A Study of Tadalafil Use With Finasteride in Men With Enlarged Prostates and Urinary Symptoms
NCT ID: NCT01139762
Last Updated: 2013-02-27
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
696 participants
Study Classification
INTERVENTIONAL
Study Start Date
2010-09-30
Study Completion Date
2012-05-31
Brief Summary
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The purpose of this study is to investigate the efficacy and safety of once daily tadalafil when taken with finasteride as a treatment for men with signs and symptoms of Benign Prostatic Hyperplasia and demonstrable prostate enlargement.
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Detailed Description
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Conditions
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Benign Prostatic Hyperplasia
Enlarged Prostate
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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Tadalafil
Group Type
EXPERIMENTAL
Tadalafil
Intervention Type
DRUG
5 milligrams (mg) administered orally, once daily for 26 weeks
Finasteride
Intervention Type
DRUG
5mg administered orally, once daily for 26 weeks
Placebo
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
Administered orally, once daily for 26 weeks
Finasteride
Intervention Type
DRUG
5mg administered orally, once daily for 26 weeks
Interventions
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Tadalafil
5 milligrams (mg) administered orally, once daily for 26 weeks
Intervention Type
DRUG
Placebo
Administered orally, once daily for 26 weeks
Intervention Type
DRUG
Finasteride
5mg administered orally, once daily for 26 weeks
Intervention Type
DRUG
Other Intervention Names
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Cialis
LY#450190
Eligibility Criteria
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Inclusion Criteria
* Have not taken the following treatments within the indicated duration and agree not to use at any time during the study:
* All other Benign Prostatic Hyperplasia (BPH) therapy (including herbal preparations) for at least 4 weeks prior to receiving study medication.
* Overactive bladder therapy (including antimuscarinics) for at least 4 weeks prior to receiving study medication.
* Erectile Dysfunction therapy (including herbal preparations) for at least 4 weeks prior to receiving study medication.
* Finasteride or dutasteride use at any time.
* Have bladder outlet obstruction as defined by a urinary peak flow rate (Qmax) of greater than or equal to 4 and less than or equal to 15 milliliters (mL)/second before receiving study drug.
* Have prostate enlargement measured by ultrasound at screening.
* All other Benign Prostatic Hyperplasia (BPH) therapy (including herbal preparations) for at least 4 weeks prior to receiving study medication.
* Overactive bladder therapy (including antimuscarinics) for at least 4 weeks prior to receiving study medication.
* Erectile Dysfunction therapy (including herbal preparations) for at least 4 weeks prior to receiving study medication.
* Finasteride or dutasteride use at any time.
* Have bladder outlet obstruction as defined by a urinary peak flow rate (Qmax) of greater than or equal to 4 and less than or equal to 15 milliliters (mL)/second before receiving study drug.
* Have prostate enlargement measured by ultrasound at screening.
Exclusion Criteria
* Have prostate cancer, are being treated for cancer or have clinical evidence of prostate cancer \[Prostate-specific antigen (PSA) greater than 10 nanograms/milliliter (ng/mL) at the start of study\].
* 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 problems with kidneys, liver, or nervous system
* Have uncontrolled diabetes
* Have had a stroke or a significant injury to brain or spinal cord.
* Have scheduled or planned surgery during the course of the study.
* 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 problems with kidneys, liver, or nervous system
* Have uncontrolled diabetes
* Have had a stroke or a significant injury to brain or spinal cord.
* Have scheduled or planned surgery during the course of the study.
Minimum Eligible Age
45 Years
Eligible Sex
MALE
Accepts Healthy Volunteers
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Davis, California, United States
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Sarasota, Florida, United States
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St. Petersburg, Florida, United States
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Shreveport, Louisiana, United States
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Georgetown, Texas, United States
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Buenos Aires, , Argentina
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Córdoba, , Argentina
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Brussels, , Belgium
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Edegem, , Belgium
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Ghent, , Belgium
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Kortrijk, , Belgium
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São Paulo, , Brazil
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Calgary, Alberta, Canada
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Nantes, , France
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Orléans, , France
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Vandœuvre-lès-Nancy, , France
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Berlin, , Germany
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Hettstedt, , Germany
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Leipzig, , Germany
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Mühlacker, , Germany
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Athens, , Greece
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Heraklion, , Greece
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Larissa, , Greece
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Pátrai, , Greece
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Thessaloniki, , Greece
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Bergamo, , Italy
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Milan, , Italy
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Napoli, , Italy
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Rome, , Italy
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Sassari, , Italy
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Chihuahua City, , Mexico
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Colima, , Mexico
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Guadalajara, , Mexico
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Mexico City, , Mexico
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Saltillo, , Mexico
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Tlalpan, , Mexico
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Bydgoszcz, , Poland
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Kutno, , Poland
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Poznan, , Poland
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Zabrze, , Poland
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Moscow, , Russia
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Rostov-on-Don, , Russia
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Saint Petersburg, , Russia
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Saratov, , Russia
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Adana, , Turkey (Türkiye)
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Denizli, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Countries
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United States
Argentina
Belgium
Brazil
Canada
France
Germany
Greece
Italy
Mexico
Poland
Russia
Turkey (Türkiye)
References
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Glina S, Roehrborn CG, Esen A, Plekhanov A, Sorsaburu S, Henneges C, Buttner H, Viktrup L. Sexual function in men with lower urinary tract symptoms and prostatic enlargement secondary to benign prostatic hyperplasia: results of a 6-month, randomized, double-blind, placebo-controlled study of tadalafil coadministered with finasteride. J Sex Med. 2015 Jan;12(1):129-38. doi: 10.1111/jsm.12714. Epub 2014 Oct 29.
Reference Type
DERIVED
Other Identifiers
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H6D-CR-LVIW
Identifier Type: OTHER
Identifier Source: secondary_id
13529
Identifier Type: -
Identifier Source: org_study_id
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Bioequivalence Study of the Second Generation Dutasteride and Tamsulosin Hydrochloride (HCL) Combination Capsule in Fasted State
NCT02052713
COMPLETED
PHASE1
Dutasteride and Flex Dose of Tamsulosin on as Needed Basis, to Treat Benign Prostatic Hyperplasia
NCT00701779
COMPLETED
PHASE4
Effects and Safety of OPK-88004 Doses in Men With Signs and Symptoms of Benign Prostatic Hyperplasia (BPH)
NCT03297398
TERMINATED
PHASE2
New Treatment Strategies and Epigenetic Biomarker for Management of Benign Prostatic Hyperplasia
NCT06944145
RECRUITING
PHASE2
The Efficacy and Safety of the Combination of Tamsulosin and Tadalafil in Men With Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia and Erectile Dysfunction
NCT02862483
UNKNOWN
PHASE3
Tadalafil Plus Tamsulosin for Male LUTS and ED
NCT04383093
COMPLETED
A Study To Compare 3 Different Formulations Of Tamsulosin At Steady State.
NCT00609596
COMPLETED
PHASE1
A Study To Compare Giving AVODART And FLOMAX Together Or In A Combination Capsule In The Fed And Fasted State
NCT00537654
COMPLETED
PHASE1