NCT00970632|CompletedPhase 3Results

A Study of Tadalafil in Men With Benign Prostatic Hyperplasia

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

Eli Lilly and Company ClinicalTrials.gov

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2 other identifiers

12932H6D-MC-LVID

Study Type

interventional

Target

511

Locations

9 countries

Sites

Timeline

RegisteredSep 2009

StartedOct 2009

CompletionJan 2011

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 Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

511

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Oct 2009

Shorter than P25 for phase_3

Geographic Reach

9 countries

40 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.3 years study duration

First Submitted

Initial submission to the registry

September 1, 2009

Completed

1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2009

Completed

29 days until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed

12 months until next milestone

Results Posted

Study results publicly available

December 23, 2011

Completed

Last Updated

March 12, 2012

Status Verified

March 1, 2012

Enrollment Period

1.3 years

First QC Date

September 1, 2009

Results QC Date

November 21, 2011

Last Update Submit

March 8, 2012

Conditions

Benign Prostatic Hyperplasia (BPH)

Outcome Measures

Primary Outcomes (1)

Change From Baseline in Total International Prostate Symptom Score (IPSS) at 12 Weeks
The IPSS Total Score was obtained by combining the scores of the responses to Component Questions 1-7. Each question was scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represented greater severity of symptoms. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.
Baseline, 12 weeks

Secondary Outcomes (16)

Change From Baseline in Total International Prostate Symptom Score (IPSS) at 4 Weeks
Baseline, 4 weeks
Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 12 Weeks
Baseline, 12 weeks
Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 12 Weeks.
Baseline, 12 weeks
Change From Baseline in International Prostate Symptom Score (IPSS) Nocturia Question at 12 Weeks
Baseline, 12 weeks
Change From Baseline in International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index at 12 Weeks
Baseline, 12 weeks
+11 more secondary outcomes

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo tabletDrug: Placebo capsule

Tadalafil 5 milligram (mg)

EXPERIMENTAL

Tadalafil 5 mg tablet po QD and placebo capsule po QD for 12 weeks

Drug: Tadalafil 5 mg

Tamsulosin 0.4 mg

ACTIVE COMPARATOR

Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks

Drug: Tamsulosin

Interventions

Tadalafil 5 mgDRUG

Tadalafil 5 mg po QD for 12 weeks

Also known as: Cialis, LY450190

Tadalafil 5 milligram (mg)

Placebo tabletDRUG

Placebo tablet po QD for 12 weeks

Placebo

TamsulosinDRUG

Tamsulosin 0.4 mg po QD for 12 weeks

Tamsulosin 0.4 mg

Placebo capsuleDRUG

Placebo capsule po QD for 12 weeks

Placebo

Eligibility Criteria

Age45 Years+

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (44)

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, South Australia, 5000, Australia

Location

Bentleigh East, Victoria, 3165, Australia

Location

Bunbury, Western Australia, 6230, Australia

Location

Nedlands, Western Australia, 6009, Australia

Location

Salzburg, 5020, Austria

Location

Vienna, 1220, Austria

Location

Brussels, 1070, Belgium

Location

Ghent, 9000, Belgium

Location

Liège, 4000, Belgium

Location

Garches, 92380, France

Location

Nice, 06002, France

Location

Orléans, 45067, France

Location

Paris, 75475, France

Location

Pierre-Bénite, 69495, France

Location

Suresnes, 92150, France

Location

Bad Rappenau, 74906, Germany

Location

Bad Wiessee, D-83707, Germany

Location

Hanover, 30625, Germany

Location

Leipzig, 04109, Germany

Location

Marburg, 35039, Germany

Location

Mühlacker, D-75417, Germany

Location

Oranienburg, D-16515, Germany

Location

Heraklion, 71110, Greece

Location

Ioannina, 45500, Greece

Location

Larissa, 41221, Greece

Location

Pátrai, 26500, Greece

Location

Thessaloniki, 56429, Greece

Location

Bergamo, 24128, Italy

Location

Cagliari, Italy

Location

Florence, 50139, Italy

Location

Napoli, 80131, Italy

Location

Sassari, 07100, Italy

Location

Monterrey, 64710, Mexico

Location

Morelia, 58000, Mexico

Location

Saltillo, 25210, Mexico

Location

Zapopan, 45070, Mexico

Location

's-Hertogenbosch, 5211 NL, Netherlands

Location

Arnhem, 6803 AA, Netherlands

Location

Breda, 4819 EV, Netherlands

Location

Tilburg, 5022 GC, Netherlands

Location

Veldhoven, 5504 DB, Netherlands

Location

Bialystok, 15-276, Poland

Location

Kutno, 99-300, Poland

Location

Warsaw, 02-005, Poland

Location

Related Publications (3)

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.
PMID: 26299520DERIVED
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.
PMID: 23346990DERIVED
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.
PMID: 22297243DERIVED

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

TadalafilTamsulosin

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

CarbolinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndole AlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-RingBenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur Compounds

Results Point of Contact

Title: Chief Medical Officer
Organization: Eli Lilly and Company

Study Officials

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)
Eli Lilly and Company
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 1, 2009

First Posted

September 2, 2009

Study Start

October 1, 2009

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

March 12, 2012

Results First Posted

December 23, 2011

Record last verified: 2012-03

Locations

ME(4)NL(5)GR(5)FR(6)AU(2)DE(7)IT(5)BE(3)PL(3)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (16)

Study Arms (3)

Placebo

Tadalafil 5 milligram (mg)

Tamsulosin 0.4 mg

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (44)

Related Publications (3)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations