drugset / Trial / NCT00398580
28-Day Study of Testosterone Co-administered With Dutasteride in Hypogonadal Men
RandomizedParallel-groupOpen-labelTreatment
Summary
The combination of testosterone and dutasteride is intended for use in hypogonadal men. This study will evaluate the effect of 28-day repeat dosing of this combination with varying BID doses of testosterone (T), in combination with a fixed BID dose of dutasteride (D), as well as a testosterone alone arm, on T and D levels in the blood. The rationale is to look for the effects of each compound on the other, and to look for any safety problems that may result when the 2 drugs are given together.
Timeline
- Start
- 2006-10
- Primary completion
- 2007-10
- Completion
- 2007-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dutasteride | Small molecule | 0.25 mg | Oral |
| Subject | Testosterone | Small molecule | 150 mg | Oral |
| Subject | Testosterone | Small molecule | 400 mg | Oral |