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COMORBID©: A Study in the Treatment of Erectile Dysfunction and Benign Prostate Hyperplasia

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00855582
Collaborator
(none)
606
Enrollment
52
Locations
3
Arms
16
Duration (Months)
11.7
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Study LVHR is a Phase 3 study which will examine the efficacy and safety of tadalafil 2.5 and 5 mg once daily versus placebo for the treatment of erectile dysfunction (ED) and signs and symptoms of benign prostatic hyperplasia (BPH) in men with both ED and signs and symptoms of BPH.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
606 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Multinational Study to Evaluate the Efficacy and Safety of Tadalafil 2.5 and 5 mg Once Daily Dosing for 12 Weeks for the Treatment of Erectile Dysfunction and Signs and Symptoms of Benign Prostatic Hyperplasia in Men With Both Erectile Dysfunction and Benign Prostatic Hyperplasia
Study Start Date :
Mar 1, 2009
Actual Primary Completion Date :
Jul 1, 2010
Actual Study Completion Date :
Jul 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tadalafil 2.5 mg

Drug: Tadalafil
tablet once daily by mouth for 12 weeks.
Other Names:
  • Cialis
  • LY450190

    		•
    Experimental: Tadalafil 5 mg

    Drug: Tadalafil
    tablet once daily by mouth for 12 weeks.
    Other Names:
  • Cialis
  • LY450190

    		•
    Placebo Comparator: Placebo

    Drug: Placebo
    Matching 2.5 or 5 mg placebo tablet once daily by mouth for 12 weeks.

    Outcome Measures

    Primary Outcome Measures

    1. Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 Endpoint (5 mg) [Baseline, 12 weeks]

      The total IPSS is obtained by combining the scores of the responses to component questions 1 through 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

    2. Change From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score at Week 12 Endpoint (5 mg) [Baseline, 12 weeks]

      Self-reported erectile function over the past 4 weeks. Questions 1-5 were scored from 0-5, and Question 15 from 1 to 5. Erectile Function Domain scores range from 1 to 30; lower numerical scores represent greater severity of erectile dysfunction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

    3. Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 Endpoint (2.5 mg) [Baseline, 12 weeks]

      The total IPSS is obtained by combining the scores of the responses to component questions 1 through 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

    4. Change From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score at Week 12 Endpoint (2.5 mg) [Baseline, 12 weeks]

      Self-reported erectile function over the past 4 weeks. Questions 1-5 were scored from 0-5, and Question 15 from 1 to 5. Erectile Function Domain scores range from 1 to 30; lower numerical scores represent greater severity of erectile dysfunction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

    Secondary Outcome Measures

    1. Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 12 Endpoint (5 mg) [Baseline, 12 weeks]

      Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 3, "Did your erection last long enough for you to have successful intercourse?" Data are presented as the mean percentage of Yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

    2. Change From Baseline in Benign Prostatic Hyperplasia (BPH) Impact Index (BII) at Week 12 Endpoint (5 mg) [Baseline, 12 weeks]

      The BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

    3. Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 12 Endpoint (2.5 mg) [Baseline, 12 weeks]

      Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 3, "Did your erection last long enough for you to have successful intercourse?" Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

    4. Change From Baseline in BPH Impact Index (BII) at Week 12 Endpoint (2.5 mg) [Baseline, 12 weeks]

      The BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

    5. Change From Baseline in Modified IPSS (mIPSS) at Week 2 Endpoint [Baseline, 2 weeks]

      The Modified IPSS is the total IPSS collected at 2 weeks post-baseline. The total IPSS is obtained by combining the scores of the responses to component questions 1 through 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from ANCOVA. The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

    6. Change From Baseline in International Prostate Symptom Score (IPSS) at Week 4 and Week 8 Endpoint [Baseline, 4 weeks, 8 weeks]

      The total IPSS is obtained by combining the scores of the responses to component questions 1 through 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

    7. Change From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain at Week 4 and Week 8 Endpoint [Baseline, 4 weeks, 8 weeks]

      Self-reported erectile function over the past 4 weeks. Questions 1-5 were scored from 0-5, and Question 15 from 1 to 5. Erectile Function Domain scores range from 1 to 30; lower numerical scores represent greater severity of erectile dysfunction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

    8. Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 4 and Week 8 Endpoint [Baseline, 4 weeks, 8 weeks]

      Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 3, "Did your erection last long enough for you to have successful intercourse?" Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

    9. Change From Baseline in BPH Impact Index (BII) at Week 4 and 8 Endpoint [Baseline, 4 weeks, 8 weeks]

      The BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

    10. Change From Baseline in International Prostate Symptom Score Voiding (Obstructive) Subscore at Week 12 Endpoint [Baseline, 12 weeks]

      IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. The obstructive subscore ranges from 0 to 20 with a higher score representing greater obstruction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

    11. Change From Baseline in International Prostate Symptom Score Storage (Irritative) Subscore at Week 12 Endpoint [Baseline, 12 weeks]

      IPSS irritative subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. The irritative subscore ranges from 0 to 15 with a higher score representing more irritative symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

    12. Change From Baseline in International Prostate Symptom Score Nocturia Question at Week 12 [Baseline, 12 weeks]

      The IPSS Nocturia question (Question 7) measures the number of times needed to get up at night to urinate. Scores range from 0 (none) to 5 (5 or more times). Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

    13. Change From Baseline in International Prostate Symptom Score Quality of Life (QoL) at Week 12 Endpoint [Baseline, 12 weeks]

      Assessment of quality of life (QoL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible). Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

    14. Change From Baseline in International Index of Erectile Function - Overall Satisfaction Domain at Week 12 Endpoint [Baseline, 12 weeks]

      Self-reported overall satisfaction over the past 4 weeks. Calculated as the sum of IIEF Questions 13 and 14. Each question is scored from 1 through 5, with a possible total score of 2 through 10. Higher scores represent greater satisfaction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

    15. Change From Baseline in International Index of Erectile Function - Intercourse Satisfaction Domain at Week 12 Endpoint [Baseline, 12 weeks]

      Self-reported intercourse satisfaction over the past 4 weeks. Calculated as the sum of IIEF Questions 6, 7 and 8. Each question is scored from 0 through 5 with a possible total score of 0 through 15. Higher score represent greater satisfaction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

    16. Change From Baseline in International Index of Erectile Function Question 3 at Week 12 Endpoint [Baseline, 12 weeks]

      IIEF Question 3 asks how often a subject 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). Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

    17. Change From Baseline in International Index of Erectile Function Question 4 at Week 12 Endpoint [Baseline, 12 weeks]

      IIEF Question 4 asks whether how often a subject 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 of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

    18. Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 2 at Week 12 Endpoint [Baseline, 12 weeks]

      Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 2, "Were you able to insert your penis into your partner's vagina?" Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

    19. Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 4 at Week 12 Endpoint [Baseline, 12 weeks]

      Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 4, "Were you satisfied with the hardness of your erection?" Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

    20. Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 5 [Baseline, 12 weeks]

      Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 5, "Were you satisfied overall with this sexual experience?" Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.

    21. Patient Global Impression of Improvement (PGI-I) at Week 12 Endpoint [12 weeks]

      A scale that measures the patient's perception of urinary symptoms at endpoint compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). The data are presented as the number of participants in each of the seven categories: very much better (1); much better (2); a little better (3); no change (4); a little worse (5); much worse (6); very much worse (7).

    22. Clinician Global Impression of Improvement (CGI-I) at Week 12 Endpoint [12 weeks]

      A scale that measures clinician's rating of the total change in the patient's urinary symptoms at endpoint compared with the start of treatment. Scores range from 1 (very much better) to 7 (very much worse).The data are presented as the number of participants in each of the seven categories: very much better (1); much better (2); a little better (3); no change (4); a little worse (5); much worse (6); very much worse (7).

    23. Erectile Function General Assessment Questionnaire (EF-GAQ) [12 weeks]

      The EF-GAQ consisted of two questions: (1) Has the treatment you have been taking during this study improved your erections? and (2) If yes, has the treatment improved your ability to engage in sexual activity? Each question has a Yes/No response.

    24. Change From Baseline in Uroflowmetry Parameters - Peak Urine Flow Rate (Qmax) at Week 12 Endpoint [Baseline, 12 weeks]

      Qmax is defined as the peak urine flow rate (measured in milliliters per second [mL/sec] using standard calibrated flowmeter). At each visit, a uroflowmetry assessment was considered valid and the data were included in the statistical analyses only if the prevoid total bladder volume (assessed by ultrasound) was >=150 to <=550 milliliters (mL) and the voided volume (Vcomp) was >= 125 mL.

    25. Change From Baseline in Uroflowmetry Parameters - Mean Urine Flow Rate (Qmean) at Week 12 Endpoint [Baseline, 12 weeks]

      Qmean is defined as the average urine flow rate (measured in milliliters per second [mL/second] using standard calibrated flowmeter). At each visit, a uroflowmetry assessment was considered valid and the data were included in the statistical analyses only if the prevoid total bladder volume (assessed by ultrasound) was >=150 to <=550 milliliters (mL) and the voided volume (Vcomp) was >= 125 mL.

    26. Change From Baseline in Uroflowmetry Parameters - Voided Volume (Vcomp) at Week 12 Endpoint [Baseline, 12 weeks]

      Vcomp is defined as the volume of urine voided (measures in mL using a standard calibrated flowmeter). At each visit, a uroflowmetry assessment was considered valid and the data were included in the statistical analyses only if the prevoid total bladder volume (assessed by ultrasound) was >=150 to <=550 milliliters (mL) and the voided volume (Vcomp) was >= 125 mL.

    Eligibility Criteria

    Criteria

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

    • Have BPH Lower Urinary Tract Symptoms (LUTS) based on the disease diagnostic criteria at 1st screening.

    • Have a history of ED based on the disease diagnostic criteria at 1st screening.

    • Have LUTS with a Total International Prostate Symptom Score (IPSS) greater than or equal to 13 at 2nd screening.

    • Have bladder outlet obstruction as defined by a Peak Urine Flow Rate (Qmax) of greater than or equal to 4 to less than or equal to 15 milliliter (mL)/second (sec) (from a prevoid total bladder volume as assessed by ultrasound of greater than or equal to 150 to less than or equal to 550 mL and a minimum voided volume of 125 mL) at 2nd screening.

    • Make at least 4 sexual intercourse attempts during the 4-weeks after 2nd screening as recorded in the Sexual Encounter Profile (SEP) diary.

    • Are sexually active with an adult female partner, and expect to remain sexually active with the same adult female partner for the duration of the study.

    • Agree not to use any other approved or experimental BPH, overactive bladder (OAB), or ED treatments as indicated in the protocol at any time during the study.

    • Have not taken treatments indicated in the protocol prior to the 2nd screening.

    Exclusion Criteria:

    • Current treatment with nitrates.

    • Prostate-specific antigen (PSA) greater than 10.0 nanogram (ng)/mL at 1st screening.

    • PSA greater than or equal to 4.0 to less than or equal to 10.0 ng/mL at 1st screening if prostate malignancy has not been ruled out to the satisfaction of a urologist.

    • Clinical evidence of prostate cancer.

    • Bladder postvoid residual volume (PVR) greater than or equal to 300 mL by ultrasound determination at 1st screening.

    • History or clinical evidence of certain pelvic, bladder, urinary tract, or urinary retention conditions described in the protocol.

    • Lower urinary tract instrumentation (including prostate biopsy) within 30 days of 1st screening.

    • Clinical evidence of severe hepatic impairment at 1st screening.

    • Current neurologic disease or condition associated with neurogenic bladder (for example, Parkinson's disease or multiple sclerosis).

    • History of significant renal insufficiency as defined by the protocol.

    • History of ED caused by other primary sexual disorders including premature ejaculation or ED caused by untreated endocrine disease.

    • Presence of penile deformity judged by the investigator to be clinically significant.

    • History of certain cardiac or cardiovascular conditions described in the protocol.

    • History of resuscitated cardiac arrest.

    • Current treatment with certain medications described in the protocol.

    • Scheduled or planned surgery (or any procedure requiring general, spinal, or epidural anesthesia) during the course of the study.

    • History of significant central nervous system injuries (including stroke or spinal cord injury) within 6 months of 1st screening.

    • Glycosylated hemoglobin (HbA1c) greater than 9% at 1st screening.

    • Prior treatment with phosphodiesterase type 5 (PDE5) inhibitors judged by the investigator to be ineffective. However, if the investigator judges that a subject's lack of response to as-needed PDE5 inhibitors is the result of inadequate coordination between dosing and sexual activity with a treatment, the subject may be enrolled.

    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. Anchorage Alaska United States 99508
    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. Phoenix Arizona United States 85050
    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. La Mesa California United States 91942
    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. Los Angeles California United States 90017
    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. Newport Beach California United States 92660
    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. San Diego California United States 92120
    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. Tarzana California United States 91356
    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. Englewood Colorado United States 80113
    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. Urbana Illinois United States 61801
    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. West Des Moines Iowa United States 50266
    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. Minneapolis Minnesota United States 55455
    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. Missoula Montana United States 59802
    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. Edmond Oklahoma United States 73034
    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. Dallas Texas United States 75231
    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. San Antonio Texas United States 78229
    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. Mountlake Terrace Washington United States 98043
    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. Spokane Washington United States 99202
    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. Surrey British Columbia Canada V3V 1N1
    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. Victoria British Columbia Canada V8V 3N1
    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. St. John New Brunswick Canada E2L 3J8
    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. Barrie Ontario Canada L4M 7G1
    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. Kitchener Ontario Canada N2N 3B9
    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. Carpentras France 84200
    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. Lyon France 69437
    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. Nice France 06002
    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. Nimes France 30029
    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. Orleans France 45067
    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. Toulouse France 31059
    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. Bad Rappenau Germany 74906
    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. Frankfurt Germany D-65933
    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. Holzminden Germany D-37603
    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. Kempen Germany 47906
    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. Athens Greece 11527
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    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:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00855582
    Other Study ID Numbers:
    • 11667
    • H6D-MC-LVHR
    First Posted:
    Mar 4, 2009
    Last Update Posted:
    Jul 28, 2011
    Last Verified:
    Jul 1, 2011
    Keywords provided by , ,
    Erectile Dysfunction
    Benign Prostatic Hyperplasia
    Additional relevant MeSH terms:
    Erectile Dysfunction
    Prostatic Hyperplasia
    Hyperplasia
    Tadalafil

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail There is a 4-week washout during Screening in order to assess symptoms and uroflowmetry data in the absence of therapy. After the screening/washout period, subjects began a 4-week single-blind, placebo lead-in period to assess treatment and study procedure compliance and to establish baseline levels.
    Arm/Group Title Tadalafil 2.5 mg Tadalafil 5 mg Placebo
    Arm/Group Description 2.5 mg tablet once daily by mouth for 12 weeks. 5 mg tablet once daily by mouth for 12 weeks. Matching placebo tablet once daily by mouth for 12 weeks.
    Period Title: Overall Study
    STARTED 198 208 200
    COMPLETED 172 184 170
    NOT COMPLETED 26 24 30

    Baseline Characteristics

    Arm/Group Title Tadalafil 2.5 mg Tadalafil 5 mg Placebo Total
    Arm/Group Description 2.5 mg tablet once daily by mouth for 12 weeks. 5 mg tablet once daily by mouth for 12 weeks. Matching placebo tablet once daily by mouth for 12 weeks. Total of all reporting groups
    Overall Participants 198 208 200 606
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    62.2
    (7.56)
    62.5
    (8.43)
    62.9
    (8.23)
    62.6
    (8.08)
    Sex: Female, Male (Count of Participants)
    Female
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Male
    198
    100%
    208
    100%
    200
    100%
    606
    100%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    33
    16.7%
    31
    14.9%
    30
    15%
    94
    15.5%
    Not Hispanic or Latino
    165
    83.3%
    177
    85.1%
    170
    85%
    512
    84.5%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    1
    0.5%
    0
    0%
    0
    0%
    1
    0.2%
    Asian
    6
    3%
    6
    2.9%
    2
    1%
    14
    2.3%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    9
    4.5%
    6
    2.9%
    8
    4%
    23
    3.8%
    White
    181
    91.4%
    194
    93.3%
    190
    95%
    565
    93.2%
    More than one race
    1
    0.5%
    2
    1%
    0
    0%
    3
    0.5%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Region of Enrollment (participants) [Number]
    France
    17
    8.6%
    24
    11.5%
    21
    10.5%
    62
    10.2%
    Portugal
    8
    4%
    3
    1.4%
    6
    3%
    17
    2.8%
    United States
    71
    35.9%
    71
    34.1%
    68
    34%
    210
    34.7%
    Mexico
    27
    13.6%
    27
    13%
    22
    11%
    76
    12.5%
    Canada
    22
    11.1%
    23
    11.1%
    26
    13%
    71
    11.7%
    Greece
    7
    3.5%
    9
    4.3%
    9
    4.5%
    25
    4.1%
    Russian Federation
    21
    10.6%
    29
    13.9%
    25
    12.5%
    75
    12.4%
    Germany
    10
    5.1%
    12
    5.8%
    9
    4.5%
    31
    5.1%
    Italy
    15
    7.6%
    10
    4.8%
    14
    7%
    39
    6.4%
    Body Mass Index (BMI) (kg/m²) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kg/m²]
    27.7
    (3.86)
    28.0
    (4.18)
    28.6
    (4.8)
    28.1
    (4.3)
    Lower Urinary Tract Symptoms (LUTS) Severity (participants) [Number]
    Moderate (IPSS <20)
    123
    62.1%
    124
    59.6%
    122
    61%
    369
    60.9%
    Severe (IPSS ≥20)
    74
    37.4%
    84
    40.4%
    78
    39%
    236
    38.9%
    Unknown
    1
    0.5%
    0
    0%
    0
    0%
    1
    0.2%
    Peak Urine Flow Rate (Qmax) (participants) [Number]
    <10 mL/sec
    96
    48.5%
    87
    41.8%
    99
    49.5%
    282
    46.5%
    10-15 mL/sec
    73
    36.9%
    83
    39.9%
    66
    33%
    222
    36.6%
    >15mL/sec
    21
    10.6%
    16
    7.7%
    16
    8%
    53
    8.7%
    Unknown
    8
    4%
    22
    10.6%
    19
    9.5%
    49
    8.1%
    Postvoid Residual Volume (PRV) (mL) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mL]
    53.0
    (51.24)
    51.1
    (60.91)
    55.5
    (60.46)
    53.2
    (57.72)
    Erectile Dysfunction (ED) - Etiology (participants) [Number]
    Psychogenic
    13
    6.6%
    15
    7.2%
    12
    6%
    40
    6.6%
    Organic
    65
    32.8%
    70
    33.7%
    85
    42.5%
    220
    36.3%
    Mixed
    76
    38.4%
    83
    39.9%
    63
    31.5%
    222
    36.6%
    Unknown
    44
    22.2%
    40
    19.2%
    40
    20%
    124
    20.5%
    ED - Severity (participants) [Number]
    Mild (IIEF EF Domain 17-30)
    104
    52.5%
    99
    47.6%
    93
    46.5%
    296
    48.8%
    Moderate (IIEF EF Domain 11-16)
    46
    23.2%
    54
    26%
    49
    24.5%
    149
    24.6%
    Severe (IIEF EF Domain 1-10)
    48
    24.2%
    55
    26.4%
    58
    29%
    161
    26.6%
    ED - Duration (participants) [Number]
    <1 year
    12
    6.1%
    20
    9.6%
    19
    9.5%
    51
    8.4%
    ≥1 year
    186
    93.9%
    188
    90.4%
    181
    90.5%
    555
    91.6%

    Outcome Measures

    1. Primary Outcome
    Title Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 Endpoint (5 mg)
    Description The total IPSS is obtained by combining the scores of the responses to component questions 1 through 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).
    Arm/Group Title Tadalafil 5 mg Placebo
    Arm/Group Description Tablet once daily by mouth for 12 weeks. Matching placebo tablet once daily by mouth for 12 weeks.
    Measure Participants 206 194
    Least Squares Mean (Standard Error) [units on a scale]
    -6.1
    (0.43)
    -3.8
    (0.45)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tadalafil 5 mg, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. The pre-specified alpha level of 0.0271 was used.
    Method ANCOVA
    Comments ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Method of Estimation Estimation Parameter Median Difference (Final Values)
    Estimated Value -2.3
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.58
    Estimation Comments
    2. Primary Outcome
    Title Change From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score at Week 12 Endpoint (5 mg)
    Description Self-reported erectile function over the past 4 weeks. Questions 1-5 were scored from 0-5, and Question 15 from 1 to 5. Erectile Function Domain scores range from 1 to 30; lower numerical scores represent greater severity of erectile dysfunction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).
    Arm/Group Title Tadalafil 5 mg Placebo
    Arm/Group Description Tablet once daily by mouth for 12 weeks. Matching placebo tablet once daily by mouth for 12 weeks.
    Measure Participants 203 190
    Least Squares Mean (Standard Error) [units on a scale]
    6.5
    (0.49)
    1.8
    (0.51)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tadalafil 5 mg, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. The pre-specified alpha level of 0.0271 was used.
    Method ANCOVA
    Comments ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 4.7
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.66
    Estimation Comments
    3. Primary Outcome
    Title Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 Endpoint (2.5 mg)
    Description The total IPSS is obtained by combining the scores of the responses to component questions 1 through 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).
    Arm/Group Title Tadalafil 2.5 mg Placebo
    Arm/Group Description Tablet once daily by mouth for 12 weeks. Matching placebo tablet once daily by mouth for 12 weeks.
    Measure Participants 191 194
    Least Squares Mean (Standard Error) [units on a scale]
    -4.6
    (0.44)
    -3.8
    (0.45)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tadalafil 5 mg, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.181
    Comments Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. The pre-specified alpha level of 0.0271 was used.
    Method ANCOVA
    Comments ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.8
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.59
    Estimation Comments
    4. Primary Outcome
    Title Change From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score at Week 12 Endpoint (2.5 mg)
    Description Self-reported erectile function over the past 4 weeks. Questions 1-5 were scored from 0-5, and Question 15 from 1 to 5. Erectile Function Domain scores range from 1 to 30; lower numerical scores represent greater severity of erectile dysfunction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).
    Arm/Group Title Tadalafil 2.5 mg Placebo
    Arm/Group Description Tablet once daily by mouth for 12 weeks. Matching placebo tablet once daily by mouth for 12 weeks.
    Measure Participants 190 190
    Least Squares Mean (Standard Error) [units on a scale]
    5.2
    (0.5)
    1.8
    (0.51)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tadalafil 5 mg, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. The pre-specified alpha level of 0.0271 was used.
    Method ANCOVA
    Comments ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 3.4
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.67
    Estimation Comments
    5. Secondary Outcome
    Title Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 12 Endpoint (5 mg)
    Description Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 3, "Did your erection last long enough for you to have successful intercourse?" Data are presented as the mean percentage of Yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Participants with non-missing baseline value and at least one non-missing post baseline value.
    Arm/Group Title Tadalafil 5 mg Placebo
    Arm/Group Description Tablet once daily by mouth for 12 weeks. Matching placebo tablet once daily by mouth for 12 weeks.
    Measure Participants 199 187
    Least Squares Mean (Standard Error) [percentage of Yes responses]
    31.7
    (2.07)
    12.0
    (2.14)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tadalafil 5 mg, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. The pre-specified alpha level of 0.0228 was used.
    Method ANCOVA
    Comments ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 19.7
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.80
    Estimation Comments
    6. Secondary Outcome
    Title Change From Baseline in Benign Prostatic Hyperplasia (BPH) Impact Index (BII) at Week 12 Endpoint (5 mg)
    Description The BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).
    Arm/Group Title Tadalafil 5 mg Placebo
    Arm/Group Description Tablet once daily by mouth for 12 weeks. Matching placebo tablet once daily by mouth for 12 weeks.
    Measure Participants 203 190
    Least Squares Mean (Standard Error) [units on scale]
    -2.1
    (0.19)
    -1.2
    (0.20)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tadalafil 5 mg, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. The pre-specified alpha level of 0.0228 was used.
    Method ANCOVA
    Comments ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.9
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.26
    Estimation Comments
    7. Secondary Outcome
    Title Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 12 Endpoint (2.5 mg)
    Description Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 3, "Did your erection last long enough for you to have successful intercourse?" Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Participants with non-missing baseline value and at least one non-missing post baseline value.
    Arm/Group Title Tadalafil 2.5 mg Placebo
    Arm/Group Description Tablet once daily by mouth for 12 weeks. Matching placebo tablet once daily by mouth for 12 weeks.
    Measure Participants 185 187
    Least Squares Mean (Standard Error) [percentage of yes responses]
    24.6
    (2.11)
    12.0
    (2.14)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tadalafil 5 mg, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. Based on the results of prior tests under this procedure, the statistical significance of this hypothesis was not assessed.
    Method ANCOVA
    Comments ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 12.5
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.85
    Estimation Comments
    8. Secondary Outcome
    Title Change From Baseline in BPH Impact Index (BII) at Week 12 Endpoint (2.5 mg)
    Description The BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).
    Arm/Group Title Tadalafil 2.5 mg Placebo
    Arm/Group Description Tablet once daily by mouth for 12 weeks. Matching placebo tablet once daily by mouth for 12 weeks.
    Measure Participants 190 190
    Least Squares Mean (Standard Deviation) [units on a scale]
    -1.6
    (0.20)
    -1.2
    (0.20)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tadalafil 5 mg, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.156
    Comments Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. Based on the results of prior tests under this procedure, the statistical significance of this hypothesis was not assessed.
    Method ANCOVA
    Comments ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.4
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.26
    Estimation Comments
    9. Secondary Outcome
    Title Change From Baseline in Modified IPSS (mIPSS) at Week 2 Endpoint
    Description The Modified IPSS is the total IPSS collected at 2 weeks post-baseline. The total IPSS is obtained by combining the scores of the responses to component questions 1 through 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from ANCOVA. The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Time Frame Baseline, 2 weeks

    Outcome Measure Data

    Analysis Population Description
    Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).
    Arm/Group Title Tadalafil 2.5 mg Tadalafil 5 mg Placebo
    Arm/Group Description 2.5 mg tablet once daily by mouth for 12 weeks. 5 mg tablet once daily by mouth for 12 weeks. Matching placebo tablet once daily by mouth for 12 weeks.
    Measure Participants 148 160 162
    Least Squares Mean (Standard Error) [units on a scale]
    -2.8
    (0.39)
    -4.0
    (0.38)
    -2.2
    (0.38)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tadalafil 5 mg, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.226
    Comments Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.
    Method ANCOVA
    Comments ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.6
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.51
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.
    Method ANCOVA
    Comments ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.8
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.50
    Estimation Comments
    10. Secondary Outcome
    Title Change From Baseline in International Prostate Symptom Score (IPSS) at Week 4 and Week 8 Endpoint
    Description The total IPSS is obtained by combining the scores of the responses to component questions 1 through 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Time Frame Baseline, 4 weeks, 8 weeks

    Outcome Measure Data

    Analysis Population Description
    Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).
    Arm/Group Title Tadalafil 2.5 mg Tadalafil 5 mg Placebo
    Arm/Group Description 2.5 mg tablet once daily by mouth for 12 weeks. 5 mg tablet once daily by mouth for 12 weeks. Matching placebo tablet once daily by mouth for 12 weeks.
    Measure Participants 198 208 200
    Week 4 Change (n=184, 197, 183)
    -3.4
    (0.39)
    -5.5
    (0.38)
    -2.6
    (0.40)
    Week 8 Change (n=174, 192, 178)
    -4.5
    (0.43)
    -5.8
    (0.41)
    -3.8
    (0.43)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tadalafil 5 mg, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.121
    Comments Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline
    Method ANCOVA
    Comments ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.8
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.53
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Tadalafil 5 mg, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.169
    Comments Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline
    Method ANCOVA
    Comments ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.8
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.57
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline
    Method ANCOVA
    Comments ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -2.9
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.52
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline
    Method ANCOVA
    Comments ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -2.1
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.56
    Estimation Comments
    11. Secondary Outcome
    Title Change From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain at Week 4 and Week 8 Endpoint
    Description Self-reported erectile function over the past 4 weeks. Questions 1-5 were scored from 0-5, and Question 15 from 1 to 5. Erectile Function Domain scores range from 1 to 30; lower numerical scores represent greater severity of erectile dysfunction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Time Frame Baseline, 4 weeks, 8 weeks

    Outcome Measure Data

    Analysis Population Description
    Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).
    Arm/Group Title Tadalafil 2.5 mg Tadalafil 5 mg Placebo
    Arm/Group Description 2.5 mg tablet once daily by mouth for 12 weeks. 5 mg tablet once daily by mouth for 12 weeks. Matching placebo tablet once daily by mouth for 12 weeks.
    Measure Participants 198 208 200
    Week 4 Change (n=186, 197, 183)
    4.2
    (0.44)
    6.1
    (0.43)
    1.0
    (0.45)
    Week 8 Change (n=176, 192, 178)
    4.9
    (0.49)
    6.6
    (0.48)
    1.8
    (0.52)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tadalafil 5 mg, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline
    Method ANCOVA
    Comments ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 3.1
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.6
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Tadalafil 5 mg, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline
    Method ANCOVA
    Comments ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 3.1
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.71
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline
    Method ANCOVA
    Comments ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 5.0
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.59
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline
    Method ANCOVA
    Comments ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 4.8
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.71
    Estimation Comments
    12. Secondary Outcome
    Title Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 4 and Week 8 Endpoint
    Description Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 3, "Did your erection last long enough for you to have successful intercourse?" Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Time Frame Baseline, 4 weeks, 8 weeks

    Outcome Measure Data

    Analysis Population Description
    Participants with non-missing baseline value and at least one non-missing post baseline value.
    Arm/Group Title Tadalafil 2.5 mg Tadalafil 5 mg Placebo
    Arm/Group Description 2.5 mg tablet once daily by mouth for 12 weeks. 5 mg tablet once daily by mouth for 12 weeks. Matching placebo tablet once daily by mouth for 12 weeks.
    Measure Participants 198 208 200
    Week 4 Change (n=180, 190, 180)
    22.3
    (2.31)
    30.7
    (2.27)
    6.2
    (2.35)
    Week 8 Change (n=172, 187, 171)
    22.9
    (2.16)
    31.7
    (2.11)
    10.9
    (2.21)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tadalafil 5 mg, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline
    Method ANCOVA
    Comments ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 16.1
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.1
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Tadalafil 5 mg, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline
    Method ANCOVA
    Comments ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 12.0
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.0
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline
    Method ANCOVA
    Comments ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 24.5
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.1
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline
    Method ANCOVA
    Comments ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 20.9
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.9
    Estimation Comments
    13. Secondary Outcome
    Title Change From Baseline in BPH Impact Index (BII) at Week 4 and 8 Endpoint
    Description The BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Time Frame Baseline, 4 weeks, 8 weeks

    Outcome Measure Data

    Analysis Population Description
    Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).
    Arm/Group Title Tadalafil 2.5 mg Tadalafil 5 mg Placebo
    Arm/Group Description 2.5 mg tablet once daily by mouth for 12 weeks. 5 mg tablet once daily by mouth for 12 weeks. Matching placebo tablet once daily by mouth for 12 weeks.
    Measure Participants 198 208 200
    Week 4 Change (n=186, 197, 183)
    -1.0
    (0.17)
    -1.5
    (0.16)
    -0.7
    (0.17)
    Week 8 Change (n=175, 192, 177)
    -1.4
    (0.18)
    -1.8
    (0.17)
    -1.2
    (0.18)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tadalafil 5 mg, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.215
    Comments Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline
    Method ANCOVA
    Comments ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.3
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.22
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Tadalafil 5 mg, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.325
    Comments Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline
    Method ANOVA
    Comments ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.2
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.24
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline
    Method ANCOVA
    Comments ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.9
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.22
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.011
    Comments Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline
    Method ANCOVA
    Comments ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.6
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.23
    Estimation Comments
    14. Secondary Outcome
    Title Change From Baseline in International Prostate Symptom Score Voiding (Obstructive) Subscore at Week 12 Endpoint
    Description IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. The obstructive subscore ranges from 0 to 20 with a higher score representing greater obstruction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).
    Arm/Group Title Tadalafil 2.5 mg Tadalafil 5 mg Placebo
    Arm/Group Description 2.5 mg tablet once daily by mouth for 12 weeks. 5 mg tablet once daily by mouth for 12 weeks. Matching placebo tablet once daily by mouth for 12 weeks.
    Measure Participants 191 206 194
    Least Squares Mean (Standard Error) [units on a scale]
    -2.7
    (0.28)
    -3.6
    (0.28)
    -2.2
    (0.29)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tadalafil 5 mg, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.230
    Comments Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.
    Method ANCOVA
    Comments ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.5
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.38
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.
    Method ANCOVA
    Comments ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.4
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.37
    Estimation Comments
    15. Secondary Outcome
    Title Change From Baseline in International Prostate Symptom Score Storage (Irritative) Subscore at Week 12 Endpoint
    Description IPSS irritative subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. The irritative subscore ranges from 0 to 15 with a higher score representing more irritative symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).
    Arm/Group Title Tadalafil 2.5 mg Tadalafil 5 mg Placebo
    Arm/Group Description 2.5 mg tablet once daily by mouth for 12 weeks. 5 mg tablet once daily by mouth for 12 weeks. Matching placebo tablet once daily by mouth for 12 weeks.
    Measure Participants 192 206 194
    Least Squares Mean (Standard Error) [units on a scale]
    -1.9
    (0.2)
    -2.5
    (0.19)
    -1.6
    (0.20)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tadalafil 5 mg, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.191
    Comments Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.
    Method ANCOVA
    Comments ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.3
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.3
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.
    Method ANCOVA
    Comments ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.9
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.3
    Estimation Comments
    16. Secondary Outcome
    Title Change From Baseline in International Prostate Symptom Score Nocturia Question at Week 12
    Description The IPSS Nocturia question (Question 7) measures the number of times needed to get up at night to urinate. Scores range from 0 (none) to 5 (5 or more times). Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).
    Arm/Group Title Tadalafil 2.5 mg Tadalafil 5 mg Placebo
    Arm/Group Description 2.5 mg tablet once daily by mouth for 12 weeks. 5 mg tablet once daily by mouth for 12 weeks. Matching placebo tablet once daily by mouth for 12 weeks.
    Measure Participants 192 206 194
    Least Squares Mean (Standard Error) [units on a scale]
    -0.5
    (0.08)
    -0.6
    (0.07)
    -0.5
    (0.08)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tadalafil 5 mg, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.763
    Comments Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.
    Method ANCOVA
    Comments ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.0
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.1
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.075
    Comments Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.
    Method ANCOVA
    Comments ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.2
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.1
    Estimation Comments
    17. Secondary Outcome
    Title Change From Baseline in International Prostate Symptom Score Quality of Life (QoL) at Week 12 Endpoint
    Description Assessment of quality of life (QoL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible). Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).
    Arm/Group Title Tadalafil 2.5 mg Tadalafil 5 mg Placebo
    Arm/Group Description 2.5 mg tablet once daily by mouth for 12 weeks. 5 mg tablet once daily by mouth for 12 weeks. Matching placebo tablet once daily by mouth for 12 weeks.
    Measure Participants 192 205 194
    Least Squares Mean (Standard Error) [units on a scale]
    -0.9
    (0.10)
    -1.0
    (0.10)
    -0.8
    (0.11)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tadalafil 5 mg, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.384
    Comments Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.
    Method ANCOVA
    Comments ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.1
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.1
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.082
    Comments Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.
    Method ANCOVA
    Comments ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.3
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.1
    Estimation Comments
    18. Secondary Outcome
    Title Change From Baseline in International Index of Erectile Function - Overall Satisfaction Domain at Week 12 Endpoint
    Description Self-reported overall satisfaction over the past 4 weeks. Calculated as the sum of IIEF Questions 13 and 14. Each question is scored from 1 through 5, with a possible total score of 2 through 10. Higher scores represent greater satisfaction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).
    Arm/Group Title Tadalafil 2.5 mg Tadalafil 5 mg Placebo
    Arm/Group Description 2.5 mg tablet once daily by mouth for 12 weeks. 5 mg tablet once daily by mouth for 12 weeks. Matching placebo tablet once daily by mouth for 12 weeks.
    Measure Participants 190 203 190
    Least Squares Mean (Standard Deviation) [units on a scale]
    1.8
    (0.16)
    2.4
    (0.16)
    0.5
    (0.16)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tadalafil 5 mg, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.
    Method ANCOVA
    Comments ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.3
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.2
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.
    Method ANCOVA
    Comments ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.9
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.2
    Estimation Comments
    19. Secondary Outcome
    Title Change From Baseline in International Index of Erectile Function - Intercourse Satisfaction Domain at Week 12 Endpoint
    Description Self-reported intercourse satisfaction over the past 4 weeks. Calculated as the sum of IIEF Questions 6, 7 and 8. Each question is scored from 0 through 5 with a possible total score of 0 through 15. Higher score represent greater satisfaction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).
    Arm/Group Title Tadalafil 2.5 mg Tadalafil 5 mg Placebo
    Arm/Group Description 2.5 mg tablet once daily by mouth for 12 weeks. 5 mg tablet once daily by mouth for 12 weeks. Matching placebo tablet once daily by mouth for 12 weeks.
    Measure Participants 190 203 190
    Least Squares Mean (Standard Deviation) [units on a scale]
    1.6
    (0.23)
    2.0
    (0.22)
    0.2
    (0.23)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tadalafil 5 mg, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.
    Method ANCOVA
    Comments ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.5
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.3
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.
    Method ANCOVA
    Comments ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 1.9
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.3
    Estimation Comments
    20. Secondary Outcome
    Title Change From Baseline in International Index of Erectile Function Question 3 at Week 12 Endpoint
    Description IIEF Question 3 asks how often a subject 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). Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).
    Arm/Group Title Tadalafil 2.5 mg Tadalafil 5 mg Placebo
    Arm/Group Description 2.5 mg tablet once daily by mouth for 12 weeks. 5 mg tablet once daily by mouth for 12 weeks. Matching placebo tablet once daily by mouth for 12 weeks.
    Measure Participants 190 203 190
    Least Squares Mean (Standard Error) [units on a scale]
    0.9
    (0.10)
    1.1
    (0.10)
    0.2
    (0.10)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tadalafil 5 mg, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.
    Method ANCOVA
    Comments ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.7
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.1
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.
    Method ANCOVA
    Comments ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.9
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.1
    Estimation Comments
    21. Secondary Outcome
    Title Change From Baseline in International Index of Erectile Function Question 4 at Week 12 Endpoint
    Description IIEF Question 4 asks whether how often a subject 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 of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).
    Arm/Group Title Tadalafil 2.5 mg Tadalafil 5 mg Placebo
    Arm/Group Description 2.5 mg tablet once daily by mouth for 12 weeks. 5 mg tablet once daily by mouth for 12 weeks. Matching placebo tablet once daily by mouth for 12 weeks.
    Measure Participants 190 203 190
    Least Squares Mean (Standard Error) [units on a scale]
    0.9
    (0.11)
    1.3
    (0.10)
    0.4
    (0.11)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tadalafil 5 mg, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.
    Method ANCOVA
    Comments ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.5
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.1
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.
    Method ANCOVA
    Comments ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.9
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.1
    Estimation Comments
    22. Secondary Outcome
    Title Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 2 at Week 12 Endpoint
    Description Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 2, "Were you able to insert your penis into your partner's vagina?" Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Participants with non-missing baseline value and at least one non-missing post baseline value.
    Arm/Group Title Tadalafil 2.5 mg Tadalafil 5 mg Placebo
    Arm/Group Description 2.5 mg tablet once daily by mouth for 12 weeks. 5 mg tablet once daily by mouth for 12 weeks. Matching placebo tablet once daily by mouth for 12 weeks.
    Measure Participants 185 199 187
    Least Squares Mean (Standard Error) [percentage of yes responses]
    21.4
    (1.82)
    25.1
    (1.78)
    9.3
    (1.84)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tadalafil 5 mg, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.
    Method ANCOVA
    Comments ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 12.1
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.4
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.
    Method ANCOVA
    Comments ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 15.8
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.4
    Estimation Comments
    23. Secondary Outcome
    Title Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 4 at Week 12 Endpoint
    Description Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 4, "Were you satisfied with the hardness of your erection?" Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Participants with non-missing baseline value and at least one non-missing post baseline value.
    Arm/Group Title Tadalafil 2.5 mg Tadalafil 5 mg Placebo
    Arm/Group Description 2.5 mg tablet once daily by mouth for 12 weeks. 5 mg tablet once daily by mouth for 12 weeks. Matching placebo tablet once daily by mouth for 12 weeks.
    Measure Participants 185 199 187
    Least Squares Mean (Standard Error) [percentage of yes responses]
    26.6
    (2.48)
    39.4
    (2.46)
    9.6
    (2.61)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tadalafil 5 mg, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.
    Method ANCOVA
    Comments ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 16.9
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.6
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.
    Method ANCOVA
    Comments ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 29.7
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.6
    Estimation Comments
    24. Secondary Outcome
    Title Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 5
    Description Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 5, "Were you satisfied overall with this sexual experience?" Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Participants with non-missing baseline value and at least one non-missing post baseline value.
    Arm/Group Title Tadalafil 2.5 mg Tadalafil 5 mg Placebo
    Arm/Group Description 2.5 mg tablet once daily by mouth for 12 weeks. 5 mg tablet once daily by mouth for 12 weeks. Matching placebo tablet once daily by mouth for 12 weeks.
    Measure Participants 185 199 187
    Least Squares Mean (Standard Error) [percentage of yes responses]
    23.7
    (2.49)
    38.2
    (2.48)
    9.9
    (2.63)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tadalafil 5 mg, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.
    Method ANCOVA
    Comments ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 13.8
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.6
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.
    Method ANOVA
    Comments ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 28.4
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.6
    Estimation Comments
    25. Secondary Outcome
    Title Patient Global Impression of Improvement (PGI-I) at Week 12 Endpoint
    Description A scale that measures the patient's perception of urinary symptoms at endpoint compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). The data are presented as the number of participants in each of the seven categories: very much better (1); much better (2); a little better (3); no change (4); a little worse (5); much worse (6); very much worse (7).
    Time Frame 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Participants started study medication, and had non-missing data.
    Arm/Group Title Tadalafil 2.5 mg Tadalafil 5 mg Placebo
    Arm/Group Description 2.5 mg tablet once daily by mouth for 12 weeks. 5 mg tablet once daily by mouth for 12 weeks. Matching placebo tablet once daily by mouth for 12 weeks.
    Measure Participants 185 197 185
    Very Much Worse
    0
    0%
    0
    0%
    1
    0.5%
    Much Worse
    3
    1.5%
    2
    1%
    4
    2%
    A Little Worse
    12
    6.1%
    3
    1.4%
    13
    6.5%
    No Change
    34
    17.2%
    34
    16.3%
    61
    30.5%
    A Little Better
    66
    33.3%
    79
    38%
    63
    31.5%
    Much Better
    57
    28.8%
    60
    28.8%
    37
    18.5%
    Very Much Better
    13
    6.6%
    19
    9.1%
    6
    3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tadalafil 5 mg, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.
    Method Cochran-Mantel-Haenszel
    Comments The Cochran-Mantel-Haenszel test was adjusted for baseline LUTS severity.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.
    Method Cochran-Mantel-Haenszel
    Comments The Cochran-Mantel-Haenszel test was adjusted for baseline LUTS severity.
    26. Secondary Outcome
    Title Clinician Global Impression of Improvement (CGI-I) at Week 12 Endpoint
    Description A scale that measures clinician's rating of the total change in the patient's urinary symptoms at endpoint compared with the start of treatment. Scores range from 1 (very much better) to 7 (very much worse).The data are presented as the number of participants in each of the seven categories: very much better (1); much better (2); a little better (3); no change (4); a little worse (5); much worse (6); very much worse (7).
    Time Frame 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Participants started study medication, and had non-missing data.
    Arm/Group Title Tadalafil 2.5 mg Tadalafil 5 mg Placebo
    Arm/Group Description 2.5 mg tablet once daily by mouth for 12 weeks. 5 mg tablet once daily by mouth for 12 weeks. Matching placebo tablet once daily by mouth for 12 weeks.
    Measure Participants 181 197 184
    Very Much Worse
    0
    0%
    0
    0%
    1
    0.5%
    Much Worse
    2
    1%
    1
    0.5%
    4
    2%
    A Little Worse
    8
    4%
    2
    1%
    9
    4.5%
    No Change
    41
    20.7%
    42
    20.2%
    64
    32%
    A Little Better
    67
    33.8%
    60
    28.8%
    58
    29%
    Much Better
    56
    28.3%
    78
    37.5%
    45
    22.5%
    Very Much Better
    7
    3.5%
    14
    6.7%
    3
    1.5%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tadalafil 5 mg, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.006
    Comments Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.
    Method Cochran-Mantel-Haenszel
    Comments The Cochran-Mantel-Haenszel test was adjusted for baseline LUTS severity.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.
    Method Cochran-Mantel-Haenszel
    Comments The Cochran-Mantel-Haenszel test was adjusted for baseline LUTS severity.
    27. Secondary Outcome
    Title Erectile Function General Assessment Questionnaire (EF-GAQ)
    Description The EF-GAQ consisted of two questions: (1) Has the treatment you have been taking during this study improved your erections? and (2) If yes, has the treatment improved your ability to engage in sexual activity? Each question has a Yes/No response.
    Time Frame 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Participants started study medication, and had non-missing data.
    Arm/Group Title Tadalafil 2.5 mg Tadalafil 5 mg Placebo
    Arm/Group Description 2.5 mg tablet once daily by mouth for 12 weeks. 5 mg tablet once daily by mouth for 12 weeks. Matching placebo tablet once daily by mouth for 12 weeks.
    Measure Participants 184 196 185
    Question 1
    135
    68.2%
    155
    74.5%
    74
    37%
    Question 2
    126
    63.6%
    146
    70.2%
    67
    33.5%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tadalafil 5 mg, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for Question 1.
    Method Regression, Logistic
    Comments Logistic regression model includes terms for treatment group, region and centered-baseline IIEF EF Domain score.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Tadalafil 5 mg, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for Question 2.
    Method Regression, Logistic
    Comments Logistic regression model includes terms for treatment group, region and centered-baseline IIEF EF Domain score.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for Question 1.
    Method Regression, Logistic
    Comments Logistic regression model includes terms for treatment group, region and centered-baseline IIEF EF Domain score.
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for Question 2.
    Method Regression, Logistic
    Comments Logistic regression model includes terms for treatment group, region and centered-baseline IIEF EF Domain score.
    28. Secondary Outcome
    Title Change From Baseline in Uroflowmetry Parameters - Peak Urine Flow Rate (Qmax) at Week 12 Endpoint
    Description Qmax is defined as the peak urine flow rate (measured in milliliters per second [mL/sec] using standard calibrated flowmeter). At each visit, a uroflowmetry assessment was considered valid and the data were included in the statistical analyses only if the prevoid total bladder volume (assessed by ultrasound) was >=150 to <=550 milliliters (mL) and the voided volume (Vcomp) was >= 125 mL.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Participants with non-missing baseline value and at least one non-missing post baseline value.
    Arm/Group Title Tadalafil 2.5 mg Tadalafil 5 mg Placebo
    Arm/Group Description 2.5 mg tablet once daily by mouth for 12 weeks. 5 mg tablet once daily by mouth for 12 weeks. Matching placebo tablet once daily by mouth for 12 weeks.
    Measure Participants 157 160 143
    Mean (Standard Deviation) [mL/sec]
    1.7
    (4.45)
    1.6
    (4.15)
    1.2
    (4.52)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Tadalafil 5 mg, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.027
    Comments Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.
    Method Ranked ANOVA
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Placebo
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.186
    Comments Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.
    Method Ranked ANOVA
    Comments
    29. Secondary Outcome
    Title Change From Baseline in Uroflowmetry Parameters - Mean Urine Flow Rate (Qmean) at Week 12 Endpoint
    Description Qmean is defined as the average urine flow rate (measured in milliliters per second [mL/second] using standard calibrated flowmeter). At each visit, a uroflowmetry assessment was considered valid and the data were included in the statistical analyses only if the prevoid total bladder volume (assessed by ultrasound) was >=150 to <=550 milliliters (mL) and the voided volume (Vcomp) was >= 125 mL.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Participants with non-missing baseline value and at least one non-missing post baseline value.
    Arm/Group Title Tadalafil 2.5 mg Tadalafil 5 mg Placebo
    Arm/Group Description 2.5 mg tablet once daily by mouth for 12 weeks. 5 mg tablet once daily by mouth for 12 weeks. Matching placebo tablet once daily by mouth for 12 weeks.
    Measure Participants 157 161 143
    Mean (Standard Deviation) [mL/sec]
    1.0
    (2.65)
    0.9
    (2.92)
    0.6
    (2.6)
    30. Secondary Outcome
    Title Change From Baseline in Uroflowmetry Parameters - Voided Volume (Vcomp) at Week 12 Endpoint
    Description Vcomp is defined as the volume of urine voided (measures in mL using a standard calibrated flowmeter). At each visit, a uroflowmetry assessment was considered valid and the data were included in the statistical analyses only if the prevoid total bladder volume (assessed by ultrasound) was >=150 to <=550 milliliters (mL) and the voided volume (Vcomp) was >= 125 mL.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Participants with non-missing baseline value and at least one non-missing post baseline value.
    Arm/Group Title Tadalafil 2.5 mg Tadalafil 5 mg Placebo
    Arm/Group Description 2.5 mg tablet once daily by mouth for 12 weeks. 5 mg tablet once daily by mouth for 12 weeks. Matching placebo tablet once daily by mouth for 12 weeks.
    Measure Participants 157 161 143
    Mean (Standard Deviation) [mL]
    18.5
    (113.9)
    13.3
    (92.75)
    11.4
    (91.84)

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Tadalafil 2.5 mg Tadalafil 5 mg Placebo
    Arm/Group Description 2.5 mg tablet once daily by mouth for 12 weeks. 5 mg tablet once daily by mouth for 12 weeks. Matching placebo tablet once daily by mouth for 12 weeks.
    All Cause Mortality
    Tadalafil 2.5 mg Tadalafil 5 mg Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Tadalafil 2.5 mg Tadalafil 5 mg Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 2/198 (1%) 1/208 (0.5%) 1/200 (0.5%)
    Cardiac disorders
    Myocardial infarction 1/198 (0.5%) 1 0/208 (0%) 0 0/200 (0%) 0
    Gastrointestinal disorders
    Pancreatitis haemorrhagic 0/198 (0%) 0 1/208 (0.5%) 1 0/200 (0%) 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion 1/198 (0.5%) 1 0/208 (0%) 0 0/200 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Non-Hodgkin's lymphoma 0/198 (0%) 0 0/208 (0%) 0 1/200 (0.5%) 1
    Other (Not Including Serious) Adverse Events
    Tadalafil 2.5 mg Tadalafil 5 mg Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 50/198 (25.3%) 56/208 (26.9%) 38/200 (19%)
    Blood and lymphatic system disorders
    Anaemia 1/198 (0.5%) 1 0/208 (0%) 0 0/200 (0%) 0
    Cardiac disorders
    Palpitations 1/198 (0.5%) 1 0/208 (0%) 0 0/200 (0%) 0
    Ear and labyrinth disorders
    Cerumen impaction 0/198 (0%) 0 1/208 (0.5%) 1 0/200 (0%) 0
    Vertigo 0/198 (0%) 0 0/208 (0%) 0 1/200 (0.5%) 1
    Vertigo positional 0/198 (0%) 0 0/208 (0%) 0 1/200 (0.5%) 1
    Eye disorders
    Cataract nuclear 1/198 (0.5%) 1 0/208 (0%) 0 0/200 (0%) 0
    Conjunctivitis 1/198 (0.5%) 1 0/208 (0%) 0 0/200 (0%) 0
    Dacryostenosis acquired 1/198 (0.5%) 1 0/208 (0%) 0 0/200 (0%) 0
    Photopsia 1/198 (0.5%) 1 0/208 (0%) 0 0/200 (0%) 0
    Retinal tear 1/198 (0.5%) 1 0/208 (0%) 0 0/200 (0%) 0
    Vision blurred 0/198 (0%) 0 2/208 (1%) 2 0/200 (0%) 0
    Vitreous detachment 1/198 (0.5%) 1 0/208 (0%) 0 0/200 (0%) 0
    Vitreous floaters 1/198 (0.5%) 1 0/208 (0%) 0 0/200 (0%) 0
    Gastrointestinal disorders
    Abdominal discomfort 1/198 (0.5%) 1 2/208 (1%) 2 2/200 (1%) 2
    Abdominal pain upper 0/198 (0%) 0 1/208 (0.5%) 2 0/200 (0%) 0
    Diarrhoea 2/198 (1%) 2 1/208 (0.5%) 1 1/200 (0.5%) 1
    Dyspepsia 1/198 (0.5%) 1 3/208 (1.4%) 3 0/200 (0%) 0
    Food poisoning 1/198 (0.5%) 1 0/208 (0%) 0 0/200 (0%) 0
    Gastritis 0/198 (0%) 0 1/208 (0.5%) 1 1/200 (0.5%) 1
    Gastrooesophageal reflux disease 0/198 (0%) 0 1/208 (0.5%) 1 0/200 (0%) 0
    Hyperchlorhydria 1/198 (0.5%) 1 0/208 (0%) 0 0/200 (0%) 0
    Inguinal hernia 0/198 (0%) 0 1/208 (0.5%) 1 0/200 (0%) 0
    Nausea 1/198 (0.5%) 1 1/208 (0.5%) 1 2/200 (1%) 2
    Toothache 0/198 (0%) 0 1/208 (0.5%) 1 0/200 (0%) 0
    Vomiting 0/198 (0%) 0 0/208 (0%) 0 1/200 (0.5%) 1
    General disorders
    Chest pain 1/198 (0.5%) 1 0/208 (0%) 0 2/200 (1%) 2
    Influenza like illness 0/198 (0%) 0 0/208 (0%) 0 1/200 (0.5%) 1
    Irritability 1/198 (0.5%) 1 0/208 (0%) 0 0/200 (0%) 0
    Non-cardiac chest pain 0/198 (0%) 0 1/208 (0.5%) 1 0/200 (0%) 0
    Pain 1/198 (0.5%) 1 0/208 (0%) 0 0/200 (0%) 0
    Immune system disorders
    Allergy to arthropod sting 1/198 (0.5%) 1 0/208 (0%) 0 0/200 (0%) 0
    Drug hypersensitivity 1/198 (0.5%) 1 0/208 (0%) 0 0/200 (0%) 0
    Seasonal allergy 0/198 (0%) 0 1/208 (0.5%) 1 0/200 (0%) 0
    Infections and infestations
    Bronchitis 2/198 (1%) 2 0/208 (0%) 0 1/200 (0.5%) 1
    Ear infection 0/198 (0%) 0 1/208 (0.5%) 1 0/200 (0%) 0
    Gastroenteritis viral 1/198 (0.5%) 1 0/208 (0%) 0 0/200 (0%) 0
    Infected bites 0/198 (0%) 0 1/208 (0.5%) 1 0/200 (0%) 0
    Influenza 4/198 (2%) 4 1/208 (0.5%) 1 5/200 (2.5%) 5
    Labyrinthitis 0/198 (0%) 0 0/208 (0%) 0 1/200 (0.5%) 1
    Localised infection 0/198 (0%) 0 0/208 (0%) 0 1/200 (0.5%) 1
    Nasopharyngitis 6/198 (3%) 6 5/208 (2.4%) 5 4/200 (2%) 4
    Pharyngitis 0/198 (0%) 0 2/208 (1%) 2 0/200 (0%) 0
    Pharyngotonsillitis 1/198 (0.5%) 1 0/208 (0%) 0 0/200 (0%) 0
    Pneumonia 1/198 (0.5%) 1 0/208 (0%) 0 0/200 (0%) 0
    Rhinitis 0/198 (0%) 0 0/208 (0%) 0 1/200 (0.5%) 1
    Sinusitis 2/198 (1%) 2 1/208 (0.5%) 1 2/200 (1%) 2
    Skin infection 0/198 (0%) 0 0/208 (0%) 0 1/200 (0.5%) 1
    Tinea pedis 0/198 (0%) 0 0/208 (0%) 0 1/200 (0.5%) 1
    Tonsillitis 1/198 (0.5%) 1 0/208 (0%) 0 0/200 (0%) 0
    Tooth infection 2/198 (1%) 2 0/208 (0%) 0 0/200 (0%) 0
    Upper respiratory tract infection 0/198 (0%) 0 3/208 (1.4%) 3 0/200 (0%) 0
    Urinary tract infection 1/198 (0.5%) 1 0/208 (0%) 0 1/200 (0.5%) 1
    Viral infection 0/198 (0%) 0 1/208 (0.5%) 1 0/200 (0%) 0
    Injury, poisoning and procedural complications
    Arthropod bite 1/198 (0.5%) 1 0/208 (0%) 0 0/200 (0%) 0
    Arthropod sting 1/198 (0.5%) 1 0/208 (0%) 0 0/200 (0%) 0
    Fall 1/198 (0.5%) 1 0/208 (0%) 0 0/200 (0%) 0
    Joint injury 1/198 (0.5%) 1 0/208 (0%) 0 0/200 (0%) 0
    Muscle injury 0/198 (0%) 0 0/208 (0%) 0 1/200 (0.5%) 1
    Road traffic accident 1/198 (0.5%) 1 0/208 (0%) 0 0/200 (0%) 0
    Investigations
    Blood calcium increased 0/198 (0%) 0 1/208 (0.5%) 1 0/200 (0%) 0
    Blood cholesterol increased 1/198 (0.5%) 1 0/208 (0%) 0 0/200 (0%) 0
    Blood creatine phosphokinase increased 2/198 (1%) 2 0/208 (0%) 0 0/200 (0%) 0
    Blood creatinine increased 1/198 (0.5%) 1 0/208 (0%) 0 0/200 (0%) 0
    Blood testosterone decreased 1/198 (0.5%) 1 0/208 (0%) 0 0/200 (0%) 0
    Blood urea increased 1/198 (0.5%) 1 0/208 (0%) 0 0/200 (0%) 0
    Blood uric acid increased 0/198 (0%) 0 1/208 (0.5%) 1 0/200 (0%) 0
    Gamma-glutamyltransferase increased 0/198 (0%) 0 1/208 (0.5%) 1 0/200 (0%) 0
    Haemoglobin decreased 0/198 (0%) 0 1/208 (0.5%) 1 0/200 (0%) 0
    Heart rate decreased 0/198 (0%) 0 1/208 (0.5%) 1 0/200 (0%) 0
    Liver function test abnormal 0/198 (0%) 0 0/208 (0%) 0 1/200 (0.5%) 1
    Scan myocardial perfusion abnormal 0/198 (0%) 0 1/208 (0.5%) 1 0/200 (0%) 0
    Metabolism and nutrition disorders
    Hypercholesterolaemia 1/198 (0.5%) 1 0/208 (0%) 0 0/200 (0%) 0
    Hyperlipidaemia 1/198 (0.5%) 1 0/208 (0%) 0 0/200 (0%) 0
    Musculoskeletal and connective tissue disorders
    Arthralgia 2/198 (1%) 2 1/208 (0.5%) 1 2/200 (1%) 2
    Back pain 1/198 (0.5%) 1 6/208 (2.9%) 6 3/200 (1.5%) 3
    Bone pain 1/198 (0.5%) 1 0/208 (0%) 0 0/200 (0%) 0
    Coccydynia 1/198 (0.5%) 2 0/208 (0%) 0 0/200 (0%) 0
    Groin pain 1/198 (0.5%) 1 0/208 (0%) 0 0/200 (0%) 0
    Muscle spasms 0/198 (0%) 0 2/208 (1%) 2 0/200 (0%) 0
    Musculoskeletal pain 1/198 (0.5%) 1 0/208 (0%) 0 0/200 (0%) 0
    Myalgia 1/198 (0.5%) 1 2/208 (1%) 2 2/200 (1%) 2
    Neck pain 0/198 (0%) 0 1/208 (0.5%) 1 1/200 (0.5%) 1
    Pain in extremity 0/198 (0%) 0 1/208 (0.5%) 1 0/200 (0%) 0
    Rheumatoid arthritis 0/198 (0%) 0 1/208 (0.5%) 1 0/200 (0%) 0
    Nervous system disorders
    Balance disorder 0/198 (0%) 0 0/208 (0%) 0 1/200 (0.5%) 1
    Dizziness 2/198 (1%) 3 2/208 (1%) 2 2/200 (1%) 2
    Drooling 0/198 (0%) 0 1/208 (0.5%) 1 0/200 (0%) 0
    Headache 5/198 (2.5%) 5 12/208 (5.8%) 12 6/200 (3%) 6
    Lethargy 0/198 (0%) 0 1/208 (0.5%) 1 0/200 (0%) 0
    Paraesthesia 0/198 (0%) 0 0/208 (0%) 0 1/200 (0.5%) 1
    Syncope 0/198 (0%) 0 1/208 (0.5%) 1 0/200 (0%) 0
    Psychiatric disorders
    Depression 0/198 (0%) 0 0/208 (0%) 0 1/200 (0.5%) 1
    Insomnia 0/198 (0%) 0 0/208 (0%) 0 1/200 (0.5%) 1
    Libido decreased 1/198 (0.5%) 1 0/208 (0%) 0 0/200 (0%) 0
    Post-traumatic stress disorder 0/198 (0%) 0 1/208 (0.5%) 1 0/200 (0%) 0
    Renal and urinary disorders
    Dysuria 0/198 (0%) 0 0/208 (0%) 0 1/200 (0.5%) 1
    Micturition urgency 0/198 (0%) 0 1/208 (0.5%) 1 0/200 (0%) 0
    Nocturia 0/198 (0%) 0 0/208 (0%) 0 1/200 (0.5%) 1
    Pollakiuria 1/198 (0.5%) 1 1/208 (0.5%) 1 0/200 (0%) 0
    Renal impairment 0/198 (0%) 0 1/208 (0.5%) 1 0/200 (0%) 0
    Terminal dribbling 1/198 (0.5%) 1 0/208 (0%) 0 0/200 (0%) 0
    Reproductive system and breast disorders
    Epididymitis 1/198 (0.5%) 1 0/208 (0%) 0 0/200 (0%) 0
    Penile pain 1/198 (0.5%) 1 0/208 (0%) 0 0/200 (0%) 0
    Priapism 0/198 (0%) 0 1/208 (0.5%) 1 0/200 (0%) 0
    Prostatitis 1/198 (0.5%) 1 0/208 (0%) 0 0/200 (0%) 0
    Testicular pain 1/198 (0.5%) 2 0/208 (0%) 0 0/200 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Bronchial hyperreactivity 0/198 (0%) 0 1/208 (0.5%) 1 0/200 (0%) 0
    Cough 1/198 (0.5%) 1 0/208 (0%) 0 0/200 (0%) 0
    Dry throat 1/198 (0.5%) 1 0/208 (0%) 0 0/200 (0%) 0
    Epistaxis 0/198 (0%) 0 1/208 (0.5%) 1 0/200 (0%) 0
    Oropharyngeal pain 0/198 (0%) 0 2/208 (1%) 2 0/200 (0%) 0
    Respiratory tract congestion 0/198 (0%) 0 0/208 (0%) 0 1/200 (0.5%) 1
    Sinus congestion 0/198 (0%) 0 1/208 (0.5%) 1 0/200 (0%) 0
    Skin and subcutaneous tissue disorders
    Acne 0/198 (0%) 0 1/208 (0.5%) 1 0/200 (0%) 0
    Dermatitis contact 0/198 (0%) 0 1/208 (0.5%) 1 0/200 (0%) 0
    Hyperhidrosis 0/198 (0%) 0 0/208 (0%) 0 1/200 (0.5%) 1
    Rash 1/198 (0.5%) 1 2/208 (1%) 2 1/200 (0.5%) 1
    Surgical and medical procedures
    Intervertebral disc operation 1/198 (0.5%) 1 0/208 (0%) 0 0/200 (0%) 0
    Nasal septal operation 1/198 (0.5%) 1 0/208 (0%) 0 0/200 (0%) 0
    Skin neoplasm excision 0/198 (0%) 0 1/208 (0.5%) 1 0/200 (0%) 0
    Vascular disorders
    Flushing 1/198 (0.5%) 1 1/208 (0.5%) 1 1/200 (0.5%) 1
    Hot flush 0/198 (0%) 0 1/208 (0.5%) 1 0/200 (0%) 0
    Hypertension 0/198 (0%) 0 3/208 (1.4%) 3 1/200 (0.5%) 1
    Orthostatic hypotension 1/198 (0.5%) 1 0/208 (0%) 0 1/200 (0.5%) 1

    Limitations/Caveats

    P-values for the peak urine flow rate outcome were corrected in this record after an error was identified.

    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 Office
    Organization Eli Lilly and Company
    Phone 800-545-5979
    Email
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00855582
    Other Study ID Numbers:
    • 11667
    • H6D-MC-LVHR
    First Posted:
    Mar 4, 2009
    Last Update Posted:
    Jul 28, 2011
    Last Verified:
    Jul 1, 2011