drugset / Trial / NCT00663793
ORAL T-6: Oral Androgens in Man-6
Phase 1
Completed
16 enrolled
University of Washington
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collabNational Institutes of Health (NIH) · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
We propose a study to determine the single-dose pharmacokinetics of these two novel formulations of testosterone in normal men with experimentally induced hypogonadism.
Timeline
- Start
- 2008-10
- Primary completion
- 2009-05
- Completion
- 2009-06
Publications
- Background Plymate SR "Male Hypogonadism" in Principles and Practice of Endocrinology and Metabolism (3rd. Ed). Ed. Kenneth Becker, pp:1125-1150
- Background Amory JK, Bremner WJ. Oral testosterone in oil plus dutasteride in men: a pharmacokinetic study. J Clin Endocrinol Metab. 2005 May;90(5):2610-7. doi: 10.1210/jc.2004-1221. Epub 2005 Feb 15.
- Background Amory JK, Page ST, Bremner WJ. Oral testosterone in oil: pharmacokinetic effects of 5alpha reduction by finasteride or dutasteride and food intake in men. J Androl. 2006 Jan-Feb;27(1):72-8. doi: 10.2164/jandrol.05058.
- Background Herbst KL, Coviello AD, Page S, Amory JK, Anawalt BD, Bremner WJ. A single dose of the potent gonadotropin-releasing hormone antagonist acyline suppresses gonadotropins and testosterone for 2 weeks in healthy young men. J Clin Endocrinol Metab. 2004 Dec;89(12):5959-65. doi: 10.1210/jc.2003-032123.
- Results Snyder CN, Clark RV, Caricofe RB, Bush MA, Roth MY, Page ST, Bremner WJ, Amory JK. Pharmacokinetics of 2 novel formulations of modified-release oral testosterone alone and with finasteride in normal men with experimental hypogonadism. J Androl. 2010 Nov-Dec;31(6):527-35. doi: 10.2164/jandrol.109.009746. Epub 2010 Apr 8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Finasteride | Small molecule | 1 mg | Oral |
| Subject | Testosterone | Small molecule | 300 mg | Oral |
| Subject | Testosterone | Small molecule | 600 mg | Oral |
| Background | Acyline | Protein / enzyme biologic | 300 ug/kg | — |