NCT01152190

Brief Summary

The purpose of this trial is to evaluate the effect of tadalafil 5 milligrams (mg) daily for 8 weeks compared to placebo on prostatic blood perfusion in men with signs and symptoms of Benign Prostatic Hyperplasia (BPH), measured by resistive index (RI) in the prostate transition zone.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
97

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2010

Geographic Reach
3 countries

5 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

First Submitted

Initial submission to the registry

June 25, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 29, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
11 months until next milestone

Results Posted

Study results publicly available

May 20, 2013

Completed
Last Updated

May 20, 2013

Status Verified

March 1, 2013

Enrollment Period

1.8 years

First QC Date

June 25, 2010

Results QC Date

March 27, 2013

Last Update Submit

March 27, 2013

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline to 8-Week Endpoint in Arterial Resistive Index (RI) in the Prostate Transition Zone

    Arterial RI was a measure of vascular resistance using Doppler ultrasound. RI was the ratio of (peak systolic velocity - end diastolic velocity)/peak systolic velocity, and increased as resistance to blood flow increased. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included fixed effects for treatment, region, visit, and treatment-by-visit interaction, baseline as a covariate, a random effect of participant within treatment, and an unstructured covariance matrix.

    Baseline, Week 8

Secondary Outcomes (3)

  • Change From Baseline to 4-Week Endpoint in Arterial Resistive Index (RI) in the Prostate Transition Zone

    Baseline, Week 4

  • Change From Baseline to 4 and 8 Weeks in Arterial Resistive Index (RI) in the Prostate Peripheral Zone and Bladder Neck

    Baseline, Week 4 and Week 8

  • Change From Baseline to 4 and 8 Weeks in Color Pixel Intensity (CPI) in the Prostate Transition Zone, Peripheral Zone, and Bladder Neck

    Baseline, Week 4 and Week 8

Study Arms (2)

5 milligrams (mg) Tadalafil

EXPERIMENTAL
Drug: Tadalafil

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

TadalafilDRUG

Administered orally, once daily for 8 weeks

Also known as: Cialis, LY450190
5 milligrams (mg) Tadalafil
PlaceboDRUG

Administered orally, once daily for 8 weeks

Placebo

Eligibility Criteria

Age45 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Present with benign prostatic hyperplasia
  • Provide signed informed consent at the screening
  • Agree not to use other treatment for Benign Prostatic Hyperplasia, Erectile Dysfunction or Overactive Bladder (including herbal treatments) during the study

You may not qualify if:

  • Have prostatic cancer or are being treated for cancer.
  • Any condition that may negatively influence the transrectal ultrasound.
  • Are being treated for heart disease with any drug that is called a nitrate (for example, nitroglycerin).
  • Any evidence of moderate to severe cardiac disease
  • Have had any of the following in the past 90 days: chest pain (called unstable angina or angina) that requires treatment, heart attack also known as myocardial infarction, heart bypass surgery (called coronary artery bypass graft surgery), had a procedure to open up blood vessels in the heart know as angioplasty or stent placement (percutaneous coronary intervention), positive cardiac stress test without effective cardiac intervention.
  • Have very high or very low blood pressure.
  • Have uncontrolled diabetes.
  • Have certain problems with your kidneys, liver, or nervous system.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

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.

Chicago, Illinois, 60611, United States

Location

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.

Garden City, New York, 11530, United States

Location

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.

New York, New York, 10016, United States

Location

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.

Innsbruck, 6020, Austria

Location

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.

Bergamo, 24128, Italy

Location

Related Publications (1)

  • Pinggera GM, Frauscher F, Paduch DA, Bolyakov A, Efros M, Kaminetsky J, Da Pozzo L, Esler A, Cox D. Effect of tadalafil once daily on prostate blood flow and perfusion in men with lower urinary tract symptoms secondary to benign prostatic hyperplasia: a randomized, double-blind, multicenter, placebo-controlled trial. Urology. 2014 Aug;84(2):412-9. doi: 10.1016/j.urology.2014.02.063. Epub 2014 Jun 14.

    PMID: 24938580DERIVED

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Tadalafil

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-Ring

Limitations and Caveats

The primary and secondary efficacy analyses of resistive index (RI) and color pixel intensity (CPI) were based on centrally-read data.

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

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, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2010

First Posted

June 29, 2010

Study Start

September 1, 2010

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

May 20, 2013

Results First Posted

May 20, 2013

Record last verified: 2013-03

Locations

US(3)AU(1)IT(1)