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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00970632




Registration number
NCT00970632
Ethics application status
Date submitted
1/09/2009
Date registered
2/09/2009
Date last updated
12/03/2012

Titles & IDs
Public title
A Study of Tadalafil in Men With Benign Prostatic Hyperplasia
Scientific title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Global Multicenter Study to Evaluate the Efficacy and Safety of Tadalafil Once Daily Dosing for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia
Secondary ID [1] 0 0
H6D-MC-LVID
Secondary ID [2] 0 0
12932
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Benign Prostatic Hyperplasia (BPH) 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tadalafil 5 mg
Treatment: Drugs - Placebo tablet
Treatment: Drugs - Tamsulosin
Treatment: Drugs - Placebo capsule

Placebo comparator: Placebo - Placebo tablet with tamsulosin dose orally (po) once daily (QD) and placebo capsule with tadalafil dose po QD for 12 weeks

Experimental: Tadalafil 5 milligram (mg) - Tadalafil 5 mg tablet po QD and placebo capsule po QD for 12 weeks

Active comparator: Tamsulosin 0.4 mg - Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks


Treatment: Drugs: Tadalafil 5 mg
Tadalafil 5 mg po QD for 12 weeks

Treatment: Drugs: Placebo tablet
Placebo tablet po QD for 12 weeks

Treatment: Drugs: Tamsulosin
Tamsulosin 0.4 mg po QD for 12 weeks

Treatment: Drugs: Placebo capsule
Placebo capsule po QD for 12 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Total International Prostate Symptom Score (IPSS) at 12 Weeks
Timepoint [1] 0 0
Baseline, 12 weeks
Secondary outcome [1] 0 0
Change From Baseline in Total International Prostate Symptom Score (IPSS) at 4 Weeks
Timepoint [1] 0 0
Baseline, 4 weeks
Secondary outcome [2] 0 0
Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 12 Weeks
Timepoint [2] 0 0
Baseline, 12 weeks
Secondary outcome [3] 0 0
Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 12 Weeks.
Timepoint [3] 0 0
Baseline, 12 weeks
Secondary outcome [4] 0 0
Change From Baseline in International Prostate Symptom Score (IPSS) Nocturia Question at 12 Weeks
Timepoint [4] 0 0
Baseline, 12 weeks
Secondary outcome [5] 0 0
Change From Baseline in International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index at 12 Weeks
Timepoint [5] 0 0
Baseline, 12 weeks
Secondary outcome [6] 0 0
Change From Baseline in Modified International Prostate Symptom Score (mIPSS) at 1 Week
Timepoint [6] 0 0
Baseline, 1 week
Secondary outcome [7] 0 0
Change From Baseline in Benign Prostatic Hyperplasia Impact Index (BII) at 4 Weeks
Timepoint [7] 0 0
Baseline, 4 weeks
Secondary outcome [8] 0 0
Change From Baseline in Benign Prostatic Hyperplasia Impact Index (BII) at 12 Weeks
Timepoint [8] 0 0
Baseline, 12 weeks
Secondary outcome [9] 0 0
Patient Global Impression of Improvement (PGI-I) at 12 Weeks
Timepoint [9] 0 0
12 weeks
Secondary outcome [10] 0 0
Clinician Global Impression of Improvement (CGI-I) at 12 Weeks
Timepoint [10] 0 0
12 weeks
Secondary outcome [11] 0 0
Treatment Satisfaction Scale - Benign Prostatic Hyperplasia (TSS-BPH) at 12 Weeks: Overall
Timepoint [11] 0 0
12 weeks
Secondary outcome [12] 0 0
Change From Baseline in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain at 12 Weeks
Timepoint [12] 0 0
Baseline, 12 weeks
Secondary outcome [13] 0 0
Change From Baseline in Peak Urine Flow Rate (Q-Max) at 12 Weeks
Timepoint [13] 0 0
Baseline, 12 weeks
Secondary outcome [14] 0 0
Change From Baseline in Mean Urine Flow Rate (Q-Mean) at 12 Weeks
Timepoint [14] 0 0
Baseline, 12 weeks
Secondary outcome [15] 0 0
Change From Baseline in Volume of Voided Urine (V-Comp) at 12 Weeks
Timepoint [15] 0 0
Baseline, 12 weeks
Secondary outcome [16] 0 0
Change From Baseline in Postvoid Residual Volume (PVR) at 12 Weeks
Timepoint [16] 0 0
Baseline, 12 weeks

Eligibility
Key inclusion criteria
* Men 45 years of age or older with benign prostatic hyperplasia (BPH) also referred to as BPH-lower urinary tract symptoms (LUTS) on the disease diagnostic criteria at the start of study.
* Provide signed informed consent at the start of the study.
* Agree not to use any other approved or experimental pharmacologic BPH, overactive bladder (OAB), or erectile dysfunction (ED) treatments anytime during the study.
* Have not taken finasteride therapy for at least 3 months before study drug is dispensed and dutasteride therapy for at least 6 months before study drug is dispensed.
* Have not taken other BPH therapy (including herbal preparations), OAB therapy, ED therapy for at least 4 weeks prior to study drug is dispensed.
* Have LUTS with a total International Prostate Symptom Score (IPSS) greater than or equal to 13 when study drug is dispensed.
* Have reduced urine flow (measured by special toilet equipment).
* Demonstrate compliance with study drug administration requirements.
Minimum age
45 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
* Treated with nitrates
* Have unstable angina or angina that requires treatment.
* Have had any of the following in the past 90 days: Heart attack, also known as a myocardial infarction (MI); Heart bypass surgery (called coronary artery bypass graft surgery); Had a procedure to open up blood vessels in the heart known as angioplasty or stent placement (percutaneous coronary intervention).
* Have very high or very low blood pressure.
* Have certain neurological conditions associated with bladder problems or injuries to brain or spinal cord within a specified time of starting this study.
* Have uncontrolled diabetes.
* Have prostate cancer, are being treated for cancer.
* Have prostate specific antigen (PSA) greater than 10 nanograms per milliliter (ng/mL) at the start of study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2011
Sample size
Target
Accrual to date
Final
511
Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
Recruitment hospital [1] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Adelaide
Recruitment hospital [2] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Bentleigh East
Recruitment hospital [3] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Bunbury
Recruitment hospital [4] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Nedlands
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3165 - Bentleigh East
Recruitment postcode(s) [3] 0 0
6230 - Bunbury
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Salzburg
Country [2] 0 0
Austria
State/province [2] 0 0
Vienna
Country [3] 0 0
Belgium
State/province [3] 0 0
Brussels
Country [4] 0 0
Belgium
State/province [4] 0 0
Gent
Country [5] 0 0
Belgium
State/province [5] 0 0
Liege
Country [6] 0 0
France
State/province [6] 0 0
Garches
Country [7] 0 0
France
State/province [7] 0 0
Nice
Country [8] 0 0
France
State/province [8] 0 0
Orleans
Country [9] 0 0
France
State/province [9] 0 0
Paris
Country [10] 0 0
France
State/province [10] 0 0
Pierre Benite
Country [11] 0 0
France
State/province [11] 0 0
Suresnes
Country [12] 0 0
Germany
State/province [12] 0 0
Bad Rappenau
Country [13] 0 0
Germany
State/province [13] 0 0
Bad Wiessee
Country [14] 0 0
Germany
State/province [14] 0 0
Hannover
Country [15] 0 0
Germany
State/province [15] 0 0
Leipzig
Country [16] 0 0
Germany
State/province [16] 0 0
Marburg
Country [17] 0 0
Germany
State/province [17] 0 0
Muehlacker
Country [18] 0 0
Germany
State/province [18] 0 0
Oranienburg
Country [19] 0 0
Greece
State/province [19] 0 0
Heraklion
Country [20] 0 0
Greece
State/province [20] 0 0
Ioannina
Country [21] 0 0
Greece
State/province [21] 0 0
Larissa
Country [22] 0 0
Greece
State/province [22] 0 0
Patras
Country [23] 0 0
Greece
State/province [23] 0 0
Thessaloniki
Country [24] 0 0
Italy
State/province [24] 0 0
Bergamo
Country [25] 0 0
Italy
State/province [25] 0 0
Cagliari
Country [26] 0 0
Italy
State/province [26] 0 0
Firenze
Country [27] 0 0
Italy
State/province [27] 0 0
Napoli
Country [28] 0 0
Italy
State/province [28] 0 0
Sassari
Country [29] 0 0
Mexico
State/province [29] 0 0
Monterrey
Country [30] 0 0
Mexico
State/province [30] 0 0
Morelia
Country [31] 0 0
Mexico
State/province [31] 0 0
Saltillo
Country [32] 0 0
Mexico
State/province [32] 0 0
Zapopan
Country [33] 0 0
Netherlands
State/province [33] 0 0
Arnhem
Country [34] 0 0
Netherlands
State/province [34] 0 0
Breda
Country [35] 0 0
Netherlands
State/province [35] 0 0
S-Hertogenbosch
Country [36] 0 0
Netherlands
State/province [36] 0 0
Tilburg
Country [37] 0 0
Netherlands
State/province [37] 0 0
Veldhoven
Country [38] 0 0
Poland
State/province [38] 0 0
Bialystok
Country [39] 0 0
Poland
State/province [39] 0 0
Kutno
Country [40] 0 0
Poland
State/province [40] 0 0
Warsaw

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine whether an experimental drug known as tadalafil given once daily can reduce the symptoms associated with Benign Prostatic Hyperplasia (straining, urinary frequency, feeling like your bladder is still full etc.)
Trial website
https://clinicaltrials.gov/study/NCT00970632
Trial related presentations / publications
Vlachopoulos C, Oelke M, Maggi M, Mulhall JP, Rosenberg MT, Brock GB, Esler A, Buttner H. Impact of cardiovascular risk factors and related comorbid conditions and medical therapy reported at baseline on the treatment response to tadalafil 5 mg once-daily in men with lower urinary tract symptoms associated with benign prostatic hyperplasia: an integrated analysis of four randomised, double-blind, placebo-controlled, clinical trials. Int J Clin Pract. 2015 Dec;69(12):1496-507. doi: 10.1111/ijcp.12722. Epub 2015 Aug 24.
Giuliano F, Oelke M, Jungwirth A, Hatzimouratidis K, Watts S, Cox D, Viktrup L. Tadalafil once daily improves ejaculatory function, erectile function, and sexual satisfaction in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia and erectile dysfunction: results from a randomized, placebo- and tamsulosin-controlled, 12-week double-blind study. J Sex Med. 2013 Mar;10(3):857-65. doi: 10.1111/jsm.12039. Epub 2013 Jan 24.
Oelke M, Giuliano F, Mirone V, Xu L, Cox D, Viktrup L. Monotherapy with tadalafil or tamsulosin similarly improved lower urinary tract symptoms suggestive of benign prostatic hyperplasia in an international, randomised, parallel, placebo-controlled clinical trial. Eur Urol. 2012 May;61(5):917-25. doi: 10.1016/j.eururo.2012.01.013. Epub 2012 Jan 20.
Public notes

Contacts
Principal investigator
Name 0 0
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00970632