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

Hypogonadism Clinical Trial

Official title:

A Phase III Open-Label Study of the Efficacy and Safety of ARD-0403, a Testosterone Cream, in Testosterone Deficient Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00448955
• Other study ID #: ARD-0403-004
• Status: Completed
• Phase: Phase 3
• First received: March 16, 2007
• Last updated: April 17, 2008
• Start date: May 2007
• Est. completion date: February 2008

Study information

• Verified date: April 2008
• Source: Ardana Bioscience Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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%

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypogonadism

Intervention

Drug:
• ARD-0403
ARD-0403

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Northwestern University	Chicago	Illinois
United States	Duke University Medical Center	Durham	North Carolina
United States	Michael E. Debakey VAMC	Houston	Texas
United States	Medical Affiliated Research Center, Inc	Huntsville	Alabama
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Oregon Health and Science University	Portland	Oregon
United States	dgd Research	San Antonio	Texas
United States	VA Puget Sound Health Care System	Seattle	Washington
United States	Stanford University	Stanford	California
United States	Los Angeles Biomedical Research Institute at Harbor-UCLA	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Ardana Bioscience Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic
Secondary	Safety and tolerability