CLINICAL TRIALS PROFILE FOR AVODART
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All Clinical Trials for AVODART
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00161421 ↗ | Oral Androgens in Man-3 (ORAL T-3) Pharmacokinetics of Oral Testosterone | Completed | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Phase 2 | 2005-03-01 | The purpose of this study is to test the how the body absorbs and processes new forms of oral testosterone. Information gained during the study may help develop better forms of testosterone therapy in the future. We will be administering three drugs. Dutasteride is FDA approved to treat prostate enlargement. Lupron is approved for treatment of prostate cancer. Testosterone is approved for treatment of testicular insufficiency. They are being used in this study for "off-label" research purposes. This study will allow us to find out the effect of food on two formulations of testosterone taken by mouth, and the relative effect of food on testosterone absorption. Information from this study may be useful in treatment of men with low testosterone levels and the development of a male hormonal contraceptive. |
| NCT00161421 ↗ | Oral Androgens in Man-3 (ORAL T-3) Pharmacokinetics of Oral Testosterone | Completed | GlaxoSmithKline | Phase 2 | 2005-03-01 | The purpose of this study is to test the how the body absorbs and processes new forms of oral testosterone. Information gained during the study may help develop better forms of testosterone therapy in the future. We will be administering three drugs. Dutasteride is FDA approved to treat prostate enlargement. Lupron is approved for treatment of prostate cancer. Testosterone is approved for treatment of testicular insufficiency. They are being used in this study for "off-label" research purposes. This study will allow us to find out the effect of food on two formulations of testosterone taken by mouth, and the relative effect of food on testosterone absorption. Information from this study may be useful in treatment of men with low testosterone levels and the development of a male hormonal contraceptive. |
| NCT00161421 ↗ | Oral Androgens in Man-3 (ORAL T-3) Pharmacokinetics of Oral Testosterone | Completed | National Institutes of Health (NIH) | Phase 2 | 2005-03-01 | The purpose of this study is to test the how the body absorbs and processes new forms of oral testosterone. Information gained during the study may help develop better forms of testosterone therapy in the future. We will be administering three drugs. Dutasteride is FDA approved to treat prostate enlargement. Lupron is approved for treatment of prostate cancer. Testosterone is approved for treatment of testicular insufficiency. They are being used in this study for "off-label" research purposes. This study will allow us to find out the effect of food on two formulations of testosterone taken by mouth, and the relative effect of food on testosterone absorption. Information from this study may be useful in treatment of men with low testosterone levels and the development of a male hormonal contraceptive. |
| NCT00161421 ↗ | Oral Androgens in Man-3 (ORAL T-3) Pharmacokinetics of Oral Testosterone | Completed | University of Washington | Phase 2 | 2005-03-01 | The purpose of this study is to test the how the body absorbs and processes new forms of oral testosterone. Information gained during the study may help develop better forms of testosterone therapy in the future. We will be administering three drugs. Dutasteride is FDA approved to treat prostate enlargement. Lupron is approved for treatment of prostate cancer. Testosterone is approved for treatment of testicular insufficiency. They are being used in this study for "off-label" research purposes. This study will allow us to find out the effect of food on two formulations of testosterone taken by mouth, and the relative effect of food on testosterone absorption. Information from this study may be useful in treatment of men with low testosterone levels and the development of a male hormonal contraceptive. |
| NCT00244309 ↗ | Study of Tamsulosin and/or Dutasteride to Relieve Urinary Symptoms After Brachytherapy for Localized Prostate Cancer | Completed | GlaxoSmithKline | Phase 3 | 2005-11-01 | The purpose of this study is to determine whether a drug named tamsulosin (Flomax), or another drug named dutasteride (Avodart), or a combination of these two drugs is effective in improving urinary symptoms and decreasing the rate of intermittent self-catheterization after prostate brachytherapy. |
| NCT00244309 ↗ | Study of Tamsulosin and/or Dutasteride to Relieve Urinary Symptoms After Brachytherapy for Localized Prostate Cancer | Completed | Case Comprehensive Cancer Center | Phase 3 | 2005-11-01 | The purpose of this study is to determine whether a drug named tamsulosin (Flomax), or another drug named dutasteride (Avodart), or a combination of these two drugs is effective in improving urinary symptoms and decreasing the rate of intermittent self-catheterization after prostate brachytherapy. |
| NCT00303446 ↗ | Dutasteride to Treat Spinal and Bulbar Muscular Atrophy (SBMA) | Completed | National Institute of Neurological Disorders and Stroke (NINDS) | Phase 2 | 2006-03-01 | This study will determine if the drug dutasteride can improve weakness, mobility, functioning, nerve function, and quality of life in patients with spinal and bulbar muscular atrophy (SBMA). Patients with this inherited disease have an abnormal androgen receptor protein. The male hormones testosterone and dihydrotestosterone (DHT) bind to this abnormal receptor, causing damage to nerve cells that innervate muscle and leading to weakness. Dutasteride decreases DHT production. Lowering DHT levels may decrease the harmful effects of DHT to the nerves and improve strength in people with SBMA. Males 18 years of age and older with SBMA who have neurological symptoms and can walk 100 feet (with or without assistive devices) may be eligible for this study. Candidates are screened with a blood test and a review of their medical records and genetic studies. Participants undergo the following procedures: - Blood and urine tests, history and physical examination, assessment of muscle strength - Quality-of-life questionnaire - Tests to assess functional abilities, such walking up steps, keeping the head up while lying down, and other measures - Nerve conduction study and motor unit number estimation to assess nerve damage. A probe placed on the skin delivers small electrical impulses and wires taped to the skin record the impulses. - Quantitative muscle testing to measure strength. The subject pushes and pulls levers attached to a gauge. Strength is recorded by a computer. - Medication. Participants are divided into two groups. One group is given the study drug, dutasteride; the other receives a placebo (sugar pill). All participants take their assigned medication once a day for 24 months. - Follow-up evaluations. Every 6 months for 2 years, participants return to NIH to repeat the tests described above to determine the effects of the dutasteride. Nerve and quantitative muscle testing is not done at the 6- and 18-month visits. - In addition to their follow-up appointments here at the NIH every 6 months, participants will also have blood tests and a physical examination performed after 3, 9, 15 and 21 months of treatment by the patient's local physician. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
Clinical Trial Conditions for AVODART
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