GSK: Result Summaries: Compounds

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Result Summaries: Dutasteride

Result Summaries for Dutasteride
GSK Study ID	Phase	Title
ARIA3001_1	Phase 3	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) (37 citation(s))
101722	Phase 4	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. (1 citation(s))
103880	Phase 1	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. (0 citation(s))
104274	Phase 4	See Detailed Description (0 citation(s))
106377	Phase 3	An randomised, double-blind, placebo-controlled, parallel group study to assess the efficacy and safety of dutasteride 0.5mg once daily for 6 months in the treatment of male subjects with androgenetic alopecia (Norwood-Hamilton classification type IIIv, IV and V) (0 citation(s))
106740	Phase 4	A scientific study to evaluate the efficacy and safety of Avodart® in patients treated for Benign prostatic hyperplasia (0 citation(s))
ARI10015	Phase 1	An Evaluation of the Absolute Bioavailability of GI198745 (dutasteride) Soft Gelatin Capsules Compared to GI198745 (dutasteride) Intravenous Solution in Healthy Volunteers. (0 citation(s))
ARI10016	Phase 1	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. (0 citation(s))
ARI10017	Phase 1	A study to investigate the effect of GI198745 (dutasteride) on the pharmacokinetics of digoxin in healthy male volunteers. (0 citation(s))
ARI10018	Phase 1	An Evaluation of the Bioequivalence of GI198745/dutasteride Soft Gelatin Capsules Compared to GI198745/dutasteride Cross-linked Gelatin Capsules in Healthy Male Volunteers. (0 citation(s))
ARI10019	Phase 1	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. (0 citation(s))
ARI10023	Phase 1	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. (1 citation(s))
ARI105326	Phase 3	Clinical Evaluation of GI198745 in Benign Prostatic Hyperplasia- A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparative Study of GI198745 in Patients with Benign Prostatic Hyperplasia (0 citation(s))
ARI108898	Phase 3	A randomized, double-blind, placebo-controlled, six-month parallel-group study to assess efficacy and safety of dutasteride 0.5mg once daily in Chinese patients with Benign Prostatic Hyperplasia (BPH), followed by a 12-month open-label treatment phase (0 citation(s))
ARI109882	Phase 1	See Detailed Description (0 citation(s))
ARI111402	Phase 1	An open label, randomized, repeat dose, 3 period cross over study to determine the bioequivalence of 3 different formulations of tamsulosin at steady state in healthy male volunteers (0 citation(s))
ARI19033	Phase 1	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 (0 citation(s))
ARI20005	Phase 2	A Multicentre, Double-Blind, Randomised, Placebo-Controlled, Parallel-Group, Dose-Finding Study of GI198745 in Subjects with Benign Prostatic Hyperplasia (0 citation(s))
ARI30015	Phase 3	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. (0 citation(s))
ARI30016	Phase 2	A Long-term Extension Study of GI198745 in Subjects with Benign Prostatic Hyperplasia (0 citation(s))
ARI40001	Phase 3	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 (R ... (0 citation(s))
ARI40001_1	Phase 3	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. (2 citation(s))
ARI40002	Phase 3	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 Hyperplasi ... (1 citation(s))
ARI40005	Phase 3	See Detailed Description (4 citation(s))
ARI40006	Phase 3	A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Dutasteride 0.5 mg Administered Orally Once Daily for Four Years to Reduce the Risk of Biopsy-Detectable Prostate Cancer (3 citation(s))
ARI40007	Phase 3	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). (0 citation(s))
ARI40010	Phase 2	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 (0 citation(s))
ARI40013	Phase 3	GI 198745 in the Treatment of Symptomatic Benign Prostatic Hyperplasia (BPH): An Open, Multicentre, Phase IIIb Study. (0 citation(s))
ARI40014	Phase 4	Effects of Dutasteride on Intraprostatic Dihydrotestosterone (DHT) Levels (0 citation(s))
ARIA1001	Phase 1	An Investigation of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GI198745 (dutasteride), an Inhibitor of the 5-Alpha Reductase Enzyme, In Healthy Adult Males (0 citation(s))
ARIA1002	Phase 1	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 (0 citation(s))
ARIA1003	Phase 1	An Investigation of the Safety, Tolerability Pharmacokinetics and Pharmacodynamics of DUT(/dutasteride) When Administered Daily for 28 Days in Patients with Benign Prostatic Hyperplasia (1 citation(s))
ARIA1004	Phase 1	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 (0 citation(s))
ARIA1007	Phase 1	The Effects of Aging on the Pharmacokinetic and Pharmacodynamic Characteristics of GI198745/Dutasteride in Healthy Adult Male Volunteers (1 citation(s))
ARIA1009	Phase 1	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 (4 citation(s))
ARIA1010	Phase 1	An Evaluation of the Effects of Cholestyramine on the Pharmacokinetics of GI198745(Dutasteride) (0 citation(s))
ARIA1011	Phase 1	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 (4 citation(s))
ARIA1012	Phase 1	An Investigation of the Metabolic Fate and Routes of Excretion of GI198745/dutasteride at Steady State in Healthy Male Subjects (0 citation(s))
ARIA2001	Phase 2	A Double-Blind, Placebo-Controlled, Dose-Ranging, Clinical Evaluation of GI198745 and Finasteride in Subjects with Benign Prostatic Hyperplasia. (0 citation(s))
ARIA2003	Phase 2	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. (3 citation(s))
ARIA2004	Phase 2	A Double-Blind, Placebo-Controlled, Dose-Ranging Clinical Evaluation of dutasteride GI198745 and Finasteride in Subjects with Male Pattern Baldness (MPB). (0 citation(s))
ARIA3001_2	Phase 3	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). (37 citation(s))
ARIA3001_4	Phase 3	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 ... (10 citation(s))
ARIA3002	Phase 3	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) (38 citation(s))
ARIA3002_2	Phase 3	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). (38 citation(s))
ARIA3002_4	Phase 3	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). (15 citation(s))
ARIB2002	Phase 2	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) (0 citation(s))
ARIB3003	Phase 3	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). (38 citation(s))
ARIB3003	Phase 3	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). (33 citation(s))
ARIB3003_4	Phase 3	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). (13 citation(s))
ARIB3004	Phase 3	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 O ... (0 citation(s))
ARIB3004_1	Phase 3	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 O ... (0 citation(s))
ARIF4012	Phase 3	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 (0 citation(s))
AVO-001/2003	Phase 4	Observational post marketing surveillance study of the safety and efficacy of dutasteride (Avodart®) in patients with benign prostatic hyperplasia (0 citation(s))

Result Summaries: Dutasteride

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