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Last Updated: May 27, 2022

CLINICAL TRIALS PROFILE FOR DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE


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All Clinical Trials for Dutasteride And Tamsulosin Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00090103 ↗ Benign Prostatic Hyperplasia Trial With Dutasteride And Tamsulosin Combination Treatment Completed GlaxoSmithKline Phase 3 2003-11-01 This study will investigate the efficacy and safety of treatment with dutasteride and tamsulosin, administered once daily for 4 years, alone and in combination, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic Benign Prostatic Hyperplasia (BPH). Study visits are every 3 months for up to 4 years (18 clinic visits). Transrectal ultrasound (TRUS) is done annually.
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.
NCT00537654 ↗ A Study To Compare Giving AVODART And FLOMAX Together Or In A Combination Capsule In The Fed And Fasted State Completed GlaxoSmithKline Phase 1 2007-10-18 This study will be an open-label, randomized, single dose, three way partial crossover study in healthy male subjects. The aim of the study is to evaluate bioequivalence of a fixed dose combination (FDC) capsule of dutasteride and tamsulosin hydrochloride (HCl) (0.5 milligram [mg]/0.4 mg) relative to co-administration of dutasteride 0.5 mg capsules and tamsulosin hydrochloride 0.4 mg tablets in both the fed and fasted states. Approximately 98 healthy adult male subjects will be enrolled into the study. Subjects will receive single oral doses in 3 treatment periods and be randomized to one of twelve different treatment sequences (ABC, ACB, BAC, BCA, CAB, CBA, ABD, ADB, BAD, BDA, DAB, DBA) wherein A= commercially available tamsulosin hydrochloride 0.4 mg and dutasteride 0.5 mg in a fed state, B= fixed dose combination formulation of dutasteride and tamsulosin hydrochloride (0.5 mg dutasteride, 0.4 mg tamsulosin hydrochloride) in a fed state, C= commercially available tamsulosin hydrochloride 0.4 mg and dutasteride 0.5 mg in a fasted state, D= fixed dose combination formulation of dutasteride and tamsulosin hydrochloride (0.5 mg dutasteride, 0.4 mg tamsulosin hydrochloride) in a fasted state. Each treatment period will be separated by a minimum 28 day washout period. The total duration of a subject's involvement in this study is approximately 15-18 weeks.
NCT00609596 ↗ A Study To Compare 3 Different Formulations Of Tamsulosin At Steady State. Completed GlaxoSmithKline Phase 1 2008-02-26 Dutasteride and tamsulosin are to treat benign prostatic hyperplasia. Studies show that when given together, there is more improvement in symptoms than either drug alone. In this study, we are looking to see if 2 different formulations of tamsulosin in our combination capsules are the same after 7 days of dosing as the US commercial tamsulosin and dutasteride.
NCT00701779 ↗ Dutasteride and Flex Dose of Tamsulosin on as Needed Basis, to Treat Benign Prostatic Hyperplasia Completed GlaxoSmithKline Phase 4 2005-09-01 This study will investigate the efficacy and safety of treatment with Dutasteride (0.5mg), administered once daily for one year in combination with Tamsulosin (0.4mg), administered once daily for 3 months, followed by counseling on flexible dosing of Tamsulosin on an as needed basis, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic benign prostatic hyperplasia (BPH). At each scheduled visit (3, 6, and 9 months), the subject will be counseled on withdrawal of Tamsulosin. After randomization, study visits are every 13 weeks for up to 52 Weeks. (Including Screening, (up to 7 clinic visits)
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Dutasteride And Tamsulosin Hydrochloride

Condition Name

Condition Name for Dutasteride And Tamsulosin Hydrochloride
Intervention Trials
Prostatic Hyperplasia 14
Benign Prostatic Hyperplasia 5
Urologic Diseases 2
Prostate Pain 1
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Condition MeSH

Condition MeSH for Dutasteride And Tamsulosin Hydrochloride
Intervention Trials
Prostatic Hyperplasia 18
Hyperplasia 18
Urologic Diseases 3
Hypertrophy 2
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Clinical Trial Locations for Dutasteride And Tamsulosin Hydrochloride

Trials by Country

Trials by Country for Dutasteride And Tamsulosin Hydrochloride
Location Trials
United States 42
Germany 31
Italy 20
United Kingdom 12
France 11
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Trials by US State

Trials by US State for Dutasteride And Tamsulosin Hydrochloride
Location Trials
Maryland 3
Indiana 3
Texas 2
Ohio 2
New York 2
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Clinical Trial Progress for Dutasteride And Tamsulosin Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Dutasteride And Tamsulosin Hydrochloride
Clinical Trial Phase Trials
Phase 4 4
Phase 3 5
Phase 1 11
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Clinical Trial Status

Clinical Trial Status for Dutasteride And Tamsulosin Hydrochloride
Clinical Trial Phase Trials
Completed 17
Terminated 2
Recruiting 1
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Clinical Trial Sponsors for Dutasteride And Tamsulosin Hydrochloride

Sponsor Name

Sponsor Name for Dutasteride And Tamsulosin Hydrochloride
Sponsor Trials
GlaxoSmithKline 18
University of California, Los Angeles 1
Dr. J. Curtis Nickel 1
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Sponsor Type

Sponsor Type for Dutasteride And Tamsulosin Hydrochloride
Sponsor Trials
Industry 18
Other 8
NIH 1
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