Pharmacokinetics of Testosterone Lotion in the Treatment of Hypogonadal Males
Information source: Acrux DDS Pty Ltd
Information obtained from ClinicalTrials.gov on March 24, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypogonadism
Intervention: Testosterone (Drug)
Phase: Phase 2
Status: Not yet recruiting
Sponsored by: Acrux DDS Pty Ltd Official(s) and/or principal investigator(s):
Tina Soulis, PhD, Study Director, Affiliation: Acrux Ltd
Overall contact:
Tina Soulis, PhD, Phone: 00 61 3 8379 0100
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.
Clinical Details
Official 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
Study design: Randomized, Open Label, Uncontrolled, Crossover Assignment
Primary outcome: Pharmacokinetic
Secondary outcome: Safety and tolerability
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Male.
Criteria:
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
Locations and Contacts
Tina Soulis, PhD, Phone: 00 61 3 8379 0100 Additional Information
Starting date: October 2006
Last updated: September 5, 2006
|
