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A Study in Erectile Dysfunction

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT01130532
Collaborator
(none)
623
Enrollment
40
Locations
3
Arms
17
Duration (Months)
15.6
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this trial is to evaluate if treatment with tadalafil once daily will allow men to return to normal erectile function in those who did not have normal erectile function following as-needed (PRN) Phosphodiesterase Type 5 (PDE5) Inhibitor treatment.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
623 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Tadalafil Once Daily Following As-Needed Phosphodiesterase Type 5 Inhibitor Treatment, an Assessment of Return to Normal Erectile Function
Study Start Date :
Aug 1, 2010
Actual Primary Completion Date :
Jan 1, 2012
Actual Study Completion Date :
Jan 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 2.5 milligram (mg) titrated to 5 mg Tadalafil

2.5 mg for 4 weeks, followed by 5 mg for 8 weeks with option to continue treatment at 5 mg for an additional 4 weeks

Drug: Tadalafil
Administer orally
Other Names:
  • Cialis
  • LY450190

    		•
    Active Comparator: 5 mg Tadalafil

    5.0 mg for 12 weeks with option to continue treatment for additional 4 weeks

    Drug: Tadalafil
    Administer orally
    Other Names:
  • Cialis
  • LY450190

    		•
    Placebo Comparator: Placebo

    for 12 weeks

    Drug: Placebo
    Administer orally

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants Having an International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score Greater Than or Equal to 26 Through 12-Week Endpoint (Double-Blind Treatment Period) [Baseline through 12 weeks]

      Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Data presented are the percentage of participants who return to normal erectile function (IIEF-EF domain score ≥26) at end of double-blind treatment period (Period III).

    Secondary Outcome Measures

    1. Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score [Baseline, 12 weeks]

      Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.

    2. Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function - Intercourse Satisfaction (IIEF-IS) Domain Score [Baseline, 12 weeks]

      Self-reported intercourse satisfaction over the past 4 weeks. IIEF-IS is the sum of Questions 6, 7 and 8 of the IIEF. Scores range from 0 (low/no satisfaction) to 5 (high satisfaction) for each question, with the total possible score for the 3 questions of 0 to 15. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.

    3. Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function - Overall Satisfaction (IIEF-OS) Domain Score [Baseline, 12 weeks]

      Self-reported overall satisfaction over the past 4 weeks. IIEF-OS is the sum of Questions 13 and 14; each question scored as 1 (low/no satisfaction) through 5 (high satisfaction) with total subscore for the 2 questions of 2 to 10. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.

    4. Change From Baseline to 12-Week in Percentage of "Yes" Responses to Sexual Encounter Profile (SEP) Questions 1-5 [Baseline, 12 weeks]

      Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Questions 1-5. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.

    5. Change From Baseline to 12-Week Endpoint in Treatment Satisfaction Scale (TSS) - Patient [Baseline, 12 weeks]

      The TSS measured participant satisfaction with treatment based on a 13-item questionnaire. The overall score for each of five TSS domains (confidence to complete sexual activity, ease of erection, pleasure from sexual activity, erectile function satisfaction, and satisfaction with orgasm) was converted to a 0-100 scale with higher numbers on the scale indicating greater satisfaction. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.

    6. Treatment Satisfaction Scale (TSS) - Patient Satisfaction With Medication Score at Week 12 Endpoint [Week 12]

      The TSS - patient satisfaction with medication measured participant satisfaction with treatment based on a 13-item questionnaire. The overall score was converted to a 0-100 scale with higher numbers on the scale indicating greater satisfaction. Satisfaction with medication was analyzed using analysis of covariance (ANOVA). The model included factors of study, treatment group, and pooled site within study.

    7. Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function (IIEF) Question 15 (Sexual Confidence) [Baseline, 12 weeks]

      Self-reported erectile function over the past 4 weeks. Question 15, confidence in the ability to get an erection, is scored from 1 (very low confidence) to 5 (very high confidence). Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.

    8. Change From Baseline to 12-Week Endpoint in Treatment Satisfaction Scale (TSS) - Partner [Baseline, 12 weeks]

      The TSS measured participant's partner satisfaction with treatment based on a 13-item questionnaire. The overall score for each of five TSS domains (confidence to complete sexual activity, ease of erection, pleasure from sexual activity, erectile function satisfaction, and satisfaction with orgasm) was converted to a 0-100 scale with higher numbers on the scale indicating greater satisfaction. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.

    9. Treatment Satisfaction Scale (TSS) - Partner Satisfaction With Medication Score at Week 12 Endpoint [Week 12]

      The TSS - partner satisfaction with medication measured participant's partner satisfaction with treatment based on a 13-item questionnaire. The overall score was converted to a 0-100 scale with higher numbers on the scale indicating greater satisfaction. Satisfaction with medication was analyzed using analysis of covariance (ANOVA). The model included factors of study, treatment group, and pooled site within study.

    10. Percentage of Participants Having International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score Greater Than or Equal to 26 From 12 to 16 Weeks [12 weeks through 16 weeks]

      Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Data presented are the percentage of participants who return to normal erectile function (IIEF-EF domain score ≥26) at end of open-label extension treatment period (Period IV).

    11. Change From 12 Weeks to 16 Weeks in Participant's International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score [12 weeks and 16 weeks]

      Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function.

    12. Change From Week 12 to Week 16 Percentage of "Yes" Responses to Sexual Encounter Profile (SEP) Questions 3 [12 weeks and 16 weeks]

      Assessed the percentage of Yes responses to the SEP diary Question 3 "Did your erection last long enough for you to have successful intercourse?" from Week 12 (end of double-Blind treatment) to Week 16 (end of open-label treatment).

    Eligibility Criteria

    Criteria

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

    • At least a 3-month history of erectile dysfunction (ED).

    • Are able to read, understand and provide signed informed consent.

    • Have an International Index of Erectile Function-Erectile Function (IIEF-EF) domain score that is greater than or equal to 17 and less than 26 at screening.

    • Have been taking a maximum dose of sildenafil citrate (100 milligram [mg]), vardenafil (20 mg), or tadalafil (20 mg) on as needed basis for at least one month prior to screening.

    • Anticipate having the same female sexual partner during the study who is willing to participate in the required number of sexual intercourse attempts and complete study measures during the study.

    • Agree to make at least four sexual intercourse attempts during both the 4-week as needed run-in period and the 4-week non-drug run-in period.

    • Agree not to use any other erectile dysfunction (ED) treatment, including herbal therapy during the 4-week non-drug, run-in, the double-blind treatment period, the open label period and for 96 hours after the end of the study.

    Partner Inclusion Criteria:

    • Are female and at least 18 years of age at screening.

    • Anticipate having the same male study subject as her sexual partner during the study.

    • Able to read, understand and provide signed informed consent.

    • Agree to make the required number of sexual intercourse attempts with the male sexual study partner during the study.

    • Willing to participate in recording responses to the treatment satisfaction scale.

    Exclusion Criteria:

    • Have an IIEF-EF domain score of greater than or equal to 26 at screening.

    • Prior ineffective treatment with (or nonresponder to) any PDE5 Inhibitor

    • Have previously used or are currently using any PDE5 inhibitor once daily.

    • Present with ED caused by other primary disorders or ED caused by untreated/inadequately treated endocrine disease.

    • Partner unwilling to complete all study requirements.

    • History of radical prostatectomy or other pelvic surgery or penile implant, or a clinically significant penile deformity, in the opinion of the investigator

    • Exhibit evidence of clinically significant renal insufficiency or hepatobiliary disease, or significant cardiac history as determined by the investigator

    • Currently receive treatment with nitrates, cancer chemotherapy, or antiandrogens

    • Have previously completed or withdrawn from this study or any other study investigating tadalafil for once-daily use.

    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. Huntsville Alabama United States 35801
    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. Lancaster California United States 93534
    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. Newport Beach California United States 92660
    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. San Diego California United States 92103
    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. Spring Valley California United States 91978
    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. Tarzana California United States 91356
    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. New Britain Connecticut United States 06052
    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. Aventura Florida United States 33180
    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. Fort Lauderdale Florida United States 33316
    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. Oviedo Florida United States 32765
    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. Meridian Idaho United States 83646
    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. Nampa Idaho United States 83686
    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. Lansing Kansas United States 66043
    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. Topeka Kansas United States 66606
    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. Haverhill Massachusetts United States 01830
    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. Troy Michigan United States 48085
    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. Toms River New Jersey United States 08753
    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. Garden City New York United States 11530
    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. Poughkeepsie New York United States 12601
    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. Concord North Carolina United States 28025
    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. Wilmington North Carolina United States 28401
    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. Fargo North Dakota United States 58103
    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. Lyndhurst Ohio United States 44124
    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. Bala Cynwyd Pennsylvania United States 19004
    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. Anderson South Carolina United States 29621
    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. Greer South Carolina United States 29651
    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. Mt. Pleasant South Carolina United States 29464
    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. Knoxville Tennessee United States 37920
    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. Austin Texas United States 78731
    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. San Antonio Texas United States 78258
    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. Clinton Utah United States 84015
    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. Bellevue Washington United States 98007
    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. Seattle Washington United States 98166
    34 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Spokane Washington United States 99220
    35 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Langley British Columbia Canada V3A 4H9
    36 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Victoria British Columbia Canada V8T 5G1
    37 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Burlington Ontario Canada L7N 3V2
    38 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. North York Ontario Canada M3B 3S6
    39 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Montreal Quebec Canada H2X 1N8
    40 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Saskatoon Saskatchewan Canada S7K 7H9

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT01130532
    Other Study ID Numbers:
    • 13461
    • H6D-US-LVIP
    First Posted:
    May 26, 2010
    Last Update Posted:
    Jan 4, 2013
    Last Verified:
    Dec 1, 2012
    Keywords provided by Eli Lilly and Company
    Erectile Dysfunction
    ED
    Impotence
    Additional relevant MeSH terms:
    Erectile Dysfunction
    Tadalafil

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail This study consisted of 4 periods. Period I was a 4-week, as needed, run-in period. Period II was a 4-week, non-drug, wash-out period. Period III was a 12-week (Weeks 0-12), double-blind treatment. Period IV was a 4-week (Weeks 13-16), open-label treatment extension. Only participants completing Period III were eligible to continue into Period IV.
    Arm/Group Title 2.5 mg Titrated to 5 mg Tadalafil 5 mg Tadalafil Placebo 5 mg Tadalafil Open-Label Extension
    Arm/Group Description 2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period. 5.0 mg Tadalafil for 12 weeks during double-blind treatment period. Placebo for 12 weeks during double-blind treatment period. 5 mg Tadalafil for 4 weeks during open-label treatment extension period.
    Period Title: Period III (Weeks 0-12)
    STARTED 207 207 209 0
    Received at Least 1 Dose of Study Drug 205 205 207 0
    COMPLETED 186 189 190 0
    NOT COMPLETED 21 18 19 0
    Period Title: Period III (Weeks 0-12)
    STARTED 0 0 0 562
    Received at Least 1 Dose of Study Drug 0 0 0 546
    COMPLETED 0 0 0 552
    NOT COMPLETED 0 0 0 10

    Baseline Characteristics

    Arm/Group Title 2.5 mg Titrated to 5 mg Tadalafil 5 mg Tadalafil Placebo Total
    Arm/Group Description 2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period. 5.0 mg Tadalafil for 12 weeks during double-blind treatment period. Placebo for 12 weeks during double-blind treatment period. Total of all reporting groups
    Overall Participants 207 207 209 623
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    57.3
    (10.68)
    58.1
    (10.36)
    57.6
    (10.17)
    57.6
    (10.39)
    Sex: Female, Male (Count of Participants)
    Female
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Male
    207
    100%
    207
    100%
    209
    100%
    623
    100%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    8
    3.9%
    10
    4.8%
    9
    4.3%
    27
    4.3%
    Not Hispanic or Latino
    199
    96.1%
    197
    95.2%
    200
    95.7%
    596
    95.7%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    2
    1%
    0
    0%
    2
    0.3%
    Asian
    2
    1%
    2
    1%
    4
    1.9%
    8
    1.3%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    1
    0.5%
    1
    0.2%
    Black or African American
    29
    14%
    24
    11.6%
    35
    16.7%
    88
    14.1%
    White
    173
    83.6%
    177
    85.5%
    167
    79.9%
    517
    83%
    More than one race
    3
    1.4%
    1
    0.5%
    2
    1%
    6
    1%
    Unknown or Not Reported
    0
    0%
    1
    0.5%
    0
    0%
    1
    0.2%
    Region of Enrollment (participants) [Number]
    United States
    199
    96.1%
    195
    94.2%
    191
    91.4%
    585
    93.9%
    Canada
    8
    3.9%
    11
    5.3%
    18
    8.6%
    37
    5.9%
    Puerto Rico
    0
    0%
    1
    0.5%
    0
    0%
    1
    0.2%

    Outcome Measures

    1. Primary Outcome
    Title Percentage of Participants Having an International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score Greater Than or Equal to 26 Through 12-Week Endpoint (Double-Blind Treatment Period)
    Description Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Data presented are the percentage of participants who return to normal erectile function (IIEF-EF domain score ≥26) at end of double-blind treatment period (Period III).
    Time Frame Baseline through 12 weeks

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline IIEF-EF measurement, excluding those with IIEF-EF domain score ≥26 ("normal") at baseline. Last observation carried forward (LOCF) principle was used.
    Arm/Group Title 2.5 mg Titrated to 5 mg Tadalafil (Period III) 5 mg Tadalafil (Period III) Placebo (Period III)
    Arm/Group Description 2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III). 5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III). Placebo for 12 weeks during double-blind treatment period (Period III).
    Measure Participants 194 197 199
    Number [percentage of participants]
    38.7
    18.7%
    39.6
    19.1%
    12.1
    5.8%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2.5 mg Titrated to 5 mg Tadalafil (Period III), Placebo (Period III)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Fisher Exact
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Tadalafil (Period III), Placebo (Period III)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Fisher Exact
    Comments
    2. Secondary Outcome
    Title Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score
    Description Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline IIEF-EF measurement, excluding those with IIEF-EF domain score ≥26 ("normal") at baseline. Last observation carried forward (LOCF) principle was used.
    Arm/Group Title 2.5 mg Titrated to 5 mg Tadalafil (Period III) 5 mg Tadalafil (Period III) Placebo (Period III)
    Arm/Group Description 2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III). 5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III). Placebo for 12 weeks during double-blind treatment period (Period III).
    Measure Participants 194 197 199
    Least Squares Mean (Standard Error) [units on a scale]
    7.9
    (0.49)
    8.1
    (0.49)
    1.8
    (0.49)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2.5 mg Titrated to 5 mg Tadalafil (Period III), Placebo (Period III)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 6.1
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.69
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Tadalafil (Period III), Placebo (Period III)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 6.2
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.68
    Estimation Comments
    3. Secondary Outcome
    Title Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function - Intercourse Satisfaction (IIEF-IS) Domain Score
    Description Self-reported intercourse satisfaction over the past 4 weeks. IIEF-IS is the sum of Questions 6, 7 and 8 of the IIEF. Scores range from 0 (low/no satisfaction) to 5 (high satisfaction) for each question, with the total possible score for the 3 questions of 0 to 15. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline IIEF-IS measurement, excluding those with International Index of Erectile Function - Erectile Function (IIEF-EF) domain score ≥26 ("normal") at baseline. Last observation carried forward (LOCF) principle was used.
    Arm/Group Title 2.5 mg Titrated to 5 mg Tadalafil (Period III) 5 mg Tadalafil (Period III) Placebo (Period III)
    Arm/Group Description 2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III). 5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III). Placebo for 12 weeks during double-blind treatment period (Period III).
    Measure Participants 194 197 198
    Least Squares Mean (Standard Error) [units on a scale]
    2.8
    (0.21)
    2.6
    (0.21)
    0.6
    (0.21)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2.5 mg Titrated to 5 mg Tadalafil (Period III), Placebo (Period III)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 2.1
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.29
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Tadalafil (Period III), Placebo (Period III)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 2.0
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.29
    Estimation Comments
    4. Secondary Outcome
    Title Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function - Overall Satisfaction (IIEF-OS) Domain Score
    Description Self-reported overall satisfaction over the past 4 weeks. IIEF-OS is the sum of Questions 13 and 14; each question scored as 1 (low/no satisfaction) through 5 (high satisfaction) with total subscore for the 2 questions of 2 to 10. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline IIEF-OS measurement, excluding those with International Index of Erectile Function - Erectile Function (IIEF-EF) domain score ≥26 ("normal") at baseline. Last observation carried forward (LOCF) principle was used.
    Arm/Group Title 2.5 mg Titrated to 5 mg Tadalafil (Period III) 5 mg Tadalafil (Period III) Placebo (Period III)
    Arm/Group Description 2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III). 5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III). Placebo for 12 weeks during double-blind treatment period (Period III).
    Measure Participants 194 197 199
    Least Squares Mean (Standard Error) [units on a scale]
    2.4
    (0.16)
    2.4
    (0.16)
    0.6
    (0.16)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2.5 mg Titrated to 5 mg Tadalafil (Period III), Placebo (Period III)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 1.7
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.23
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Tadalafil (Period III), Placebo (Period III)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 1.7
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.22
    Estimation Comments
    5. Secondary Outcome
    Title Change From Baseline to 12-Week in Percentage of "Yes" Responses to Sexual Encounter Profile (SEP) Questions 1-5
    Description Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Questions 1-5. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline SEP Questions assessment, excluding those with International Index of Erectile Function - Erectile Function (IIEF-EF) domain score ≥26 ("normal") at baseline. Last observation carried forward (LOCF) principle was used.
    Arm/Group Title 2.5 mg Titrated to 5 mg Tadalafil (Period III) 5 mg Tadalafil (Period III) Placebo (Period III)
    Arm/Group Description 2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III). 5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III). Placebo for 12 weeks during double-blind treatment period (Period III).
    Measure Participants 193 195 196
    Question 1: Able to Achieve Erection
    12.2
    (1.63)
    11.4
    (1.62)
    1.8
    (1.62)
    Question 2: Able to Insert
    26.2
    (2.25)
    26.1
    (2.23)
    6.9
    (2.23)
    Question 3: Successful Intercourse
    37.3
    (2.52)
    39.4
    (2.50)
    12.6
    (2.51)
    Question 4: Satisfied with Hardness
    44.2
    (2.73)
    42.8
    (2.70)
    11.5
    (2.71)
    Question 5: Overall Satisfaction with Experience
    43.6
    (2.70)
    41.2
    (2.68)
    10.6
    (2.68)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2.5 mg Titrated to 5 mg Tadalafil (Period III), Placebo (Period III)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for Question 1. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 10.4
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.28
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Tadalafil (Period III), Placebo (Period III)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for Question 1. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 9.6
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.26
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 2.5 mg Titrated to 5 mg Tadalafil (Period III), Placebo (Period III)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for Question 2. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 19.3
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.14
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection 5 mg Tadalafil (Period III), Placebo (Period III)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for Question 2. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 19.3
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.12
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection 2.5 mg Titrated to 5 mg Tadalafil (Period III), Placebo (Period III)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for Question 3. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 24.7
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.53
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection 5 mg Tadalafil (Period III), Placebo (Period III)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for Question 3. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 26.8
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.50
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection 2.5 mg Titrated to 5 mg Tadalafil (Period III), Placebo (Period III)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for Question 4. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 32.7
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.82
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection 5 mg Tadalafil (Period III), Placebo (Period III)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for Question 4. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 31.3
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.79
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection 2.5 mg Titrated to 5 mg Tadalafil (Period III), Placebo (Period III)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for Question 5. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 33.0
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.78
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection 5 mg Tadalafil (Period III), Placebo (Period III)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for Question 5. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 30.5
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.75
    Estimation Comments
    6. Secondary Outcome
    Title Change From Baseline to 12-Week Endpoint in Treatment Satisfaction Scale (TSS) - Patient
    Description The TSS measured participant satisfaction with treatment based on a 13-item questionnaire. The overall score for each of five TSS domains (confidence to complete sexual activity, ease of erection, pleasure from sexual activity, erectile function satisfaction, and satisfaction with orgasm) was converted to a 0-100 scale with higher numbers on the scale indicating greater satisfaction. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline TSS measurement, excluding those with International Index of Erectile Function - Erectile Function (IIEF-EF) domain score ≥26 ("normal") at baseline. Last observation carried forward (LOCF) principle was used.
    Arm/Group Title 2.5 mg Titrated to 5 mg Tadalafil (Period III) 5 mg Tadalafil (Period III) Placebo (Period III)
    Arm/Group Description 2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III). 5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III). Placebo for 12 weeks during double-blind treatment period (Period III).
    Measure Participants 189 189 192
    Confidence to complete sexual activity
    27.0
    (1.78)
    29.2
    (1.78)
    3.8
    (1.77)
    Ease of erection
    24.0
    (1.69)
    24.7
    (1.69)
    4.1
    (1.68)
    Pleasure from sexual activity
    22.6
    (1.58)
    22.7
    (1.58)
    3.3
    (1.57)
    Erectile function satisfaction
    31.0
    (1.82)
    33.6
    (1.81)
    4.9
    (1.81)
    Satisfaction with orgasm
    25.6
    (1.90)
    26.3
    (1.89)
    6.2
    (1.88)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2.5 mg Titrated to 5 mg Tadalafil (Period III), Placebo (Period III)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for confidence to complete sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 23.1
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.49
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Tadalafil (Period III), Placebo (Period III)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for confidence to complete sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 25.4
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.48
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 2.5 mg Titrated to 5 mg Tadalafil (Period III), Placebo (Period III)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for ease of erection. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 19.9
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.36
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection 5 mg Tadalafil (Period III), Placebo (Period III)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for ease of erection. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 20.6
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.35
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection 2.5 mg Titrated to 5 mg Tadalafil (Period III), Placebo (Period III)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for pleasure from sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 19.3
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.21
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection 5 mg Tadalafil (Period III), Placebo (Period III)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for pleasure from sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 19.5
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.20
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection 2.5 mg Titrated to 5 mg Tadalafil (Period III), Placebo (Period III)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for erectile function satisfaction. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 26.0
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.54
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection 5 mg Tadalafil (Period III), Placebo (Period III)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for erectile function satisfaction. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 28.7
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.53
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection 2.5 mg Titrated to 5 mg Tadalafil (Period III), Placebo (Period III)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for satisfaction with orgasm. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 19.3
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.65
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection 5 mg Tadalafil (Period III), Placebo (Period III)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for satisfaction with orgasm. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 20.1
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.64
    Estimation Comments
    7. Secondary Outcome
    Title Treatment Satisfaction Scale (TSS) - Patient Satisfaction With Medication Score at Week 12 Endpoint
    Description The TSS - patient satisfaction with medication measured participant satisfaction with treatment based on a 13-item questionnaire. The overall score was converted to a 0-100 scale with higher numbers on the scale indicating greater satisfaction. Satisfaction with medication was analyzed using analysis of covariance (ANOVA). The model included factors of study, treatment group, and pooled site within study.
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline participant's satisfaction with medication measurement, excluding those with IIEF-EF domain score ≥26 ("normal") at baseline. Last observation carried forward (LOCF) principle was used.
    Arm/Group Title 2.5 mg Titrated to 5 mg Tadalafil (Period III) 5 mg Tadalafil (Period III) Placebo (Period III)
    Arm/Group Description 2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III). 5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III). Placebo for 12 weeks during double-blind treatment period (Period III).
    Measure Participants 189 189 192
    Least Squares Mean (Standard Error) [units on a scale]
    53.7
    (1.98)
    55.9
    (1.98)
    24.8
    (1.97)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2.5 mg Titrated to 5 mg Tadalafil (Period III), Placebo (Period III)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 28.9
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.77
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Tadalafil (Period III), Placebo (Period III)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 31.0
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.76
    Estimation Comments
    8. Secondary Outcome
    Title Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function (IIEF) Question 15 (Sexual Confidence)
    Description Self-reported erectile function over the past 4 weeks. Question 15, confidence in the ability to get an erection, is scored from 1 (very low confidence) to 5 (very high confidence). Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline IIEF question 15 (Sexual Confidence) assessment, excluding those with IIEF-EF domain score ≥26 ("normal") at baseline. Last observation carried forward (LOCF) principle was used.
    Arm/Group Title 2.5 mg Titrated to 5 mg Tadalafil (Period III) 5 mg Tadalafil (Period III) Placebo (Period III)
    Arm/Group Description 2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III). 5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III). Placebo for 12 weeks during double-blind treatment period (Period III).
    Measure Participants 194 197 199
    Least Squares Mean (Standard Error) [units on a scale]
    1.2
    (0.08)
    1.3
    (0.08)
    0.3
    (0.08)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2.5 mg Titrated to 5 mg Tadalafil (Period III), Placebo (Period III)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.9
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.11
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Tadalafil (Period III), Placebo (Period III)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 1.0
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.11
    Estimation Comments
    9. Secondary Outcome
    Title Change From Baseline to 12-Week Endpoint in Treatment Satisfaction Scale (TSS) - Partner
    Description The TSS measured participant's partner satisfaction with treatment based on a 13-item questionnaire. The overall score for each of five TSS domains (confidence to complete sexual activity, ease of erection, pleasure from sexual activity, erectile function satisfaction, and satisfaction with orgasm) was converted to a 0-100 scale with higher numbers on the scale indicating greater satisfaction. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline partner's TSS measurement, excluding those with IIEF-EF domain score ≥26 ("normal") at baseline. Last observation carried forward (LOCF) principle was used.
    Arm/Group Title 2.5 mg Titrated to 5 mg Tadalafil (Period III) 5 mg Tadalafil (Period III) Placebo (Period III)
    Arm/Group Description 2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III). 5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III). Placebo for 12 weeks during double-blind treatment period (Period III).
    Measure Participants 184 186 187
    Confidence to complete sexual activity
    23.7
    (2.01)
    27.2
    (1.99)
    2.0
    (1.99)
    Ease of erection
    23.1
    (1.76)
    25.3
    (1.75)
    0.7
    (1.75)
    Pleasure from sexual activity
    18.2
    (1.69)
    18.5
    (1.68)
    1.3
    (1.68)
    Erectile function satisfaction
    28.6
    (1.84)
    28.5
    (1.83)
    3.4
    (1.83)
    Satisfaction with orgasm
    18.7
    (2.06)
    21.0
    (2.05)
    3.6
    (2.04)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2.5 mg Titrated to 5 mg Tadalafil (Period III), Placebo (Period III)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for confidence to complete sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 21.7
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.81
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Tadalafil (Period III), Placebo (Period III)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for confidence to complete sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 25.2
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.78
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 2.5 mg Titrated to 5 mg Tadalafil (Period III), Placebo (Period III)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for ease of erection. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 22.3
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.46
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection 5 mg Tadalafil (Period III), Placebo (Period III)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for ease of erection. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 24.5
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.44
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection 2.5 mg Titrated to 5 mg Tadalafil (Period III), Placebo (Period III)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for pleasure from sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 16.9
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.37
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection 5 mg Tadalafil (Period III), Placebo (Period III)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for pleasure from sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 17.2
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.35
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection 2.5 mg Titrated to 5 mg Tadalafil (Period III), Placebo (Period III)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for erectile function satisfaction. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 25.2
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.57
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection 5 mg Tadalafil (Period III), Placebo (Period III)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for erectile function satisfaction. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 25.1
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.56
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection 2.5 mg Titrated to 5 mg Tadalafil (Period III), Placebo (Period III)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for satisfaction with orgasm. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 15.1
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.88
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection 5 mg Tadalafil (Period III), Placebo (Period III)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for satisfaction with orgasm. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 17.3
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.86
    Estimation Comments
    10. Secondary Outcome
    Title Treatment Satisfaction Scale (TSS) - Partner Satisfaction With Medication Score at Week 12 Endpoint
    Description The TSS - partner satisfaction with medication measured participant's partner satisfaction with treatment based on a 13-item questionnaire. The overall score was converted to a 0-100 scale with higher numbers on the scale indicating greater satisfaction. Satisfaction with medication was analyzed using analysis of covariance (ANOVA). The model included factors of study, treatment group, and pooled site within study.
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline partner's satisfaction with medication measurement, excluding those with IIEF-EF domain score ≥26 ("normal") at baseline. Last observation carried forward (LOCF) principle was used.
    Arm/Group Title 2.5 mg Titrated to 5 mg Tadalafil (Period III) 5 mg Tadalafil (Period III) Placebo (Period III)
    Arm/Group Description 2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III). 5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III). Placebo for 12 weeks during double-blind treatment period (Period III).
    Measure Participants 184 186 187
    Least Squares Mean (Standard Error) [units on a scale]
    52.5
    (1.97)
    55.7
    (1.96)
    27.5
    (1.96)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2.5 mg Titrated to 5 mg Tadalafil (Period III), Placebo (Period III)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 25.1
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.76
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Tadalafil (Period III), Placebo (Period III)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 28.2
    Confidence Interval () 95%
    to
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.74
    Estimation Comments
    11. Secondary Outcome
    Title Percentage of Participants Having International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score Greater Than or Equal to 26 From 12 to 16 Weeks
    Description Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Data presented are the percentage of participants who return to normal erectile function (IIEF-EF domain score ≥26) at end of open-label extension treatment period (Period IV).
    Time Frame 12 weeks through 16 weeks

    Outcome Measure Data

    Analysis Population Description
    All participants who were entered the open-label treatment, received at least 1 dose of study drug during open-label treatment, had Week 12 and at least 1 IIEF-EF measurement during open-label treatment, excluding those with IIEF-EF domain score ≥26 ("normal") at baseline. Last observation carried forward (LOCF) principle was used.
    Arm/Group Title 2.5 mg Titrated to 5 mg Tadalafil (Period IV) 5 mg Tadalafil (Period IV) Placebo (Period IV)
    Arm/Group Description 5.0 milligram (mg) Tadalafil for 4 weeks during open-label extension treatment period (Period IV). 5.0 mg Tadalafil for 4 weeks during open-label extension treatment period (Period IV). 5.0 mg Tadalafil for 4 weeks during open-label extension treatment period (Period IV).
    Measure Participants 178 179 183
    Number [percentage of participants]
    54.5
    26.3%
    59.8
    28.9%
    62.8
    30%
    12. Secondary Outcome
    Title Change From 12 Weeks to 16 Weeks in Participant's International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score
    Description Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function.
    Time Frame 12 weeks and 16 weeks

    Outcome Measure Data

    Analysis Population Description
    All participants who were entered the open-label treatment, received at least 1 dose of study drug during open-label treatment, had Week 12 and at least 1 IIEF-EF measurement during open-label treatment, excluding those with IIEF-EF domain score ≥26 ("normal") at baseline. Last observation carried forward (LOCF) principle was used.
    Arm/Group Title 2.5 mg Titrated to 5 mg Tadalafil (Period IV) 5 mg Tadalafil (Period IV) Placebo (Period IV)
    Arm/Group Description 5.0 milligram (mg) Tadalafil for 4 weeks during open-label extension treatment period (Period IV). 5.0 mg Tadalafil for 4 weeks during open-label extension treatment period (Period IV). 5.0 mg Tadalafil for 4 weeks during open-label extension treatment period (Period IV).
    Measure Participants 178 179 183
    End of Week 12
    22.4
    (6.71)
    22.5
    (7.07)
    16.0
    (7.39)
    End of Week 16
    24.1
    (6.44)
    24.2
    (6.46)
    24.4
    (6.73)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2.5 mg Titrated to 5 mg Tadalafil (Period III)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Comparison of Week 16 to Week 12. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
    Method Paired t-test
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Tadalafil (Period III)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Comparison of Week 16 to Week 12. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
    Method Paired t-test
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo (Period III)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Comparison of Week 16 to Week 12. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
    Method Paired t-test
    Comments
    13. Secondary Outcome
    Title Change From Week 12 to Week 16 Percentage of "Yes" Responses to Sexual Encounter Profile (SEP) Questions 3
    Description Assessed the percentage of Yes responses to the SEP diary Question 3 "Did your erection last long enough for you to have successful intercourse?" from Week 12 (end of double-Blind treatment) to Week 16 (end of open-label treatment).
    Time Frame 12 weeks and 16 weeks

    Outcome Measure Data

    Analysis Population Description
    All participants who were entered the open-label treatment, received at least 1 dose of study drug during open-label treatment, had Week 12 and at least 1 SEP diary Question 3 measurement during open-label treatment, excluding those with IIEF-EF domain score ≥26 ("normal") at baseline. Last observation carried forward (LOCF) principle was used.
    Arm/Group Title 2.5 mg Titrated to 5 mg Tadalafil (Period IV) 5 mg Tadalafil (Period IV) Placebo (Period IV)
    Arm/Group Description 5.0 milligram (mg) Tadalafil for 4 weeks during open-label extension treatment period (Period IV). 5.0 mg Tadalafil for 4 weeks during open-label extension treatment period (Period IV). 5.0 mg Tadalafil for 4 weeks during open-label extension treatment period (Period IV).
    Measure Participants 176 177 181
    End of Week 12
    68.3
    (38.25)
    69.0
    (37.88)
    43.1
    (39.03)
    End of Week 16
    75.0
    (34.49)
    75.5
    (34.89)
    80.0
    (34.37)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 2.5 mg Titrated to 5 mg Tadalafil (Period III)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.002
    Comments Comparison of Week 16 to Week 12. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
    Method Paired t-test
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 5 mg Tadalafil (Period III)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.004
    Comments Comparison of Week 16 to Week 12. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
    Method Paired t-test
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo (Period III)
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Comparison of Week 16 to Week 12. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.
    Method Paired t-test
    Comments

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title 2.5 mg Titrated to 5 mg Tadalafil 5 mg Tadalafil Placebo 5 mg Tadalafil Open-Label Extension
    Arm/Group Description 2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period. 5.0 mg Tadalafil for 12 weeks during double-blind treatment period. Placebo for 12 weeks during double-blind treatment period. 5 mg Tadalafil for 4 weeks during open-label treatment extension period.
    All Cause Mortality
    2.5 mg Titrated to 5 mg Tadalafil 5 mg Tadalafil Placebo 5 mg Tadalafil Open-Label Extension
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    2.5 mg Titrated to 5 mg Tadalafil 5 mg Tadalafil Placebo 5 mg Tadalafil Open-Label Extension
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/205 (0.5%) 1/205 (0.5%) 1/207 (0.5%) 3/546 (0.5%)
    Gastrointestinal disorders
    Small intestinal obstruction 0/205 (0%) 0 1/205 (0.5%) 1 0/207 (0%) 0 0/546 (0%) 0
    General disorders
    Chest discomfort 1/205 (0.5%) 1 0/205 (0%) 0 0/207 (0%) 0 0/546 (0%) 0
    Hepatobiliary disorders
    Cholecystitis acute 0/205 (0%) 0 0/205 (0%) 0 0/207 (0%) 0 1/546 (0.2%) 1
    Infections and infestations
    Meningitis viral 0/205 (0%) 0 0/205 (0%) 0 0/207 (0%) 0 1/546 (0.2%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Prostate cancer 0/205 (0%) 0 0/205 (0%) 0 1/207 (0.5%) 1 0/546 (0%) 0
    Nervous system disorders
    Syncope 0/205 (0%) 0 0/205 (0%) 0 0/207 (0%) 0 1/546 (0.2%) 1
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea exertional 1/205 (0.5%) 1 0/205 (0%) 0 0/207 (0%) 0 0/546 (0%) 0
    Other (Not Including Serious) Adverse Events
    2.5 mg Titrated to 5 mg Tadalafil 5 mg Tadalafil Placebo 5 mg Tadalafil Open-Label Extension
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 46/205 (22.4%) 68/205 (33.2%) 50/207 (24.2%) 23/546 (4.2%)
    Blood and lymphatic system disorders
    Anaemia 0/205 (0%) 0 1/205 (0.5%) 1 0/207 (0%) 0 1/546 (0.2%) 1
    Cardiac disorders
    Palpitations 0/205 (0%) 0 1/205 (0.5%) 1 0/207 (0%) 0 0/546 (0%) 0
    Supraventricular tachycardia 0/205 (0%) 0 0/205 (0%) 0 0/207 (0%) 0 1/546 (0.2%) 1
    Tachycardia 0/205 (0%) 0 0/205 (0%) 0 0/207 (0%) 0 1/546 (0.2%) 1
    Ear and labyrinth disorders
    Hearing impaired 1/205 (0.5%) 1 0/205 (0%) 0 0/207 (0%) 0 0/546 (0%) 0
    Motion sickness 1/205 (0.5%) 1 0/205 (0%) 0 0/207 (0%) 0 0/546 (0%) 0
    Vertigo 1/205 (0.5%) 1 0/205 (0%) 0 0/207 (0%) 0 0/546 (0%) 0
    Vertigo positional 1/205 (0.5%) 1 0/205 (0%) 0 0/207 (0%) 0 0/546 (0%) 0
    Eye disorders
    Cataract 0/205 (0%) 0 1/205 (0.5%) 1 0/207 (0%) 0 0/546 (0%) 0
    Ocular hyperaemia 0/205 (0%) 0 1/205 (0.5%) 1 0/207 (0%) 0 0/546 (0%) 0
    Vision blurred 0/205 (0%) 0 1/205 (0.5%) 1 0/207 (0%) 0 1/546 (0.2%) 1
    Vitreous floaters 0/205 (0%) 0 0/205 (0%) 0 0/207 (0%) 0 1/546 (0.2%) 1
    Gastrointestinal disorders
    Abdominal discomfort 0/205 (0%) 0 0/205 (0%) 0 0/207 (0%) 0 1/546 (0.2%) 1
    Abdominal hernia 1/205 (0.5%) 1 0/205 (0%) 0 0/207 (0%) 0 0/546 (0%) 0
    Abdominal pain lower 0/205 (0%) 0 0/205 (0%) 0 1/207 (0.5%) 1 0/546 (0%) 0
    Abdominal pain upper 0/205 (0%) 0 1/205 (0.5%) 1 0/207 (0%) 0 0/546 (0%) 0
    Dental caries 0/205 (0%) 0 0/205 (0%) 0 1/207 (0.5%) 1 0/546 (0%) 0
    Diarrhoea 2/205 (1%) 2 3/205 (1.5%) 3 3/207 (1.4%) 3 0/546 (0%) 0
    Dry mouth 0/205 (0%) 0 1/205 (0.5%) 1 0/207 (0%) 0 0/546 (0%) 0
    Dyspepsia 2/205 (1%) 2 6/205 (2.9%) 6 1/207 (0.5%) 1 0/546 (0%) 0
    Gastrooesophageal reflux disease 0/205 (0%) 0 2/205 (1%) 2 0/207 (0%) 0 0/546 (0%) 0
    Haematochezia 0/205 (0%) 0 0/205 (0%) 0 1/207 (0.5%) 1 0/546 (0%) 0
    Nausea 0/205 (0%) 0 1/205 (0.5%) 1 2/207 (1%) 2 0/546 (0%) 0
    Oesophageal ulcer 0/205 (0%) 0 1/205 (0.5%) 1 0/207 (0%) 0 0/546 (0%) 0
    Retching 0/205 (0%) 0 1/205 (0.5%) 1 0/207 (0%) 0 0/546 (0%) 0
    Toothache 0/205 (0%) 0 1/205 (0.5%) 1 0/207 (0%) 0 0/546 (0%) 0
    General disorders
    Chest pain 0/205 (0%) 0 0/205 (0%) 0 1/207 (0.5%) 1 0/546 (0%) 0
    Fatigue 0/205 (0%) 0 0/205 (0%) 0 1/207 (0.5%) 1 0/546 (0%) 0
    Hernia 0/205 (0%) 0 1/205 (0.5%) 1 0/207 (0%) 0 0/546 (0%) 0
    Impaired healing 0/205 (0%) 0 0/205 (0%) 0 0/207 (0%) 0 1/546 (0.2%) 1
    Influenza like illness 0/205 (0%) 0 0/205 (0%) 0 0/207 (0%) 0 1/546 (0.2%) 1
    Irritability 0/205 (0%) 0 1/205 (0.5%) 1 0/207 (0%) 0 0/546 (0%) 0
    Non-cardiac chest pain 0/205 (0%) 0 1/205 (0.5%) 1 0/207 (0%) 0 0/546 (0%) 0
    Oedema peripheral 2/205 (1%) 2 1/205 (0.5%) 1 0/207 (0%) 0 0/546 (0%) 0
    Pyrexia 0/205 (0%) 0 0/205 (0%) 0 1/207 (0.5%) 1 0/546 (0%) 0
    Suprapubic pain 0/205 (0%) 0 1/205 (0.5%) 1 0/207 (0%) 0 0/546 (0%) 0
    Immune system disorders
    Seasonal allergy 0/205 (0%) 0 1/205 (0.5%) 1 0/207 (0%) 0 0/546 (0%) 0
    Infections and infestations
    Abdominal abscess 0/205 (0%) 0 1/205 (0.5%) 1 0/207 (0%) 0 0/546 (0%) 0
    Acute tonsillitis 0/205 (0%) 0 1/205 (0.5%) 1 0/207 (0%) 0 0/546 (0%) 0
    Bronchitis 3/205 (1.5%) 3 2/205 (1%) 2 0/207 (0%) 0 0/546 (0%) 0
    Cellulitis 0/205 (0%) 0 1/205 (0.5%) 1 0/207 (0%) 0 0/546 (0%) 0
    Device related infection 0/205 (0%) 0 1/205 (0.5%) 1 0/207 (0%) 0 0/546 (0%) 0
    Furuncle 0/205 (0%) 0 0/205 (0%) 0 0/207 (0%) 0 1/546 (0.2%) 1
    Gastroenteritis 0/205 (0%) 0 1/205 (0.5%) 1 1/207 (0.5%) 1 0/546 (0%) 0
    Gastroenteritis viral 1/205 (0.5%) 1 0/205 (0%) 0 1/207 (0.5%) 1 0/546 (0%) 0
    Infected bites 0/205 (0%) 0 0/205 (0%) 0 1/207 (0.5%) 1 0/546 (0%) 0
    Influenza 0/205 (0%) 0 0/205 (0%) 0 0/207 (0%) 0 1/546 (0.2%) 1
    Laryngitis 1/205 (0.5%) 1 0/205 (0%) 0 1/207 (0.5%) 1 0/546 (0%) 0
    Nasopharyngitis 2/205 (1%) 2 3/205 (1.5%) 3 1/207 (0.5%) 1 0/546 (0%) 0
    Otitis externa 0/205 (0%) 0 1/205 (0.5%) 1 0/207 (0%) 0 0/546 (0%) 0
    Otitis media 0/205 (0%) 0 0/205 (0%) 0 1/207 (0.5%) 1 0/546 (0%) 0
    Perirectal abscess 0/205 (0%) 0 1/205 (0.5%) 1 0/207 (0%) 0 0/546 (0%) 0
    Pharyngitis streptococcal 0/205 (0%) 0 1/205 (0.5%) 1 0/207 (0%) 0 0/546 (0%) 0
    Pneumonia 0/205 (0%) 0 0/205 (0%) 0 1/207 (0.5%) 1 0/546 (0%) 0
    Pneumonia bacterial 0/205 (0%) 0 0/205 (0%) 0 1/207 (0.5%) 1 0/546 (0%) 0
    Pneumonia primary atypical 0/205 (0%) 0 0/205 (0%) 0 1/207 (0.5%) 1 0/546 (0%) 0
    Prostate infection 1/205 (0.5%) 1 0/205 (0%) 0 0/207 (0%) 0 0/546 (0%) 0
    Sinusitis 1/205 (0.5%) 1 3/205 (1.5%) 3 1/207 (0.5%) 1 2/546 (0.4%) 2
    Tonsillitis 0/205 (0%) 0 1/205 (0.5%) 1 0/207 (0%) 0 0/546 (0%) 0
    Tooth abscess 0/205 (0%) 0 0/205 (0%) 0 1/207 (0.5%) 1 0/546 (0%) 0
    Upper respiratory tract infection 3/205 (1.5%) 3 2/205 (1%) 2 3/207 (1.4%) 3 0/546 (0%) 0
    Viral infection 0/205 (0%) 0 0/205 (0%) 0 1/207 (0.5%) 1 0/546 (0%) 0
    Wound infection 0/205 (0%) 0 1/205 (0.5%) 1 0/207 (0%) 0 0/546 (0%) 0
    Injury, poisoning and procedural complications
    Arthropod bite 1/205 (0.5%) 1 1/205 (0.5%) 1 0/207 (0%) 0 0/546 (0%) 0
    Arthropod sting 0/205 (0%) 0 0/205 (0%) 0 1/207 (0.5%) 1 0/546 (0%) 0
    Contusion 0/205 (0%) 0 2/205 (1%) 2 0/207 (0%) 0 0/546 (0%) 0
    Craniocerebral injury 0/205 (0%) 0 0/205 (0%) 0 1/207 (0.5%) 1 0/546 (0%) 0
    Excoriation 0/205 (0%) 0 1/205 (0.5%) 1 0/207 (0%) 0 0/546 (0%) 0
    Exposure via father 1/205 (0.5%) 1 0/205 (0%) 0 0/207 (0%) 0 0/546 (0%) 0
    Foot fracture 0/205 (0%) 0 2/205 (1%) 2 0/207 (0%) 0 0/546 (0%) 0
    Laceration 0/205 (0%) 0 1/205 (0.5%) 1 1/207 (0.5%) 1 0/546 (0%) 0
    Ligament sprain 1/205 (0.5%) 1 0/205 (0%) 0 0/207 (0%) 0 0/546 (0%) 0
    Limb injury 0/205 (0%) 0 1/205 (0.5%) 1 0/207 (0%) 0 0/546 (0%) 0
    Muscle strain 0/205 (0%) 0 0/205 (0%) 0 2/207 (1%) 2 0/546 (0%) 0
    Overdose 1/205 (0.5%) 1 0/205 (0%) 0 0/207 (0%) 0 1/546 (0.2%) 1
    Procedural pain 0/205 (0%) 0 0/205 (0%) 0 1/207 (0.5%) 1 0/546 (0%) 0
    Rib fracture 0/205 (0%) 0 1/205 (0.5%) 1 0/207 (0%) 0 0/546 (0%) 0
    Investigations
    Cytology abnormal 1/205 (0.5%) 1 0/205 (0%) 0 0/207 (0%) 0 0/546 (0%) 0
    Heart rate increased 0/205 (0%) 0 1/205 (0.5%) 1 0/207 (0%) 0 0/546 (0%) 0
    Prostatic specific antigen increased 0/205 (0%) 0 1/205 (0.5%) 1 0/207 (0%) 0 0/546 (0%) 0
    Weight increased 0/205 (0%) 0 1/205 (0.5%) 1 0/207 (0%) 0 0/546 (0%) 0
    Metabolism and nutrition disorders
    Gout 0/205 (0%) 0 1/205 (0.5%) 1 0/207 (0%) 0 0/546 (0%) 0
    Hypercholesterolaemia 0/205 (0%) 0 0/205 (0%) 0 1/207 (0.5%) 1 0/546 (0%) 0
    Hyperkalaemia 0/205 (0%) 0 1/205 (0.5%) 1 0/207 (0%) 0 0/546 (0%) 0
    Hypokalaemia 1/205 (0.5%) 1 0/205 (0%) 0 0/207 (0%) 0 0/546 (0%) 0
    Musculoskeletal and connective tissue disorders
    Arthralgia 0/205 (0%) 0 0/205 (0%) 0 3/207 (1.4%) 3 0/546 (0%) 0
    Back pain 3/205 (1.5%) 3 6/205 (2.9%) 6 1/207 (0.5%) 1 2/546 (0.4%) 2
    Exostosis 1/205 (0.5%) 1 0/205 (0%) 0 0/207 (0%) 0 0/546 (0%) 0
    Groin pain 0/205 (0%) 0 1/205 (0.5%) 1 0/207 (0%) 0 0/546 (0%) 0
    Joint hyperextension 1/205 (0.5%) 1 0/205 (0%) 0 0/207 (0%) 0 0/546 (0%) 0
    Metatarsalgia 0/205 (0%) 0 0/205 (0%) 0 1/207 (0.5%) 1 0/546 (0%) 0
    Muscle spasms 1/205 (0.5%) 1 0/205 (0%) 0 0/207 (0%) 0 0/546 (0%) 0
    Musculoskeletal chest pain 0/205 (0%) 0 1/205 (0.5%) 1 0/207 (0%) 0 0/546 (0%) 0
    Musculoskeletal discomfort 0/205 (0%) 0 2/205 (1%) 2 0/207 (0%) 0 0/546 (0%) 0
    Myalgia 1/205 (0.5%) 1 1/205 (0.5%) 1 1/207 (0.5%) 1 1/546 (0.2%) 1
    Pain in extremity 1/205 (0.5%) 1 3/205 (1.5%) 3 0/207 (0%) 0 0/546 (0%) 0
    Spinal osteoarthritis 0/205 (0%) 0 0/205 (0%) 0 1/207 (0.5%) 1 0/546 (0%) 0
    Tendonitis 0/205 (0%) 0 2/205 (1%) 2 1/207 (0.5%) 1 0/546 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Prostate cancer 0/205 (0%) 0 1/205 (0.5%) 1 0/207 (0%) 0 0/546 (0%) 0
    Skin papilloma 0/205 (0%) 0 1/205 (0.5%) 3 0/207 (0%) 0 0/546 (0%) 0
    Squamous cell carcinoma of skin 1/205 (0.5%) 1 0/205 (0%) 0 0/207 (0%) 0 0/546 (0%) 0
    Nervous system disorders
    Balance disorder 0/205 (0%) 0 0/205 (0%) 0 1/207 (0.5%) 1 0/546 (0%) 0
    Dizziness 1/205 (0.5%) 1 3/205 (1.5%) 3 1/207 (0.5%) 1 1/546 (0.2%) 2
    Headache 4/205 (2%) 4 9/205 (4.4%) 9 7/207 (3.4%) 8 4/546 (0.7%) 4
    Nerve compression 1/205 (0.5%) 1 0/205 (0%) 0 0/207 (0%) 0 0/546 (0%) 0
    Paraesthesia 0/205 (0%) 0 0/205 (0%) 0 1/207 (0.5%) 1 0/546 (0%) 0
    Radiculopathy 0/205 (0%) 0 1/205 (0.5%) 1 0/207 (0%) 0 0/546 (0%) 0
    Restless legs syndrome 0/205 (0%) 0 1/205 (0.5%) 1 0/207 (0%) 0 0/546 (0%) 0
    Sciatica 0/205 (0%) 0 0/205 (0%) 0 0/207 (0%) 0 1/546 (0.2%) 1
    Sensory disturbance 0/205 (0%) 0 0/205 (0%) 0 0/207 (0%) 0 1/546 (0.2%) 1
    Sinus headache 0/205 (0%) 0 1/205 (0.5%) 1 0/207 (0%) 0 0/546 (0%) 0
    Syncope 1/205 (0.5%) 1 0/205 (0%) 0 0/207 (0%) 0 0/546 (0%) 0
    Psychiatric disorders
    Abnormal dreams 0/205 (0%) 0 1/205 (0.5%) 1 0/207 (0%) 0 0/546 (0%) 0
    Anxiety 0/205 (0%) 0 0/205 (0%) 0 2/207 (1%) 2 0/546 (0%) 0
    Depression 1/205 (0.5%) 1 0/205 (0%) 0 0/207 (0%) 0 0/546 (0%) 0
    Insomnia 0/205 (0%) 0 0/205 (0%) 0 0/207 (0%) 0 1/546 (0.2%) 1
    Libido decreased 0/205 (0%) 0 0/205 (0%) 0 2/207 (1%) 2 0/546 (0%) 0
    Nightmare 0/205 (0%) 0 0/205 (0%) 0 1/207 (0.5%) 1 0/546 (0%) 0
    Renal and urinary disorders
    Chromaturia 0/205 (0%) 0 1/205 (0.5%) 1 0/207 (0%) 0 0/546 (0%) 0
    Dysuria 1/205 (0.5%) 1 1/205 (0.5%) 1 0/207 (0%) 0 0/546 (0%) 0
    Haematuria 1/205 (0.5%) 1 0/205 (0%) 0 0/207 (0%) 0 0/546 (0%) 0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia 0/205 (0%) 0 1/205 (0.5%) 1 1/207 (0.5%) 1 0/546 (0%) 0
    Genital rash 0/205 (0%) 0 0/205 (0%) 0 1/207 (0.5%) 1 0/546 (0%) 0
    Nipple pain 1/205 (0.5%) 1 0/205 (0%) 0 0/207 (0%) 0 0/546 (0%) 0
    Organic erectile dysfunction 0/205 (0%) 0 0/205 (0%) 0 1/207 (0.5%) 1 0/546 (0%) 0
    Paraesthesia of genital male 1/205 (0.5%) 1 0/205 (0%) 0 0/207 (0%) 0 0/546 (0%) 0
    Penile discharge 0/205 (0%) 0 0/205 (0%) 0 1/207 (0.5%) 1 0/546 (0%) 0
    Spermatocele 0/205 (0%) 0 1/205 (0.5%) 1 0/207 (0%) 0 0/546 (0%) 0
    Testicular pain 0/205 (0%) 0 1/205 (0.5%) 1 0/207 (0%) 0 0/546 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Asthma 1/205 (0.5%) 1 0/205 (0%) 0 0/207 (0%) 0 0/546 (0%) 0
    Chronic obstructive pulmonary disease 0/205 (0%) 0 0/205 (0%) 0 1/207 (0.5%) 1 0/546 (0%) 0
    Cough 2/205 (1%) 2 0/205 (0%) 0 1/207 (0.5%) 1 0/546 (0%) 0
    Dyspnoea 0/205 (0%) 0 1/205 (0.5%) 1 0/207 (0%) 0 0/546 (0%) 0
    Epistaxis 1/205 (0.5%) 1 0/205 (0%) 0 0/207 (0%) 0 0/546 (0%) 0
    Nasal congestion 2/205 (1%) 2 0/205 (0%) 0 3/207 (1.4%) 3 0/546 (0%) 0
    Oropharyngeal pain 1/205 (0.5%) 1 0/205 (0%) 0 0/207 (0%) 0 0/546 (0%) 0
    Pharyngeal inflammation 0/205 (0%) 0 0/205 (0%) 0 1/207 (0.5%) 1 0/546 (0%) 0
    Respiratory tract congestion 0/205 (0%) 0 0/205 (0%) 0 1/207 (0.5%) 1 0/546 (0%) 0
    Sinus congestion 1/205 (0.5%) 1 1/205 (0.5%) 1 1/207 (0.5%) 1 1/546 (0.2%) 1
    Upper-airway cough syndrome 0/205 (0%) 0 1/205 (0.5%) 1 0/207 (0%) 0 0/546 (0%) 0
    Skin and subcutaneous tissue disorders
    Dermatitis 0/205 (0%) 0 0/205 (0%) 0 0/207 (0%) 0 1/546 (0.2%) 1
    Dermatitis allergic 0/205 (0%) 0 1/205 (0.5%) 1 0/207 (0%) 0 0/546 (0%) 0
    Eczema 1/205 (0.5%) 1 0/205 (0%) 0 0/207 (0%) 0 0/546 (0%) 0
    Hyperhidrosis 0/205 (0%) 0 1/205 (0.5%) 1 0/207 (0%) 0 0/546 (0%) 0
    Night sweats 0/205 (0%) 0 0/205 (0%) 0 1/207 (0.5%) 1 0/546 (0%) 0
    Pruritus 0/205 (0%) 0 1/205 (0.5%) 1 0/207 (0%) 0 0/546 (0%) 0
    Psoriasis 0/205 (0%) 0 0/205 (0%) 0 1/207 (0.5%) 1 0/546 (0%) 0
    Rash 0/205 (0%) 0 0/205 (0%) 0 0/207 (0%) 0 1/546 (0.2%) 1
    Rosacea 0/205 (0%) 0 0/205 (0%) 0 0/207 (0%) 0 1/546 (0.2%) 1
    Surgical and medical procedures
    Anal polypectomy 0/205 (0%) 0 0/205 (0%) 0 1/207 (0.5%) 1 0/546 (0%) 0
    Blepharoplasty 1/205 (0.5%) 1 0/205 (0%) 0 0/207 (0%) 0 0/546 (0%) 0
    Cataract operation 0/205 (0%) 0 0/205 (0%) 0 1/207 (0.5%) 2 0/546 (0%) 0
    Dental care 0/205 (0%) 0 0/205 (0%) 0 0/207 (0%) 0 1/546 (0.2%) 1
    Endodontic procedure 0/205 (0%) 0 1/205 (0.5%) 1 0/207 (0%) 0 0/546 (0%) 0
    Knee operation 1/205 (0.5%) 1 0/205 (0%) 0 0/207 (0%) 0 0/546 (0%) 0
    Medical device removal 0/205 (0%) 0 1/205 (0.5%) 1 0/207 (0%) 0 0/546 (0%) 0
    Tooth extraction 1/205 (0.5%) 1 0/205 (0%) 0 0/207 (0%) 0 0/546 (0%) 0
    Tooth repair 0/205 (0%) 0 0/205 (0%) 0 1/207 (0.5%) 1 0/546 (0%) 0
    Umbilical hernia repair 0/205 (0%) 0 0/205 (0%) 0 1/207 (0.5%) 1 0/546 (0%) 0
    Vasectomy 1/205 (0.5%) 1 0/205 (0%) 0 0/207 (0%) 0 0/546 (0%) 0
    Vascular disorders
    Flushing 1/205 (0.5%) 1 3/205 (1.5%) 3 0/207 (0%) 0 0/546 (0%) 0
    Hypertension 2/205 (1%) 2 2/205 (1%) 2 3/207 (1.4%) 3 1/546 (0.2%) 1
    Hypotension 0/205 (0%) 0 1/205 (0.5%) 1 1/207 (0.5%) 1 0/546 (0%) 0
    Orthostatic hypertension 0/205 (0%) 0 0/205 (0%) 0 1/207 (0.5%) 1 0/546 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

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

    Results Point of Contact

    Name/Title Chief Medical Officer
    Organization Eli Lilly and Company
    Phone 800-545-5979
    Email
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT01130532
    Other Study ID Numbers:
    • 13461
    • H6D-US-LVIP
    First Posted:
    May 26, 2010
    Last Update Posted:
    Jan 4, 2013
    Last Verified:
    Dec 1, 2012