Text Size

Study to Treat Patients Who Have Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) With Tadalafil Daily

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00827242
First received: January 20, 2009
Last updated: October 19, 2010
Last verified: October 2010
History of Changes
  Purpose

The purpose of this study is to determine whether an experimental drug known as tadalafil given once daily can reduce the symptoms associated with Benign Prostatic Hyperplasia (straining, urinary frequency, feeling like your bladder is still full, etc.)


Condition Intervention Phase
Benign Prostatic Hyperplasia
 Drug: Placebo
Drug: tadalafil
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multinational Study to Evaluate the Efficacy and Safety of Daily Tadalafil for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia

Resource links provided by NLM:

Drug Information available for: Tadalafil
U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS) [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
    The IPSS Total Score is obtained by combining the scores of the responses to Question 1 through Question 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.


Secondary Outcome Measures:
  • Change From Baseline to 4 Weeks, Benign Prostatic Hyperplasia (BPH) Impact Index [ Time Frame: Baseline, 4 weeks ] [ Designated as safety issue: No ]
    The BPH Impact Index (BII) is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.

  • Change From Baseline to 12 Weeks, Benign Prostatic Hyperplasia (BPH) Impact Index [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
    The BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.

  • Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
    IPSS irritative subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores range from 0 (few irritative symptoms) to 5 (frequent irritative symptoms), thus the 3 questions of the irritative subscore range from 0 to 15. LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.

  • Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
    IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (few obstructive symptoms) to 5 (frequent obstructive symptoms), thus the 4 questions of the obstructive score range from 0 to 20. LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.

  • Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS) Nocturia Question [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
    Measures nocturia (the need to get up at night to urinate). Scores range from 0 (few episodes of nocturia) to 5 (frequent episodes of nocturia). LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.

  • Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
    Assessment of QoL by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible). LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.

  • Patient Global Impression of Improvement (PGI-I), Number of Participants in 7 Response Categories [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).

  • Clinical Global Impression of Improvement (CGI-I), Number of Participants in 7 Response Categories [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Measures clinician's perception of patient improvement at the time of assessment compared with the start of treatment. Scores range from 1 (very much better) to 7 (very much worse).

  • Change From Baseline to 1 Week, International Prostate Symptom Score (IPSS) [ Time Frame: Baseline, 1 week ] [ Designated as safety issue: No ]
    The IPSS Total Score is obtained by combining the scores of the responses to Question 1 through Question 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.

  • Change From Baseline to 4 Weeks, International Prostate Symptom Score (IPSS) [ Time Frame: Baseline, 4 Weeks ] [ Designated as safety issue: No ]
    The IPSS Total Score is obtained by combining the scores of the responses to Question 1 through Question 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.

  • Change From Baseline to 12 Weeks, International Index of Erectile Function (IIEF)- Erectile Function (EF) Domain Scores [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
    Self-reported EF. Scores range from 0 (low or no EF) to 5 (high EF) on 6 questions (1-5, 15 of the IIEF). EF Domain scores range from 0 to 30. LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.

  • Change From Baseline to 12 Weeks, Peak Flow Rate (Qmax) by Uroflowmetry [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
    Qmax was defined as the peak urine flow rate (measured in milliliters per second [mL/sec] using standard calibrated flowmeter). At each visit, a uroflowmetry assessment was considered valid and the data were included in the statistical analyses only if the prevoid total bladder volume (assessed by ultrasound) was >=150 to <=550 milliliters (mL) and the voided volume (Vcomp) was >=125 mL.

  • Change From Baseline to 12 Weeks, Mean Flow Rate (Qmean) by Uroflowmetry [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
    Qmean was defined as the mean urine flow rate (measured in mL/sec using standard calibrated flowmeter). At each visit, a uroflowmetry assessment was considered valid and the data were included in the statistical analyses only if the prevoid total bladder volume (assessed by ultrasound) was >=150 to <=550 mL and the Vcomp was >=125 mL.

  • Change From Baseline to 12 Weeks, Voided Volume (Vcomp) by Uroflowmetry [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
    Vcomp was defined as the volume of urine voided (measured in mL using standard calibrated flowmeter). At each visit, a uroflowmetry assessment was considered valid and the data were included in the statistical analyses only if the prevoid total bladder volume (assessed by ultrasound) was >=150 to <=550 mL and the Vcomp was >=125 mL.

  • Change From Baseline to 12 Weeks, Postvoid Residual (PVR) Volume [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
    The amount of urine remaining in the bladder after void completion.


Enrollment: 325
Study Start Date: January 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tadalafil Drug: tadalafil
Following a 4-week placebo lead-in period, subjects received tadalafil 5 mg tablet by mouth once daily over a 12-week period.
Other Names:
  • Cialis
  • LY450190
Placebo Comparator: Placebo Drug: Placebo
Following a 4-week placebo lead-in period, subjects received placebo tablet by mouth once daily over a 12-week period.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men 45 years of age or older with Benign Prostatic Hyperplasia (BPH) also referred to as BPH-LUTS [lower urinary tract symptoms] based on the disease diagnostic criteria at the start of study.
  • Provide signed informed consent at the start of the study.
  • Have not taken Finasteride therapy for at least 3 months before study drug is dispensed and Dutasteride therapy for at least 6 months before study drug is dispensed.
  • Have not taken other BPH therapy (including herbal preparations), overactive bladder (OAB) therapy, or erectile dysfunction (ED) therapy for at least 4 weeks prior to study drug is dispensed.
  • Agree not to use any other approved or experimental pharmacologic BPH, OAB, or ED treatments anytime during the study
  • Have LUTS with a Total International Prostate Symptom Score (IPSS) greater than or equal to 13 when study drug is dispensed.
  • Have reduced peak urine flow rate when study drug is dispensed (measured by a special toilet equipment).
  • Demonstrate compliance with study drug administration requirements.

Exclusion Criteria:

  • Treated with nitrates for a cardiac conditions.
  • Have unstable angina or angina that requires treatment.
  • 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 very high or very low blood pressure
  • 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 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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00827242

  Show 27 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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
  More Information

No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00827242     History of Changes
Other Study ID Numbers: 10893, H6D-MC-LVHJ
Study First Received: January 20, 2009
Results First Received: October 19, 2010
Last Updated: October 19, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Signs and Symptoms
Prostatic Hyperplasia
Hyperplasia
 Genital Diseases, Male
Prostatic Diseases
BPH-LUTS

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Signs and Symptoms
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Tadalafil
Phosphodiesterase 5 Inhibitors
 Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013