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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00384930
Recruitment Status : Completed
First Posted : October 6, 2006
Results First Posted : August 19, 2009
Last Update Posted : September 2, 2009
Sponsor:
Collaborator:
ICOS Corporation
Information provided by:
Eli Lilly and Company

Study Description
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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.

Condition or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia Drug: tadalafil Drug: placebo Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1058 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, 5-Group, Multinational Study to Evaluate the Efficacy, Dose Response, and Safety of Tadalafil Once-a-Day Dosing for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia
Study Start Date : August 2006
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Tadalafil

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: 1
placebo tablet
 Drug: placebo
Placebo tablet taken by mouth one a day for twelve weeks
Active Comparator: 2
2.5 mg tadalafil tablet
 Drug: tadalafil
2.5 mg tadalafil tablet by mouth once a day for twelve weeks.
Other Names:
  • LY450190
  • Cialis
  • IC351
Active Comparator: 3
5 mg tadalafil tablet
 Drug: tadalafil
5 mg tadalafil tablet by mouth once a day for twelve weeks.
Other Names:
  • LY450190
  • Cialis
  • IC351
Active Comparator: 4
10 mg tadalafil tablet
 Drug: tadalafil
10 mg tadalafil tablet by mouth once a day for twelve weeks.
Other Names:
  • LY450190
  • Cialis
  • IC351
Active Comparator: 5
20 mg tadalafil tablet
 Drug: tadalafil
20 mg tadalafil tablet by mouth once a day for twelve weeks.
Other Names:
  • LY450190
  • Cialis
  • IC351


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS): Primary Analysis [ Time Frame: Baseline and 12 weeks ]
    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.

  2. Change From Baseline to Week 12 in International Prostate Symptom Score (IPSS): Supportive Analysis [ Time Frame: Baseline and 12 weeks ]
    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.


Secondary Outcome Measures :
  1. Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) (Irritative) Subscore [ Time Frame: baseline and 12 weeks ]
    Measures irritative symptoms over the past 4 weeks of the IPSS. IPSS irritative subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores range from 1 (few irritative symptoms) to 5 (frequent irritative symptoms), thus the 3 questions of the irritative subscore range from 0 to 15.

  2. Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore [ Time Frame: 12 weeks ]
    Measures obstructive symptoms over the past 4 weeks of the IPSS. IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 1 (few obstructive symptoms) to 5 (frequent obstructive symptoms), thus the 4 questions of the obstructive score range from 0 to 20.

  3. Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Question 7 (Nocturia) [ Time Frame: baseline and 12 weeks ]
    Measures nocturia (the need to get up at night to urinate) over the past 4 weeks. Scores range from 1 (few episodes of nocturia) to 5 (frequent episodes of nocturia).

  4. Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index [ Time Frame: baseline and 12 weeks ]
    Assessment of quality of life (QOL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible).

  5. Change From Baseline to 12 Week Endpoint in Benign Prostatic Hyperplasia Impact Index (BII) [ Time Frame: baseline and 12 weeks ]
    Measures the impact that symptoms of BPH has on the patients well being. This questionnaire has 4 questions assessing the level of urinary discomfort and it's impact on the patients. Three questions range from 0 (no impact) to 4 (high impact); one question ranges from 0 (low impact) to 4 (high impact). The BII score ranges from 0 to 16.

  6. Number of Participants Who Answer "Yes" to the Lower Urinary Tract Symptoms (LUTS) Global Assessment Question (LUTS-GAQ) [ Time Frame: 12 weeks ]
    LUTS-GAQ Question asks the participant if the treatment they have been on has improved their uninary symptoms.

  7. Change From Baseline to 12 Week Endpoint in Peak Urinary Flow [ Time Frame: baseline and 12 weeks ]
    Measures the maximum flow rate of urine (measured in mL/s). This is a continuous parameter with positive numeric values.

  8. Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF) EF Domain [ Time Frame: baseline and 12 weeks ]
    Measures erectile function over the past 4 weeks on Questions 1-5 and 15 (6 questions) of the International Index of Erecile Function (IIEF) questionnaire. Scores range from 0 (low/no erectile function) to 5 (high erectile function), thus the 6 questions of the IIEF-EF domain range from 0 to 30.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00384930


Locations
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United States, Indiana
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
Sponsors and Collaborators
Eli Lilly and Company
ICOS Corporation
Investigators
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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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00384930    
Other Study ID Numbers: 9797
H6D-MC-LVHG
First Posted: October 6, 2006    Key Record Dates
Results First Posted: August 19, 2009
Last Update Posted: September 2, 2009
Last Verified: August 2009
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Male Urogenital Diseases
 Tadalafil
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents