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

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.

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Key information

Conditions

Hypogonadism Endocrine System Diseases Gonadal Disorders

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Medical Affiliated Research Center, Inc, Huntsville, Alabama, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

ARD-0403

Drug

ARD-0403

Primary outcomes

Pharmacokinetic

Secondary outcomes

Safety and tolerability

Sponsors and collaborators

Lead sponsor

Ardana Bioscience Ltd

Industry

Registry information

Official study title

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

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2008
First posted: Mar 19, 2007
Registry last updated: Apr 18, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed