Dutasteride Studies
Select the study ID number to view the trial summary
| Study ID | Phase | Title |
| ARI40014 | IV | Effects of Dutasteride on Intraprostatic Dihydrotestosterone (DHT) Levels |
| AVO-001/2003 | IV | Observational post marketing surveillance study of the safety and efficacy of dutasteride (Avodart®) in patients with benign prostatic hyperplasia |
| AVO106740 | IV | A scientific study to evaluate the efficacy and safety of Avodart® in patients treated for Benign prostatic hyperplasia |
| ARI 40013 (Prostawell). | III | GI 198745 in the Treatment of Symptomatic Benign Prostatic Hyperplasia (BPH): An Open, Multicentre, Phase IIIb Study. |
| ARI105326 | III | Clinical Evaluation of dutasteride in Benign Prostatic Hyperplasia: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparative Study of GI198745 (dutasteride) in Subjects with Benign Prostatic Hyperplasia. |
| ARI40001 Open-label | III | A Multicentre, Randomised, Double-Blind, Double-Dummy, Parallel-Group Study to Compare the Efficacy of dutasteride/GI198745 0.5mg od Versus Finasteride 5mg od for 12 Months in the Treatment of Subjects with Benign Prostatic Hyperplasia (BPH), Followed by an Optional 24 Months Open-Label Phase (Report on Open-Label Treatment Phase) |
| ARI40001 Year 1 | III | A Multicentre, Randomised, Double-Blind, Double-Dummy, Parallel-Group Study to Compare the Efficacy of Dutasteride/GI198745 0.5mg od Versus Finasteride 5mg od for 12 Months in the Treatment of Subjects with Benign Prostatic Hyperplasia (BPH), Followed by an Optional 24 Months Open Label Phase |
| ARI40002 | III | A Pilot, Multi-centre, Double-Blind, Parallel Group, Randomised Study, to Investigate the Effect on Symptoms of Discontinuing Tamsulosin, Following 24 Weeks Combination Treatment with 0.5mg GI198745 (Dutasteride) and 0.4mg Tamsulosin Daily in Subjects with Symptomatic Benign Prostatic Hyperplasia (BPH) (Amendment 1 with follow-up, cumulative data) |
| ARI40005 | III | A randomised, double-blind, parallel group study to investigate the efficacy and safety of treatment with Dutasteride (0.5mg) and Tamsulosin (0.4mg), 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 (Year 2 analysis). |
| ARI40007 | III | A Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study Investigating the Effects of Either 4 or 6 Weeks Dutasteride 0.5mg Daily on Peri-Operative Bleeding Following Transurethral Resection of the Prostate (TURP) in Subjects with Benign Prostatic Hyperplasia (BPH). |
| ARIA3001 Year 1 | III | A Randomized, Double-Blind, Placebo-Controlled, Two Year Parallel Group Study of the Efficacy and Safety of Dutasteride GI198745 0.5mg in the Treatment and Prevention of Progression of Benign Prostatic Hyperplasia, Followed by a Two-Year Open-Label Treatment Phase (Report on Year 1 Data) |
| ARIA3001 Year 2 | III | A Randomized, Double-Blind, Placebo-Controlled, Two Year Parallel Group Study of the Efficacy and Safety of dutasteride GI198745 0.5mg in the Treatment and Prevention of Progression of Benign Prostatic Hyperplasia, Followed by a Two-Year Open-Label Treatment Phase (Report on 2 Year Data) |
| ARIA3001 Year 4 | III | A Randomized, Double-Blind, Placebo-Controlled, Two-Year Parallel Group Study of the Efficacy and Safety of Dutasteride GI198745 0.5mg in the Treatment and Prevention of Progression of Benign Prostatic Hyperplasia, Followed by a Two-Year Open-Label Treatment Phase (Report on Open-Label Treatment Phase) |
| ARIA3002 Year 1 | III | A Randomized, Double-Blind, Placebo-Controlled, Two Year Parallel Group Study of the Efficacy and Safety of GI198745 0.5mg in the Treatment and Prevention of Progression of Benign Prostatic Hyperplasia, Followed by a Two-Year Open-Label Treatment Phase (Report on Year 1 Data) |
| ARIA3002 Year 2 | III | A Randomized, Double-Blind, Placebo-Controlled, Two Year Parallel Group Study of the Efficacy and Safety of GI198745 0.5mg in the Treatment and Prevention of Progression of Benign Prostatic Hyperplasia, Followed by a Two-Year Open-Label Treatment Phase (Report on 2 Year Data) |
| ARIA3002 Year 4 | III | A Randomized, Double-Blind, Placebo-Controlled, Two Year Parallel Group Study of the Efficacy and Safety of GI198745 0.5mg in the Treatment and Prevention of Progression of Benign Prostatic Hyperplasia, Followed by a Two-Year Open-Label Treatment Phase (Report on Open-Label Treatment Phase) |
| ARIB3003 Year 1 | III | A Randomized, Double-Blind, Placebo-Controlled, Two-Year Parallel-Group Study of the Efficacy and Safety of GI198745 in the Treatment and Modification of Progression of Benign Prostatic Hyperplasia, Followed by a Two Year Open-Label GI198745 Treatment Phase (Report on Year 1 Data) |
| ARIB3003 Year 2 | III | A Randomized, Double-Blind, Placebo-Controlled, Two-Year Parallel-Group Study of the Efficacy and Safety of GI198745 in the Treatment and Modification of Progression of Benign Prostatic Hyperplasia, Followed by a Two Year Open-Label GI198745 Treatment Phase (ARIB3003 Report on 2 Year Data) |
| ARIB3003 Year 4 | III | A Randomized, Double-Blind, Placebo-Controlled, Two-Year Parallel-Group Study of the Efficacy and Safety of GI198745 in the Treatment and Modification of Progression of Benign Prostatic Hyperplasia, Followed by a Two Year Open-Label GI198745 Treatment Phase (Report on Open-Label Treatment Phase) |
| ARIB3004 Double-blind | III | A Six-Month, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Effects of Repeat Dose Oral Dutasteride GI198745 on Detrusor Pressure and Urinary Flow in Patients with Lower Urinary Tract Symptoms Suggestive of Bladder Outlet Obstruction, with Optional Six Month Open-Label Extension |
| ARIB3004 Open-label | III | A Six-Month, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Effects of Repeat Dose Oral Dutasteride GI198745 on Detrusor Pressure and Urinary Flow in Patients with Lower Urinary Tract Symptoms Suggestive of Bladder Outlet Obstruction, with Optional Six Month Open-Label Extension |
| ARIF 4005 | III | Prospective, national, multicentre, non comparative study evaluating the improvement of urinary symptoms, discomfort and quality of life in subjects with benign prostatic hyperplasia (BPH) after 24 weeks of treatment by dutasteride. |
| ARIF 4010 | III | Multicentre, randomized, placebo-controlled, double-blind, parallel-group, phase IIIB clinical trial evaluating the efficacy of dutasteride in the prevention of bleeding related to prostate transurethral resection in subjects presenting with BPH. |
| ARIF 4012 | III | Multicentric, randomised, double-blind, double-dummy, parallel-group clinical trial evaluating short-term efficacy and safety of dutasteride compared to finasteride in patients presenting with BPH when switching from finasteride |
| ARI20005 | II | A Multicentre, Double-Blind, Randomised, Placebo-Controlled, Parallel-Group, Dose-Finding Study of GI198745 in Subjects with Benign Prostatic Hyperplasia |
| ARI30016 | II | A long-term extension study of GI198745 in patients with benign prostatic hyperplasia |
| ARI40010 | II | Multicenter, double-blind, randomized, parallel-group study, comparing 0.5 mg and 3.5 mg dutasteride daily for 4 months prior to radical prostatectomy versus radical prostatectomy alone in men with biopsy-proven and clinically localized prostate cancer |
| ARIA2001 | II | A Double-Blind, Placebo-Controlled, Dose-Ranging, Clinical Evaluation of GI198745 and Finasteride in Subjects with Benign Prostatic Hyperplasia. |
| ARIA2003 | II | A Randomized, Double-Blind, Placebo-Controlled Pilot Study to Evaluate the Safety And Preliminary Efficacy of Neoadjuvant Therapy With GI198745 in Subjects With Localized Prostate Cancer Undergoing Radical Prostatectomy |
| ARIA2004 | II | A Double-Blind, Placebo-Controlled, Dose-Ranging Clinical Evaluation of dutasteride GI198745 and Finasteride in Subjects with Male Pattern Baldness (MPB) |
| ARIB2002 | II | A Randomised, Double-Blind, Placebo-Controlled, Double-Dummy Study of Dutasteride (GI198745) in Subjects Awaiting Transurethral Resection of the Prostate (TURP) for Treatment of Benign Prostatic Hyperplasia (BPH) |
| ARI10015 | I | An Evaluation of the Absolute Bioavailability of GI198745 (dutasteride) Soft Gelatin Capsules Compared to GI198745 (dutasteride) Intravenous Solution in Healthy Volunteers |
| ARI10016 | I | A Double-Blind, Randomized, Placebo-Controlled Study to Determine the Effect of GI198645 (dutasteride) Dose for 21 Days on the Pharmacokinetics and Pharmacodynamics of Warfarin in Healthy Male Volunteers |
| ARI10017 | I | A study to investigate the effect of GI198745 (dutasteride) on the pharmacokinetics of digoxin in healthy male volunteers |
| ARI10018 | I | An Evaluation of the Bioequivalence of GI198745/dutasteride Soft Gelatin Capsules Compared to GI198745/dutasteride Cross-linked Gelatin Capsules in Healthy Male Volunteers |
| ARI10019 | I | A Double-Blind, Placebo Controlled, Randomized, Parallel Group Study To Investigate The Changes In The Corrected QT Interval Following Repeat Oral Doses Of GI198745 (dutasteride) In Healthy Male Volunteers |
| ARI10023 | I | A double blind, randomized and placebo-controlled parallel group study to evaluate the safety and pharmacokinetics/pharmacodynamics of a single oral 0.5mg dose of dutasteride in healthy Korean male volunteers. |
| ARI103880 | I | An open label, single dose, randomized, three period crossover study to investigate the relative bioavailability of 0.5 mg of dutasteride from soft gelatin capsules (reference) vs. soft gelatin capsules containing two investigational formulations in healthy male volunteers. |
| ARI19033 | I | An open label, single dose, randomised, three period crossover study to investigate the relative bioavailability of dutasteride softgel vs. dutasteride tablet and dutasteride softgel vs. dutasteride capsule in healthy male volunteers |
| ARIA1001 | I | An Investigation of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GI198745 (dutasteride), an Inhibitor of the 5-Alpha Reductase Enzyme, In Healthy Adult Males |
| ARIA1002 | I | A pilot investigation of the relative bioavailability of oral formulations of GI198745 (dutasteride), an inhibitor of the 5-alpha reductase enzyme, in healthy adult male volunteers |
| ARIA1003 | I | An Investigation of the Safety, Tolerability Pharmacokinetics and Pharmacodynamics of DUT(/dutasteride) When Administered Daily for 28 Days in Patients with Benign Prostatic Hyperplasia |
| ARIA1004 | I | An Evaluation of the Relative Bioavailability of the GI198745 (Dutasteride) Soft Gelatin Capsule with Monodiglycerides of Caprylic/Capric Acid (MDC) in Healthy Adult Male Volunteers |
| ARIA1007 | I | The Effects of Aging on the Pharmacokinetic and Pharmacodynamic Characteristics of GI198745/Dutasteride in Healthy Adult Male Volunteers |
| ARIA1009 | I | An Investigation of the Pharmacokinetics of GI198745 (Dutasteride) and the Effects of GI198745(Dutasteride) on Semen Characteristics When Administered Daily for 12 Months to Healthy Male Subjects |
| ARIA1010 | I | An Evaluation of the Effects of Cholestyramine on the Pharmacokinetics of GI198745(Dutasteride) |
| ARIA1011 | I | An Open-label, Crossover Study to Investigate the Pharmacokinetic-Pharmacodynamic Interaction Between (1) Tamsulosin and GI198745(dutasteride) and (2) Terazosin and GI198745 (dutasteride) When Co-administered to Healthy Male Subjects for 14 Days |
| ARIA1012 | I | An Investigation of the Metabolic Fate and Routes of Excretion of GI198745/dutasteride at Steady State in Healthy Male Subjects |
| TDC106218 | I | Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride |