MedDataX Logo

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

NCT ID: NCT00448955

Last Updated: 2008-04-18

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2008-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypogonadism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ARD-0403

ARD-0403

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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%
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ardana Bioscience Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ardana Bioscience Ltd.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medical Affiliated Research Center, Inc

Huntsville, Alabama, United States

Site Status

Stanford University

Stanford, California, United States

Site Status

Los Angeles Biomedical Research Institute at Harbor-UCLA

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

Michael E. Debakey VAMC

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

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ARD-0403-004

Identifier Type: -

Identifier Source: org_study_id