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Study to Determine Safety and Effectiveness of Tadalafil on Prostate Related Sex Organ/Urinary Tract Problems

NCT ID: NCT00547625

Last Updated: 2007-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

275 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2005-07-31

Brief Summary

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Study to look at safety and effectiveness of different doses of tadalafil on prostate related genital/urinary tract problems.

Detailed Description

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Conditions

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Prostatic Hyperplasia Prostate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Placebo run in followed by 5 mg treatment phase 1 and then 20 mg treatment phase 2 which both include a placebo control.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Placebo tablet run in followed by placebo treatment period with one tablet taken by mouth once a day for twelve weeks.

2

Treatment phase 1 includes 5 mg tadalafil 6 weeks then treatment phase 2 which includes 20 mg tadalafil for 6 weeks.

Group Type ACTIVE_COMPARATOR

tadalafil

Intervention Type DRUG

Treatment phase 1 includes 5 mg tadalafil tablet taken by mouth once a day for 6 weeks then treatment phase 2 which includes 20 mg tadalafil tablet taken by mouth once a day for 6 weeks.

Interventions

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tadalafil

Treatment phase 1 includes 5 mg tadalafil tablet taken by mouth once a day for 6 weeks then treatment phase 2 which includes 20 mg tadalafil tablet taken by mouth once a day for 6 weeks.

Intervention Type DRUG

placebo

Placebo tablet run in followed by placebo treatment period with one tablet taken by mouth once a day for twelve weeks.

Intervention Type DRUG

Other Intervention Names

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LY450190 Cialis IC351

Eligibility Criteria

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Inclusion Criteria

* 6 month history of lower urinary tract symptoms either obstructive and/or irritative secondary to prostate related problems as diagnosed by a urologist.
* Stopped using treatments at least four weeks prior to study and agree to not use any other treatments during the study.
* Meet required prostate symptom score and urine flow rate.

Exclusion Criteria

* Serum prostate specific antigen (PSA) greater than 10 (between 4 and 10, inclusive, without a negative biopsy w/in the last 6 months.
* Prostate removal and various other pelvic surgeries.
* Neurological disease or condition known to affect the bladder.
* Clinical evidence of prostate cancer, urinary tract inflammation or infection, including prostatitis.
* Have taken medications such as nitrates, finasteride, or dutasteride within the year.
Minimum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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ICOS Corporation

INDUSTRY

Sponsor Role collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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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, United States

Site Status

Countries

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United States

Other Identifiers

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H6D-MC-LVGC

Identifier Type: -

Identifier Source: secondary_id

9120

Identifier Type: -

Identifier Source: org_study_id