NCT00372008
Completed
Phase 2
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
ConditionsHypogonadism
DrugsTestosterone
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Hypogonadism
- Sponsor
- Acrux DDS Pty Ltd
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Pharmacokinetic
- Status
- Completed
- Last Updated
- 17 years ago
Overview
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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
Pharmacokinetic
Secondary Outcomes
- Safety and tolerability
Study Sites (1)
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