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

NCT00547625 | Completed Phase 2

• 2 other identifiers: 9120H6D-MC-LVGC
• Study Type: interventional
• Target: 275
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostatic Hyperplasia; Prostate

Outcome Measures

Primary Outcomes (1)

• International Prostate Symptom Score (IPSS) sum total of questions 1-7

  6 and 12 weeks

Secondary Outcomes (3)

• Evaluate different domains of the IPSS sums along with other questionnaires such as the LUTS GAQ and BII.

  12 weeks

• Measure Uroflowmetry parameters

  12 weeks

• Evaluate safety by PSA levels and postvoid residual volume (PVR)

  12 weeks

Study Arms (2)

1

PLACEBO COMPARATOR

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

Drug: placebo

2

ACTIVE COMPARATOR

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

Drug: tadalafil

Interventions

tadalafil 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.

Also known as: LY450190, Cialis, IC351

2

placebo DRUG

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

1

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead
• ICOS Corporation: collaborator

Study Sites (1)

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

Location

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 18, 2007
• First Posted: October 22, 2007
• Study Start: October 1, 2004
• Study Completion: July 1, 2005
• Last Updated: October 22, 2007

Record last verified: 2007-10

Locations

US (1)