Puget Sound Health Care System

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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ARD-0403-010

Identifier Type: -

Identifier Source: org_study_id