NCT00562731

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2007

Shorter than P25 for phase_3

Geographic Reach
1 country

12 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 22, 2007

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

April 1, 2008

Status Verified

March 1, 2008

First QC Date

November 21, 2007

Last Update Submit

March 28, 2008

Conditions

Hypogonadism

Outcome Measures

Primary Outcomes (1)

  • Efficacy

    Study Duration

Secondary Outcomes (1)

  • Safety and Tolerability

    Study Duration

Interventions

ARD-0403DRUG

Daily transdermal ARD-0403

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Testosterone deficiency
  • Completed study ARD-0403-004

You may not qualify if:

  • Previous treatment with testosterone replacement therapy within 4 weeks
  • Moderate-severe benign prostatic hypertrophy or prostatic cancer
  • Haematocrit \>50%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Medical Affiliated Research Center, Inc

Huntsville, Alabama, 35801, United States

Location

Stanford University

Stanford, California, 94305-5826, United States

Location

Harbor-UCLA Medical Center

Torrance, California, 90502, United States

Location

Northwestern University

Chicago, Illinois, 60611-3008, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Duke University Medical Center

Durham, North Carolina, 27706, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

dgd Research

San Antonio, Texas, 78229-4801, United States

Location

VA Puget Sound Health Care System

Seattle, Washington, 98493, United States

Location

MeSH Terms

Conditions

Hypogonadism

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System Diseases

Study Officials

  • R Swerdloff

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 21, 2007

First Posted

November 22, 2007

Study Start

October 1, 2007

Study Completion

June 1, 2008

Last Updated

April 1, 2008

Record last verified: 2008-03

Locations

US(12)