Last updated: 11/07/2018 15:41:13
A Randomized, double-blind, placebo-controlled, two year parallel group study of the efficacy and safety of GI198745 0.5 mg in the treatment and prevention of progression of benign prostatic hyperplasia
Clinicaltrials.gov ID
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EudraCT ID
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EU CT Number
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Trial status
Study complete
Study complete
Trial overview
Official title: A Randomized, double-blind, placebo-controlled, two year parallel group study of the efficacy and safety of GI198745 0.5 mg in the treatment and prevention of progression of benign prostatic hyperplasia
Trial description: A Randomized, double-blind, placebo-controlled, two year parallel group study of the efficacy and safety of GI198745 0.5 mg in the treatment and prevention of progression of benign prostatic hyperplasia
Primary purpose:
Not applicable
Trial design:
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Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Abstract: Earlier initiation of treatment with the dual 5 reductase inhibitor dutasteride reduces the risk of acute urinary retention and surgical intervention in men with benign prostatic hyperplasia. Emberton, M. 2 1 19th Congress of the European Association of Urology 3/24/2004 Vienna; Austria
Abstract: effect of dutasteride on tue incidence of prostate cancer (pca) in men with benign prostatic hyperplasia. GeraldAndriole, Claus Roehrborn Claude Schulman Kevin Slawin Matt Somerville Roger Rittmaster. 99th Annual Meeting of the American Urological Association 5/8/2004
Abstract: efficacy and safety of long-term treatment with the dual 5-alpha-reductase inhibitor dutasteride in men with symptomatic benign prostatic hyperplasia. Debruyne, F., Barkin, J., Van Erps, P., Reis, M., Tammela, T. L., Roehrborn, C., and ARIA3001, 3002 and ARIB3003 Study Investigators 27th Congress of the Societe Internationale dUrologie 10/3/2004 Honolulu, HI; USA
Abstract: long-term dutasteride therapy results in continued improvements in symptoms and peak urinary flow in men with symptomatic benign prostatic hyperplasia. Debruyne, F. 2 1, Barkin, J. 3 1, and Roehrbom, C. 4 1 19th Congress of the European Association of Urology 3/24/2004 Vienna; Austria
Abstract: The transition zone hypothesis in benign prostatic hyperplasia. Roehrborn, C. 1, Marks, L. 2, Wolford, E. 3, and Wilson, T. 4 20th Congress of the European Association of Urology 3/16/2005 Istanbul; Turkey
Andriole G, Roehrborn CG, Nickel CJ, et al. Effect of the dual 5alpha-reductase inhibitor dutasteride on serum total PSA, free PSA and the ratio of F/T PSA. AUA 2002
Andriole G, Roehrborn CG, Schulman C, et al. Effect of dutasteride on the incidence of prostate cancer (PCa) in men with benign prostatic hyperplasia. AUA 2004
Boyle P, Andriole G, Nickel CJ, et al. Effect of the dual 5alpha-reductase inhibitor dutasteride on total and transitional zone prostate volume. SIU 2002
Boyle P, Robertson C, Wilson T, et al. Risk factors for acute urinary retention in men with benign prostatic hyperplasia. EAU 2003
Boyle P, Roehrborn C, Andriole G, et al. The impact of dutasteride, a novel 5alpha-reductase inhibitor, on the hallmarks of BPH progression and outcomes. EAU 2002
Boyle P, Roehrborn C, Marks L, et al. The novel dual 5alpha-reductase inhibitor dutasteride is effective for the treatment and prevention of complications in men with a PV =30 - <40cc and =40cc. EAU 2003
Boyle P, Siami P, Wachs B, et al. Effect of Dutasteride on the risk of acute urinary retention and the need for surgical treatment. AUA 2002
Boyle P. Early use of dutasteride arrests prostate growth, improves clinical parameters and prevents complications in men with benign prostatic hyperplasia. AUA 2003
Boyle P. Predictive model for acute urinary retention in man with benign prostatic hyperplasia. AUA 2003
Carson C. Effect of maximal DHT suppression with Dutasteride on sexual function and gynecomastia. AUA 2003
Costa F, Walls R. The dual 5alpha-reductase inhibitor dutasteride is safe and effective in men with benign prostatic hyperplasia receiving a PDE-5 inhibitor. AUA 2004
Debruyne F, Barkin J, Roehrborn CG. Long-term dutasteride therapy results in continued improvements in symptoms and peak urinary flow in men with symptomatic benign prostatic hyperplasia. EAU 2004
Efficacy and safety of dutasteride in the four-year treatment of men with benign prostatic hyperplasia. Roehrborn, C. G., Marks, L. S., Fenter, T., Freedman, S., Tuttle, J., Gittleman, M., Morrill, B., and Wolford, E. T. Urology 2004; 63 (4):709-15.
Efficacy and safety of long-term treatment with the dual 5 alpha-reductase inhibitor dutasteride in men with symptomatic benign prostatic hyperplasia. Debruyne, F., Barkin, J., van Erps, P., Reis, M., Tammela, T. L., and Roehrborn, C. Eur Urol 2004; 46. 46(4. 4):488-94; discussion 495, 488-94; discussion 495.
Emberton M. Earlier initiation of treatment with the dual 5alpha reductase inhibitor dutasteride reduces the risk of acute urinary retention and surgical intervention in men with benign prostatic hyperplasia. EAU 2004
Fenter T, Tully A, Debruyne F. Long-term therapy with the dual 5alpha reductase inhibitor dutasteride is well tolerated in men with symptomatic benign prostatic hyperplasia. AUA 2004
Freedman S, Brosman S, Emberton M, et al. Earlier initiation of treatment with the dual 5alpha reductase inhibitor dutasteride reduces the risk of acute urinary retention and surgical intervention in men with benign prostatic hyperplasia. AUA 2004
Gittelman M, Barkin J, Zinner N. Sustained prostate volume reduction with dutasteride over 4 years is independent of baseline prostate volume. AUA 2004
Long-term sustained improvement in symptoms of benign prostatic hyperplasia with the dual 5alpha-reductase inhibitor dutasteride: results of 4-year studies. Roehrborn, C. G., Lukkarinen, O., Mark, S., Siami, P., Ramsdell, J., and Zinner, N. BJU Int 2005; 96 (4):572-7.
Marks L, Roehrborn CG, Rittmaster R. Duration of dihydrotestosterone suppression following discontinuation of dutasteride: implications for missed doses. AUA 2004
McNicholas T, Tamella T, Te A, et al. The novel dual 5alpha-reductase inhibitor Dutasteride is well tolerated with the concomitant use of commonly prescribed cardiovascular medications and PDE-5 inhibitors. EAU 2003
O'Leary MP, Roehrborn CG, Andriole G, et al. Improvements in benign prostatic hyperplasia-specific quality of life with dutasteride, the novel dual 5alpha-reductase inhibitor. BJU International 2003; 92: 262-6.
O., Mark, S., Siami, P., Ramsdell, J., and Zinner, N. BJU Int 2005; 96 (4):572-7.
OLeary M, Roehrborn C, Andriole G et al. Baseline bother and symptom scores determine which BPH subjects will be bothered following treatment. EAU 2003
OLeary M, Roehrborn C, Andriole G, et al. Baseline bother and symptom scores predict men likely to benefit from treatment with the novel dual 5alpha-reductase inhibitor Dutasteride. AUA 2003
Roehrborn C, Andriole G, Nickel C, et al. Long-term effect of dutasteride on symptoms, BPH-specific health status and urinary flow rate abstract P-1.2.19. Br J Urol Int 2002;90 (Suppl 2):17
Roehrborn C. Dutasteride provides sustained and continued improvement in BPH-related symptoms over 4 years. AUA 2003
Roehrborn C. PSA is a significant predictor of objective parameters in men at risk for BPH progression. AUA 2003
Roehrborn CG, Andriole G, Nickel CJ, et al. Effect of Dutasteride, a novel dual 5alpha-reductase inhibitor, on BPH related signs and symptoms. AUA 2002
Roehrborn CG, Andriole G, Nickel CJ, et al. Effect of the dual 5alpha-reductase inhibitor Dutasteride on endocrine parameters. AUA 2002
Roehrborn CG, Andriole G, Nickel CJ, et al. Long-term effect of Dutasteride on symptoms, BPH-Specific Health Status and Urinary flow rate. SIU 2002
Roehrborn CG, Andriole G, Nickel CJ, et al. The impact of the dual 5alpha-reductase inhibitor Dutasteride on outcome of benign prostatic hyperplasia (BPH). SIU 2002
Roehrborn CG, Andriole G, Schalken J, et al. Dutasteride, a novel 5alpha-reductase inhibitor, reduces serum DHT to a greater extent versus finasteride and achieves finasteride maximal reduction in a larger proportion of patients. EAU 2003
Roehrborn CG, Boyle P, Gabriel H, et total and transition zone volume assessed by TRUS in men with clinical BPH. Journal of Urology 1999; 161: 1405al. Relationships between serum PSA,
Roehrborn CG, Boyle P, Nickel JC, et al. Efficacy and safety of a dual inhibitor of 5 alpha-reductase types 1 and 2 (dutasteride) in men with benign prostatic hyperplasia. Urology 2002; 60: 434-441.
Roehrborn CG, Clark R, Hobbs S, et al. Total and free PSA correlate with total prostate and transition zone volume in men aged >50 with BPH; GI198745 clinical trials. AUA 2001
Roehrborn CG, de la Rosette J, Andriole G. The utility of serial PSA measurements for the diagnosis of prostate cancer is preserved in men treated with the dual 5alpha-reductase inhibitor dutasteride. AUA 2004
Roehrborn CG, Dineen M, Bock D, et al. Change in symptom severity status in 4-year dutasteride studies in men with symptomatic BPH. AUA 2004
Roehrborn CG, Logie JW, Blackman N, Lamerato LE, Brown RR, Hoke GP. Racial differences in the risk of BPH progression and prostate cancer. AUA 2004
Roehrborn CG, Marks L, Fenter T, et al. Long-term dutasteride therapy results in continued improvements in symptoms and peak urinary flow in men with symptomatic benign prostatic hyperplasia. AUA 2004
Roehrborn CG, Ramsdell J, Siami P, et al. Prostate volume at baseline predicts the margin of therapeutic response with the 5alpha-reductase inhibitor, dutasteride. AUA 2002
Roehrborn CG, Ray P, Gittelman M, et al. The novel dual 5alpha-reductase inhibitor, Dutasteride, is effective and well-tolerated for benign prostatic hyperplasia in black men. EAU 2003
Roehrborn CG, Wilson T, Rittmaster R. Does Hypogonadism (T < 300 ng/dl) affect prostate function or response to dutasteride?: Analysis of data from dutasteride Phase III BPH studies. AUA 2004
Tammela T, Barkin J, Roehrborn CG. Long-term dutasteride therapy results in sustained reductions in total prostate volume in men with symptomatic benign prostatic hyperplasia. EAU 2004
Te A, Kaplan S. Dutasteride provides improvement in urodynamic parameters over 2 years: analysis of data from the Phase III dutasteride studies. AUA 2004
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2002-06-08
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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