drugset / Trial / NCT00702650
A Titration Trial to Determine the Effectiveness of Testosterone MD-Lotion (Cutaneous Solution) Formulations
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2008-06
- Primary completion
- 2009-07
- Completion
- 2009-07
Publications
- Results Wang C, Ilani N, Arver S, McLachlan RI, Soulis T, Watkinson A. Efficacy and safety of the 2% formulation of testosterone topical solution applied to the axillae in androgen-deficient men. Clin Endocrinol (Oxf). 2011 Dec;75(6):836-43. doi: 10.1111/j.1365-2265.2011.04152.x.
- Muram D, Ni X. Utility of a single serum testosterone measurement to determine response to topical testosterone replacement in hypogonadal men. Curr Med Res Opin. 2016;32(2):263-9. doi: 10.1185/03007995.2015.1117434. Epub 2015 Dec 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Testosterone | Small molecule | 30 mg | Topical |
| Subject | Testosterone | Small molecule | 60 mg | Topical |
| Subject | Testosterone | Small molecule | 90 mg | Topical |
| Subject | Testosterone | Small molecule | 120 mg | Topical |