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Testosterone and dutasteride for hypogonadism
NCT00398580Phase 2
Key facts
- Status
- Completed
- Start
- Oct 2006
- Primary completion
- Oct 2007
- Countries
- 1
- Sponsor
- GSK
- Modality
- Small Molecules
- Drugs
- testosterone
- Conditions
- male hypogonadism
01
Overview
Phase 2, randomised, open-label trial of testosterone in male hypogonadism (3 arms), sponsored by GSK. Primary endpoint: Safety measured by: monitoring laboratory tests changes in blood pressure and heart rate and heart activity on an ECG machine at 28 days. Started Oct 2006; status: completed.
02
Design
3 arms- Study design
- RandomizedOpen-label
Testosterone + Dutasteride
Twice daily oral doses of 150, 250 or 400 mg testosterone with 0.25 mg dutasteride
Testosterone Alone
Twice daily oral dose of 400 mg testosterone alone
Dutasteride Alone
Twice daily oral dose of 0.25 mg dutasteride alone
03
Endpoints
Primary
Safety measured by: monitoring laboratory tests changes in blood pressure and heart rate and heart activity on an ECG machine
Secondary
Testosterone concentration
Pharmacokinetics of testosterone, DHT, estradiol, estrone & dutasteride
Anabolic & androgenic Pharmacodynamic biomarkers
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