Clinical Trials Directory

Trials / Completed

CompletedNCT00702650

A Titration Trial to Determine the Effectiveness of Testosterone MD-Lotion (Cutaneous Solution) Formulations

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

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
155 (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 (cutaneous solution), and this study will evaluate the efficacy via pharmacokinetics of various doses of this product. The study will also assess safety of the product.

Conditions

Interventions

TypeNameDescription
DRUGTestosterone MD-Lotion30 mg to 120 mg administered topically once daily for 120 days

Timeline

Start date
2008-06-01
Primary completion
2009-07-01
Completion
2009-07-01
First posted
2008-06-20
Last updated
2011-07-25
Results posted
2011-01-05

Locations

27 sites across 6 countries: United States, Australia, France, Germany, Sweden, United Kingdom

Source: ClinicalTrials.gov record NCT00702650. Inclusion in this directory is not an endorsement.