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OpenTrials
Completed

NCT Number: NCT00386009

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

The purpose of this study is to evaluate the function of the bladder and urethra during urinary storage or voiding in men with signs and symptoms of benign prostatic hyperplasia treated with either placebo or tadalafil.

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Key information

Conditions

Benign Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

40 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary 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., Pátrai, Greece

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men 40 years of age or older with Lower Urinary Tract Symptoms (LUTS) with a total International Prostate Symptom Score (IPSS) greater than or equal to 13 at Visit 1.
  • Agree not to use any other approved or experimental medications for Benign Prostate Hyperplasia (BPH)-Lower Urinary Tract Symptoms, including alpha blockers, 5-alpha reductase inhibitors, PDE5 inhibitors, or herbal preparations at any time during the study.
  • Have not taken finasteride or dutasteride therapy for at least 4 months prior to Visit 2; have not taken any other LUTS therapy (including herbal preparations) or PDE5 inhibitors for at least 4 weeks prior to Visit 2.
  • Have had BPH-LUTS for greater than 6 months prior to Visit 1.

Exclusion criteria

  • Any pelvic surgical procedure on the urinary tract, including minimally invasive BPH-LUTS therapies and penile implant surgery.
  • History of urethral obstruction due to stricture, valves, sclerosis, or tumor.
  • Current neurologic disease or condition associated with neurogenic bladder (for example, Parkinson's disease, multiple sclerosis).
  • History of cardiac conditions including myocardial infarction, bypass surgery, angioplasty or stent placement for a specified time before starting the study.
  • History of angina requiring treatment with nitrates.
  • Prostate Specific Antigen (PSA) greater than 10 nanogram/milliliter (ng/ml) at Visit 1.

Treatment and study plan

Tadalafil

Drug

20 mg tadalafil tablet taken by mouth once a day for 12 weeks.

Other names: LY450190, Cialis, IC351

Placebo

Drug

Placebo tablet taken by mouth once a day for 12 weeks.

Primary outcomes

  1. Change From Baseline to 12 Week Endpoint in Detrusor Pressure at Peak Urinary Flow Rate (PdetQmax)

    Time frame: Baseline and 12 weeks

Secondary outcomes

  1. Change From Baseline to 12 Week Endpoint in Peak Urinary Flow Rate (Qmax) Measured During Free-Flow Studies

    Time frame: Baseline and 12 weeks

    Qmax was measured during free-flow tests using a standard calibrated flow meter.

  2. Change From Baseline to 12 Week Endpoint in Mean Urinary Flow Rate (Qave) Measured During Free-Flow Studies

    Time frame: Baseline and 12 weeks

    Qave was measured during free-flow tests using a standard calibrated flow meter.

  3. Change From Baseline to 12 Week Endpoint in Volume of Voided Urine (Vcomp) Measured During Free-Flow Studies

    Time frame: Baseline and 12 weeks

  4. Change From Baseline to 12 Week Endpoint in Postvoid Residual Volume (PVRcath) Measured During Free-Flow Studies

    Time frame: Baseline and 12 weeks

    PVRcath is the volume of urine remaining int he bladder after voiding, measured by catheterization.

  5. Change From Baseline to 12 Week Endpoint in Total Bladder Capacity Measured During Free-Flow Studies

    Time frame: Baseline and 12 weeks

    Total bladder capacity was defined as Vcomp + PVRcath (obtained when the bladder was full).

  6. Change From Baseline to 12 Week Endpoint in Bladder Voiding Efficiency (BVE) Measured During Free-Flow Studies

    Time frame: Baseline and 12 weeks

    Bladder voiding efficiency was defined as (Vcomp/total bladder capacity) X 100 (obtained when the bladder was full).

  7. Change From Baseline to 12 Week Endpoint in Peak Urinary Flow Rate (Qmax) Measured During Pressure-Flow Studies

    Time frame: Baseline and 12 weeks

    Qmax was measured duirng pressure-flow tests.

  8. Change From Baseline to 12 Week Endpoint in Mean Urinary Flow Rate (Qave) Measured During Pressure-Flow Studies

    Time frame: Baseline and 12 weeks

    Qave was measured during pressure-flow tests.

  9. Change From Baseline to 12 Week Endpoint in Volume of Voided Urine (Vcomp) Measured During Pressure-Flow Studies

    Time frame: Baseline and 12 weeks

    Vcomp was defined as the volume of voided urine measured during pressure-flow tests.

  10. Change From Baseline to 12 Week Endpoint in Maximum Detrusor Pressure (Max Pdet) Measured During Pressure-Flow Studies

    Time frame: Baseline and 12 weeks

    Max Pdet was defined as the maximum detrusor pressure observed during voiding.

  11. Change From Baseline to 12 Week Endpoint in Bladder Contractility Index (BCI) Measured During Pressure-Flow Studies

    Time frame: Baseline and 12 weeks

    BCI was derived from the equation PdetQmax + 5Qmax. Scores: <100 means weak, 100-150 menas normal, >150 means strong. A decrease means a decrease in contractility of the bladder.

  12. Change From Baseline to 12 Week Endpoint in Bladder Outlet Obstruction Index (BOOI) Measured During Pressure-Flow Studies

    Time frame: Baseline and 12 weeks

    BOOI, formerly known as the Abrams-Griffith number, was derived from the equation PdetQmax - 2Qmax. Scores: <20 means unobstructed, 20-40 means equivocol, >40 means obstructed. An increase means worsening of obstruction, a decreased means lessening of obstruction (improvement).

  13. Presence of Involuntary Detrusor Contractions During Bladder Filling

    Time frame: Baseline and 12 weeks

  14. Change From Baseline to 12 Week Endpoint in Bladder Volume at First Involuntary Detrusor Contraction

    Time frame: Baseline and 12 weeks

    Assessed in participants with involuntary detrusor contractions during the bladder filling at both baseline and endpoint.

  15. Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Total Score

    Time frame: 12 weeks

    The IPSS Total Score is obtained by combining the scores of the responses to the 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.

  16. Clinically Adverse and Statistically Significant Changes From Baseline to 12 Week Endpoint in Laboratory Tests

    Time frame: Baseline and 12 weeks

    Laboratory tests that were statistically significant and clinically adverse would be reported for safety.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • ICOS Corporation

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multicenter Study to Evaluate the Urodynamic Effects of Tadalafil Once a Day for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Oct 11, 2006
Registry last updated
Jul 9, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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