NCT00857454

A Trial to Evaluate the Ongoing Skin Safety of Testosterone MD-Lotion Formulations

A Phase III Open-label Extension of the MTE08 Trial (A Phase III Open-label Titration Trial to Evaluate the Effectiveness and Safety of Different Doses of a Dermal Application of Testosterone MD-Lotion® (Cutaneous Solution) in Hypogonadal Men) to Evaluate Skin-safety

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Testosterone replacement treatment is the most effective way of treating hypogonadism in men. Acrux has a propriety testosterone replacement product, Testosterone MD-Lotion and this study will assess the occurrence of skin safety events for a further two months of continuous use of the Testosterone MD-Lotion® (cutaneous solution) after completion of the MTE08 (NCT00702650) trial.

Conditions

• Hypogonadism

Interventions

Type	Name	Description
DRUG	Testosterone MD-Lotion	30 mg to 120 mg administered topically once daily for 60 days

Timeline

• Start date: 2008-10-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2009-03-06
• Last updated: 2011-01-05
• Results posted: 2011-01-05

Locations

11 sites across 1 country: United States