Clinical Trial: 28-Day Study of Testosterone Co-administered With Dutasteride in Hypogonadal Men
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase II, 28-Day, Randomized, Parallel-Group, Open-Label Study Evaluating the Efficacy and Safety of Twice Daily Oral Doses of Testosterone (150-400mg) Co-administered With 0.25mg Dutasteride Compar
Brief 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.
Detailed Summary:
Sponsor: GlaxoSmithKline
Current Primary Outcome: Safety measured by: monitoring laboratory tests changes in blood pressure and heart rate and heart activity on an ECG machine [ Time Frame: days 1 and 28 ]
Original Primary Outcome:
- Safety measured by: monitoring laboratory tests
- changes in blood pressure and heart rate
- and heart activity on an ECG machine days 1 and 28.
Current Secondary Outcome:
- Testosterone concentration . [ Time Frame: on days 1 and 28 ]
- Pharmacokinetics of testosterone, DHT, estradiol, estrone & dutasteride [ Time Frame: days 1 and 28. ]
- Anabolic & androgenic Pharmacodynamic biomarkers [ Time Frame: pre- and post-dose ]
Original Secondary Outcome:
- Testosterone concentration on days 1 and 28
- Pharmacokinetics of testosterone, DHT, estradiol, estrone and dutasteride days 1 & 28.
- Anabolic and androgenic Pharmacodynamic biomarkers pre- and post-dose.
Information By: GlaxoSmithKline
Dates:
Date Received: November 8, 2006
Date Started: October 2006
Date Completion:
Last Updated: March 29, 2013
Last Verified: March 2013
