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| Sponsor: | Acrux DDS Pty Ltd |
|---|---|
| Information provided by: | Acrux DDS Pty Ltd |
| ClinicalTrials.gov Identifier: | NCT00372008 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypogonadism |
Drug: Testosterone |
Phase II |
| Study Type: | Interventional |
| Study Design: | Randomized, Open Label, Uncontrolled, Crossover Assignment |
| 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 |
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Alabama | |
| Birmingham | |
| Birmingham, Alabama, United States | |
| United States, California | |
| Torrance, California, United States | |
| La Mesa, California, United States | |
| United States, Connecticut | |
| New Britain, Connecticut, United States | |
| United States, Florida | |
| Ocala, Florida, United States | |
| United States, Louisiana | |
| Shreveport, Louisiana, United States | |
| United States, Texas | |
| San Antonio, Texas, United States | |
| Study Director: | Tina Soulis, PhD | Acrux Ltd |
More Information
| Study ID Numbers: | MTE05 |
| Study First Received: | September 5, 2006 |
| Last Updated: | June 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00372008 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Antineoplastic Agents, Hormonal Gonadal Disorders Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Endocrine System Diseases Methyltestosterone Hormones |
Pharmacologic Actions Testosterone 17 beta-cypionate Anabolic Agents Testosterone Hypogonadism Therapeutic Uses Androgens |