drugset / Trial / NCT00438321
Effect of Increasing Testosterone on Insulin Sensitivity in Men With the Metabolic Syndrome
Phase 1
Terminated
66 enrolled
Massachusetts General Hospital
American Diabetes Association · collabNational Institutes of Health (NIH) · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of the study is to examine the effect of testosterone treatment on insulin in men with the metabolic syndrome with testosterone levels at or below the lower end of the normal range.
Timeline
- Start
- 2006-09
- Primary completion
- 2010-02-26
- Completion
- 2010-02-26
Publications
- Background Pitteloud N, Hardin M, Dwyer AA, Valassi E, Yialamas M, Elahi D, Hayes FJ. Increasing insulin resistance is associated with a decrease in Leydig cell testosterone secretion in men. J Clin Endocrinol Metab. 2005 May;90(5):2636-41. doi: 10.1210/jc.2004-2190. Epub 2005 Feb 15.
- Background Pitteloud N, Mootha VK, Dwyer AA, Hardin M, Lee H, Eriksson KF, Tripathy D, Yialamas M, Groop L, Elahi D, Hayes FJ. Relationship between testosterone levels, insulin sensitivity, and mitochondrial function in men. Diabetes Care. 2005 Jul;28(7):1636-42. doi: 10.2337/diacare.28.7.1636.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Anastrozole | Other / unclassified | 10 mg | Oral |
| Comparator | Testosterone | Small molecule | 7.5 g | Other |
| Comparator | Goserelin | Other / unclassified | 3.6 mg | Intramuscular |