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Dutasteride and Flex Dose of Tamsulosin on as Needed Basis, to Treat Benign Prostatic Hyperplasia

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ClinicalTrials.gov Identifier: NCT00701779
Recruitment Status : Completed
First Posted : June 19, 2008
Results First Posted : January 1, 2015
Last Update Posted : November 2, 2018
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Paul F. Siami, MD, Siami, Paul F., M.D.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Benign Prostatic Hyperplasia
Intervention Drug: Tamsulosin
Enrollment 63
Recruitment Details Medical Clinic
Pre-assignment Details The population of subjects will be the 'Intent-toTreat' population.
Arm/Group Title Dutasteride
Hide Arm/Group Description

Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.

Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks.

Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.

Period Title: Overall Study
Started 63
3 Month 60
6 Month 58
9 Month 56
12 Month 54
Completed 54
Not Completed 9
Reason Not Completed
Adverse Event             6
Lost to Follow-up             1
Withdrawal by Subject             2
Arm/Group Title Dutasteride
Hide Arm/Group Description

Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.

Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks.

Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.

Overall Number of Baseline Participants 54
Hide Baseline Analysis Population Description
Enrollment of ~ 60 subjects will allow the proportion of subjects able to discontinue Tamsulosin, (assuming 50% able to discontinue), usage within 13% using a 95% confidence interval. Assuming 75% of the subjects are able to discontinue Tamsulosin, the proportion of subjects can be estimated to within 11% using a 95% confidence interval.
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 54 participants
66.63  (8.50)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Male Number Analyzed 54 participants
54
International Prostate Symptom Score (IPSS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 54 participants
19.80  (5.86)
[1]
Measure Description:

Questionnaire consisting of seven symptom scores: incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Symptoms are scored on a 5 point scale with 0 representing absence of symptoms and 5 representing the most severe presentation of a symptom.

Total range is from 0-35. The scores are evaluated as such:

0-7: Mild 8-19: Moderate 20-35: Severe

Peak Flow Rate  
Mean (Standard Deviation)
Unit of measure:  Ml/sec
Number Analyzed 54 participants
10.14  (2.64)
Prostate Specific Antigen  
Mean (Standard Deviation)
Unit of measure:  ng/mL
Number Analyzed 54 participants
4.70  (3.01)
Prostate Volume  
Mean (Standard Deviation)
Unit of measure:  Cc
Number Analyzed 54 participants
57.61  (22.83)
Post-Void Residual Volume  
Mean (Standard Deviation)
Unit of measure:  Ml
Number Analyzed 54 participants
82.33  (58.36)
Benign Prostatic Hyperplasia Impact Index (BII)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 54 participants
6.31  (3.11)
[1]
Measure Description:

Benign Prostatic Hyperplasia Impact Index asked the following:

  1. Over the past month, how much physical discomfort did any urinary problems cause you? (0-3)
  2. Over the past month, how much did you worry about yoru health because of any urinary problems? (0-3)
  3. Overall, how bothersome has any trouble with urination been during the past month? (0-3)
  4. Over the past month, how much of the time has any urinary problem kept you from doing the kinds of things you usually do? (0-4) 0 indicates no symptoms, high values indicate high frequency of symptoms.

Total symptom score range 0-13.

1.Primary Outcome
Title International Prostate Symptom Score
Hide Description

Reported mean total IPSS values from end of study (12 month visit) to assess efficacy of starting with combination treatment with Dutasteride for one year and Tamsulosin for 3 months with subsequent as needed use of Tamsulosin in providing superior symptomatic improvement to BPH patients.

Questionnaire consisting of seven symptom scores: incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Symptoms are scored on a 5 point scale with 0 representing absence of symptoms and 5 representing the most severe presentation of a symptom.

Total range is from 0-35. The scores are evaluated as such:

0-7: Mild 8-19: Moderate 20-35: Severe

Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dutasteride
Hide Arm/Group Description:

Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.

Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks.

Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.

Overall Number of Participants Analyzed 54
Mean (Standard Deviation)
Unit of Measure: units on a scale
11.31  (6.48)
2.Primary Outcome
Title Peak Flow Rate (QMax)
Hide Description Peak flow rate recorded at final study visit (12 month) to assess efficacy of starting with combination treatment with Dutasteride for one year and Tamsulosin for 3 months with subsequent as needed use of Tamsulosin in providing superior symptomatic improvement to BPH patients.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dutasteride
Hide Arm/Group Description:

Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.

Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks.

Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.

Overall Number of Participants Analyzed 54
Mean (Standard Deviation)
Unit of Measure: ml/sec
20.43  (38.68)
3.Primary Outcome
Title Benign Prostate Hyperplasia Impact Index
Hide Description

Benign prostate hyperplasia Impact Index obtained at final study visit (12 month) to assess efficacy of starting with combination treatment with Dutasteride for one year and Tamsulosin for 3 months with subsequent as needed use of Tamsulosin in providing superior symptomatic improvement to BPH patients.

Benign Prostatic Hyperplasia Impact Index asked the following:

  1. Over the past month, how much physical discomfort did any urinary problems cause you? (0-3)
  2. Over the past month, how much did you worry about yoru health because of any urinary problems? (0-3)
  3. Overall, how bothersome has any trouble with urination been during the past month? (0-3)
  4. Over the past month, how much of the time has any urinary problem kept you from doing the kinds of things you usually do? (0-4) 0 indicates no symptoms, high values indicate high frequency of symptoms. Total symptom score range 0-13.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dutasteride
Hide Arm/Group Description:

Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.

Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks.

Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.

Overall Number of Participants Analyzed 54
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.28  (2.81)
4.Primary Outcome
Title Post-void Residual Volume
Hide Description Post-void residual volume taken at final study visit (12 month) to assess efficacy of starting with combination treatment with Dutasteride for one year and Tamsulosin for 3 months with subsequent as needed use of Tamsulosin in providing superior symptomatic improvement to BPH patients.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dutasteride
Hide Arm/Group Description:

Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.

Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks.

Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.

Overall Number of Participants Analyzed 54
Mean (Standard Deviation)
Unit of Measure: mL
87.19  (83.47)
5.Primary Outcome
Title Prostate Specific Antigen
Hide Description Prostate Specific Antigen (PSA) taken at final study visit (12 month) to assess efficacy of starting with combination treatment with Dutasteride for one year and Tamsulosin for 3 months with subsequent as needed use of Tamsulosin in providing superior symptomatic improvement to BPH patients.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dutasteride
Hide Arm/Group Description:

Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.

Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks.

Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.

Overall Number of Participants Analyzed 54
Mean (Standard Deviation)
Unit of Measure: ng/mL
1.91  (1.52)
6.Secondary Outcome
Title Health Outcome Measures
Hide Description Number of participants who are able to subsequently reduce or discontinue Tamsulosin usage after starting with combination therapy with Dutasteride and Tamsulosin while still maintaining the same degree of improvement in lower urinary tract symptoms
Time Frame 13 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dutasteride
Hide Arm/Group Description:

Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.

Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks.

Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.

Overall Number of Participants Analyzed 54
Measure Type: Count of Participants
Unit of Measure: Participants
31
  57.4%
7.Secondary Outcome
Title Safety and Tolerability
Hide Description To assess safety and tolerability of starting with combination therapy with Dutasteride and Tamsulosin and subsequent elimination of Tamsulosin. Evaluating number of reported adverse events designated as possibly or probably study-drug related.
Time Frame 13 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dutasteride
Hide Arm/Group Description:

Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.

Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks.

Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.

Overall Number of Participants Analyzed 54
Measure Type: Number
Unit of Measure: adverse events
27
8.Secondary Outcome
Title Economic Impact
Hide Description Annual financial cost per participant starting with combination therapy with Dutasteride and Tamsulosin with subsequent withdrawal of Tamsulosin.
Time Frame 13 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dutasteride
Hide Arm/Group Description:

Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.

Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks.

Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.

Overall Number of Participants Analyzed 54
Mean (Standard Deviation)
Unit of Measure: US dollars
643.99  (306.91)
9.Secondary Outcome
Title Number of Participants With a Reduction of AUR and BPH-related Surgery
Hide Description To assess efficacy of starting with combination treatment with Dutasteride for one year and Tamsulosin for 3 months with subsequent as needed use of Tamsulosin in providing superior improvement in the clinical outcomes of AUR or BPH-related prostatic surgery to BPH patients.
Time Frame 13 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dutasteride
Hide Arm/Group Description:

Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.

Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks.

Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.

Overall Number of Participants Analyzed 54
Measure Type: Count of Participants
Unit of Measure: Participants
54
 100.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dutasteride
Hide Arm/Group Description

Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.

Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks.

Tamsulosin: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.

All-Cause Mortality
Dutasteride
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Dutasteride
Affected / at Risk (%) # Events
Total   6/63 (9.52%)    
Blood and lymphatic system disorders   
Pancytopenia   1/63 (1.59%)  1
Cardiac disorders   
Chest Pain   3/63 (4.76%)  3
Atrial Fibrillation   1/63 (1.59%)  1
Bradycardia   1/63 (1.59%)  1
Musculoskeletal and connective tissue disorders   
Osteoarthritis worsening  [1]  1/63 (1.59%)  1
Respiratory, thoracic and mediastinal disorders   
Shortness of Breath   1/63 (1.59%)  1
Acute Bronchitis   1/63 (1.59%)  1
Pneumonia  [2]  1/63 (1.59%)  1
Vascular disorders   
Cerebrovascular Accident   1/63 (1.59%)  1
Deep Vein Thrombosis   1/63 (1.59%)  1
Peripheral Vascular Disease   1/63 (1.59%)  1
Indicates events were collected by systematic assessment
[1]
Left knee
[2]
Right Lower Lobe
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dutasteride
Affected / at Risk (%) # Events
Total   27/63 (42.86%)    
Gastrointestinal disorders   
Lower Abdominal Pain   4/63 (6.35%)  4
General disorders   
Fatigue   3/63 (4.76%)  3
Injury, poisoning and procedural complications   
Laceration  [1]  3/63 (4.76%)  3
Musculoskeletal and connective tissue disorders   
Back Pain   4/63 (6.35%)  4
Reproductive system and breast disorders   
Retrograde Ejaculation   8/63 (12.70%)  9
Respiratory, thoracic and mediastinal disorders   
Bronchitis   4/63 (6.35%)  5
Cough   7/63 (11.11%)  7
Sinus Infection   4/63 (6.35%)  4
Skin and subcutaneous tissue disorders   
Rash  [2]  4/63 (6.35%)  4
Indicates events were collected by systematic assessment
[1]
Hand, arm, finger
[2]
calf(s), groin, arm(s), abdomen, neck
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Paul F. Siami, MD CPI
Organization: Deaconess Clinic, Inc.
Phone: 812-426-9576
EMail: research.paul.siami@deaconess.com
Layout table for additonal information
Responsible Party: Paul F. Siami, MD, Siami, Paul F., M.D.
ClinicalTrials.gov Identifier: NCT00701779     History of Changes
Other Study ID Numbers: Siami104907
First Submitted: June 17, 2008
First Posted: June 19, 2008
Results First Submitted: July 28, 2014
Results First Posted: January 1, 2015
Last Update Posted: November 2, 2018