| 1 |
NCT01957189 |
Completed |
This Will be an Open-label, Three-period, Fixed-sequence Study to Evaluate the Drug-drug Interaction, Pharmacokinetics and Safety of Dutasteride and Tamsulosin When Administered Alone and In-combination in Chinese Healthy Male Volunteers. The Study Will Last Approximately Eleven Weeks. Blood Samples |
|
- Drug: Dutasteride and Tamsulosin
|
Interventional
|
Phase 1 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To evaluate the pharmacokinetics of dutasteride and tamsulosin when dosed alone and in combination
- To evaluate the safety and tolerability of dutasteride and tamsulosin when administered alone and in combination.
|
24 |
Male |
18 Years to 45 Years (Adult) |
NCT01957189 |
200254 |
|
October 25, 2013 |
January 22, 2014 |
January 22, 2014 |
October 8, 2013 |
June 19, 2018 |
|
- GSK Investigational Site
Shanghai, China
|
|
| 2 |
NCT02578953 |
Completed |
Bioequivalence Study of Dutasteride Capsules in Healthy Japanese Male Subjects |
|
- Drug: Dutasteride-Test product
- Drug: Dutasteride-Reference product
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC 0-t) of dutasteride test product and reference product
- Maximal measured plasma concentration (Cmax) of dutasteride test product and reference product
- Number of subjects with adverse events
- (and 17 more...)
|
36 |
Male |
20 Years to 64 Years (Adult) |
NCT02578953 |
204646 |
|
September 9, 2015 |
December 15, 2015 |
December 15, 2015 |
October 19, 2015 |
June 19, 2018 |
|
- GSK Investigational Site
Fukuoka, Japan
|
|
| 3 |
NCT01525914 |
Completed |
Response of Patients on Surveillance for Prostate Cancer to Dutasteride |
|
|
Observational
|
|
- Sunnybrook Health Sciences Centre
- Toronto Sunnybrook Regional Cancer Centre
|
Other |
- Observational Model: Cohort
- Time Perspective: Retrospective
|
- change in serum PSA
- rate of secondary rise in serum PSA
|
100 |
Male |
18 Years and older (Adult, Older Adult) |
NCT01525914 |
CRT114918 |
|
May 2010 |
August 2010 |
August 2010 |
February 3, 2012 |
February 3, 2012 |
|
- Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
|
|
| 4 |
NCT00985738 |
Terminated
Has Results |
Role of Dutasteride in Patients Undergoing 3D Mapping Biopsy in Early Stage Prostate Cancer |
|
- Drug: Dutasteride
- Other: Placebo
|
Interventional
|
Phase 2 |
- University of Colorado, Denver
- GlaxoSmithKline
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- To Determine the Effect of Short-term Intake of Daily Dutasteride Prostate Cancer Volume, Distribution Within the Gland and Gleason Score Sum in Patients in Comparison to Placebo After Adjusting for Changes in Prostate Gland Volume.
|
16 |
Male |
40 Years to 85 Years (Adult, Older Adult) |
NCT00985738 |
09-0247.cc |
|
September 2009 |
January 2013 |
January 2013 |
September 28, 2009 |
May 17, 2016 |
April 18, 2016 |
- University of Colorado Hospital
Aurora, Colorado, United States
|
|
| 5 |
NCT03240939 |
Completed |
Pharmacokinetics and Safety/Tolerability of YY-201 in Comparison to Dutasteride and Tadalafil |
- Benign Prostatic Hyperplasia
|
- Drug: Dutasteride 0.5 mg
- Drug: Tadalafil 5 mg
- Drug: YY-201
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
|
36 |
Male |
19 Years to 45 Years (Adult) |
NCT03240939 |
YY-201_PK |
|
March 27, 2017 |
July 7, 2017 |
October 10, 2017 |
August 7, 2017 |
November 24, 2017 |
|
- Asan Medical Center
Seoul, Korea, Republic of
|
|
| 6 |
NCT01004809 |
Completed |
AVODART® Alopecia Post-marketing Surveillance (PMS) |
|
|
Observational
|
|
|
Industry |
- Observational Model: Other
- Time Perspective: Prospective
|
- Occurrence of adverse event after dutasteride administration
- Occurrence of unexpected adverse drug reaction after dutasteride administration
- Occurrence of serious adverse events after dutasteride administration
- Effectiveness of dutasteride judged by a physician
|
712 |
Male |
18 Years to 41 Years (Adult) |
NCT01004809 |
113797 |
AVODART®PMS |
April 29, 2010 |
December 1, 2012 |
December 21, 2012 |
October 30, 2009 |
June 19, 2018 |
|
- GSK Investigational Site
Daejeon, Korea, Republic of
|
|
| 7 |
NCT02509104 |
Completed |
Bioavailability Study of Fixed Dose Combination (FDC) Dutasteride and Tamsulosin Hydrochloride (HCl) Relative to One Dutasteride and One Tamsulosin HCl Tablet in Healthy Male Subjects |
|
- Drug: FDC capsule of dutasteride and tamsulosin
- Drug: Dutasteride soft gelatine capsule and tamsulosin HCl oral disintegrating tablet
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximum observed serum concentration (Cmax) for dutasteride and tamsulosin
- Area under the serum concentration-time curve (AUC) zero to time 't' (AUC[0-t]) for tamsulosin and dutasteride; AUC 0 to infinity (AUC 0-inf) will be determined for tamsulosin as data permit
- Time of occurrence of Cmax (Tmax) for dutasteride and tamsulosin
- (and 4 more...)
|
56 |
Male |
18 Years to 65 Years (Adult, Older Adult) |
NCT02509104 |
201897 |
|
July 30, 2015 |
October 10, 2015 |
October 10, 2015 |
July 27, 2015 |
June 19, 2018 |
|
- GSK Investigational Site
Baltimore, Maryland, United States
|
|
| 8 |
NCT00802321 |
Completed |
Pharmacokinetic Study of Single Dose Dutasteride in Healthy Subjects |
- Alcohol Related Disorders
- Alcoholism
- Alcohol Abuse
|
|
Interventional
|
Not Applicable |
- UConn Health
- National Institutes of Health (NIH)
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: Double (Participant, Care Provider)
|
- Change in 5AR enzyme activity as measured by the DHT/testosterone ratio and levels of 3a-androstanediol glucuronide as a function of time after a single loading dose of dutasteride.
- Secondary outcomes include the moderating effect of genetic variation in type I 5AR enzyme on DHT levels and any effects of dutasteride on subjects self report of alcohol use in their everyday life.
|
40 |
Male |
21 Years to 55 Years (Adult) |
NCT00802321 |
06-217S-2
620
5R01AA015606-02 |
|
April 2006 |
November 2006 |
November 2006 |
December 4, 2008 |
September 23, 2010 |
|
- Unversity of Connecticut Health Center
Farmington, Connecticut, United States
|
|
| 9 |
NCT01262287 |
Completed
Has Results |
Dutasteride for the Reduction of Alcohol Use in Male Drinkers |
- Alcoholism
- Alcohol Abuse
- Alcohol Dependence
|
- Drug: Dutasteride
- Drug: Placebo
|
Interventional
|
Phase 4 |
- UConn Health
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change Number of Standard Drinks Per Week.
- Change in Standard Drinks Per Week - Moderation by Genetic Variation
|
47 |
Male |
18 Years to 65 Years (Adult, Older Adult) |
NCT01262287 |
11-036-2
P60AA003510 |
|
January 2011 |
December 2012 |
December 2012 |
December 17, 2010 |
March 20, 2017 |
February 10, 2017 |
- University of Connecticut Health Center
Farmington, Connecticut, United States
|
|
| 10 |
NCT00706966 |
Completed
Has Results |
MRI and Magnetic Resonance Spectroscopy Imaging in Patients Receiving Dutasteride for Benign Prostatic Hypertrophy and Low-Risk Prostate Cancer |
- Nonmalignant Neoplasm
- Prostate Cancer
|
|
Interventional
|
Not Applicable |
- University of California, San Francisco
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Change in Extent of Cancer
- Adverse Events Indicative of Safety of Dutasteride
- Symptom Indices Over Time - IPSS
- (and 6 more...)
|
10 |
Male |
Child, Adult, Older Adult |
NCT00706966 |
CDR0000596822
UCSF-05551
H7056-26910-03 |
|
June 2005 |
December 2008 |
August 2011 |
June 30, 2008 |
January 17, 2014 |
January 17, 2014 |
- UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
|
|
| 11 |
NCT00805701 |
Completed |
Study Assessing The Efficacy And Safety Of Avodart (Dutasteride) At Improving Urinary Symptoms In Men With Prostate Cancer Who Are Undergoing Seed Implantation |
|
- Drug: avodart
- Drug: Placebo
|
Interventional
|
Phase 4 |
- Bay State Clinical Trials, Inc.
- GlaxoSmithKline
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- the effect of dutasteride on dysuria, voiding and LUTS
|
40 |
Male |
35 Years to 90 Years (Adult, Older Adult) |
NCT00805701 |
047838 |
|
January 2009 |
April 2014 |
April 2014 |
December 10, 2008 |
May 14, 2014 |
|
- Bay State Clinical Trials, Inc.
Watertown, Massachusetts, United States
|
|
| 12 |
NCT01831791 |
Completed
Has Results |
A Long-term Study to Determine Safety and Efficacy of Dutasteride in Male Subjects With Androgenetic Alopecia |
|
|
Interventional
|
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs)
- Number of Participants With Drug-related, Treatment-emergent AEs and AE Leading to Premature Study Drug Discontinuation and Possible Suicidality-related Adverse Event (PSRAE)
- Number of Participants With Change From Baseline in Breast Examination Results Any Time Post-Baseline Visit
- (and 20 more...)
|
120 |
Male |
20 Years to 50 Years (Adult) |
NCT01831791 |
114264 |
|
April 14, 2013 |
July 19, 2014 |
July 19, 2014 |
April 15, 2013 |
June 20, 2018 |
March 12, 2015 |
- GSK Investigational Site
Fukuoka, Japan - GSK Investigational Site
Osaka, Japan - GSK Investigational Site
Osaka, Japan - (and 2 more...)
|
|
| 13 |
NCT01758523 |
Completed |
Dutasteride Treatment for the Reduction of Heavy Drinking in Men |
- Alcoholism
- Alcohol Abuse
- Alcohol Dependence
|
- Drug: Dutasteride
- Drug: sugar pill
|
Interventional
|
Phase 4 |
- UConn Health
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Drinks per week and heavy drinking days per week
- Moderation of treatment effect by genetic variation in AKR1C3
- Moderation of treatment effect by genetic variation in SRD5A1 and SRD5A2
- Severity of alcohol-related problems
|
189 |
Male |
18 Years to 70 Years (Adult, Older Adult) |
NCT01758523 |
13-056-2
2P60AA003510 |
|
January 2013 |
February 28, 2018 |
February 28, 2018 |
January 1, 2013 |
August 31, 2018 |
|
- University of Connecticut Health Center
Farmington, Connecticut, United States
|
|
| 14 |
NCT01254071 |
Completed |
A Study to Determine the Bioavailability of a Fixed Dose Combination Product of Dutasteride (0.5mg) and Tamsulosin Hydrochloride (0.2mg) Relative to Co-administration of the Individual Components in Healthy Male Subjects of North East Asian and Non-Asian Ancestry. |
|
- Drug: Dutasteride (0.5mg); Tamsulosin hydrochloride (0.2mg); fixed dose combination product of duatsteride (0.5mg) and tamsulosin hydrochloride (0.2mg)
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- 1. To investigate the bioavailability of a combination capsule formulation of dutasteride 0.5 mg/ tamsulosin HCl 0.2 mg relative to concomitant dosing of dutasteride 0.5 mg capsules and tamsulosin 0.2 mg tablets in the fed and fasted states.
- 1. To investigate the effect of food on the bioavailability of a combination capsule formulation of dutasteride 0.5 mg/ tamsulosin HCl 0.2 mg relative to concomitant dosing of dutasteride 0.5 mg capsules and tamsulosin 0.2 mg tablets.
|
86 |
Male |
20 Years to 45 Years (Adult) |
NCT01254071 |
114694 |
ARI114694 |
September 10, 2010 |
December 21, 2010 |
December 21, 2010 |
December 6, 2010 |
June 12, 2017 |
|
- GSK Investigational Site
Randwick, New South Wales, Australia
|
|
| 15 |
NCT01657851 |
Completed |
Bioequivalence - Duodart Against Avodart & Omnic |
|
- Drug: dutasteride/tamsulosin
- Drug: dutasteride
- Drug: tamsulosin
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- bioequivalence of a Combination Capsule formulation of dutasteride 0.5 mg/ tamsulosin HCl 0.4 mg (Duodart® 0.5 mg/ 0.4 mg fixed combination) relative to concomitant dosing of Avodart® 0.5 mg and the Omnic® 0.4
- to evaluate the safety and tolerability of the Combination Capsule formulation of dutasteride 0.5 mg/ tamsulosin HCl 0.4 mg
|
35 |
Male |
18 Years to 45 Years (Adult) |
NCT01657851 |
116502 |
|
August 23, 2012 |
December 5, 2012 |
December 5, 2012 |
August 6, 2012 |
June 20, 2017 |
|
- GSK Investigational Site
Reutov, Moscow Region, Russian Federation
|
|
| 16 |
NCT01471678 |
Completed |
Bioavailability of Two Combination Products of Dutasteride (0.5mg) and Tamsulosin Hydrochloride (0.2mg) in Asian Males. |
|
- Drug: Dutasteride (0.5mg)
- Drug: FDC product of dutasteride (0.5mg) and tamsulosin HCl (0.2mg)
- Drug: Harnal D Tablets and Harnal Capsules (both comprising 0.2 mg tamsulosin HCl)
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Bioavailability of tamsulosin in 2 FDC formulations (Tamsulosin 0.2 mg and Dutasteride 0.5 mg) relative to co-administration of AVODART capsules with Harnal-D tablets or Harnal capsules in male subjects of Asian ancestry in the fed state
- Bioavailability of tamsulosin in one FDC formulation relative to the other FDC formulation (each capsule containing 0.2 mg tamsulosin HCl and 0.5 mg dutasteride) in healthy male subjects of Asian ancestry in the fed state.
- Safety and tolerability of dosing with one FDC formulation relative to the other FDC formulation (each capsule containing 0.2 mg tamsulosin HCl and 0.5 mg dutasteride) in healthy male subjects of Asian ancestry in the fed state
|
27 |
Male |
20 Years to 45 Years (Adult) |
NCT01471678 |
115707 |
ARI115707 |
June 30, 2011 |
September 7, 2011 |
September 7, 2011 |
November 16, 2011 |
June 19, 2018 |
|
- GSK Investigational Site
Randwick, New South Wales, Australia
|
|
| 17 |
NCT02014584 |
Completed
Has Results |
Sexual Function in Men Receiving Dutasteride for Androgenetic Alopecia |
|
- Drug: Dutasteride
- Drug: Placebo
|
Interventional
|
Phase 3 |
- Stiefel, a GSK Company
- GlaxoSmithKline
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Number of Participants With Adverse Events (AE) Related to Sexual Function in the Double-blind Treatment Period
- Number of Participants With AE Related to Sexual Function in the Open-label Treatment Period
- Number of Participants With AE Related to Sexual Function for the Double-blind and Open-label Combined Periods
- (and 55 more...)
|
117 |
Male |
18 Years to 50 Years (Adult) |
NCT02014584 |
200209 |
|
July 2, 2014 |
March 19, 2016 |
March 19, 2016 |
December 18, 2013 |
October 11, 2018 |
March 8, 2017 |
- GSK Investigational Site
Santiago, Región Metro De Santiago, Chile - GSK Investigational Site
Pokfulam, Hong Kong - GSK Investigational Site
Shatin, Hong Kong - (and 15 more...)
|
|
| 18 |
NCT00382356 |
Completed |
Dutasteride After Failure of Finasteride In the Management of Symptomatic Prostatic Enlargement/Hypertrophy (BPE/H) |
- Benign Prostatic Hypertrophy
|
|
Interventional
|
Not Applicable |
- North Florida/South Georgia Veterans Health System
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Urodynamic parameters (Qmax, Voided volume, and PVR) and AUASS
- To assess safety and tolerability of Dutasteride
|
20 |
Male |
50 Years and older (Adult, Older Adult) |
NCT00382356 |
AVODART-550-04 |
|
November 2004 |
July 2009 |
July 2009 |
September 29, 2006 |
October 19, 2012 |
|
|
|
| 19 |
NCT01673490 |
Terminated
Has Results |
Safety and Efficacy of 0.5mg Dutasteride and 0.4mg Tamsulosin Combination Once Daily for Six Months for Benign Prostatic Hyperplasia |
|
- Drug: Dutasteride/Tamsulosin
|
Interventional
|
Phase 4 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Participants With Any On-treatment Adverse Events (AEs) or Any Serious Adverse Event (SAEs) and Treatment-related AEs
- Number of Participants With Any Post-treatment Adverse Events (AEs) or Any Serious Adverse Event (SAEs) and Treatment-related AEs
- Number of Participants With Abnormal Electrocardiogram (ECG) Findings at the Indicated Time Points
- (and 7 more...)
|
59 |
Male |
50 Years and older (Adult, Older Adult) |
NCT01673490 |
114785 |
FDC114785 |
June 29, 2012 |
March 20, 2015 |
March 20, 2015 |
August 28, 2012 |
August 20, 2018 |
December 17, 2015 |
- GSK Investigational Site
Ho Chi Minh, Vietnam
|
|
| 20 |
NCT02052713 |
Completed |
Bioequivalence Study of the Second Generation Dutasteride and Tamsulosin Hydrochloride (HCL) Combination Capsule in Fasted State |
|
- Drug: Commercially available combination of dutasteride 0.5 mg and tamsulosin HCL 0.4 mg
- Drug: Second generation dutasteride 0.5 mg and tamsulosin HCL 0.4 mg combination capsule
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Pharmacokinetic (PK) profile of second generation dutasteride when co-administered with tamsulosin HCL relative to the commercial combination of dutasteride 0.5 mg and tamsulosin HCL 0.4 mg in the fed state to investigate bioequivalence
- Composite of PK parameters for tamsulosin HCl when it is co-administered with second generation dutasteride relative to the currently available commercial dutasteride 0.5 mg + tamsulosin HCL 0.4 mg in the fed state to investigate bioequivalence
- PK profile of dutasteride
- (and 4 more...)
|
78 |
Male |
18 Years to 50 Years (Adult) |
NCT02052713 |
116897 |
|
February 19, 2014 |
December 29, 2014 |
December 29, 2014 |
February 3, 2014 |
September 13, 2018 |
|
- GSK Investigational Site
Belfast, United Kingdom
|
|
| 21 |
NCT01929330 |
Completed |
Bioequivalence Study of Dutasteride Five 0.1 mg and One 0.5 mg Soft Gelatin Capsules in Healthy Male Volunteers |
|
- Drug: GI198745 0.1 mg
- Drug: GI198745 0.5 mg
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Serum pharmacokinetic (PK) parameters: maximum observed concentration (Cmax) and Area under the concentration-time curve from time zero to last time of quantifiable concentration within a subject (AUC[0-t]) for dutasteride
- Time to Cmax (tmax) for dutasteride as data permit
- Safety and tolerability of all treatments as assessed by vital signs, electrocardiogram (ECG) measurements, review of adverse events (AEs) and clinical laboratory safety data
|
36 |
Male |
18 Years to 65 Years (Adult, Older Adult) |
NCT01929330 |
117342 |
|
September 23, 2013 |
January 9, 2014 |
January 9, 2014 |
August 27, 2013 |
June 19, 2018 |
|
- GSK Investigational Site
Randwick, New South Wales, Australia
|
|
| 22 |
NCT01577693 |
Completed |
Study to Compare the Bioavailability of Dutasteride Novel Formulation Form to the Soft Gel Capsule Form in Healthy Male Subjects |
|
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
35 |
Male |
20 Years to 45 Years (Adult) |
NCT01577693 |
115148 |
ARI115148 |
May 12, 2011 |
August 31, 2011 |
August 31, 2011 |
April 16, 2012 |
June 19, 2018 |
|
- GSK Investigational Site
Austin, Texas, United States
|
|
| 23 |
NCT01299571 |
Completed
Has Results |
AVODART(Dutasteride) Post-marketing Surveillance(PMS) |
- Benign Prostatic Hyperplasia
- Prostatic Hyperplasia
|
|
Observational
|
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Number of Participants With an Adverse Event
- Number of Participants With a Serious Adverse Event
- Number of Participants With the Indicated Unexpected Adverse Events
|
3977 |
Male |
Child, Adult, Older Adult |
NCT01299571 |
105194 |
AVO PMS |
December 2004 |
July 2010 |
July 2010 |
February 18, 2011 |
July 5, 2017 |
April 18, 2011 |
- GSK Investigational Site
Seoul, Korea, Republic of
|
|
| 24 |
NCT00441116 |
Completed
Has Results |
A 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 |
|
- Drug: Dutasteride 0.5mg oral tablets
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 6 Months.
- Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 3 Months.
- Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost?
- (and 28 more...)
|
153 |
Male |
18 Years to 49 Years (Adult) |
NCT00441116 |
106377 |
|
December 15, 2006 |
January 21, 2008 |
January 21, 2008 |
February 28, 2007 |
August 16, 2018 |
April 22, 2009 |
|
|
| 25 |
NCT00853697 |
Completed |
Exogenous Testosterone Plus Dutasteride for the Treatment of Castrate Metastatic Prostate Cancer |
- Prostate Cancer
- Castration-resistant, Metastatic
|
- Other: testosterone (AndroGel®) with the 5α-reductase inhibitor dutasteride
|
Interventional
|
Phase 2 |
- Memorial Sloan Kettering Cancer Center
- GlaxoSmithKline
- University of Washington
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- determine anti-tumor effects of the combination of testosterone + dutasteride in pts with castration-resistant prostate ca, as indicated by the proportion of pts remaining alive & progression free
- To explore the association between AR expression in CRPC, as determined at baseline separately by AR FISH (performed on CTCs) and by 18F-FDHT uptake on PET scan, and progression free survival to the combination of testosterone plus dutasteride.
- To correlate post-treatment changes in CTCs and FDG and FDHT PET scans with post-treatment alterations in PSA and standard CT (or MRI) and bone scans.
|
6 |
Male |
18 Years and older (Adult, Older Adult) |
NCT00853697 |
09-008 |
|
March 2009 |
November 2012 |
November 2012 |
March 2, 2009 |
October 30, 2015 |
|
- Memorial Sloan-Kettering Cancer Center
New York, New York, United States
|
|
| 26 |
NCT02058576 |
Completed |
Bioequivalence Study of the Second Generation Dutasteride and Tamsulosin HCl Combination Capsule in Fed State |
|
- Drug: Commercially available combination of dutasteride 0.5 mg and tamsulosin HCL 0.4 mg
- Drug: Second generation dutasteride 0.5 mg and tamsulosin HCL 0.4 mg combination capsule
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Pharmacokinetic profile for second generation dutasteride when co-administered with tamsulosin HCL relative to the currently available commercial combination of dutasteride 0.5 mg and tamsulosin HCL 0.4 mg in the fed state to investigate bioequivalence
- Composite of PK parameters for tamsulosin HCL when it is co-adminstered with second generation dutasteride relative to the currently available commercial dutasteride 0.5 mg and tamsulosin HCL 0.4 mg in the fed state to investigate bioequivalence
- PK profile of dutasteride
- (and 4 more...)
|
77 |
Male |
18 Years to 50 Years (Adult) |
NCT02058576 |
116108 |
|
February 11, 2014 |
January 2, 2015 |
January 2, 2015 |
February 10, 2014 |
September 13, 2018 |
|
- GSK Investigational Site
Belfast, United Kingdom
|
|
| 27 |
NCT02213107 |
Active, not recruiting |
Enzalutamide & Dutasteride as 1st Line Treatment for Patients =/> 65 Years Old With Prostate Cancer. |
|
- Drug: Enzalutamide and Dutasteride
|
Interventional
|
Phase 2 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
40 |
All |
65 Years to 85 Years (Older Adult) |
NCT02213107 |
53018 |
|
September 2014 |
September 2019 |
September 2020 |
August 11, 2014 |
September 3, 2018 |
|
- University of Rochester
Rochester, New York, United States
|
|
| 28 |
NCT00553878 |
Completed |
Comparing 0.5 mg Dutasteride vs Placebo Daily in Men Receiving Androgen Ablation Therapy for Prostate Cancer |
|
|
Interventional
|
Phase 2
Phase 3 |
- Canadian Urology Research Consortium
- GlaxoSmithKline
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: Double (Participant, Care Provider)
- Primary Purpose: Prevention
|
- To assess whether repeat oral once daily dosing of dutasteride 0.5mg increases the length of the off treatment interval in men receiving intermittent androgen ablation therapy for localized prostate cancer
|
100 |
Male |
45 Years to 80 Years (Adult, Older Adult) |
NCT00553878 |
CURC/CUOG-AVIAS-0601 |
AVIAS |
March 2007 |
September 2009 |
December 2012 |
November 6, 2007 |
October 14, 2016 |
|
- Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
|
|
| 29 |
NCT00673127 |
Completed
Has Results |
Ketoconazole, Hydrocortisone and Dutasteride in Asymptomatic Hormone Refractory Prostate Cancer |
|
- Drug: Ketoconazole, Hydrocortisone and Dutasteride
|
Interventional
|
Phase 2 |
- Beth Israel Deaconess Medical Center
- Massachusetts General Hospital
- Dana-Farber Cancer Institute
- (and 4 more...)
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- PSA Response
- Time to Progression
|
57 |
Male |
18 Years and older (Adult, Older Adult) |
NCT00673127 |
04-414 |
KHAD |
February 2005 |
February 2012 |
December 2012 |
May 7, 2008 |
April 22, 2015 |
April 22, 2015 |
- Sidney Kimmel Comprehensive Cancer Center at John Hopkins University
Baltimore, Maryland, United States - Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States - Dana-Farber Cancer Institute
Boston, Massachusetts, United States - (and 4 more...)
|
|
| 30 |
NCT00880672 |
Completed |
Effect of Dutasteride on HIF-1alpha and VEGF in the Prostate |
- Benign Prostatic Hyperplasia
|
|
Interventional
|
Phase 4 |
- Seoul National University Hospital
- The Korean Urological Association
- GlaxoSmithKline
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- HIF-1a and VEGF expression
|
40 |
Male |
50 Years and older (Adult, Older Adult) |
NCT00880672 |
JHKu1 |
|
January 2008 |
December 2008 |
April 2009 |
April 14, 2009 |
June 12, 2013 |
|
|
|
| 31 |
NCT00827814 |
Completed |
Effect of Dutasteride on Bladder Wall Hypertrophy in Patients With Benign Prostatic Obstruction |
- Benign Prostatic Hyperplasia
|
|
Interventional
|
Phase 4 |
- Samsung Medical Center
- GlaxoSmithKline
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percent (numeric) changes in ultrasound-estimated bladder weight (UEBW)
- Urodynamic parameters
- Micturition diary efficacy parameters
- (and 6 more...)
|
36 |
Male |
50 Years to 79 Years (Adult, Older Adult) |
NCT00827814 |
2006-06-022 |
|
June 2006 |
April 2009 |
April 2009 |
January 23, 2009 |
June 11, 2009 |
|
- Samsung Medical Center
Seoul, Korea, Republic of
|
|
| 32 |
NCT00303446 |
Completed
Has Results |
Dutasteride to Treat Spinal and Bulbar Muscular Atrophy (SBMA) |
- Kennedy's Disease
- Spinal and Bulbar Muscular Atrophy
|
- Drug: Dutasteride
- Drug: Placebo
|
Interventional
|
Phase 2 |
- National Institute of Neurological Disorders and Stroke (NINDS)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Muscle Strength Change From Baseline
- Creatine Kinase, Change From Baseline
- Manual Muscle Testing, Change From Baseline.
- (and 12 more...)
|
57 |
Male |
18 Years and older (Adult, Older Adult) |
NCT00303446 |
060113
06-N-0113 |
|
March 2006 |
December 2009 |
December 2009 |
March 16, 2006 |
January 27, 2011 |
June 22, 2010 |
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
|
| 33 |
NCT00363311 |
Completed
Has Results |
Assessment Of Dutasteride (AVODART) In Extending The Time To Progression Of Low-Risk, Localized Prostate Cancer In Men |
|
- Drug: Dutasteride
- Drug: Matching placebo
|
Interventional
|
Phase 4 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Number of Participants With Prostate Cancer (PCa) Progression [Restricted Crude Rate Analysis: Number of Participants With PCa Divided by Number of Participants in the Intent-to-Treat (ITT) Population Who Had >=1 Post-baseline Biopsy or Had a Progression
- Number of Participants With Therapeutic Progression
- Number of Participants With Pathologic Progression
- (and 27 more...)
|
302 |
Male |
50 Years to 80 Years (Adult, Older Adult) |
NCT00363311 |
AVO105948 |
|
July 2006 |
March 2010 |
July 2010 |
August 15, 2006 |
January 18, 2017 |
June 14, 2011 |
- GSK Investigational Site
Little Rock, Arkansas, United States - GSK Investigational Site
Beverly Hills, California, United States - GSK Investigational Site
Laguna Hills, California, United States - (and 79 more...)
|
|
| 34 |
NCT00668642 |
Completed |
Effect of Dutasteride on Androgen-Response Gene Expression in Patients With Advanced Prostate Cancer |
|
- Drug: Dutasteride
- Drug: Placebo
|
Interventional
|
Phase 2 |
- NorthShore University HealthSystem Research Institute
- University of Chicago
- Northwestern University
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Level of U19 gene expression in tumor from prostate gland.
- Determination of PSA doubling time during off-phase of treatment
|
21 |
Male |
18 Years and older (Adult, Older Adult) |
NCT00668642 |
EH07-109 |
|
March 2007 |
May 2013 |
May 2013 |
April 29, 2008 |
February 14, 2014 |
|
- Northwestern University Medical Center
Chicago, Illinois, United States - University of Chicago Hospitals and Clinics
Chicago, Illinois, United States - NorthShore University HealthSystem
Evanston, Illinois, United States
|
|
| 35 |
NCT02839122 |
Completed |
A Study to Investigate the Pharmacokinetic Drug Interactions Between Dutasteride and Tadalafil in Healthy Male Subjects |
- Benign Prostate Hyperplasia
|
- Drug: Tadalafil
- Drug: Dutasteride
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Area Under the Curve(AUC) of Dutasteride
- Area Under the Curve(AUC) of Tadalafil, Dutasteride
|
28 |
Male |
19 Years to 45 Years (Adult) |
NCT02839122 |
YY_DUTA_2016 |
|
May 2016 |
September 2016 |
September 23, 2016 |
July 20, 2016 |
April 4, 2017 |
|
|
|
| 36 |
NCT00780754 |
Completed |
Prevention of Prostate Cancer With Dutasteride in Case of High Grade PIN Neoplasia |
|
- Drug: dutasteride
- Procedure: prostate biopsy
|
Interventional
|
Phase 3 |
- Kaunas University of Medicine
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- rate of prostate cancer at repeated transrectal ultrasound guided biopsies in case of HPIN
- effect of 5 alfa reductase inhibitor (dutasteride) on prevention of prostate cancer development for patients with high grade intraepithelial neoplasia (HPIN).
|
200 |
Male |
40 Years to 80 Years (Adult, Older Adult) |
NCT00780754 |
BE-2-27 |
|
April 2007 |
December 2010 |
December 2010 |
October 28, 2008 |
March 6, 2018 |
|
- Urology dep. of Kaunas University of Medicine
Kaunas, Lithuania
|
|
| 37 |
NCT00400335 |
Completed |
Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride |
- Hypogonadism
- Hypogonadism, Male
|
- Drug: Nanomilled testosterone
- Drug: commercially available dutasteride
- Drug: Nanomilled dutasteride
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- lab tests for relative bioavailability of testosterone and dutasteride,
- safety lab tests of various testosterone/dutasteride formulations,
- lab tests for additional pharmacokinetic parameters for testosterone & dutasteride,
|
60 |
Male |
18 Years to 50 Years (Adult) |
NCT00400335 |
TDC106222 |
|
October 2006 |
|
|
November 16, 2006 |
June 4, 2012 |
|
- GSK Investigational Site
Tacoma, Washington, United States
|
|
| 38 |
NCT00194675 |
Completed
Has Results |
TRADE-Testosterone Replacement and Dutasteride Effectiveness |
- Hypogonadism
- Benign Prostatic Hyperplasia
|
- Drug: Dutasteride
- Drug: Testosterone gel
- Drug: Placebo dutasteride
|
Interventional
|
Phase 4 |
- University of Washington
- GlaxoSmithKline
- Seattle Institute for Biomedical and Clinical Research
- (and 2 more...)
|
Other / Industry / U.S. Fed |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Effects of Testosterone Gel Alone or in Combination With Oral Dutasteride on Prostate Volume in Hypogonadal Men With Benign Prostatic Hyperplasia.
- Serum and Intraprostatic Hormone Levels: Prostate Specific Antigen (PSA)
- The Effects of T Alone or in Combination With Dutasteride on Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) in Hypogonadal Men With Benign Prostatic Hyperplasia. (International Prostate Symptom Score)
- (and 3 more...)
|
53 |
Male |
50 Years and older (Adult, Older Adult) |
NCT00194675 |
01166
01166, 4-2280-V |
TRADE |
March 2005 |
April 2010 |
December 2010 |
September 19, 2005 |
December 5, 2017 |
August 20, 2012 |
- VA Puget Sound Health Care System
Seattle, Washington, United States
|
|
| 39 |
NCT00701779 |
Completed
Has Results |
Dutasteride and Flex Dose of Tamsulosin on as Needed Basis, to Treat Benign Prostatic Hyperplasia |
- Benign Prostatic Hyperplasia
|
|
Interventional
|
Phase 4 |
- Siami, Paul F., M.D.
- GlaxoSmithKline
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- International Prostate Symptom Score
- Peak Flow Rate (QMax)
- Benign Prostate Hyperplasia Impact Index
- (and 6 more...)
|
63 |
Male |
50 Years and older (Adult, Older Adult) |
NCT00701779 |
Siami104907 |
|
September 2005 |
July 2009 |
July 2009 |
June 19, 2008 |
November 2, 2018 |
January 1, 2015 |
- Research Institute of Deaconess Clinic
Evansville, Indiana, United States
|
|
| 40 |
NCT01368003 |
Withdrawn |
STA-9090 in Castration-Resistant Prostate Cancer With Assessment of Androgen Receptor Pathway Signaling |
- Adenocarcinoma of the Prostate
|
- Drug: STA9090
- Drug: STA9090 with Dutasteride
|
Interventional
|
Phase 2 |
- Toni Choueiri, MD
- Dana-Farber Cancer Institute
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To assess AR transcriptional activity based on expression of a series of AR regulated genes, in baseline and on therapy tumor biopsies in CRPC patients treated with STA- 9090 +/-dutasteride.
- To assess the safety and tolerability of STA9090 in men the CRPC
- To evaluate progression-free survival (PFS) of men with CRPC treated with STA9090 with or without dutasteride
- (and 2 more...)
|
0 |
Male |
18 Years and older (Adult, Older Adult) |
NCT01368003 |
10-333 |
|
April 2011 |
November 2012 |
November 2012 |
June 7, 2011 |
September 1, 2015 |
|
- Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States - Dana-Farber Cancer Institute
Boston, Massachusetts, United States
|
|
| 41 |
NCT00939120 |
Completed
Has Results |
Dutasteride With Tolterodine ER or Placebo to Treat Lower Urinary Tract Symptoms (LUTS) |
- Benign Prostatic Hyperplasia (BPH)
|
- Drug: Tolterodine ER 4mg
- Drug: Placebo
- Drug: Pre-randomization Dutasteride
|
Interventional
|
Phase 4 |
- Siami, Paul F., M.D.
- GlaxoSmithKline
- Pfizer
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Post-void Residual (PVR) Volume
- Maximum Urine Flow Rate (Qmax).
- Urine Voided Volume (Voiding)
- (and 6 more...)
|
46 |
Male |
50 Years and older (Adult, Older Adult) |
NCT00939120 |
110983 |
LUTS |
July 2009 |
September 2014 |
September 2014 |
July 14, 2009 |
May 1, 2015 |
May 1, 2015 |
- Deaconess Clinic Gateway Health Center
Newburgh, Indiana, United States
|
|
| 42 |
NCT00866554 |
Unknown † |
Efficacy and Toxicity of Bicalutamide and Dutasteride vs. Standard Care for Prostate Cytoreduction for Brachytherapy |
- Prostate Cancer
- Erectile Dysfunction
- Lower Urinary Tract Symptoms
|
- Drug: administration of a LHRH agonist and Bicalutamide
- Drug: administration of Bicalutamide, Dutasteride and Tamoxifen
|
Interventional
|
Phase 2 |
- CHU de Quebec-Universite Laval
- GlaxoSmithKline
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Investigator)
- Primary Purpose: Treatment
|
- Total prostate volume
- EPIC questionnaire urinary function and bother scores
- EPIC questionnaire sexual function and bother scores
- (and 11 more...)
|
88 |
Male |
18 Years and older (Adult, Older Adult) |
NCT00866554 |
DUT112661
Health Canada-112661 |
|
March 2009 |
June 2015 |
December 2015 |
March 20, 2009 |
April 16, 2015 |
|
- CHUQ- Hotel-Dieu de Quebec
Quebec, Canada
|
|
| 43 |
NCT00090103 |
Completed
Has Results |
Benign Prostatic Hyperplasia Trial With Dutasteride And Tamsulosin Combination Treatment |
|
- Drug: dutasteride 0.5mg once daily for 4 years
- Drug: tamsulosin 0.4mg once daily for 4 years
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Number of Events of Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery at the Indicated Time Periods.
- Number of Participants With AUR or BPH-related Surgery
- Number of Events of First BPH Clinical Progression at Years 1, 2, 3 and 4
- (and 28 more...)
|
4844 |
Male |
50 Years and older (Adult, Older Adult) |
NCT00090103 |
ARI40005 |
|
November 2003 |
April 2009 |
April 2009 |
August 26, 2004 |
February 28, 2017 |
March 16, 2010 |
- GSK Investigational Site
Birmingham, Alabama, United States - GSK Investigational Site
Birmingham, Alabama, United States - GSK Investigational Site
Birmingham, Alabama, United States - (and 501 more...)
|
|
| 44 |
NCT01393730 |
Completed
Has Results |
Abiraterone Acetate Combined With Dutasteride for Metastatic Castrate Resistant Prostate Cancer |
|
- Drug: Abiraterone acetate
- Drug: Dutasteride
- Drug: Prednisone
|
Interventional
|
Phase 2 |
- Mary-Ellen Taplin, MD
- Dana-Farber Cancer Institute
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Participants With Androgen Receptor (AR) Related Mutations
- Change in Serum Levels of Testosterone
- Prostate-Specific Antigen (PSA) Response
- (and 6 more...)
|
40 |
Male |
18 Years and older (Adult, Older Adult) |
NCT01393730 |
10-448 |
|
September 2011 |
January 2016 |
March 15, 2017 |
July 13, 2011 |
March 15, 2018 |
June 14, 2017 |
- Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States - Dana-Farber Cancer Institute
Boston, Massachusetts, United States - Seattle Cancer Care Alliance
Seattle, Washington, United States - University of Washington Medical Center
Seattle, Washington, United States
|
|
| 45 |
NCT00527605 |
Completed
Has Results |
Dutasteride 0.5mg For The Treatment Of Chinese Patients With Benign Prostatic Hyperplasia (BPH) |
- Benign Prostatic Hyperplasia
- Prostatic Hyperplasia
|
- Drug: Dutasteride 0.5mg capsule
- Drug: Dutasteride matched placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Percent Change From Baseline in the Prostate Volume at Month 6
- Percent Change From Baseline in the Prostate Volume at Month 3
- Change From Baseline in the Prostate Volume at Month 6
- (and 13 more...)
|
253 |
Male |
50 Years and older (Adult, Older Adult) |
NCT00527605 |
ARI108898 |
|
October 2007 |
March 2009 |
March 2009 |
September 11, 2007 |
March 21, 2012 |
March 11, 2010 |
- GSK Investigational Site
Guangzhou, Guangdong, China - GSK Investigational Site
Wuhan, Hubei, China - GSK Investigational Site
Nanjing, Jiangsu, China - (and 9 more...)
|
|
| 46 |
NCT00368979 |
Completed
Has Results |
Dutasteride (GI198745) In Benign Prostatic Hyperplasia Subjects |
|
- Drug: Dutasteride
- Drug: Placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Change From Baseline in International Prostate Symptom Score (IPSS) at Week 52
- Percent Change From Baseline in Prostate Volume at Week 52
- Number of Participants With IPSS Improvement From Baseline at Week 52
- (and 2 more...)
|
378 |
Male |
50 Years and older (Adult, Older Adult) |
NCT00368979 |
ARI105326 |
|
February 17, 2006 |
December 1, 2007 |
December 6, 2007 |
August 29, 2006 |
September 26, 2018 |
April 2, 2009 |
- GSK Investigational Site
Chiba, Japan - GSK Investigational Site
Chiba, Japan - GSK Investigational Site
Chiba, Japan - (and 23 more...)
|
|
| 47 |
NCT00062790 |
Completed |
Effect Of Dutasteride On Intraprostatic Dihydrotestosterone (DHT) Levels |
|
|
Interventional
|
Phase 4 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- Effect of repeat oral daily dosing of 0.5mg dutasteride compared to placebo on prostate tissue content of DHT in patients treated for 3 months prior to transurethral resection of the prostate (TURP).
- Effect of repeat oral once daily dosing of 0.5mg dutasteride compared to placebo on prostatic tissue content of testosterone.
- Changes in serum DHT (dihydrotestosterone) and T (testosterone).
|
50 |
Male |
50 Years and older (Adult, Older Adult) |
NCT00062790 |
ARI40014 |
|
October 2003 |
|
July 2005 |
June 17, 2003 |
September 15, 2016 |
|
- GSK Investigational Site
Long Beach, California, United States - GSK Investigational Site
New Britain, Connecticut, United States - GSK Investigational Site
Trumbull, Connecticut, United States - (and 8 more...)
|
|
| 48 |
NCT00558363 |
Completed
Has Results |
ARTS - AVODART After Radical Therapy For Prostate Cancer Study |
- Neoplasms, Prostate
- Prostate Cancer After a Radical Treatment
|
- Drug: Avodart
- Other: placebo
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Time to Prostate-specific Antigen (PSA) Doubling From Baseline (in Days)
- Number of Participants With PSA Doubling From Baseline
- Time to PSA Doubling From Baseline (in Days) Within Year 1
- (and 20 more...)
|
294 |
All |
18 Years to 85 Years (Adult, Older Adult) |
NCT00558363 |
ARI109924 |
ARTS |
November 2007 |
December 2010 |
March 2011 |
November 14, 2007 |
March 21, 2012 |
December 13, 2011 |
- GSK Investigational Site
Tallinn, Estonia - GSK Investigational Site
Tallinn, Estonia - GSK Investigational Site
Kouvola, Finland - (and 63 more...)
|
|
| 49 |
NCT01495026 |
Completed |
A Study Assessing a Range of Formulations of the Fixed Dose Combination Product Containing Dutasteride (0.5mg) and Tamsulosin Hydrochloride (0.2mg) to Find a Formulation Which is Bioequivalent to Harnal-D Tablets (Tamsulosin Hydrochloride, 0.2mg) in Healthy Male Subjects From North East Asia |
|
- Drug: Dutasteride (0.5mg, fasted state)
- Drug: Dutasteride (0.5mg, fed state)
- Drug: Fixed dose combination capsule containing dutasteride 0.5mg and tamsulosin 0.2mg (fasted state)
- (and 4 more...)
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Relative bioavailability of tamsulosin from FDC products (0.5 mg dutasteride /0.2 mg tamsulosin HCl) containing a size 3-oblong dutasteride soft gel capsule and tamsulosin pellets having a range of tamsulosin release rates produced by different mixtures
- Effect of food on the relative bioavailability of tamsulosin in a selected FDC product in healthy male subjects of North East Asian ancestry
- Effect of water on the relative bioavailability of tamsulosin in Harnal-D Tablets in the fasted state in healthy male subjects of North East Asian ancestry.
- Safety and tolerability of dosing with the different FDC capsule formulations in healthy male subjects of North East Asian ancestry
|
63 |
Male |
20 Years to 45 Years (Adult) |
NCT01495026 |
115708 |
|
November 6, 2011 |
April 3, 2012 |
April 3, 2012 |
December 19, 2011 |
June 19, 2018 |
|
- GSK Investigational Site
Randwick, New South Wales, Australia
|
|
| 50 |
NCT00398281 |
Completed |
Dutasteride Followed By Ultrasound-Guided Biopsy in Finding Prostate Cancer |
|
- Drug: dutasteride
- Other: placebo
|
Interventional
|
Phase 3 |
- Sidney Kimmel Cancer Center at Thomas Jefferson University
- National Cancer Institute (NCI)
|
Other / NIH |
- Allocation: Randomized
- Masking: Double
- Primary Purpose: Diagnostic
|
- Efficacy of short-term dutasteride in improving prostate cancer detection
- Detection rate of prostate cancer
- Cost effectiveness of contrast-enhanced ultrasound
|
450 |
Male |
18 Years to 80 Years (Adult, Older Adult) |
NCT00398281 |
CDR0000513051
TJUH-06F-145 |
|
November 2006 |
July 2010 |
September 2012 |
November 10, 2006 |
January 10, 2014 |
|
- Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States
|
|
| 51 |
NCT00398580 |
Completed |
28-Day Study of Testosterone Co-administered With Dutasteride in Hypogonadal Men |
- Hypogonadism
- Hypogonadism, Male
|
- Drug: Nanomilled testosterone
- Drug: Nanomilled dutasteride
- Drug: commercially available dutasteride
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Safety measured by: monitoring laboratory tests changes in blood pressure and heart rate and heart activity on an ECG machine
- Testosterone concentration .
- Pharmacokinetics of testosterone, DHT, estradiol, estrone & dutasteride
- Anabolic & androgenic Pharmacodynamic biomarkers
|
43 |
Male |
18 Years to 70 Years (Adult, Older Adult) |
NCT00398580 |
TDC106220 |
|
October 2006 |
October 2007 |
October 2007 |
November 10, 2006 |
May 30, 2017 |
|
- GSK Investigational Site
Torrance, California, United States - GSK Investigational Site
Louisville, Kentucky, United States - GSK Investigational Site
Baltimore, Maryland, United States - (and 4 more...)
|
|
| 52 |
NCT02184585 |
Completed |
Comparative Bioavailability of Two Fixed Dose Combination (FDC) Formulations of Dutasteride and Tamsulosin Hydrochloride Relative to Co-administration of Dutasteride With Tamsulosin Hydrochloride in Healthy Male Subjects Under Fed and Fasted States |
|
- Drug: Treatment sequence A
- Drug: Treatment sequence B
- Drug: Treatment sequence C
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Area under the curve from 0 to the time of the last quantifiable concentration (AUC[0-t]) of tamsulosin in serum
- Area under the curve from 0 to infinity (AUC[0-infinity]) of tamsulosin in serum
- Maximum drug concentration (Cmax) of dutasteride in serum
- (and 7 more...)
|
84 |
Male |
18 Years to 65 Years (Adult, Older Adult) |
NCT02184585 |
117057 |
|
July 10, 2014 |
February 23, 2015 |
February 23, 2015 |
July 9, 2014 |
June 19, 2018 |
|
- GSK Investigational Site
Baltimore, Maryland, United States
|
|
| 53 |
NCT00431626 |
Terminated
Has Results |
A Clinical Trial Comparing Laser TURP With and Without Dutasteride. |
- Benign Prostatic Hyperplasia
|
- Drug: Dutasteride (Avodart)
- Drug: Placebo
|
Interventional
|
Phase 3 |
- Northwestern University
- GlaxoSmithKline
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Primary Outcome Measure Will be the 5 Point Change in AUA Symptom Index
|
4 |
Male |
50 Years and older (Adult, Older Adult) |
NCT00431626 |
0348-040 |
|
October 2006 |
April 2009 |
April 2009 |
February 6, 2007 |
October 28, 2015 |
January 1, 2015 |
|
|
| 54 |
NCT02352311 |
Unknown † |
Safety and Pharmacokinetic Characteristics of DKF-313 |
- Benign Prostate Hyperplasia
- Healthy
|
- Drug: DKF-313
- Drug: AVODART
- Drug: CIALIS
|
Interventional
|
Phase 1 |
- Dongkook Pharmaceutical Co., Ltd.
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
|
- AUClast and Cmax of dutasteride and tadalafil
|
54 |
Male |
19 Years to 29 Years (Adult) |
NCT02352311 |
DK-DT-002 |
|
January 2015 |
June 2015 |
June 2015 |
February 2, 2015 |
February 3, 2015 |
|
- Chonbuk National University Hospital
Jeonju, Jeollabuk-do, Korea, Republic of
|
|
| 55 |
NCT01653925 |
Active, not recruiting |
Molecular Mechanisms of Dutasteride and Dietary Interventions to Prevent Prostate Cancer and Reduce Its Progression |
- Prostatic Neoplasms
- Low Grade Prostate Cancer
|
- Other: Dietary intervention first
- Drug: Drug (Dutasteride) intervention first
|
Interventional
|
Not Applicable |
- CHU de Quebec-Universite Laval
- Prostate Cancer Canada
|
Other |
- Allocation: Randomized
- Intervention Model: Factorial Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Effects of the Interventions on Lipid Metabolism From Blood and Prostatic Microenvironment
- Effect of Interventions on Gene Expression Profile
- Effects of Interventions on Hormonal Metabolism
- Determine the Clinical Utility of Urine-Based Cancer Markers in the Context of Interventions to Reduce Cancer Progression
|
120 |
Male |
35 Years to 75 Years (Adult, Older Adult) |
NCT01653925 |
INAF-2010-H09-10-114 |
|
November 2010 |
June 2019 |
December 2019 |
July 31, 2012 |
November 9, 2018 |
|
- Hotel-Dieu of Quebec
Quebec, Canada - Institute of nutraceuticals and functional food of Laval University
Quebec, Canada
|
|
| 56 |
NCT01231607 |
Completed
Has Results |
Dutasteride Versus Placebo and Finasteride in Men With Androgenetic Alopecia |
|
- Drug: 1mg Finasteride active
- Drug: 0.02mg dutasteride
- Drug: 0.1mg dutasteride
- (and 3 more...)
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change From Baseline (BL) in Target Area Hair Count (HC) Within a 2.54 Centimeter (cm) (1 Inch) Diameter Circle at the Vertex at Week 24, as Assessed by Macrophotographic Technique (MT)
- Change From Baseline in Target Area Hair Count Within a 1.13 cm (0.44 Inch) Diameter Circle at the Vertex at Week 24, as Assessed by MT
- Change From Baseline in Target Area Hair Count Within a 2.54 cm (1 Inch) Diameter Circle at the Vertex at Week 12 as Assessed by MT
- (and 14 more...)
|
917 |
Male |
20 Years to 50 Years (Adult) |
NCT01231607 |
114263 |
|
October 28, 2010 |
February 1, 2012 |
February 28, 2012 |
November 1, 2010 |
August 10, 2018 |
October 4, 2012 |
- GSK Investigational Site
Caba, Buenos Aires, Argentina - GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina - GSK Investigational Site
La Boca, Buenos Aires, Argentina - (and 36 more...)
|
|
| 57 |
NCT00752869 |
Completed |
Efficacy Study for Use of Dutasteride (Avodart) With Testosterone Replacement |
|
- Drug: dutasteride
- Drug: placebo
|
Interventional
|
Phase 4 |
- The Miriam Hospital
- GlaxoSmithKline
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- PSA reduction
- PV reduction with up to 12 months of treatment
- DHT and T levels: serum
- (and 2 more...)
|
24 |
Male |
40 Years to 85 Years (Adult, Older Adult) |
NCT00752869 |
GSK 111504
FDA IND # 101,619 |
DUT/T |
September 2008 |
March 2012 |
March 2012 |
September 16, 2008 |
February 26, 2013 |
|
- Men's Health Boston
Boston, Massachusetts, United States - The Miriam Hospital
Providence, Rhode Island, United States
|
|
| 58 |
NCT01428869 |
Completed |
Combination Statin, Acetylsalicylic Acid and Dutasteride Use in Prostate Cancer |
|
|
Observational
|
|
- University Health Network, Toronto
|
Other |
- Time Perspective: Retrospective
|
- Diagnosis of Prostate Cancer
- Diagnosis of High Grade Prostate Cancer
- Improvement of Lower Urinary Tract Symptoms
|
8231 |
Male |
Child, Adult, Older Adult |
NCT01428869 |
10-1000AE |
|
August 2011 |
|
August 2011 |
September 5, 2011 |
September 9, 2011 |
|
- University Health Network
Toronto, Ontario, Canada
|
|
| 59 |
NCT01473030 |
Active, not recruiting |
Long-term Effects of Dutasteride on Architectural and Nuclear Morphometric Features of Benign Prostate Tissue |
|
|
Observational
|
|
- University of Illinois at Chicago
- GlaxoSmithKline
|
Other / Industry |
- Observational Model: Case-Control
- Time Perspective: Cross-Sectional
|
- Architectural Features
- Morphometric features
- Independent changes in architecture and morphometry
- Changes in cytomorphology
|
80 |
Male |
50 Years to 75 Years (Adult, Older Adult) |
NCT01473030 |
2011-0646 |
|
November 2011 |
December 2017 |
December 2018 |
November 17, 2011 |
November 6, 2017 |
|
- University of Illinois at Chicago
Chicago, Illinois, United States
|
|
| 60 |
NCT00082043 |
Completed |
Dutasteride to Treat Women With Menstrually Related Mood Disorders |
- Premenstrual Syndrome
- PMS
- Healthy
- Depression
|
- Drug: Dutasteride
- Drug: Placebo oral capsule
|
Interventional
|
Phase 1 |
- National Institute of Mental Health (NIMH)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Rating Scale for Premenstrual Tension (PMTS); Daily symptom rating form (DRF); Visual Analogue Symptom (VAS) self-rating form.
- Neuroendocrine response to DEX/crh test; Beck Depression Inventory (BDI)
|
34 |
Female |
30 Years to 50 Years (Adult) |
NCT00082043 |
040139
04-M-0139 |
|
March 31, 2004 |
March 6, 2014 |
March 6, 2014 |
April 28, 2004 |
March 13, 2019 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
|
| 61 |
NCT00403000 |
Completed |
Dutasteride in Treating Patients With Recurrent Prostate Cancer That Did Not Respond to Androgen-Deprivation Therapy |
|
|
Interventional
|
Phase 2 |
- Roswell Park Cancer Institute
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Time to disease progression
- Toxicity
- Objective response (complete and partial) rate and serum prostate-specific antigen levels
- Survival
|
27 |
Male |
18 Years and older (Adult, Older Adult) |
NCT00403000 |
CDR0000514492
RPCI-I-34904 |
|
December 2004 |
March 2007 |
April 2013 |
November 23, 2006 |
May 1, 2013 |
|
- Roswell Park Cancer Institute
Buffalo, New York, United States
|
|
| 62 |
NCT02058368 |
Completed |
Study to Compare the Efficacy and Safety of Combination Treatment With Dutasteride and Tamsulosin With Tamsulosin Monotherapy, in Men With Moderate to Severe Benign Prostatic Hyperplasia |
|
- Drug: Dutasteride 0.5mg capsules
- Drug: Dutasteride placebo capsules
- Drug: Tamsulosin 0.2mg tablets
- Drug: Disintegrating placebo tamsulosin tablet
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Change From Baseline in the International Prostate Symptom Score (IPSS) at Year 2
- Percentage change from Baseline in Prostate Volume
- Proportion of subjects with IPSS improvement of >=2 points and >=3 points from baseline and, separately, >=25% improvement from Baseline
- (and 5 more...)
|
609 |
Male |
50 Years and older (Adult, Older Adult) |
NCT02058368 |
114265 |
|
February 10, 2014 |
March 3, 2017 |
March 3, 2017 |
February 10, 2014 |
April 5, 2017 |
|
- GSK Investigational Site
Xiame, Fujian, China - GSK Investigational Site
Guangzhou, Guangdong, China - GSK Investigational Site
Wuhan, Hubei, China - (and 43 more...)
|
|
| 63 |
NCT00274417 |
Unknown † |
Dutasteride for Improving Peri-Operative and Long-Term Outcomes of Photoselective Vaporization of the Prostate (DOP) |
- Benign Prostatic Hyperplasia
- Lower Urinary Tract Symptoms
|
|
Interventional
|
Not Applicable |
- Urology of Virginia
- GlaxoSmithKline
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- Change in American Urologic Association Sympton Score
- Change in BPH Quality of Life
- Change in urinary flow rate
- (and 5 more...)
|
60 |
Male |
50 Years and older (Adult, Older Adult) |
NCT00274417 |
UVA-001 |
|
January 2006 |
|
May 2009 |
January 10, 2006 |
April 18, 2007 |
|
- Urology of Virginia
Norfolk, Virginia, United States - Urology of Virginia
Virginia Beach, Virginia, United States
|
|
| 64 |
NCT00421421 |
Terminated |
Effects Of Dutasteride On Risk Reduction Of Acute Urinary Retention Relapse Following Trial Without Catheter |
- Benign Prostatic Hyperplasia
|
|
Interventional
|
Phase 4 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- Acute Urinary Retention (AUR) relapse rate during the 24 week treatment period
- Benign prostatic hyperplasia (BPH) related surgical intervention rates during study IPSS score during study Relationship between length of time of catheter in situ and Intravesical prostatic protrusion measurements on relapse rates
|
276 |
Male |
50 Years and older (Adult, Older Adult) |
NCT00421421 |
ARI106807 |
|
March 2007 |
|
|
January 12, 2007 |
November 27, 2007 |
|
- GSK Clinical Trials Call Center
Barnet, United Kingdom - GSK Clinical Trials Call Center
Bath, United Kingdom - GSK Clinical Trials Call Centre
Birmingham, United Kingdom - (and 22 more...)
|
|
| 65 |
NCT00399165 |
Completed |
Oral Androgens in Man-4: (Short Title: Oral T-4) |
|
- Drug: Testosterone Enanthate
- Drug: Dutasteride
- Other: placebo sesame oil
|
Interventional
|
Phase 1
Phase 2 |
- University of Washington
- GlaxoSmithKline
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Dutasteride can suppress the secretion of LH and FSH after four weeks of administration.
- The ability of oral testosterone enanthate plus dutasteride to maintain short-term androgen-medicated endpoints such as mood and sexual function over the 4-week treatment period
|
20 |
Male |
18 Years to 55 Years (Adult) |
NCT00399165 |
06-2962-A
U54HD042454
K23HD045386 |
|
November 2006 |
May 2007 |
May 2007 |
November 14, 2006 |
September 22, 2008 |
|
- University of Washington
Seattle, Washington, United States
|
|
| 66 |
NCT01942551 |
Completed |
Safety and Pharmacokinetic Interaction Study of Tadalafil and Dutasteride |
- Benign Prostate Hyperplasia
|
- Drug: Tadalafil
- Drug: Dutasteride
|
Interventional
|
Phase 1 |
- Dongkook Pharmaceutical Co., Ltd.
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
|
- Area Under Curve (AUC) of tadalafil
- Cmax of tadalafil
- Area Under Curve (AUC) of dutasteride
- Cmax of dutasteride
|
47 |
Male |
20 Years to 29 Years (Adult) |
NCT01942551 |
DK-DT-001 |
|
September 2013 |
December 2013 |
December 2013 |
September 16, 2013 |
January 26, 2015 |
|
- Chungnam National University Hospital
Daejeon, Korea, Republic of
|
|
| 67 |
NCT00969072 |
Completed |
Extension Study of GI198745 to Treat Benign Prostatic Hyperplasia |
- Benign Prostatic Hyperplasia
- Prostatic Hyperplasia
|
- Drug: GI198745 0.05mg
- Drug: GI198745 0.5mg
- Drug: GI198745 2.5mg
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- adverse events, laboratory test values (hematology, serum chemistry, electrolyte, and urinalysis), prostate specific antigen (PSA), vital signs (blood pressure, pulse rate), and post-void residual volume.
- prostate volume, symptom scores (IPSS), maximum urinary flow (Qmax), serum dihydrotestosterone (DHT), and testosterone
|
121 |
Male |
50 Years and older (Adult, Older Adult) |
NCT00969072 |
ARI30016 |
|
August 2003 |
February 2005 |
February 2005 |
August 31, 2009 |
September 13, 2010 |
|
|
|
| 68 |
NCT01376284 |
Completed |
Drug Use Investigation for AVOLVE(BPH) |
|
|
Observational
|
|
|
Industry |
- Time Perspective: Prospective
|
- The number of adverse events in Japanese subjects with BPH treated with dutasteride capsules
|
1000 |
Male |
15 Years and older (Child, Adult, Older Adult) |
NCT01376284 |
114125 |
|
December 2010 |
October 2013 |
June 2014 |
June 20, 2011 |
July 28, 2014 |
|
|
|
| 69 |
NCT00690950 |
Unknown † |
A Study to Determine the Improvement of the Symptoms of Benign Prostatic Hyperplasia (BPH) When Switching Subjects From Proscar to Avodart |
- Benign Prostatic Hyperplasia
|
|
Interventional
|
Phase 4 |
- Urologic Consultants of Southeastern PA
|
Other |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Laboratory parameters: including serum testosterone, DHT level and PSA
- volume measurements of TRUSP and PVR
- A decrease in the AUASI
|
50 |
Male |
50 Years to 80 Years (Adult, Older Adult) |
NCT00690950 |
110895 |
|
May 2008 |
July 2009 |
|
June 5, 2008 |
June 5, 2008 |
|
- Urologic Consultants of Southeastern PA
Bala Cynwyd, Pennsylvania, United States
|
|
| 70 |
NCT01529086 |
Completed |
For Cause Prostate Biopsy in REDUCE Population Trial |
|
|
Observational
|
|
- The Cleveland Clinic
- GlaxoSmithKline
|
Other / Industry |
- Observational Model: Cohort
- Time Perspective: Retrospective
|
- Cancer detection risk among the groups in the "for cause" context
- Dutasteride as a key factor in the likelihood of "for cause" biopsy
|
6608 |
Male |
50 Years to 75 Years (Adult, Older Adult) |
NCT01529086 |
REDUCE-FOR CAUSE
115686 |
|
February 2012 |
February 2012 |
February 2012 |
February 8, 2012 |
August 23, 2016 |
|
- Cleveland Clinic
Cleveland, Ohio, United States
|
|
| 71 |
NCT00244309 |
Completed |
Study of Tamsulosin and/or Dutasteride to Relieve Urinary Symptoms After Brachytherapy for Localized Prostate Cancer |
|
- Drug: tamsulosin and/or dutasteride
|
Interventional
|
Phase 3 |
- Case Comprehensive Cancer Center
- GlaxoSmithKline
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Factorial Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- AUA score will be used to assess severity of urinary symptoms. All patients will be contacted weekly by telephone for 12 weeks then monthly postoperatively to get their AUA score. A total of 21 AUA scores postoperatively.
- Use of intermittent self-catheterization
|
348 |
Male |
18 Years and older (Adult, Older Adult) |
NCT00244309 |
CASE14804
GSK106046 (formerly 103988) |
|
November 2005 |
June 2006 |
June 2006 |
October 26, 2005 |
May 4, 2011 |
|
- Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
|
|
| 72 |
NCT01923090 |
Unknown † |
Finasteride, Dutasteride and Insulin Action |
|
- Drug: Finasteride
- Drug: Dutasteride
|
Interventional
|
Phase 2 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- insulin sensitivity
- adipose tissue insulin sensitivity
|
12 |
Male |
18 Years to 65 Years (Adult, Older Adult) |
NCT01923090 |
RG_12-098
12/WM/0122 |
FIND-IT |
August 2012 |
October 2013 |
October 2013 |
August 14, 2013 |
August 14, 2013 |
|
- Wellcome Trust Clinical Research Facility, Queen Elizabeth Hospital
Birmingham, West Midlands, United Kingdom
|
|
| 73 |
NCT01294592 |
Completed
Has Results |
Comparative Efficacy of Dutasteride Plus Tamulosin With Lifestyle Advice Versus Watchful Waiting Plus Lifestyle Advice in the Management of Treatment naïve Men With Moderately Symptomatic Benign Prostatic Hyperplasia and Prostate Enlargement |
|
- Drug: Dutasteride plus tamsulosin
- Drug: tamsulosin
|
Interventional
|
Phase 4 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the Last Observation Carried Forward (LOCF) Approach
- Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach
- Change From Baseline in the BPH Impact Index (BII) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach
- (and 8 more...)
|
742 |
Male |
50 Years and older (Adult, Older Adult) |
NCT01294592 |
114615 |
CONDUCT |
December 22, 2010 |
October 17, 2013 |
October 17, 2013 |
February 11, 2011 |
August 20, 2018 |
June 16, 2014 |
- GSK Investigational Site
Aigrefeuille Sur Maine, France - GSK Investigational Site
Angers, France - GSK Investigational Site
Angers, France - (and 77 more...)
|
|
| 74 |
NCT00953576 |
Terminated
Has Results |
Ketoconazole, Hydrocortisone, Dutasteride and Lapatinib (KHAD-L) in Prostate Cancer |
|
- Drug: ketoconazole
- Drug: hydrocortisone
- Drug: dutasteride
- Drug: lapatinib
|
Interventional
|
Phase 1
Phase 2 |
- Dana-Farber Cancer Institute
- Beth Israel Deaconess Medical Center
- Brigham and Women's Hospital
- (and 3 more...)
|
Other / Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Lapatinib Maximum Tolerated Dose (MTD) [Phase I]
- Lapatinib Dose Limiting Toxicity (DLT) [Phase I]
- Plasma Lapatinib Levels [Phase I]
- Grade 3-4 Treatment-Related Adverse Events Rate
|
11 |
Male |
18 Years and older (Adult, Older Adult) |
NCT00953576 |
08-374 |
KHLAD |
September 29, 2009 |
April 11, 2013 |
April 11, 2013 |
August 6, 2009 |
September 3, 2018 |
September 3, 2018 |
- Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States - Dana-Farber Cancer Institute
Boston, Massachusetts, United States
|
|
| 75 |
NCT02159690 |
Withdrawn |
A Phase II Neoadjuvant Study of Enzalutamide, Abiraterone Acetate, Dutasteride and Degarelix in Men With Localized Prostate Cancer Pre-prostatectomy |
- Prostate Cancer
- Localized Prostate Cancer
|
- Drug: Enzalutamide
- Drug: Abiraterone acetate
- Drug: Prednisone
- (and 2 more...)
|
Interventional
|
Phase 2 |
- Kenneth Pienta, MD
- Prostate Cancer Foundation Norway
- Johns Hopkins University
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Proportion of prostatectomy specimens with a complete response rate
- Proportion of prostatectomy specimens with a negative surgical margin rate
- Proportion of prostatectomy specimens with a near-pathologic complete response
- (and 8 more...)
|
0 |
Male |
18 Years and older (Adult, Older Adult) |
NCT02159690 |
Neoadj enz/abi/dut/deg |
|
September 2014 |
January 2015 |
January 2015 |
June 10, 2014 |
January 26, 2015 |
|
- Johns Hopkins Hospital
Baltimore, Maryland, United States
|
|
| 76 |
NCT00734656 |
Completed
Has Results |
Pharmacogenetics of Alcohol: Treatment Implications |
- Alcohol Related Disorders
- Alcoholism
- Alcohol Abuse
|
- Drug: dutasteride + ethanol
- Drug: placebo medication + ethanol
- Drug: dutasteride + placebo alcohol
- Drug: placebo medication + placebo alcohol
|
Interventional
|
Not Applicable |
- UConn Health
- National Institutes of Health (NIH)
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Factorial Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
|
- Breath Alcohol
- BAES Sedation Response, Average of 6 Time Points
- BAES Stimulation Response, Average of 6 Time Points
- Change in Serum 3a-androstanediol Glucuronide
|
94 |
Male |
21 Years to 45 Years (Adult) |
NCT00734656 |
06-218S-2
619
5R01AA015606-02 |
|
March 2007 |
October 2010 |
July 2011 |
August 14, 2008 |
March 28, 2012 |
March 27, 2012 |
- University of Connecticut Health Center
Farmington, Connecticut, United States
|
|
| 77 |
NCT00537654 |
Completed |
A Study To Compare Giving AVODART And FLOMAX Together Or In A Combination Capsule In The Fed And Fasted State |
|
- Drug: Treatment sequence A
- Drug: Treatment sequence B
- Drug: Treatment sequence C
- Drug: Treatment sequence D
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Area under the curve (AUC) from time zero to 24 hours (AUC[0-24]) of plasma tamsulosin in fed state
- Area under the curve from time zero to infinity (AUC[0-inf]) of plasma tamsulosin in fed state
- Concentration maximum (Cmax) of plasma tamsulosin in fed state
- (and 19 more...)
|
81 |
Male |
18 Years to 45 Years (Adult) |
NCT00537654 |
ARI109882 |
|
October 18, 2007 |
February 22, 2008 |
February 22, 2008 |
October 1, 2007 |
August 17, 2017 |
|
- GSK Investigational Site
Evansville, Indiana, United States - GSK Investigational Site
Austin, Texas, United States
|
|
| 78 |
NCT01594502 |
Active, not recruiting |
Validation of Digital Morphometry for Cancer Risk in Benign Prostate Biopsies |
|
- Drug: Dutasteride
- Drug: Placebo
|
Observational
|
|
- University of Illinois at Chicago
- National Cancer Institute (NCI)
|
Other / NIH |
- Observational Model: Case-Control
- Time Perspective: Cross-Sectional
|
- Effects of dutasteride (vs. placebo) using multi-feature scores derived from digital image analysis on both nuclear and architectural features in benign prostate tissue.
- Multivariable treatment-response score between subjects who develop PCa while on dutasteride and those who do not.
- Magnitude of association between nuclear phenotype in benign biopsies, and subsequent risk of PCa in untreated men at elevated risk.
|
300 |
Male |
50 Years to 75 Years (Adult, Older Adult) |
NCT01594502 |
2010-0670
R01CA155301 |
|
September 2011 |
November 2018 |
July 2021 |
May 9, 2012 |
November 6, 2017 |
|
- University of Illinois at Chicago
Chicago, Illinois, United States
|
|
| 79 |
NCT01193855 |
Unknown † |
Dutasteride in Treating Patients With Prostate Cancer |
|
- Drug: dutasteride
- Drug: gadolinium-chelate
- Other: active surveillance
- (and 4 more...)
|
Interventional
|
Phase 2 |
- University College London Hospitals
- National Cancer Institute (NCI)
|
Other |
- Allocation: Randomized
- Masking: Double
- Primary Purpose: Treatment
|
- The change in volume of foci of prostate cancer (PC) as assessed by T2-weighted (T2w) MRI between baseline and 6 months
- The change in volume of PC as determined by gadolinium-enhanced (GE) MRI and diffusion-weighted (DW) MRI at 6 months
- The change in volume of PC as determined by T2w MRI, GE MRI, and DW MRI at 3 months
- (and 6 more...)
|
42 |
Male |
up to 80 Years (Child, Adult, Older Adult) |
NCT01193855 |
CDR0000684018
UCL-09-0221
EUDRACT-2009-012405-18
EU-21067 |
|
June 2010 |
January 2012 |
|
September 2, 2010 |
August 26, 2013 |
|
- University College of London Hospitals
London, England, United Kingdom
|
|
| 80 |
NCT00161421 |
Completed |
Oral Androgens in Man-3 (ORAL T-3) Pharmacokinetics of Oral Testosterone |
- Contraception
- Hypogonadism
|
- Drug: Oral Testosterone
- Drug: Leuprolide (Lupron)
- Drug: Dutasteride
|
Interventional
|
Phase 2 |
- University of Washington
- GlaxoSmithKline
- National Institutes of Health (NIH)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
Other / Industry / NIH |
- Allocation: Non-Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Elevations in serum testosterone
- Monitoring for any adverse changes in liver function or general health.
|
18 |
Male |
18 Years to 50 Years (Adult) |
NCT00161421 |
04-4115-D
HD42454
K23HD045386
GSK002590 |
|
March 2005 |
July 2006 |
July 2006 |
September 12, 2005 |
September 19, 2008 |
|
- University of Washington
Seattle, Washington, United States
|
|
| 81 |
NCT00375765 |
Completed |
Effects On Dihydrotestosterone Regulated Gene Expression In Benign Prostatic Hyperplasia Or Prostate Cancer |
- Benign Prostatic Hyperplasia
- Prostate Cancer
|
|
Interventional
|
Phase 4 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Relative change in PSA(Prostate-specific antigen)expression per cell at 3 months
- Relative change in PCA3 (a prostate cancer-specific gene) expression per cell at 3 months Relative change in prostate volume at 3 months
|
40 |
Male |
50 Years and older (Adult, Older Adult) |
NCT00375765 |
104274 |
|
April 2005 |
July 2007 |
July 2007 |
September 13, 2006 |
January 19, 2017 |
|
- GSK Investigational Site
Nijmegen, Netherlands - GSK Investigational Site
Nijmegen, Netherlands
|
|
| 82 |
NCT00470834 |
Completed
Has Results |
Prostate Cancer Study In Men Who Have Failed First-Line Androgen Deprivation Therapy |
|
- Drug: dutasteride
- Drug: placebo
- Drug: bicalutamide
|
Interventional
|
Phase 4 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Time to Disease Progression
- Time to Treatment Failure
- Number of Participants With PSA Response
- (and 2 more...)
|
127 |
Male |
40 Years to 90 Years (Adult, Older Adult) |
NCT00470834 |
AVO108943 |
|
May 2007 |
February 2013 |
February 2013 |
May 8, 2007 |
February 27, 2017 |
November 1, 2013 |
- GSK Investigational Site
Homewood, Alabama, United States - GSK Investigational Site
Huntsville, Alabama, United States - GSK Investigational Site
Little Rock, Arkansas, United States - (and 59 more...)
|
|
| 83 |
NCT01332435 |
Completed
Has Results |
Dutasteride in Enlarged Prostate Economic Assessment: A Retrospective Database Pooled Analysis of Early 5-alpha Reductase Inhibitor Use |
|
|
Observational
|
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Retrospective
|
- Number of Participants With Clinical Progression
- Number of Participants With Acute Urinary Retention
- Number of Participants Who Needed Prostate-Related Surgery
- (and 3 more...)
|
6896 |
Male |
50 Years and older (Adult, Older Adult) |
NCT01332435 |
113984 |
|
November 2009 |
January 2010 |
January 2010 |
April 11, 2011 |
June 27, 2017 |
July 22, 2011 |
|
|
| 84 |
NCT00316732 |
Completed |
Observational AVODART (Dutasteride) Study In Benign Prostatic Hyperplasia Subjects - OASIS |
|
- Procedure: IPSS Questionnaire
- Procedure: EQ-5D Questionnaire
|
Observational
|
|
|
Industry |
- Time Perspective: Prospective
|
|
173 |
Male |
Child, Adult, Older Adult |
NCT00316732 |
103500 |
|
October 25, 2004 |
December 19, 2006 |
December 19, 2006 |
April 21, 2006 |
October 16, 2017 |
|
- GSK Investigational Site
Exeter, Devon, United Kingdom - GSK Investigational Site
Plymouth, Devon, United Kingdom - GSK Investigational Site
Colchester, Essex, United Kingdom - (and 24 more...)
|
|
| 85 |
NCT00593593 |
Completed |
Pharmacovigilance Study To Evaluate Safety Of AVODART In Subjects With Benign Prostate Hyperplasia |
- Benign Prostatic Hyperplasia
|
|
Observational
|
|
|
Industry |
- Time Perspective: Prospective
|
|
1000 |
Male |
Child, Adult, Older Adult |
NCT00593593 |
104244
Avodart-pv/GR |
|
December 2004 |
|
|
January 15, 2008 |
October 15, 2008 |
|
|
|
| 86 |
NCT00056407 |
Completed
Has Results |
"REDUCE" - A Clinical Research Study To Reduce The Incidence Of Prostate Cancer In Men Who Are At Increased Risk |
|
- Drug: Dutasteride
- Drug: Placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Crude Rate Approach)
- Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Modified Crude Rate Approach)
- Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Restricted Crude Rate Approach)
- (and 23 more...)
|
8231 |
Male |
50 Years to 75 Years (Adult, Older Adult) |
NCT00056407 |
ARI40006 |
REDUCE |
March 2003 |
January 2009 |
April 2009 |
March 13, 2003 |
September 23, 2016 |
March 5, 2010 |
- GSK Investigational Site
Birmingham, Alabama, United States - GSK Investigational Site
Homewood, Alabama, United States - GSK Investigational Site
Huntsville, Alabama, United States - (and 929 more...)
|
|
| 87 |
NCT00680680 |
Completed |
Treatment of Refractory Urinary Retention Secondary to Benign Prostatic Hyperplasia (BPH) With Dual Five Alpha Reductase Inhibition Combined With an Alpha Blocker |
- Urinary Retention
- Benign Prostatic Hyperplasia
|
|
Interventional
|
Not Applicable |
- Franklin D. Gaylis, MD Inc.
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
20 |
Male |
50 Years to 90 Years (Adult, Older Adult) |
NCT00680680 |
AUR |
AUR |
May 2004 |
February 2008 |
February 2008 |
May 20, 2008 |
May 20, 2008 |
|
|
|
| 88 |
NCT01337258 |
Completed |
Economic Analyses of the REDUCE Trial |
- Neoplasms, Prostate
- Benign Prostatic Hyperplasia
- Cancer
|
- Drug: Dutasteride
- Drug: Placebo
|
Observational
|
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Retrospective
|
- Cost of treating prostate-related events
|
1 |
Male |
50 Years to 75 Years (Adult, Older Adult) |
NCT01337258 |
113979 |
|
January 2010 |
July 2010 |
July 2010 |
April 18, 2011 |
May 30, 2017 |
|
|
|
| 89 |
NCT00983554 |
Unknown † |
Metabolic Effects of Steroids in Obese Men |
- Obesity
- Insulin Resistance
|
- Drug: Anastrazole
- Drug: Testosterone
- Drug: Dutasteride
- Drug: GnRH antagonist
|
Interventional
|
Not Applicable |
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- University of California, San Diego
|
NIH / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- insulin sensitivity
- body composition
- lipid profile
|
57 |
Male |
24 Years to 51 Years (Adult) |
NCT00983554 |
DK65038 (completed) |
|
June 2005 |
May 2009 |
October 2009 |
September 24, 2009 |
March 16, 2011 |
|
- University of California, San Diego
San Diego, California, United States - VA San Diego Healthcare System
San Diego, California, United States
|
|
| 90 |
NCT01484808 |
Unknown † |
The Utility of PSADv (PSA Density Velocity) While on Dutasteride for Predicting Prostate Cancer Incidence and Grade and Stage |
|
|
Observational
|
|
- University Urological Associates Inc.
|
Other |
- Observational Model: Case Control
- Time Perspective: Retrospective
|
|
6600 |
Male |
50 Years to 74 Years (Adult, Older Adult) |
NCT01484808 |
8DUT115799 |
PSADv |
January 2012 |
April 2012 |
May 2012 |
December 2, 2011 |
December 2, 2011 |
|
- Division of Urology, Brown University
Providence, Rhode Island, United States
|
|
| 91 |
NCT01351987 |
Unknown † |
An Observational Study of Dutasteride and Alpha-blocker Combination Therapy in Men With Symptomatic Benign Prostatic Hyperplasia and PSA Level Over 4 ng/mL |
- Benign Prostatic Hyperplasia
|
|
Observational
|
|
- Taipei Medical University WanFang Hospital
|
Other |
- Observational Model: Case-Only
|
|
855 |
Male |
50 Years and older (Adult, Older Adult) |
NCT01351987 |
100006 |
|
December 2010 |
|
December 2013 |
May 11, 2011 |
May 11, 2011 |
|
- Taipei Medical University - WanFang Hospital
Taipei, Taiwan
|
|
| 92 |
NCT00609596 |
Completed |
A Study To Compare 3 Different Formulations Of Tamsulosin At Steady State. |
|
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- PK at 0,1,2,3,4,5,6,7,8,10,12,16,24,36,48,72
- Clinical safety labs
- measurement of orthostatic hypotension
- (and 3 more...)
|
24 |
Male |
18 Years to 45 Years (Adult) |
NCT00609596 |
ARI111402 |
|
February 26, 2008 |
April 23, 2008 |
April 23, 2008 |
February 7, 2008 |
August 4, 2017 |
|
- GSK Investigational Site
Buffalo, New York, United States
|
|
| 93 |
NCT00883909 |
Completed |
ARI103094-Follow-Up Study for REDUCE Study Subjects |
|
|
Observational
|
|
|
Industry |
- Observational Model: Other
- Time Perspective: Prospective
|
- To collect and summarize data for 2 years beyond the prospectively planned 4 year double blind, placebo-controlled REDUCE study.
- To collect and summarize data on Adverse Events for 2 years beyond the prospectively planned 4 year double blind, placebo-controlled REDUCE study.
|
2795 |
Male |
50 Years and older (Adult, Older Adult) |
NCT00883909 |
103094 |
|
April 9, 2009 |
December 1, 2010 |
December 29, 2010 |
April 20, 2009 |
July 11, 2017 |
|
- GSK Investigational Site
Anchorage, Alaska, United States - GSK Investigational Site
Phoenix, Arizona, United States - GSK Investigational Site
Little Rock, Arkansas, United States - (and 264 more...)
|
|
| 94 |
NCT01830829 |
Terminated |
JALYN for Benign Prostatic Hyperplasia (BPH) and Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) |
- Benign Prostatic Hyperplasia
- Chronic Prostatitis
|
|
Interventional
|
Phase 3 |
- Dr. J. Curtis Nickel
- The Cleveland Clinic
- University of California, Los Angeles
- Queen's University
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Chronic Prostatitis Symptom Index (CPSI)
- Pain subdomain
- IPSS
- (and 3 more...)
|
1 |
Male |
45 Years and older (Adult, Older Adult) |
NCT01830829 |
JALYN |
|
April 2013 |
October 2014 |
October 2014 |
April 12, 2013 |
October 22, 2014 |
|
- Centre for Applied Urological Research
Kingston, Ontario, Canada
|
|
| 95 |
NCT01547299 |
Completed
Has Results |
Study of Enzalutamide (Formerly MDV3100) as a Neoadjuvant Therapy for Patients Undergoing Prostatectomy for Localized Prostate Cancer |
|
- Drug: Enzalutamide
- Drug: Leuprolide
- Drug: Dutasteride
|
Interventional
|
Phase 2 |
- Pfizer
- Astellas Pharma Inc
- Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Pathologic Complete Response Rate
- Percentage of Participants With Positive Surgical Margins
- Percentage of Participants With Extracapsular Extension: Local Review
- (and 28 more...)
|
52 |
Male |
18 Years and older (Adult, Older Adult) |
NCT01547299 |
MDV3100-07
C3431019 |
|
March 31, 2012 |
November 30, 2013 |
November 30, 2013 |
March 7, 2012 |
October 23, 2018 |
April 10, 2015 |
- Boston, Massachusetts, United States
- Seattle, Washington, United States
- Vancouver, British Columbia, Canada
- Toronto, Ontario, Canada
|
|
| 96 |
NCT01777269 |
Completed
Has Results |
Prospective Sexual Function Study for BPH Subjects |
|
- Drug: Dutasteride plus tamsulosin
- Drug: Placebo
|
Interventional
|
Phase 4 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Changes From Baseline (BL) in Total Score From the Full Men's Sexual Health Questionnaire (MSHQ) at 12 Months
- Change From Baseline in Scores From the Full Men's Sexual Health Questionnaire (MSHQ) at 1, 3, 6 and 9 Months
- Number of Participants Reaching Various Thresholds of Change in Total MSHQ From Baseline at 12 Months
- (and 8 more...)
|
489 |
Male |
50 Years and older (Adult, Older Adult) |
NCT01777269 |
116115
2012-002047-26 |
|
February 18, 2013 |
April 5, 2016 |
April 5, 2016 |
January 28, 2013 |
August 20, 2018 |
July 14, 2017 |
- GSK Investigational Site
Randwick, New South Wales, Australia - GSK Investigational Site
Sydney, New South Wales, Australia - GSK Investigational Site
Wahroonga, New South Wales, Australia - (and 64 more...)
|
|
| 97 |
NCT01342367 |
Recruiting |
Feasibility of Hormones and Radiation for Intermediate or High Risk Prostate Cancer |
|
- Drug: Bicalutamide
- Drug: Dutasteride
- Drug: Finasteride
- Radiation: Radiation
|
Interventional
|
Not Applicable |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Quality of Life
- Progression Free Survival
|
40 |
Male |
18 Years and older (Adult, Older Adult) |
NCT01342367 |
10-625-A |
|
December 17, 2010 |
October 2018 |
April 2019 |
April 27, 2011 |
March 23, 2018 |
|
- University of Chicago
Chicago, Illinois, United States
|
|
| 98 |
NCT00490555 |
Completed
Has Results |
PROS-1-Male Hormonal Contraceptive Regimens on Prostate Tissue |
|
- Drug: Testosterone gel
- Drug: Dutasteride
- Drug: Depo-Medroxyprogesterone (DMPA)
- (and 3 more...)
|
Interventional
|
Phase 2
Phase 3 |
- University of Washington
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Prostate-specific Antigen (PSA)
- Testosterone Concentration
- Dihydrotestosterone (DHT) Concentration
- (and 2 more...)
|
32 |
Male |
25 Years to 55 Years (Adult) |
NCT00490555 |
31434-A
RFA-HD-06-014;
06-4795-A 01 |
PROS-1 |
January 2009 |
January 2012 |
March 2012 |
June 22, 2007 |
November 15, 2013 |
November 15, 2013 |
- University of Washington
Seattle, Washington, United States
|
|
| 99 |
NCT00298155 |
Completed
Has Results |
Maximal Suppression of the Androgen Axis in Clinically Localized Prostate Cancer |
|
- Drug: goserelin with dutasteride
- Drug: goserelin with bicalutamide and dutasteride
- Drug: goserelin with bicalutamide and dutasteride and ketoconazole
|
Interventional
|
Phase 2 |
- University of Washington
- GlaxoSmithKline
- AstraZeneca
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Prostate Tissue DHT
- To Determine the Effects of Different Modes of Androgen Deprivation on Serum DHT
|
35 |
Male |
18 Years to 100 Years (Adult, Older Adult) |
NCT00298155 |
28741
FHCRC-05026
05-8538-V 01
28741-A
01253 |
TAPS |
July 2006 |
June 2010 |
January 2014 |
March 1, 2006 |
August 9, 2018 |
May 8, 2017 |
- Veterans' Administration Puget Sound Health Care System (VAPSHCS)
Seattle, Washington, United States - University of Washington
Seattle, Washington, United States
|
|
| 100 |
NCT02147964 |
Not yet recruiting |
ITT-5 Mechanisms of Spermatogenesis in Man |
|
- Drug: Testosterone 1% Gel
- Drug: Acyline
- Drug: Dutasteride
- (and 4 more...)
|
Interventional
|
Phase 2 |
|
Other |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Sperm concentration
- IT steroid concentration
|
60 |
Male |
18 Years to 55 Years (Adult) |
NCT02147964 |
STUDY00001449 |
ITT-5 |
June 2019 |
December 2021 |
December 2026 |
May 28, 2014 |
October 24, 2018 |
|
- University of Washington Medical Center (Health Sciences)
Seattle, Washington, United States
|
|
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