| November 8, 2006 |
| May 15, 2009 |
| October 2006 |
| |
| 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 ] |
- and heart activity on an ECG machine days 1 and 28.
- Safety measured by: monitoring laboratory tests
- changes in blood pressure and heart rate
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| Complete list of historical versions of study NCT00398580 on ClinicalTrials.gov Archive Site |
- 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 ]
|
- 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.
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| |
| 28-Day Study of Testosterone Co-Administered With Dutasteride in Hypogonadal Men |
| 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 Compared With 400mg Testosterone Alone and 0.25mg Dutasteride Alone in the Treatment of Hypogonadism |
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. |
| |
| Phase II |
| Interventional |
| Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
| Hypogonadism |
- Drug: Nanomilled testosterone
- Drug: Nanomilled dutasteride
- Drug: commercially available dutasteride
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| |
| |
| |
| Completed |
| 43 |
|
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Inclusion criteria:
- Have a diagnosis of primary or secondary hypogonadism.
- Have very low testosterone levels on 2 separate days.
- Have a BMI within range of 18.5-35kg/m2.
- Have not taken dutasteride for one year, or finasteride for the past 3 months.
Exclusion criteria:
- Have had or have breast or prostate cancer, malabsorption syndrome, sleep apnea, psychiatric illness, polycythemia, or any other clinically significant current condition.
- Are diabetic with an HbA1c >= 8.
- Are taking any androgens, such as testosterone, saw palmetto.
- Are taking ritonavir, indinavir, itraconazole, ketoconazole, erythromycin, warfarin, digoxin, cholestyramine, or any dietary/herbal/vitamin supplements.
- Would donate more than 500 ML of blood over a 2 month period.
- Physician does not think it is a good idea for you to participate in the trial. - Are unwilling to abstain from alcohol during the study.
- Have a positive urine drug screen test.
- Plan to change your smoking habits during the course of the trial.
- Have Hepatitis C, Hepatitis B, or HIV.
- Have a lab or EKG abnormality.
- High or low blood pressure.
- Have used of any investigational drug or device during the study or within 30 days prior to 1st dosing of study medication.
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| Male |
| 18 Years to 70 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00398580 |
| Study Director, GSK |
| TDC106220, 106220 |
| GlaxoSmithKline |
|
| Study Director: |
GSK Clinical Trials, M.D., Ph.D., FACP |
GlaxoSmithKline |
|
|
| GlaxoSmithKline |
| May 2009 |
