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A Study of Tadalafil Use With Finasteride in Men With Enlarged Prostates and Urinary Symptoms

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT01139762
Collaborator
(none)
696
Enrollment
65
Locations
2
Arms
20
Duration (Months)
10.7
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate the efficacy and safety of once daily tadalafil when taken with finasteride as a treatment for men with signs and symptoms of Benign Prostatic Hyperplasia and demonstrable prostate enlargement.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
696 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 3b, Randomized, Double-blind, Placebo-controlled Parallel-design Study to Evaluate the Efficacy and Safety of Tadalafil Co-administered With Finasteride for 6 Months in Men With Lower Urinary Tract Symptoms and Prostatic Enlargement Secondary to Benign Prostatic Hyperplasia
Study Start Date :
Sep 1, 2010
Actual Primary Completion Date :
Feb 1, 2012
Actual Study Completion Date :
May 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tadalafil

Drug: Tadalafil
5 milligrams (mg) administered orally, once daily for 26 weeks
Other Names:
  • Cialis
  • LY#450190

    • Drug: Finasteride
    5mg administered orally, once daily for 26 weeks
    Placebo Comparator: Placebo

    Drug: Placebo
    Administered orally, once daily for 26 weeks

    Drug: Finasteride
    5mg administered orally, once daily for 26 weeks

    Outcome Measures

    Primary Outcome Measures

    1. Change in Total International Prostate Symptom Score (IPSS) From Baseline to 12 Weeks [Baseline, 12 weeks]

      The International Prostate Symptom Score (IPSS) is a rating scale for severity of lower urinary tract symptoms (LUTS). The IPSS has a 7-component questionnaire. Each question is scored on a scale from 0 (none/no symptoms) to 5 (frequent symptoms), for a total score range of 0 to 35. Higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline total IPSS, and visit-by-treatment interaction.

    Secondary Outcome Measures

    1. Change in Total International Prostate Symptom Score (IPSS) From Baseline to 4 and 26 Weeks [Baseline, 4 weeks, 26 weeks]

      The International Prostate Symptom Score (IPSS) is a rating scale for severity of lower urinary tract symptoms (LUTS). The IPSS has a 7-component questionnaire. Each question is scored on a scale from 0 (none/no symptoms) to 5 (frequent symptoms), for a total score range of 0 to 35. Higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline total IPSS, and visit-by-treatment interaction.

    2. Change in International Prostate Symptom Score (IPSS) Subscores Index From Baseline to 4, 12, and 26 Weeks [Baseline, 4 weeks, 12 weeks, 26 weeks]

      IPSS storage (irritative) subscore is the sum of Questions 2, 4 and 7 of the 7-component IPSS questionnaire. Scores range from 0 (no irritative symptoms) to 5 (frequent irritative symptoms), with total subscore of the 3 questions for irritative subscore range from 0 to 15. IPSS voiding (obstructive) subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (no obstructive symptoms) to 5 (frequent obstructive symptoms), with total subscore of the 4 questions of the obstructive score range from 0 to 20. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline total IPSS, and visit-by-treatment interaction.

    3. Change in International Prostate Symptom Score (IPSS) Quality of Life Index From Baseline to 4, 12, and 26 Weeks [Baseline, 4 weeks, 12 weeks, 26 weeks]

      IPSS Quality of Life Index assesses participant response to the following question: "If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?" Response options are Delighted (0); Pleased (1); Mostly satisfied (2); Mixed-about equally satisfied and dissatisfied (3); Mostly dissatisfied (4); Unhappy (5); Terrible (6), with a total range of 0-6. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline total IPSS, and visit-by-treatment interaction.

    4. Change in International Index of Erectile Function (IIEF) - Erectile Function Domain Scores From Baseline to 4, 12, and 26 Weeks [Baseline, 4 weeks, 12 weeks, 26 weeks]

      Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.

    5. Change in International Index of Erectile Function (IIEF) - Overall Satisfaction Domain Scores From Baseline to 4, 12, and 26 Weeks [Baseline, 4 weeks, 12 weeks, 26 weeks]

      Self-reported overall satisfaction over the past 4 weeks. IIEF-Overall Satisfaction is the sum of Questions 13 and 14 of IIEF questionnaire. Scores range from 1 (low/no satisfaction) to 5 (high satisfaction) for each question, with the total possible score for the 2 questions ranging from 2 to 10. Higher total scores indicate higher satisfaction. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.

    6. Change in International Index of Erectile Function (IIEF) - Intercourse Satisfaction Domain Scores From Baseline to 4, 12, and 26 Weeks [Baseline, 4 weeks, 12 weeks, 26 weeks]

      Self-reported intercourse satisfaction over the past 4 weeks. IIEF-intercourse satisfaction is the sum of Questions 6, 7 and 8 of the IIEF. Scores range from 0 (low/no satisfaction) to 5 (high satisfaction) for each question, with the total possible score for the 3 questions of 0 to 15. Higher total scores indicate higher satisfaction. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.

    7. Change in International Index of Erectile Function (IIEF) - Orgasmic Function Domain Scores From Baseline to 4, 12, and 26 Weeks [Baseline, 4 weeks, 12 weeks, 26 weeks]

      Orgasmic Function domain scores is the sum of Questions 9 and 10 from the IIEF questionnaire. Scores range from 0 (low/no orgasm) to 5 (high orgasm) for each question, with the total possible score for the 2 questions ranging from 0 to 10. Higher total scores indicate higher orgasm. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.

    8. Change in International Index of Erectile Function (IIEF) - Sexual Desire Domain Scores From Baseline to 4, 12, and 26 Weeks [Baseline, 4 weeks, 12 weeks, 26 weeks]

      Sexual desire domain scores is the sum of Questions 11 and 12 from the IIEF questionnaire. Scores range from 1 (low/no desire) to 5 (high desire) for each question, with the total possible score for the 2 questions ranging from 2 to 10. Higher total scores indicate higher desire. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.

    9. Patient Global Impression of Improvement (PGI-I) at 26 Weeks [26 weeks]

      Patient Global Impression of Improvement (PGI-I) measures the participant's perception of improvement at the time of assessment compared with the start of treatment. Number of participants is reported by the categorized score ranging from 1 (very much better) to 7 (very much worse).

    10. Treatment Satisfaction Scale - Benign Prostatic Hyperplasia (TSS-BPH) at 26 Weeks [26 weeks]

      The TSS-BPH was a validated participant-rated instrument that measured participant satisfaction with treatment based on a 13-item questionnaire. It consists of 10 items on a Likert-like scale with scores ranging from 1 (higher satisfaction) to 5 (lower satisfaction), 1 item with score ranging from 0 (higher satisfaction) to 5 (lower satisfaction), and 2 yes/no questions. The mean score for each participant ranges from 0.9 (higher satisfaction) to 5.0 (lower satisfaction). Data presented are the average of mean scores for each treatment group.

    11. Clinician Global Impression of Improvement (CGI-I) at 26 Weeks [26 weeks]

      Clinician Global Impression of Improvement (CGI-I) measures clinician's perception of participant improvement at the time of assessment compared with the start of treatment. Number of participants is reported by the categorized score ranging from 1 (very much better) to 7 (very much worse).

    12. Change in Post Void Residual (PVR) Volume From Baseline to 26 Weeks [Baseline, 26 weeks]

      Postvoid Residual Volume (PVR) is determined using a portable, calibrated ultrasound device. It consists of the average of a minimum of 3 scans where the residual bladder volume was calculated by averaging the most accurate of the 3 imaging attempts.

    13. Change in International Index of Erectile Function (IIEF) Question 3 and 4 Scores From Baseline to 4, 12, and 26 Weeks [Baseline, 4 weeks, 12 weeks, 26 weeks]

      IIEF Question 3 asks how often a participant was able to penetrate his partner over the past 4 weeks. Scores range from 0 (did not attempt intercourse) to 5 (almost always or always). IIEF Question 4 asks whether/how often a participant was able to maintain an erection after penetration over the past 4 weeks. Scores range from 0 (did not attempt intercourse) to 5 (almost always or always). Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Have not taken the following treatments within the indicated duration and agree not to use at any time during the study:

    • All other Benign Prostatic Hyperplasia (BPH) therapy (including herbal preparations) for at least 4 weeks prior to receiving study medication.

    • Overactive bladder therapy (including antimuscarinics) for at least 4 weeks prior to receiving study medication.

    • Erectile Dysfunction therapy (including herbal preparations) for at least 4 weeks prior to receiving study medication.

    • Finasteride or dutasteride use at any time.

    • Have bladder outlet obstruction as defined by a urinary peak flow rate (Qmax) of greater than or equal to 4 and less than or equal to 15 milliliters (mL)/second before receiving study drug.

    • Have prostate enlargement measured by ultrasound at screening.

    Exclusion Criteria:

    • 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].

    • 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 problems with kidneys, liver, or nervous system

    • Have uncontrolled diabetes

    • Have had a stroke or a significant injury to brain or spinal cord.

    • Have scheduled or planned surgery during the course of the study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    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. Davis California United States 95616
    2 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. Fresno California United States 93720
    3 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. Laguna Hills California United States 92367
    4 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. Long Beach California United States 90806
    5 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. Vacaville California United States 95688
    6 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. Sarasota Florida United States 34237
    7 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. St. Petersburg Florida United States 33710
    8 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. West Palm Beach Florida United States 33407
    9 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. Shreveport Louisiana United States 71106
    10 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. Georgetown Texas United States 78626
    11 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. Buenos Aires Argentina C1060AAA
    12 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. Córdoba Argentina X5016KEH
    13 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. Brussels Belgium 1090
    14 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. Edegem Belgium 2650
    15 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. Gent Belgium 9000
    16 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. Kortrijk Belgium 8500
    17 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. Porto Alegre Brazil 90610-970
    18 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. Rio De Janeiro Brazil 20551-030
    19 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. São Paulo Brazil 04262-000
    20 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. Calgary Alberta Canada T2W 1P9
    21 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. Abbottsford British Columbia Canada V2S 3N5
    22 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. Surrey British Columbia Canada V3V 1N1
    23 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. Victoria British Columbia Canada V8V 3N1
    24 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. Kitchener Ontario Canada N2N 3B9
    25 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. North York Ontario Canada M6A 3B5
    26 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. Thunder Bay Ontario Canada P7E 6E7
    27 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. Pointe Claire Quebec Canada H9R 4S3
    28 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. Trois-Rivieres Quebec Canada G9A3V7
    29 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. Nantes France 44093
    30 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. Nimes France 30029
    31 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. Orleans France 45067
    32 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. Suresnes France 92150
    33 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. Vandoeuvre Les Nancy France 54511
    34 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. Berlin Germany 13465
    35 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. Hettstedt Germany 06333
    36 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. Leipzig Germany 04109
    37 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. Muehlacker Germany 75417
    38 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. Athens Greece 10552
    39 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. Heraklion Greece 71110
    40 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. Larissa Greece 41221
    41 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. Patras Greece 26500
    42 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. Thessaloniki Greece 56429
    43 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. Bergamo Italy 24128
    44 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. Milano Italy 20122
    45 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. Napoli Italy 80131
    46 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. Rome Italy 00189
    47 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. Sassari Italy 07100
    48 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. Chihuahua Mexico 31000
    49 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. Colima Mexico 28000
    50 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. Guadalajara Mexico 44610
    51 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. Mexico City Mexico 06700
    52 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. Saltillo Mexico 25210
    53 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. Tlalpan Mexico 14000
    54 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. Bydgoszcz Poland 85-168
    55 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. Kutno Poland 99-300
    56 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. Poznan Poland 61-251
    57 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. Zabrze Poland 41-800
    58 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. Moscow Russian Federation 109472
    59 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. Rostov-On-Don Russian Federation 344011
    60 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. Saint Petersburg Russian Federation 197136
    61 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. Saratov Russian Federation 410026
    62 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. Adana Turkey 1330
    63 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. Denizli Turkey 06111
    64 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. Istanbul Turkey 34303
    65 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. Izmir Turkey 35340

    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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT01139762
    Other Study ID Numbers:
    • 13529
    • H6D-CR-LVIW
    First Posted:
    Jun 9, 2010
    Last Update Posted:
    Feb 27, 2013
    Last Verified:
    Jan 1, 2013
    Keywords provided by Eli Lilly and Company
    Benign Prostatic Hyperplasia (BPH)
    Enlarged Prostate
    Additional relevant MeSH terms:
    Prostatic Hyperplasia
    Hyperplasia
    Tadalafil
    Finasteride

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail The study consisted of 3 periods: a 4-week washout period, a 4-week, single-blind, placebo lead-in period, and a 26-week double-blind randomized active treatment period. Participants who did not complete the washout and placebo lead-in period were considered screen failures.
    Arm/Group Title Screening-Washout and Placebo Lead-In Tadalafil Placebo
    Arm/Group Description 4 weeks washout period and followed by placebo orally, once daily for 4 weeks during placebo lead-in period. 5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks during double-blind randomized active treatment period. Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks during double-blind randomized active treatment period.
    Period Title: Washout and Placebo Lead-In Period
    STARTED 1070 0 0
    COMPLETED 696 0 0
    NOT COMPLETED 374 0 0
    Period Title: Washout and Placebo Lead-In Period
    STARTED 0 346 350
    Received at Least 1 Dose of Study Drug 0 345 350
    COMPLETED 0 306 286
    NOT COMPLETED 0 40 64

    Baseline Characteristics

    Arm/Group Title Tadalafil Placebo Total
    Arm/Group Description 5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks. Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks. Total of all reporting groups
    Overall Participants 345 350 695
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    63.8
    (7.50)
    63.6
    (7.85)
    63.7
    (7.68)
    Sex: Female, Male (Count of Participants)
    Female
    0
    0%
    0
    0%
    0
    0%
    Male
    345
    100%
    350
    100%
    695
    100%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    4
    1.2%
    5
    1.4%
    9
    1.3%
    Not Hispanic or Latino
    39
    11.3%
    41
    11.7%
    80
    11.5%
    Unknown or Not Reported
    302
    87.5%
    304
    86.9%
    606
    87.2%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    33
    9.6%
    37
    10.6%
    70
    10.1%
    Asian
    5
    1.4%
    1
    0.3%
    6
    0.9%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    6
    1.7%
    15
    4.3%
    21
    3%
    White
    298
    86.4%
    296
    84.6%
    594
    85.5%
    More than one race
    3
    0.9%
    1
    0.3%
    4
    0.6%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Region of Enrollment (participants) [Number]
    United States
    43
    12.5%
    46
    13.1%
    89
    12.8%
    Greece
    18
    5.2%
    12
    3.4%
    30
    4.3%
    Turkey
    26
    7.5%
    19
    5.4%
    45
    6.5%
    Russian Federation
    32
    9.3%
    37
    10.6%
    69
    9.9%
    Italy
    21
    6.1%
    25
    7.1%
    46
    6.6%
    France
    21
    6.1%
    9
    2.6%
    30
    4.3%
    Mexico
    33
    9.6%
    37
    10.6%
    70
    10.1%
    Canada
    30
    8.7%
    28
    8%
    58
    8.3%
    Argentina
    46
    13.3%
    41
    11.7%
    87
    12.5%
    Belgium
    7
    2%
    16
    4.6%
    23
    3.3%
    Poland
    32
    9.3%
    39
    11.1%
    71
    10.2%
    Brazil
    12
    3.5%
    13
    3.7%
    25
    3.6%
    Germany
    24
    7%
    28
    8%
    52
    7.5%
    Lower urinary tract symptoms (LUTS) severity (participants) [Number]
    Moderate (IPSS<20)
    238
    69%
    235
    67.1%
    473
    68.1%
    Severe (IPSS≥20)
    106
    30.7%
    114
    32.6%
    220
    31.7%
    Unknown
    1
    0.3%
    1
    0.3%
    2
    0.3%
    Peak urine flow rate (participants) [Number]
    <10 milliliters/second (mL/sec)
    154
    44.6%
    169
    48.3%
    323
    46.5%
    10-15 mL/sec
    190
    55.1%
    180
    51.4%
    370
    53.2%
    >15 mL/sec
    1
    0.3%
    1
    0.3%
    2
    0.3%
    Postvoid residual volume (PVR) (milliliters (mL)) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [milliliters (mL)]
    65.5
    (60.69)
    62.6
    (59.57)
    64.1
    (60.10)
    Prostate Volume (milliliters (mL)) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [milliliters (mL)]
    48.2
    (19.43)
    50.6
    (21.17)
    49.4
    (20.35)
    Prostate Specific Antigen (PSA) (nanograms/milliliter (ng/mL)) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [nanograms/milliliter (ng/mL)]
    2.3
    (2.02)
    2.5
    (2.06)
    2.4
    (2.04)
    Erectile Dysfunction (participants) [Number]
    Yes
    227
    65.8%
    223
    63.7%
    450
    64.7%
    No
    118
    34.2%
    127
    36.3%
    245
    35.3%
    Sexual activity with female partner (participants) [Number]
    Yes
    305
    88.4%
    305
    87.1%
    610
    87.8%
    No
    40
    11.6%
    44
    12.6%
    84
    12.1%
    Not Applicable
    0
    0%
    1
    0.3%
    1
    0.1%
    Height (centimeters (cm)) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [centimeters (cm)]
    173.5
    (7.90)
    173.8
    (7.65)
    173.7
    (7.77)
    Weight (kilograms (kg)) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kilograms (kg)]
    85.3
    (14.16)
    85.6
    (14.16)
    85.4
    (14.15)
    Body Mass Index (BMI) (kilograms/square meter (kg/m²)) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kilograms/square meter (kg/m²)]
    28.3
    (4.00)
    28.3
    (3.80)
    28.3
    (3.90)

    Outcome Measures

    1. Primary Outcome
    Title Change in Total International Prostate Symptom Score (IPSS) From Baseline to 12 Weeks
    Description The International Prostate Symptom Score (IPSS) is a rating scale for severity of lower urinary tract symptoms (LUTS). The IPSS has a 7-component questionnaire. Each question is scored on a scale from 0 (none/no symptoms) to 5 (frequent symptoms), for a total score range of 0 to 35. Higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline total IPSS, and visit-by-treatment interaction.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IPSS measurement.
    Arm/Group Title Tadalafil Placebo
    Arm/Group Description 5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks. Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
    Measure Participants 345 350
    Least Squares Mean (Standard Error) [units on a scale]
    -5.18
    (0.32)
    -3.76
    (0.32)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
    Comments MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.001
    Comments
    Method Mixed Model Repeated Measures Analysis
    Comments The Kenward-Roger approximation was used to estimate denominator degrees of freedom.
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -1.41
    Confidence Interval (2-Sided) 95%
    -2.27 to -0.55
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Secondary Outcome
    Title Change in Total International Prostate Symptom Score (IPSS) From Baseline to 4 and 26 Weeks
    Description The International Prostate Symptom Score (IPSS) is a rating scale for severity of lower urinary tract symptoms (LUTS). The IPSS has a 7-component questionnaire. Each question is scored on a scale from 0 (none/no symptoms) to 5 (frequent symptoms), for a total score range of 0 to 35. Higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline total IPSS, and visit-by-treatment interaction.
    Time Frame Baseline, 4 weeks, 26 weeks

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IPSS measurement.
    Arm/Group Title Tadalafil Placebo
    Arm/Group Description 5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks. Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
    Measure Participants 345 350
    4 weeks
    -3.95
    (0.29)
    -2.29
    (0.28)
    26 weeks
    -5.51
    (0.33)
    -4.47
    (0.33)
    3. Secondary Outcome
    Title Change in International Prostate Symptom Score (IPSS) Subscores Index From Baseline to 4, 12, and 26 Weeks
    Description IPSS storage (irritative) subscore is the sum of Questions 2, 4 and 7 of the 7-component IPSS questionnaire. Scores range from 0 (no irritative symptoms) to 5 (frequent irritative symptoms), with total subscore of the 3 questions for irritative subscore range from 0 to 15. IPSS voiding (obstructive) subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (no obstructive symptoms) to 5 (frequent obstructive symptoms), with total subscore of the 4 questions of the obstructive score range from 0 to 20. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline total IPSS, and visit-by-treatment interaction.
    Time Frame Baseline, 4 weeks, 12 weeks, 26 weeks

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IPSS subscore measurement.
    Arm/Group Title Tadalafil Placebo
    Arm/Group Description 5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks. Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
    Measure Participants 345 350
    IPSS storage (irritative) subscore - 4 weeks
    -1.27
    (0.14)
    -0.76
    (0.14)
    IPSS storage (irritative) subscore - 12 weeks
    -1.74
    (0.14)
    -1.34
    (0.14)
    IPSS storage (irritative) subscore - 26 weeks
    -2.00
    (0.15)
    -1.66
    (0.15)
    IPSS voiding (obstructive) subscore - 4 weeks
    -2.65
    (0.19)
    -1.47
    (0.19)
    IPSS voiding (obstructive) subscore - 12 weeks
    -3.41
    (0.21)
    -2.37
    (0.21)
    IPSS voiding (obstructive) subscore - 26 weeks
    -3.50
    (0.22)
    -2.77
    (0.22)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
    Comments MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.007
    Comments P-value is for IPSS storage (irritative) subscore - 4 weeks.
    Method Mixed Model Repeated Measures Analysis
    Comments The Kenward-Roger approximation was used to estimate denominator degrees of freedom.
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.51
    Confidence Interval (2-Sided) 95%
    -0.87 to -0.14
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
    Comments MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.040
    Comments P-value is for IPSS storage (irritative) subscore - 12 weeks.
    Method Mixed Model Repeated Measures Analysis
    Comments The Kenward-Roger approximation was used to estimate denominator degrees of freedom.
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.41
    Confidence Interval (2-Sided) 95%
    -0.80 to -0.02
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
    Comments MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.107
    Comments P-value is for IPSS storage (irritative) subscore - 26 weeks
    Method Mixed Model Repeated Measures Analysis
    Comments The Kenward-Roger approximation was used to estimate denominator degrees of freedom.
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.34
    Confidence Interval (2-Sided) 95%
    -0.75 to 0.07
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
    Comments MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for IPSS voiding (obstructive) subscore - 4 weeks.
    Method Mixed Model Repeated Measures Analysis
    Comments The Kenward-Roger approximation was used to estimate denominator degrees of freedom.
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -1.18
    Confidence Interval (2-Sided) 95%
    -1.69 to -0.68
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
    Comments MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for IPSS voiding (obstructive) subscore - 12 weeks.
    Method Mixed Model Repeated Measures Analysis
    Comments The Kenward-Roger approximation was used to estimate denominator degrees of freedom.
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -1.04
    Confidence Interval (2-Sided) 95%
    -1.62 to -0.46
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
    Comments MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.015
    Comments P-value is IPSS voiding (obstructive) subscore - 26 weeks.
    Method Mixed Model Repeated Measures Analysis
    Comments The Kenward-Roger approximation was used to estimate denominator degrees of freedom.
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.73
    Confidence Interval (2-Sided) 95%
    -1.32 to -0.14
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    4. Secondary Outcome
    Title Change in International Prostate Symptom Score (IPSS) Quality of Life Index From Baseline to 4, 12, and 26 Weeks
    Description IPSS Quality of Life Index assesses participant response to the following question: "If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?" Response options are Delighted (0); Pleased (1); Mostly satisfied (2); Mixed-about equally satisfied and dissatisfied (3); Mostly dissatisfied (4); Unhappy (5); Terrible (6), with a total range of 0-6. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline total IPSS, and visit-by-treatment interaction.
    Time Frame Baseline, 4 weeks, 12 weeks, 26 weeks

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IPSS quality of life measurement.
    Arm/Group Title Tadalafil Placebo
    Arm/Group Description 5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks. Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
    Measure Participants 345 350
    4 weeks
    -0.63
    (0.07)
    -0.32
    (0.06)
    12 weeks
    -0.95
    (0.07)
    -0.76
    (0.07)
    26 weeks
    -1.10
    (0.08)
    -0.92
    (0.08)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
    Comments MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for 4 weeks.
    Method Mixed Model Repeated Measures Analysis
    Comments The Kenward-Roger approximation was used to estimate denominator degrees of freedom.
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.32
    Confidence Interval (2-Sided) 95%
    -0.50 to -0.14
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
    Comments MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.051
    Comments P-value is for 12 weeks.
    Method Mixed Model Repeated Measures Analysis
    Comments The Kenward-Roger approximation was used to estimate denominator degrees of freedom.
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.19
    Confidence Interval (2-Sided) 95%
    -0.38 to 0.00
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
    Comments MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.107
    Comments P-value is for 26 weeks.
    Method Mixed Model Repeated Measures Analysis
    Comments The Kenward-Roger approximation was used to estimate denominator degrees of freedom.
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.17
    Confidence Interval (2-Sided) 95%
    -0.38 to 0.04
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    5. Secondary Outcome
    Title Change in International Index of Erectile Function (IIEF) - Erectile Function Domain Scores From Baseline to 4, 12, and 26 Weeks
    Description Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.
    Time Frame Baseline, 4 weeks, 12 weeks, 26 weeks

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who were sexually active with female partner and had erectile dysfunction (ED), received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IIEF-EF measurement.
    Arm/Group Title Tadalafil Placebo
    Arm/Group Description 5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks. Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
    Measure Participants 203 201
    4 weeks
    3.71
    (0.50)
    -1.14
    (0.51)
    12 weeks
    4.71
    (0.56)
    0.63
    (0.57)
    26 weeks
    4.71
    (0.57)
    -0.02
    (0.60)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
    Comments MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for 4 weeks.
    Method Mixed Model Repeated Measures Analysis
    Comments The Kenward-Roger approximation was used to estimate denominator degrees of freedom.
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 4.85
    Confidence Interval (2-Sided) 95%
    3.49 to 6.21
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
    Comments MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for 12 weeks.
    Method Mixed Model Repeated Measures Analysis
    Comments The Kenward-Roger approximation was used to estimate denominator degrees of freedom.
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 4.08
    Confidence Interval (2-Sided) 95%
    2.55 to 5.60
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
    Comments MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for 26 weeks.
    Method Mixed Model Repeated Measures Analysis
    Comments The Kenward-Roger approximation was used to estimate denominator degrees of freedom.
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 4.73
    Confidence Interval (2-Sided) 95%
    3.15 to 6.31
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    6. Secondary Outcome
    Title Change in International Index of Erectile Function (IIEF) - Overall Satisfaction Domain Scores From Baseline to 4, 12, and 26 Weeks
    Description Self-reported overall satisfaction over the past 4 weeks. IIEF-Overall Satisfaction is the sum of Questions 13 and 14 of IIEF questionnaire. Scores range from 1 (low/no satisfaction) to 5 (high satisfaction) for each question, with the total possible score for the 2 questions ranging from 2 to 10. Higher total scores indicate higher satisfaction. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.
    Time Frame Baseline, 4 weeks, 12 weeks, 26 weeks

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who were sexually active with female partner and had erectile dysfunction (ED), received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IIEF-Overall Satisfaction measurement.
    Arm/Group Title Tadalafil Placebo
    Arm/Group Description 5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks. Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
    Measure Participants 203 201
    4 weeks
    0.91
    (0.15)
    -0.10
    (0.15)
    12 weeks
    1.38
    (0.16)
    0.31
    (0.17)
    26 weeks
    1.61
    (0.17)
    0.40
    (0.18)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
    Comments MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for 4 weeks.
    Method Mixed Model Repeated Measures Analysis
    Comments The Kenward-Roger approximation was used to estimate denominator degrees of freedom.
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 1.01
    Confidence Interval (2-Sided) 95%
    0.61 to 1.40
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
    Comments MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for 12 weeks.
    Method Mixed Model Repeated Measures Analysis
    Comments The Kenward-Roger approximation was used to estimate denominator degrees of freedom.
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 1.06
    Confidence Interval (2-Sided) 95%
    0.61 to 1.51
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
    Comments MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for 26 weeks.
    Method Mixed Model Repeated Measures Analysis
    Comments The Kenward-Roger approximation was used to estimate denominator degrees of freedom.
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 1.22
    Confidence Interval (2-Sided) 95%
    0.74 to 1.69
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    7. Secondary Outcome
    Title Change in International Index of Erectile Function (IIEF) - Intercourse Satisfaction Domain Scores From Baseline to 4, 12, and 26 Weeks
    Description Self-reported intercourse satisfaction over the past 4 weeks. IIEF-intercourse satisfaction is the sum of Questions 6, 7 and 8 of the IIEF. Scores range from 0 (low/no satisfaction) to 5 (high satisfaction) for each question, with the total possible score for the 3 questions of 0 to 15. Higher total scores indicate higher satisfaction. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.
    Time Frame Baseline, 4 weeks, 12 weeks, 26 weeks

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who were sexually active with female partner and had erectile dysfunction (ED), received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IIEF-intercourse satisfaction measurement.
    Arm/Group Title Tadalafil Placebo
    Arm/Group Description 5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks. Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
    Measure Participants 203 201
    4 weeks
    1.36
    (0.24)
    -0.46
    (0.24)
    12 weeks
    1.68
    (0.26)
    0.08
    (0.27)
    26 weeks
    1.72
    (0.27)
    -0.26
    (0.28)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
    Comments MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for 4 weeks.
    Method Mixed Model Repeated Measures Analysis
    Comments The Kenward-Roger approximation was used to estimate denominator degrees of freedom.
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 1.82
    Confidence Interval (2-Sided) 95%
    1.18 to 2.47
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
    Comments MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for 12 weeks.
    Method Mixed Model Repeated Measures Analysis
    Comments The Kenward-Roger approximation was used to estimate denominator degrees of freedom.
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 1.59
    Confidence Interval (2-Sided) 95%
    0.88 to 2.31
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
    Comments MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for 26 weeks.
    Method Mixed Model Repeated Measures Analysis
    Comments The Kenward-Roger approximation was used to estimate denominator degrees of freedom.
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 1.98
    Confidence Interval (2-Sided) 95%
    1.23 to 2.73
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    8. Secondary Outcome
    Title Change in International Index of Erectile Function (IIEF) - Orgasmic Function Domain Scores From Baseline to 4, 12, and 26 Weeks
    Description Orgasmic Function domain scores is the sum of Questions 9 and 10 from the IIEF questionnaire. Scores range from 0 (low/no orgasm) to 5 (high orgasm) for each question, with the total possible score for the 2 questions ranging from 0 to 10. Higher total scores indicate higher orgasm. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.
    Time Frame Baseline, 4 weeks, 12 weeks, 26 weeks

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who were sexually active with female partner and had erectile dysfunction (ED), received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IIEF-orgasmic function domain score measurement.
    Arm/Group Title Tadalafil Placebo
    Arm/Group Description 5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks. Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
    Measure Participants 203 201
    4 weeks
    0.90
    (0.22)
    -0.63
    (0.23)
    12 weeks
    1.08
    (0.23)
    0.18
    (0.24)
    26 weeks
    0.89
    (0.24)
    -0.18
    (0.25)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
    Comments MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for 4 weeks.
    Method Mixed Model Repeated Measures Analysis
    Comments The Kenward-Roger approximation was used to estimate denominator degrees of freedom.
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 1.53
    Confidence Interval (2-Sided) 95%
    0.92 to 2.13
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
    Comments MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.006
    Comments P-value is for 12 weeks.
    Method Mixed Model Repeated Measures Analysis
    Comments The Kenward-Roger approximation was used to estimate denominator degrees of freedom.
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.90
    Confidence Interval (2-Sided) 95%
    0.27 to 1.54
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
    Comments MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.002
    Comments P-value is for 26 weeks.
    Method Mixed Model Repeated Measures Analysis
    Comments The Kenward-Roger approximation was used to estimate denominator degrees of freedom.
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 1.07
    Confidence Interval (2-Sided) 95%
    0.41 to 1.74
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    9. Secondary Outcome
    Title Change in International Index of Erectile Function (IIEF) - Sexual Desire Domain Scores From Baseline to 4, 12, and 26 Weeks
    Description Sexual desire domain scores is the sum of Questions 11 and 12 from the IIEF questionnaire. Scores range from 1 (low/no desire) to 5 (high desire) for each question, with the total possible score for the 2 questions ranging from 2 to 10. Higher total scores indicate higher desire. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.
    Time Frame Baseline, 4 weeks, 12 weeks, 26 weeks

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who were sexually active with female partner and had erectile dysfunction (ED), received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IIEF-sexual desire domain score measurement.
    Arm/Group Title Tadalafil Placebo
    Arm/Group Description 5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks. Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
    Measure Participants 203 201
    4 weeks
    0.46
    (0.12)
    -0.47
    (0.12)
    12 weeks
    0.56
    (0.13)
    -0.23
    (0.13)
    26 weeks
    0.71
    (0.13)
    -0.05
    (0.14)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
    Comments MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for 4 weeks.
    Method Mixed Model Repeated Measures Analysis
    Comments The Kenward-Roger approximation was used to estimate denominator degrees of freedom.
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.93
    Confidence Interval (2-Sided) 95%
    0.61 to 1.25
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
    Comments MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for 12 weeks.
    Method Mixed Model Repeated Measures Analysis
    Comments The Kenward-Roger approximation was used to estimate denominator degrees of freedom.
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.79
    Confidence Interval (2-Sided) 95%
    0.44 to 1.14
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
    Comments MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for 26 weeks.
    Method Mixed Model Repeated Measures Analysis
    Comments The Kenward-Roger approximation was used to estimate denominator degrees of freedom.
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.76
    Confidence Interval (2-Sided) 95%
    0.39 to 1.13
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    10. Secondary Outcome
    Title Patient Global Impression of Improvement (PGI-I) at 26 Weeks
    Description Patient Global Impression of Improvement (PGI-I) measures the participant's perception of improvement at the time of assessment compared with the start of treatment. Number of participants is reported by the categorized score ranging from 1 (very much better) to 7 (very much worse).
    Time Frame 26 weeks

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of the study drug and had PGI-I measurement at 26 weeks endpoint.
    Arm/Group Title Tadalafil Placebo
    Arm/Group Description 5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks. Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
    Measure Participants 309 288
    1 = Very much better
    21
    6.1%
    29
    8.3%
    2 = Much better
    124
    35.9%
    82
    23.4%
    3 = Little better
    102
    29.6%
    112
    32%
    4 = No change
    49
    14.2%
    52
    14.9%
    5 = A little worse
    10
    2.9%
    5
    1.4%
    6 = Much worse
    2
    0.6%
    7
    2%
    7 = Very much worse
    1
    0.3%
    1
    0.3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.034
    Comments P-value is for overall distribution of responses.
    Method Cochran-Mantel-Haenszel
    Comments Adjusted for baseline lower urinary tract symptoms (LUTS) severity.
    11. Secondary Outcome
    Title Treatment Satisfaction Scale - Benign Prostatic Hyperplasia (TSS-BPH) at 26 Weeks
    Description The TSS-BPH was a validated participant-rated instrument that measured participant satisfaction with treatment based on a 13-item questionnaire. It consists of 10 items on a Likert-like scale with scores ranging from 1 (higher satisfaction) to 5 (lower satisfaction), 1 item with score ranging from 0 (higher satisfaction) to 5 (lower satisfaction), and 2 yes/no questions. The mean score for each participant ranges from 0.9 (higher satisfaction) to 5.0 (lower satisfaction). Data presented are the average of mean scores for each treatment group.
    Time Frame 26 weeks

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of the study drug and had TSS-BPH measurement at 26 weeks endpoint.
    Arm/Group Title Tadalafil Placebo
    Arm/Group Description 5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks. Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
    Measure Participants 303 293
    Mean (Standard Deviation) [units on a scale]
    2.0
    (0.63)
    2.1
    (0.66)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.031
    Comments
    Method Van Elteren test
    Comments Van Elteren test was stratified by region.
    12. Secondary Outcome
    Title Clinician Global Impression of Improvement (CGI-I) at 26 Weeks
    Description Clinician Global Impression of Improvement (CGI-I) measures clinician's perception of participant improvement at the time of assessment compared with the start of treatment. Number of participants is reported by the categorized score ranging from 1 (very much better) to 7 (very much worse).
    Time Frame 26 weeks

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of the study drug and had CGI-I measurement at 26 weeks endpoint.
    Arm/Group Title Tadalafil Placebo
    Arm/Group Description 5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks. Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
    Measure Participants 307 290
    1 = Very much improved
    23
    6.7%
    22
    6.3%
    2 = Much improved
    129
    37.4%
    97
    27.7%
    3 = Minimally improved
    98
    28.4%
    106
    30.3%
    4 = No change
    47
    13.6%
    48
    13.7%
    5 = Minimally worse
    5
    1.4%
    10
    2.9%
    6 = Much worse
    5
    1.4%
    6
    1.7%
    7 = Very much worse
    0
    0%
    1
    0.3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.328
    Comments P-value is for overall distribution of responses.
    Method Cochran-Mantel-Haenszel
    Comments Adjusted for baseline lower urinary tract symptoms (LUTS) severity.
    13. Secondary Outcome
    Title Change in Post Void Residual (PVR) Volume From Baseline to 26 Weeks
    Description Postvoid Residual Volume (PVR) is determined using a portable, calibrated ultrasound device. It consists of the average of a minimum of 3 scans where the residual bladder volume was calculated by averaging the most accurate of the 3 imaging attempts.
    Time Frame Baseline, 26 weeks

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of the study drug, had baseline and at least 1 post-baseline PVR measurement.
    Arm/Group Title Tadalafil Placebo
    Arm/Group Description 5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks. Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
    Measure Participants 307 293
    Mean (Standard Deviation) [milliliters (mL)]
    -24.8
    (73.08)
    -23.1
    (66.15)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.157
    Comments
    Method Wilcoxon Rank-Sum test
    Comments
    14. Secondary Outcome
    Title Change in International Index of Erectile Function (IIEF) Question 3 and 4 Scores From Baseline to 4, 12, and 26 Weeks
    Description IIEF Question 3 asks how often a participant was able to penetrate his partner over the past 4 weeks. Scores range from 0 (did not attempt intercourse) to 5 (almost always or always). IIEF Question 4 asks whether/how often a participant was able to maintain an erection after penetration over the past 4 weeks. Scores range from 0 (did not attempt intercourse) to 5 (almost always or always). Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.
    Time Frame Baseline, 4 weeks, 12 weeks, 26 weeks

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IIEF Questions 3 and 4 measurement.
    Arm/Group Title Tadalafil Placebo
    Arm/Group Description 5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks. Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
    Measure Participants 345 350
    Question 3 - 4 weeks
    0.42
    (0.09)
    -0.32
    (0.09)
    Question 3 - 12 weeks
    0.72
    (0.09)
    0.04
    (0.09)
    Question 3 - 26 weeks
    0.68
    (0.10)
    -0.07
    (0.10)
    Question 4 - 4 weeks
    0.49
    (0.09)
    -0.21
    (0.09)
    Question 4 - 12 weeks
    0.74
    (0.09)
    0.13
    (0.09)
    Question 4 - 26 weeks
    0.68
    (0.10)
    0.06
    (0.10)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
    Comments MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for Question 3 - 4 weeks.
    Method Mixed Model Repeated Measures Analysis
    Comments The Kenward-Roger approximation was used to estimate denominator degrees of freedom.
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.74
    Confidence Interval (2-Sided) 95%
    0.49 to 0.98
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
    Comments MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for Question 3 - 12 weeks.
    Method Mixed Model Repeated Measures Analysis
    Comments The Kenward-Roger approximation was used to estimate denominator degrees of freedom.
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.68
    Confidence Interval (2-Sided) 95%
    0.43 to 0.93
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
    Comments MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for Question 3 - 26 weeks.
    Method Mixed Model Repeated Measures Analysis
    Comments The Kenward-Roger approximation was used to estimate denominator degrees of freedom.
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.75
    Confidence Interval (2-Sided) 95%
    0.48 to 1.02
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
    Comments MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for Question 4 - 4 weeks.
    Method Mixed Model Repeated Measures Analysis
    Comments The Kenward-Roger approximation was used to estimate denominator degrees of freedom.
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.71
    Confidence Interval (2-Sided) 95%
    0.46 to 0.95
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
    Comments MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for Question 4 - 12 weeks.
    Method Mixed Model Repeated Measures Analysis
    Comments The Kenward-Roger approximation was used to estimate denominator degrees of freedom.
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.61
    Confidence Interval (2-Sided) 95%
    0.36 to 0.85
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Tadalafil, Placebo
    Comments MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for Question 4 - 26 weeks.
    Method Mixed Model Repeated Measures Analysis
    Comments The Kenward-Roger approximation was used to estimate denominator degrees of freedom.
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.62
    Confidence Interval (2-Sided) 95%
    0.35 to 0.89
    Parameter Dispersion Type:
    Value:
    Estimation Comments

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Screening-Washout and Placebo Lead-In Tadalafil Placebo
    Arm/Group Description 4 weeks washout period and followed by placebo orally, once daily for 4 weeks during placebo lead-in period. 5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks during double-blind randomized active treatment period. Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks during double-blind randomized active treatment period.
    All Cause Mortality
    Screening-Washout and Placebo Lead-In Tadalafil Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Screening-Washout and Placebo Lead-In Tadalafil Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/1070 (0.1%) 9/345 (2.6%) 5/350 (1.4%)
    Gastrointestinal disorders
    Gastritis 0/1070 (0%) 0 0/345 (0%) 0 1/350 (0.3%) 1
    General disorders
    Death 0/1070 (0%) 0 0/345 (0%) 0 1/350 (0.3%) 1
    Sudden death 1/1070 (0.1%) 1 0/345 (0%) 0 0/350 (0%) 0
    Hepatobiliary disorders
    Cholangitis 0/1070 (0%) 0 1/345 (0.3%) 1 0/350 (0%) 0
    Cholecystitis acute 0/1070 (0%) 0 0/345 (0%) 0 1/350 (0.3%) 1
    Infections and infestations
    Device related infection 0/1070 (0%) 0 1/345 (0.3%) 1 0/350 (0%) 0
    Diverticulitis 0/1070 (0%) 0 0/345 (0%) 0 1/350 (0.3%) 1
    Gastroenteritis 0/1070 (0%) 0 1/345 (0.3%) 1 0/350 (0%) 0
    Metabolism and nutrition disorders
    Hyperglycaemia 0/1070 (0%) 0 1/345 (0.3%) 1 0/350 (0%) 0
    Musculoskeletal and connective tissue disorders
    Back pain 0/1070 (0%) 0 1/345 (0.3%) 1 0/350 (0%) 0
    Intervertebral disc protrusion 0/1070 (0%) 0 1/345 (0.3%) 1 0/350 (0%) 0
    Osteoarthritis 0/1070 (0%) 0 1/345 (0.3%) 1 0/350 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Pancreatic carcinoma metastatic 0/1070 (0%) 0 1/345 (0.3%) 1 0/350 (0%) 0
    Nervous system disorders
    Cerebrovascular accident 0/1070 (0%) 0 0/345 (0%) 0 1/350 (0.3%) 1
    Ischaemic stroke 0/1070 (0%) 0 1/345 (0.3%) 1 0/350 (0%) 0
    Renal and urinary disorders
    Urinary retention 0/1070 (0%) 0 1/345 (0.3%) 1 1/350 (0.3%) 1
    Vascular disorders
    Haematoma 0/1070 (0%) 0 1/345 (0.3%) 1 0/350 (0%) 0
    Thrombophlebitis 0/1070 (0%) 0 0/345 (0%) 0 1/350 (0.3%) 1
    Other (Not Including Serious) Adverse Events
    Screening-Washout and Placebo Lead-In Tadalafil Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 153/1070 (14.3%) 105/345 (30.4%) 94/350 (26.9%)
    Blood and lymphatic system disorders
    Anaemia 1/1070 (0.1%) 1 0/345 (0%) 0 1/350 (0.3%) 1
    Leukocytosis 1/1070 (0.1%) 1 0/345 (0%) 0 0/350 (0%) 0
    Macrocytosis 1/1070 (0.1%) 1 1/345 (0.3%) 1 0/350 (0%) 0
    Thrombocytopenia 0/1070 (0%) 0 0/345 (0%) 0 1/350 (0.3%) 1
    Cardiac disorders
    Angina pectoris 0/1070 (0%) 0 1/345 (0.3%) 1 0/350 (0%) 0
    Atrial fibrillation 1/1070 (0.1%) 1 1/345 (0.3%) 1 0/350 (0%) 0
    Cardiac failure 0/1070 (0%) 0 1/345 (0.3%) 1 0/350 (0%) 0
    Left ventricular hypertrophy 1/1070 (0.1%) 1 0/345 (0%) 0 0/350 (0%) 0
    Palpitations 0/1070 (0%) 0 3/345 (0.9%) 3 0/350 (0%) 0
    Sinus bradycardia 1/1070 (0.1%) 1 0/345 (0%) 0 0/350 (0%) 0
    Tachycardia 0/1070 (0%) 0 0/345 (0%) 0 1/350 (0.3%) 1
    Congenital, familial and genetic disorders
    Hydrocele 1/1070 (0.1%) 1 0/345 (0%) 0 0/350 (0%) 0
    Ear and labyrinth disorders
    Tinnitus 1/1070 (0.1%) 1 0/345 (0%) 0 0/350 (0%) 0
    Vertigo 1/1070 (0.1%) 1 0/345 (0%) 0 0/350 (0%) 0
    Eye disorders
    Cataract 0/1070 (0%) 0 2/345 (0.6%) 3 0/350 (0%) 0
    Conjunctival haemorrhage 0/1070 (0%) 0 0/345 (0%) 0 1/350 (0.3%) 1
    Conjunctivitis 0/1070 (0%) 0 0/345 (0%) 0 3/350 (0.9%) 3
    Eye irritation 0/1070 (0%) 0 1/345 (0.3%) 1 0/350 (0%) 0
    Glaucoma 0/1070 (0%) 0 1/345 (0.3%) 1 0/350 (0%) 0
    Vision blurred 0/1070 (0%) 0 1/345 (0.3%) 1 0/350 (0%) 0
    Gastrointestinal disorders
    Abdominal discomfort 1/1070 (0.1%) 1 1/345 (0.3%) 1 0/350 (0%) 0
    Abdominal pain 1/1070 (0.1%) 1 1/345 (0.3%) 1 0/350 (0%) 0
    Abdominal pain lower 1/1070 (0.1%) 1 0/345 (0%) 0 0/350 (0%) 0
    Abdominal pain upper 3/1070 (0.3%) 3 3/345 (0.9%) 3 1/350 (0.3%) 1
    Cheilosis 0/1070 (0%) 0 1/345 (0.3%) 1 0/350 (0%) 0
    Constipation 3/1070 (0.3%) 3 0/345 (0%) 0 3/350 (0.9%) 3
    Diarrhoea 5/1070 (0.5%) 5 5/345 (1.4%) 5 6/350 (1.7%) 7
    Dry mouth 1/1070 (0.1%) 1 0/345 (0%) 0 0/350 (0%) 0
    Dyspepsia 7/1070 (0.7%) 9 8/345 (2.3%) 11 2/350 (0.6%) 2
    Flatulence 1/1070 (0.1%) 1 0/345 (0%) 0 0/350 (0%) 0
    Gastritis 1/1070 (0.1%) 1 2/345 (0.6%) 2 0/350 (0%) 0
    Gastrooesophageal reflux disease 1/1070 (0.1%) 1 1/345 (0.3%) 1 0/350 (0%) 0
    Haemorrhoids 1/1070 (0.1%) 1 0/345 (0%) 0 1/350 (0.3%) 1
    Hyperchlorhydria 1/1070 (0.1%) 1 0/345 (0%) 0 0/350 (0%) 0
    Inguinal hernia 1/1070 (0.1%) 1 0/345 (0%) 0 0/350 (0%) 0
    Nausea 1/1070 (0.1%) 1 2/345 (0.6%) 2 2/350 (0.6%) 2
    Paraesthesia oral 0/1070 (0%) 0 0/345 (0%) 0 1/350 (0.3%) 1
    Periodontitis 0/1070 (0%) 0 1/345 (0.3%) 1 0/350 (0%) 0
    Rectal haemorrhage 0/1070 (0%) 0 1/345 (0.3%) 1 1/350 (0.3%) 2
    Stomatitis 1/1070 (0.1%) 1 0/345 (0%) 0 0/350 (0%) 0
    Toothache 2/1070 (0.2%) 2 1/345 (0.3%) 1 1/350 (0.3%) 1
    Umbilical hernia 1/1070 (0.1%) 1 0/345 (0%) 0 1/350 (0.3%) 1
    Vomiting 1/1070 (0.1%) 1 0/345 (0%) 0 0/350 (0%) 0
    General disorders
    Asthenia 4/1070 (0.4%) 4 0/345 (0%) 0 0/350 (0%) 0
    Chest pain 1/1070 (0.1%) 1 0/345 (0%) 0 1/350 (0.3%) 1
    Fatigue 4/1070 (0.4%) 4 1/345 (0.3%) 1 0/350 (0%) 0
    Fibrosis 1/1070 (0.1%) 1 0/345 (0%) 0 0/350 (0%) 0
    Irritability 1/1070 (0.1%) 1 0/345 (0%) 0 0/350 (0%) 0
    Oedema peripheral 0/1070 (0%) 0 0/345 (0%) 0 3/350 (0.9%) 3
    Pyrexia 0/1070 (0%) 0 1/345 (0.3%) 1 1/350 (0.3%) 1
    Hepatobiliary disorders
    Biliary colic 1/1070 (0.1%) 1 1/345 (0.3%) 1 1/350 (0.3%) 1
    Hyperbilirubinaemia 0/1070 (0%) 0 0/345 (0%) 0 1/350 (0.3%) 1
    Immune system disorders
    Hypersensitivity 0/1070 (0%) 0 1/345 (0.3%) 1 0/350 (0%) 0
    Infections and infestations
    Abscess 0/1070 (0%) 0 0/345 (0%) 0 1/350 (0.3%) 1
    Bronchitis 3/1070 (0.3%) 3 0/345 (0%) 0 0/350 (0%) 0
    Cellulitis 1/1070 (0.1%) 1 0/345 (0%) 0 0/350 (0%) 0
    Dengue fever 0/1070 (0%) 0 0/345 (0%) 0 1/350 (0.3%) 1
    Ear infection 0/1070 (0%) 0 1/345 (0.3%) 1 0/350 (0%) 0
    Erysipelas 0/1070 (0%) 0 1/345 (0.3%) 1 0/350 (0%) 0
    Gastroenteritis 3/1070 (0.3%) 3 0/345 (0%) 0 2/350 (0.6%) 2
    Hordeolum 1/1070 (0.1%) 1 0/345 (0%) 0 0/350 (0%) 0
    Infected dermal cyst 1/1070 (0.1%) 1 0/345 (0%) 0 0/350 (0%) 0
    Influenza 6/1070 (0.6%) 6 8/345 (2.3%) 8 8/350 (2.3%) 11
    Laryngitis 0/1070 (0%) 0 0/345 (0%) 0 1/350 (0.3%) 1
    Lower respiratory tract infection 0/1070 (0%) 0 0/345 (0%) 0 1/350 (0.3%) 1
    Nasopharyngitis 13/1070 (1.2%) 14 5/345 (1.4%) 5 3/350 (0.9%) 3
    Onychomycosis 0/1070 (0%) 0 0/345 (0%) 0 2/350 (0.6%) 2
    Oral herpes 1/1070 (0.1%) 1 0/345 (0%) 0 0/350 (0%) 0
    Orchitis 0/1070 (0%) 0 0/345 (0%) 0 1/350 (0.3%) 1
    Pneumonia 0/1070 (0%) 0 0/345 (0%) 0 1/350 (0.3%) 1
    Pseudomonas infection 0/1070 (0%) 0 1/345 (0.3%) 1 0/350 (0%) 0
    Respiratory tract infection 0/1070 (0%) 0 0/345 (0%) 0 1/350 (0.3%) 1
    Rhinitis 0/1070 (0%) 0 1/345 (0.3%) 1 0/350 (0%) 0
    Sinusitis 0/1070 (0%) 0 1/345 (0.3%) 1 1/350 (0.3%) 1
    Tooth abscess 1/1070 (0.1%) 1 0/345 (0%) 0 0/350 (0%) 0
    Tooth infection 0/1070 (0%) 0 0/345 (0%) 0 1/350 (0.3%) 1
    Upper respiratory tract infection 5/1070 (0.5%) 5 0/345 (0%) 0 0/350 (0%) 0
    Urethritis 0/1070 (0%) 0 0/345 (0%) 0 1/350 (0.3%) 1
    Urinary tract infection 1/1070 (0.1%) 1 1/345 (0.3%) 1 2/350 (0.6%) 2
    Injury, poisoning and procedural complications
    Arthropod bite 0/1070 (0%) 0 1/345 (0.3%) 1 0/350 (0%) 0
    Fall 1/1070 (0.1%) 1 0/345 (0%) 0 1/350 (0.3%) 1
    Hand fracture 0/1070 (0%) 0 0/345 (0%) 0 1/350 (0.3%) 1
    Joint injury 2/1070 (0.2%) 2 0/345 (0%) 0 0/350 (0%) 0
    Laceration 1/1070 (0.1%) 1 0/345 (0%) 0 0/350 (0%) 0
    Ligament injury 0/1070 (0%) 0 1/345 (0.3%) 1 0/350 (0%) 0
    Limb injury 0/1070 (0%) 0 0/345 (0%) 0 1/350 (0.3%) 2
    Rib fracture 1/1070 (0.1%) 1 1/345 (0.3%) 1 0/350 (0%) 0
    Thermal burn 1/1070 (0.1%) 1 0/345 (0%) 0 0/350 (0%) 0
    Tooth fracture 1/1070 (0.1%) 1 0/345 (0%) 0 1/350 (0.3%) 1
    Wrist fracture 0/1070 (0%) 0 1/345 (0.3%) 1 0/350 (0%) 0
    Investigations
    Blood alkaline phosphatase increased 1/1070 (0.1%) 1 0/345 (0%) 0 0/350 (0%) 0
    Blood creatine phosphokinase increased 1/1070 (0.1%) 1 1/345 (0.3%) 1 1/350 (0.3%) 1
    Blood thyroid stimulating hormone decreased 1/1070 (0.1%) 1 0/345 (0%) 0 0/350 (0%) 0
    Blood thyroid stimulating hormone increased 1/1070 (0.1%) 1 0/345 (0%) 0 0/350 (0%) 0
    Blood uric acid increased 1/1070 (0.1%) 1 0/345 (0%) 0 0/350 (0%) 0
    Endoscopy upper gastrointestinal tract 0/1070 (0%) 0 1/345 (0.3%) 1 0/350 (0%) 0
    Gastric ph decreased 0/1070 (0%) 0 4/345 (1.2%) 4 1/350 (0.3%) 2
    Glomerular filtration rate decreased 2/1070 (0.2%) 2 0/345 (0%) 0 0/350 (0%) 0
    Glucose urine present 1/1070 (0.1%) 1 0/345 (0%) 0 0/350 (0%) 0
    Glycosylated haemoglobin increased 1/1070 (0.1%) 1 0/345 (0%) 0 0/350 (0%) 0
    Heart rate irregular 0/1070 (0%) 0 0/345 (0%) 0 1/350 (0.3%) 1
    Intraocular pressure increased 0/1070 (0%) 0 0/345 (0%) 0 1/350 (0.3%) 1
    Oestradiol increased 12/1070 (1.1%) 12 1/345 (0.3%) 1 0/350 (0%) 0
    Prostatic specific antigen increased 1/1070 (0.1%) 1 0/345 (0%) 0 0/350 (0%) 0
    Semen volume decreased 0/1070 (0%) 0 1/345 (0.3%) 1 0/350 (0%) 0
    White blood cell count increased 0/1070 (0%) 0 0/345 (0%) 0 1/350 (0.3%) 1
    Metabolism and nutrition disorders
    Diabetes mellitus 1/1070 (0.1%) 1 0/345 (0%) 0 0/350 (0%) 0
    Dyslipidaemia 1/1070 (0.1%) 1 0/345 (0%) 0 0/350 (0%) 0
    Glucose tolerance impaired 1/1070 (0.1%) 1 0/345 (0%) 0 0/350 (0%) 0
    Gout 1/1070 (0.1%) 1 1/345 (0.3%) 1 0/350 (0%) 0
    Hypercholesterolaemia 3/1070 (0.3%) 3 0/345 (0%) 0 2/350 (0.6%) 2
    Hyperglycaemia 0/1070 (0%) 0 1/345 (0.3%) 1 0/350 (0%) 0
    Hypernatraemia 2/1070 (0.2%) 2 0/345 (0%) 0 0/350 (0%) 0
    Hyperuricaemia 1/1070 (0.1%) 1 0/345 (0%) 0 0/350 (0%) 0
    Hypoglycaemia 0/1070 (0%) 0 0/345 (0%) 0 1/350 (0.3%) 1
    Type 2 diabetes mellitus 0/1070 (0%) 0 0/345 (0%) 0 1/350 (0.3%) 1
    Musculoskeletal and connective tissue disorders
    Arthralgia 2/1070 (0.2%) 2 3/345 (0.9%) 3 2/350 (0.6%) 3
    Arthritis 1/1070 (0.1%) 1 0/345 (0%) 0 0/350 (0%) 0
    Back pain 6/1070 (0.6%) 6 15/345 (4.3%) 16 6/350 (1.7%) 7
    Coccydynia 0/1070 (0%) 0 0/345 (0%) 0 1/350 (0.3%) 1
    Flank pain 1/1070 (0.1%) 1 0/345 (0%) 0 2/350 (0.6%) 2
    Groin pain 1/1070 (0.1%) 1 0/345 (0%) 0 1/350 (0.3%) 1
    Joint stiffness 0/1070 (0%) 0 0/345 (0%) 0 1/350 (0.3%) 1
    Joint swelling 0/1070 (0%) 0 1/345 (0.3%) 2 0/350 (0%) 0
    Ligament disorder 0/1070 (0%) 0 1/345 (0.3%) 1 0/350 (0%) 0
    Muscle contracture 1/1070 (0.1%) 1 0/345 (0%) 0 0/350 (0%) 0
    Muscle spasms 1/1070 (0.1%) 1 0/345 (0%) 0 0/350 (0%) 0
    Muscular weakness 0/1070 (0%) 0 1/345 (0.3%) 1 1/350 (0.3%) 1
    Musculoskeletal chest pain 0/1070 (0%) 0 0/345 (0%) 0 1/350 (0.3%) 1
    Musculoskeletal pain 3/1070 (0.3%) 3 1/345 (0.3%) 1 0/350 (0%) 0
    Myalgia 1/1070 (0.1%) 1 2/345 (0.6%) 2 3/350 (0.9%) 3
    Neck pain 2/1070 (0.2%) 2 0/345 (0%) 0 0/350 (0%) 0
    Osteoarthritis 0/1070 (0%) 0 2/345 (0.6%) 2 0/350 (0%) 0
    Osteopenia 1/1070 (0.1%) 1 0/345 (0%) 0 0/350 (0%) 0
    Pain in extremity 5/1070 (0.5%) 5 5/345 (1.4%) 5 5/350 (1.4%) 6
    Sacroiliitis 0/1070 (0%) 0 0/345 (0%) 0 1/350 (0.3%) 1
    Synovial cyst 0/1070 (0%) 0 1/345 (0.3%) 1 0/350 (0%) 0
    Tendonitis 1/1070 (0.1%) 1 0/345 (0%) 0 2/350 (0.6%) 2
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    B-cell lymphoma 1/1070 (0.1%) 1 0/345 (0%) 0 0/350 (0%) 0
    Lung neoplasm 0/1070 (0%) 0 1/345 (0.3%) 1 0/350 (0%) 0
    Oral fibroma 1/1070 (0.1%) 1 0/345 (0%) 0 0/350 (0%) 0
    Nervous system disorders
    Amnesia 0/1070 (0%) 0 0/345 (0%) 0 1/350 (0.3%) 1
    Burning sensation 0/1070 (0%) 0 1/345 (0.3%) 1 0/350 (0%) 0
    Cerebrovascular disorder 0/1070 (0%) 0 0/345 (0%) 0 1/350 (0.3%) 1
    Cognitive disorder 1/1070 (0.1%) 1 0/345 (0%) 0 0/350 (0%) 0
    Dizziness 3/1070 (0.3%) 3 2/345 (0.6%) 2 2/350 (0.6%) 3
    Dizziness postural 1/1070 (0.1%) 1 0/345 (0%) 0 0/350 (0%) 0
    Facial paresis 1/1070 (0.1%) 1 0/345 (0%) 0 0/350 (0%) 0
    Headache 12/1070 (1.1%) 13 12/345 (3.5%) 20 12/350 (3.4%) 15
    Lethargy 0/1070 (0%) 0 1/345 (0.3%) 1 0/350 (0%) 0
    Loss of consciousness 0/1070 (0%) 0 0/345 (0%) 0 1/350 (0.3%) 1
    Memory impairment 0/1070 (0%) 0 0/345 (0%) 0 1/350 (0.3%) 1
    Mental impairment 1/1070 (0.1%) 1 0/345 (0%) 0 0/350 (0%) 0
    Paraesthesia 0/1070 (0%) 0 0/345 (0%) 0 1/350 (0.3%) 1
    Radiculitis brachial 0/1070 (0%) 0 0/345 (0%) 0 1/350 (0.3%) 1
    Restless legs syndrome 0/1070 (0%) 0 1/345 (0.3%) 1 0/350 (0%) 0
    Sciatica 1/1070 (0.1%) 1 2/345 (0.6%) 2 1/350 (0.3%) 1
    Sinus headache 1/1070 (0.1%) 1 0/345 (0%) 0 0/350 (0%) 0
    Psychiatric disorders
    Abnormal dreams 0/1070 (0%) 0 1/345 (0.3%) 1 0/350 (0%) 0
    Anxiety 1/1070 (0.1%) 1 1/345 (0.3%) 1 0/350 (0%) 0
    Depression 0/1070 (0%) 0 0/345 (0%) 0 1/350 (0.3%) 1
    Insomnia 1/1070 (0.1%) 1 2/345 (0.6%) 2 0/350 (0%) 0
    Libido decreased 4/1070 (0.4%) 4 0/345 (0%) 0 4/350 (1.1%) 4
    Loss of libido 0/1070 (0%) 0 0/345 (0%) 0 1/350 (0.3%) 1
    Mood swings 1/1070 (0.1%) 1 0/345 (0%) 0 0/350 (0%) 0
    Nervousness 1/1070 (0.1%) 1 0/345 (0%) 0 0/350 (0%) 0
    Renal and urinary disorders
    Azotaemia 1/1070 (0.1%) 1 0/345 (0%) 0 0/350 (0%) 0
    Calculus ureteric 0/1070 (0%) 0 1/345 (0.3%) 1 0/350 (0%) 0
    Dysuria 1/1070 (0.1%) 1 1/345 (0.3%) 1 5/350 (1.4%) 5
    Lower urinary tract symptoms 0/1070 (0%) 0 0/345 (0%) 0 1/350 (0.3%) 1
    Micturition urgency 0/1070 (0%) 0 0/345 (0%) 0 1/350 (0.3%) 1
    Nephrolithiasis 1/1070 (0.1%) 1 0/345 (0%) 0 0/350 (0%) 0
    Pollakiuria 0/1070 (0%) 0 2/345 (0.6%) 2 3/350 (0.9%) 3
    Proteinuria 2/1070 (0.2%) 2 0/345 (0%) 0 0/350 (0%) 0
    Renal failure chronic 0/1070 (0%) 0 0/345 (0%) 0 1/350 (0.3%) 1
    Urinary hesitation 0/1070 (0%) 0 1/345 (0.3%) 1 0/350 (0%) 0
    Urinary incontinence 0/1070 (0%) 0 0/345 (0%) 0 1/350 (0.3%) 1
    Urinary retention 1/1070 (0.1%) 1 0/345 (0%) 0 0/350 (0%) 0
    Urine flow decreased 2/1070 (0.2%) 2 0/345 (0%) 0 1/350 (0.3%) 1
    Reproductive system and breast disorders
    Ejaculation delayed 0/1070 (0%) 0 1/345 (0.3%) 1 0/350 (0%) 0
    Ejaculation failure 0/1070 (0%) 0 1/345 (0.3%) 1 0/350 (0%) 0
    Epididymitis 0/1070 (0%) 0 0/345 (0%) 0 1/350 (0.3%) 1
    Erectile dysfunction 0/1070 (0%) 0 1/345 (0.3%) 1 5/350 (1.4%) 5
    Nipple pain 0/1070 (0%) 0 1/345 (0.3%) 1 1/350 (0.3%) 1
    Peyronie's disease 0/1070 (0%) 0 1/345 (0.3%) 1 0/350 (0%) 0
    Prostatitis 1/1070 (0.1%) 1 1/345 (0.3%) 1 1/350 (0.3%) 1
    Testicular mass 0/1070 (0%) 0 0/345 (0%) 0 1/350 (0.3%) 1
    Testicular pain 2/1070 (0.2%) 2 1/345 (0.3%) 1 1/350 (0.3%) 1
    Respiratory, thoracic and mediastinal disorders
    Asthmatic crisis 1/1070 (0.1%) 2 0/345 (0%) 0 0/350 (0%) 0
    Bronchial wall thickening 0/1070 (0%) 0 1/345 (0.3%) 1 0/350 (0%) 0
    Cough 3/1070 (0.3%) 3 3/345 (0.9%) 3 3/350 (0.9%) 3
    Dyspnoea 1/1070 (0.1%) 1 0/345 (0%) 0 2/350 (0.6%) 2
    Epistaxis 0/1070 (0%) 0 2/345 (0.6%) 2 1/350 (0.3%) 1
    Nasal congestion 0/1070 (0%) 0 2/345 (0.6%) 2 0/350 (0%) 0
    Rhinitis allergic 0/1070 (0%) 0 1/345 (0.3%) 1 0/350 (0%) 0
    Rhinitis seasonal 1/1070 (0.1%) 1 0/345 (0%) 0 0/350 (0%) 0
    Rhinorrhoea 1/1070 (0.1%) 1 0/345 (0%) 0 0/350 (0%) 0
    Sinus congestion 0/1070 (0%) 0 0/345 (0%) 0 1/350 (0.3%) 1
    Sneezing 1/1070 (0.1%) 1 0/345 (0%) 0 0/350 (0%) 0
    Upper-airway cough syndrome 0/1070 (0%) 0 0/345 (0%) 0 1/350 (0.3%) 1
    Skin and subcutaneous tissue disorders
    Dermatitis 0/1070 (0%) 0 2/345 (0.6%) 2 0/350 (0%) 0
    Dry skin 0/1070 (0%) 0 1/345 (0.3%) 1 0/350 (0%) 0
    Ecchymosis 1/1070 (0.1%) 1 0/345 (0%) 0 0/350 (0%) 0
    Eczema 1/1070 (0.1%) 1 0/345 (0%) 0 0/350 (0%) 0
    Hyperhidrosis 0/1070 (0%) 0 1/345 (0.3%) 1 0/350 (0%) 0
    Pruritus 0/1070 (0%) 0 1/345 (0.3%) 1 1/350 (0.3%) 1
    Pruritus generalised 2/1070 (0.2%) 2 0/345 (0%) 0 0/350 (0%) 0
    Rash 2/1070 (0.2%) 2 3/345 (0.9%) 3 2/350 (0.6%) 2
    Urticaria 1/1070 (0.1%) 2 0/345 (0%) 0 1/350 (0.3%) 1
    Surgical and medical procedures
    Carpal tunnel decompression 1/1070 (0.1%) 1 0/345 (0%) 0 0/350 (0%) 0
    Cataract operation 0/1070 (0%) 0 1/345 (0.3%) 2 0/350 (0%) 0
    Dental operation 0/1070 (0%) 0 1/345 (0.3%) 1 0/350 (0%) 0
    Endodontic procedure 0/1070 (0%) 0 1/345 (0.3%) 1 0/350 (0%) 0
    Hernia repair 0/1070 (0%) 0 0/345 (0%) 0 1/350 (0.3%) 1
    Toe operation 0/1070 (0%) 0 0/345 (0%) 0 1/350 (0.3%) 1
    Tooth extraction 0/1070 (0%) 0 1/345 (0.3%) 1 1/350 (0.3%) 1
    Transurethral prostatectomy 0/1070 (0%) 0 1/345 (0.3%) 1 0/350 (0%) 0
    Vascular disorders
    Flushing 1/1070 (0.1%) 1 1/345 (0.3%) 1 0/350 (0%) 0
    Hypertension 2/1070 (0.2%) 2 4/345 (1.2%) 4 1/350 (0.3%) 1
    Orthostatic hypotension 0/1070 (0%) 0 1/345 (0.3%) 1 0/350 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Chief Medical Officer
    Organization Eli Lilly and Company
    Phone 800-545-5979
    Email
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT01139762
    Other Study ID Numbers:
    • 13529
    • H6D-CR-LVIW
    First Posted:
    Jun 9, 2010
    Last Update Posted:
    Feb 27, 2013
    Last Verified:
    Jan 1, 2013