Pharmacokinetics of Testosterone Lotion in the Treatment of Hypogonadal Males

Phase 2

Completed

• Conditions: Hypogonadism

• Registration Number: NCT00372008
• Lead Sponsor: Acrux DDS Pty Ltd

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-09-05
• Study First Submitted QC: 2006-09-05
• Study First Posted: 2006-09-06
• Study Start: 2006-10
• Primary Completion: 2007-04
• Study Completion: 2007-04
• Status Verified: 2008-06
• Last Update Submitted: 2008-06-18
• Last Update Posted: 2008-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability

Trial Locations

Locations (1)

Birmingham; 🇺🇸 Birmingham, Alabama, United States