Study of Tadalafil Once-a Day for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia

NCT00384930 | Completed Phase 2 Results

• 2 other identifiers: 9797H6D-MC-LVHG
• Study Type: interventional
• Target: 1,058
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-blind, placebo-controlled, parallel-design, multinational, 12-week study to compare the efficacy, dose response, and safety of tadalafil once a day versus placebo in men with signs and symptoms of benign prostatic hyperplasia, including lower urinary tract symptoms.

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (2)

• Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS): Primary Analysis

  Assesses the severity of BPH-LUTS and the response to therapy. The total score was derived by summing the scores of the responses to the 7 component questions. Scores range from 0 to 35; 0-7 Mildly symptomatic; 8-19 moderately symptomatic; 20-35 severely symptomatic.

  Baseline and 12 weeks

• Change From Baseline to Week 12 in International Prostate Symptom Score (IPSS): Supportive Analysis

  Assesses the severity of BPH-LUTS and the response to therapy. The total score was derived by summing the scores of the responses to the 7 component questions. Scores range from 0 to 35; 0-7 Mildly symptomatic; 8-19 moderately symptomatic; 20-35 severely symptomatic.

  Baseline and 12 weeks

Secondary Outcomes (8)

• Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) (Irritative) Subscore

  baseline and 12 weeks

• Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore

  12 weeks

• Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Question 7 (Nocturia)

  baseline and 12 weeks

• Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index

  baseline and 12 weeks

• Change From Baseline to 12 Week Endpoint in Benign Prostatic Hyperplasia Impact Index (BII)

  baseline and 12 weeks

Study Arms (5)

1

PLACEBO COMPARATOR

placebo tablet

Drug: placebo

2

ACTIVE COMPARATOR

2.5 mg tadalafil tablet

Drug: tadalafil

3

ACTIVE COMPARATOR

5 mg tadalafil tablet

Drug: tadalafil

4

ACTIVE COMPARATOR

10 mg tadalafil tablet

Drug: tadalafil

5

ACTIVE COMPARATOR

20 mg tadalafil tablet

Drug: tadalafil

Interventions

tadalafil DRUG

2.5 mg tadalafil tablet by mouth once a day for twelve weeks.

Also known as: LY450190, Cialis, IC351

2

placebo DRUG

Placebo tablet taken by mouth one 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:

• Males, 45 years or older, with benign prostatic hyperplasia, including lower urinary tract symptoms for at least 6 months prior to Visit 1 and an International Prostate Symptom Score (IPSS) greater than or equal to 13 at Visit 2.
• Agree not to use approved or experimental benign prostatic hyperplasia or erectile dysfunction treatments anytime during the study
• Have not taken finasteride or dutasteride therapy, any other lower urinary tract symptom (LUTS) therapy or phosphodiesterase type 5 (PDE5) inhibitors for specified duration of time prior to Visit 2.
• Have a prostate specific antigen (PSA) score within acceptable range defined for study or negative biopsy of the prostate for cancer within 12 months of Visit 1.

You may not qualify if:

• History of urinary retention or lower urinary tract (bladder) stones 6 months before the start of the study
• History of bladder outlet obstruction or urethral obstruction due to stricture, valves, sclerosis, or tumor.
• History of cardiac conditions including angina requiring certain treatment with nitrates, heart disease or coronary conditions including myocardial infarction, bypass surgery, angioplasty or stent placement for a specified time before starting the study.
• Certain neurological conditions associated with bladder problems or injuries to the brain or spinal cord within a specified time before starting the study.
• Nitrate use

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.

Greenwood, Indiana, United States

Location

Related Publications (4)

• 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: 26299520 DERIVED

• Broderick GA, Brock GB, Roehrborn CG, Watts SD, Elion-Mboussa A, Viktrup L. Effects of tadalafil on lower urinary tract symptoms secondary to benign prostatic hyperplasia in men with or without erectile dysfunction. Urology. 2010 Jun;75(6):1452-8. doi: 10.1016/j.urology.2009.09.093. Epub 2010 Feb 16.

  PMID: 20163842 DERIVED

• Porst H, McVary KT, Montorsi F, Sutherland P, Elion-Mboussa A, Wolka AM, Viktrup L. Effects of once-daily tadalafil on erectile function in men with erectile dysfunction and signs and symptoms of benign prostatic hyperplasia. Eur Urol. 2009 Oct;56(4):727-35. doi: 10.1016/j.eururo.2009.04.033. Epub 2009 Apr 22.

  PMID: 19409693 DERIVED

• Roehrborn CG, McVary KT, Elion-Mboussa A, Viktrup L. Tadalafil administered once daily for lower urinary tract symptoms secondary to benign prostatic hyperplasia: a dose finding study. J Urol. 2008 Oct;180(4):1228-34. doi: 10.1016/j.juro.2008.06.079. Epub 2008 Aug 22.

  PMID: 18722631 DERIVED

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

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

1-800-545-5979

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

Study Record Dates

• First Submitted: October 3, 2006
• First Posted: October 6, 2006
• Study Start: August 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2008
• Last Updated: September 2, 2009
• Results First Posted: August 19, 2009

Record last verified: 2009-08

Locations

US (1)