ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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 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

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




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

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 ]
  2. Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore [ Time Frame: 12 weeks ]
  3. Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Question 7 (Nocturia) [ Time Frame: baseline and 12 weeks ]
  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 ]
  5. Change From Baseline to 12 Week Endpoint in Benign Prostatic Hyperplasia Impact Index (BII) [ Time Frame: baseline and 12 weeks ]
  6. Number of Participants Who Answer "Yes" to the Lower Urinary Tract Symptoms (LUTS) Global Assessment Question (LUTS-GAQ) [ Time Frame: 12 weeks ]
  7. Change From Baseline to 12 Week Endpoint in Peak Urinary Flow [ Time Frame: baseline and 12 weeks ]
  8. Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF) EF Domain [ Time Frame: baseline and 12 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
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
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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00384930     History of Changes
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:
Hyperplasia
Prostatic Hyperplasia
Signs and Symptoms
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Tadalafil
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents