Pharmacokinetics of Testosterone Lotion in the Treatment of Hypogonadal Males

Testosterone replacement treatment is the most effective way of treating hypogonadism in men. Acrux has a proprietry testosterone replacement product - Testosterone-MD Lotion, and this study will evaluate the efficacy and safety of this product.

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Key information

Conditions

Hypogonadism Endocrine System Diseases Gonadal Disorders

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Birmingham, Alabama, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Hypogonadal males between 18-70 years old with qualifying general medical health

Exclusion criteria

Disqualifying concurrent conditions or allergy/sensitivity to testosterone replacement therapy

Treatment and study plan

Testosterone

Drug

Primary outcomes

Pharmacokinetic

Secondary outcomes

Safety and tolerability

Sponsors and collaborators

Lead sponsor

Acrux DDS Pty Ltd

Industry

Registry information

Official study title

A Phase II Randomised, Two-Way Crossover Study to Compare the Steady State Pharmacokinetics of Testosterone Following Application of Different Testosterone Metered-Dose (MD) Lotion Doses in Hypogonadal Male Subjects

Important dates

Study start: 2006
Primary completion: 2007
Study completion: 2007
First posted: Sep 6, 2006
Registry last updated: Jun 20, 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