NCT01139762|CompletedPhase 3Results

A Study of Tadalafil Use With Finasteride in Men With Enlarged Prostates and Urinary Symptoms

A Phase 3b, Randomized, Double-blind, Placebo-controlled Parallel-design Study to Evaluate the Efficacy and Safety of Tadalafil Co-administered With Finasteride for 6 Months in Men With Lower Urinary Tract Symptoms and Prostatic Enlargement Secondary to Benign Prostatic Hyperplasia

Eli Lilly and Company ClinicalTrials.gov

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2 other identifiers

13529H6D-CR-LVIW

Study Type

interventional

Target

696

Locations

13 countries

Sites

Timeline

RegisteredJun 2010

StartedSep 2010

CompletionMay 2012

Brief Summary

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.

Trial Health

On Track

Trial Health Score

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

Enrollment

696

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Sep 2010

Geographic Reach

13 countries

65 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

1.7 years study duration

First Submitted

Initial submission to the registry

June 1, 2010

Completed

8 days until next milestone

First Posted

Study publicly available on registry

June 9, 2010

Completed

3 months until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed

1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed

10 months until next milestone

Results Posted

Study results publicly available

February 27, 2013

Completed

Last Updated

February 27, 2013

Status Verified

January 1, 2013

Enrollment Period

1.4 years

First QC Date

June 1, 2010

Results QC Date

January 23, 2013

Last Update Submit

January 23, 2013

Conditions

Benign Prostatic Hyperplasia Enlarged Prostate

Keywords

Benign Prostatic Hyperplasia (BPH)Enlarged Prostate

Outcome Measures

Primary Outcomes (1)

Change in Total International Prostate Symptom Score (IPSS) From Baseline to 12 Weeks
The International Prostate Symptom Score (IPSS) is a rating scale for severity of lower urinary tract symptoms (LUTS). The IPSS has a 7-component questionnaire. Each question is scored on a scale from 0 (none/no symptoms) to 5 (frequent symptoms), for a total score range of 0 to 35. Higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline total IPSS, and visit-by-treatment interaction.
Baseline, 12 weeks

Secondary Outcomes (13)

Change in Total International Prostate Symptom Score (IPSS) From Baseline to 4 and 26 Weeks
Baseline, 4 weeks, 26 weeks
Change in International Prostate Symptom Score (IPSS) Subscores Index From Baseline to 4, 12, and 26 Weeks
Baseline, 4 weeks, 12 weeks, 26 weeks
Change in International Prostate Symptom Score (IPSS) Quality of Life Index From Baseline to 4, 12, and 26 Weeks
Baseline, 4 weeks, 12 weeks, 26 weeks
Change in International Index of Erectile Function (IIEF) - Erectile Function Domain Scores From Baseline to 4, 12, and 26 Weeks
Baseline, 4 weeks, 12 weeks, 26 weeks
Change in International Index of Erectile Function (IIEF) - Overall Satisfaction Domain Scores From Baseline to 4, 12, and 26 Weeks
Baseline, 4 weeks, 12 weeks, 26 weeks
+8 more secondary outcomes

Study Arms (2)

Tadalafil

EXPERIMENTAL

Drug: TadalafilDrug: Finasteride

Placebo

PLACEBO COMPARATOR

Drug: PlaceboDrug: Finasteride

Interventions

TadalafilDRUG

5 milligrams (mg) administered orally, once daily for 26 weeks

Also known as: Cialis, LY#450190

Tadalafil

PlaceboDRUG

Administered orally, once daily for 26 weeks

Placebo

FinasterideDRUG

5mg administered orally, once daily for 26 weeks

PlaceboTadalafil

Eligibility Criteria

Age45 Years+

Sexmale

Healthy VolunteersNo

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

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (65)

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.

Davis, California, 95616, United States

Location

Fresno, California, 93720, United States

Location

Laguna Hills, California, 92367, United States

Location

Long Beach, California, 90806, United States

Location

Vacaville, California, 95688, United States

Location

Sarasota, Florida, 34237, United States

Location

St. Petersburg, Florida, 33710, United States

Location

West Palm Beach, Florida, 33407, United States

Location

Shreveport, Louisiana, 71106, United States

Location

Georgetown, Texas, 78626, United States

Location

Buenos Aires, C1060AAA, Argentina

Location

Córdoba, X5016KEH, Argentina

Location

Brussels, 1090, Belgium

Location

Edegem, 2650, Belgium

Location

Ghent, 9000, Belgium

Location

Kortrijk, 8500, Belgium

Location

Porto Alegre, 90610-970, Brazil

Location

Rio de Janeiro, 20551-030, Brazil

Location

São Paulo, 04262-000, Brazil

Location

Calgary, Alberta, T2W 1P9, Canada

Location

Abbottsford, British Columbia, V2S 3N5, Canada

Location

Surrey, British Columbia, V3V 1N1, Canada

Location

Victoria, British Columbia, V8V 3N1, Canada

Location

Kitchener, Ontario, N2N 3B9, Canada

Location

North York, Ontario, M6A 3B5, Canada

Location

Thunder Bay, Ontario, P7E 6E7, Canada

Location

Pointe-Claire, Quebec, H9R 4S3, Canada

Location

Trois-Rivières, Quebec, G9A3V7, Canada

Location

Nantes, 44093, France

Location

Nîmes, 30029, France

Location

Orléans, 45067, France

Location

Suresnes, 92150, France

Location

Vandœuvre-lès-Nancy, 54511, France

Location

Berlin, 13465, Germany

Location

Hettstedt, 06333, Germany

Location

Leipzig, 04109, Germany

Location

Mühlacker, 75417, Germany

Location

Athens, 10552, Greece

Location

Heraklion, 71110, Greece

Location

Larissa, 41221, Greece

Location

Pátrai, 26500, Greece

Location

Thessaloniki, 56429, Greece

Location

Bergamo, 24128, Italy

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Milan, 20122, Italy

Location

Napoli, 80131, Italy

Location

Rome, 00189, Italy

Location

Sassari, 07100, Italy

Location

Chihuahua City, 31000, Mexico

Location

Colima, 28000, Mexico

Location

Guadalajara, 44610, Mexico

Location

Mexico City, 06700, Mexico

Location

Saltillo, 25210, Mexico

Location

Tlalpan, 14000, Mexico

Location

Bydgoszcz, 85-168, Poland

Location

Kutno, 99-300, Poland

Location

Poznan, 61-251, Poland

Location

Zabrze, 41-800, Poland

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Moscow, 109472, Russia

Location

Rostov-on-Don, 344011, Russia

Location

Saint Petersburg, 197136, Russia

Location

Saratov, 410026, Russia

Location

Adana, 1330, Turkey (Türkiye)

Location

Denizli, 06111, Turkey (Türkiye)

Location

Istanbul, 34303, Turkey (Türkiye)

Location

Izmir, 35340, Turkey (Türkiye)

Location

Related Publications (1)

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.
PMID: 25353053DERIVED

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

TadalafilFinasteride

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-RingAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsAzasteroidsSteroids, Heterocyclic

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: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 1, 2010

First Posted

June 9, 2010

Study Start

September 1, 2010

Primary Completion

February 1, 2012

Study Completion

May 1, 2012

Last Updated

February 27, 2013

Results First Posted

February 27, 2013

Record last verified: 2013-01

Locations

BE(4)ME(6)FR(5)CA(9)PL(4)US(10)RU(4)DE(4)GR(5)TU(4)AR(2)IT(5)BR(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

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (13)

Study Arms (2)

Tadalafil

Placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (65)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations