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A Study of Tadalafil (LY450190) in Chinese Men With Erectile Dysfunction

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT02224846
Collaborator
(none)
635
Enrollment
17
Locations
2
Arms
31
Duration (Months)
37.4
Patients Per Site
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of the study drug, taken once daily, known as tadalafil in Chinese participants with erectile dysfunction (ED). The study will last about up to 25 months for each participant.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
635 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Postmarketing Surveillance Study: A Randomized, Open-Label, 3-Month Interventional Study of Tadalafil Effectiveness (2.5 mg and 5 mg) and Long-Term Safety Administered Once Daily in Chinese Men With Erectile Dysfunction
Study Start Date :
Oct 1, 2014
Actual Primary Completion Date :
May 1, 2016
Actual Study Completion Date :
May 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: 2.5 mg/5 mg tadalafil

2.5 mg tadalafil orally once daily for 3 months (Period 1) and then 5 mg tadalafil orally once daily for 21 months (Period 2).

Drug: Tadalafil
Administered orally
Other Names:
  • LY450190

    		•
    Experimental: 5 mg tadalafil

    5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).

    Drug: Tadalafil
    Administered orally
    Other Names:
  • LY450190

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants Experiencing at Least One Treatment Emergent Adverse Event (Serious or Non-Serious) [Baseline through Month 12]

      A Treatment Emergent Adverse Event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline, regardless of causality or severity. The percentage of participants with TEAEs was calculated by dividing the number of participants with at least 1 TEAE over the 12-Month treatment period by the total number of participants analyzed, multiplied by 100%. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.

    2. Percentage of Participants Experiencing at Least One Adverse Event Leading to Discontinuation [Baseline through Month 12]

      Data presented are the number of participants who experienced 1 or more AEs (all causalities and drug-related) and serious AEs (SAEs) that lead to discontinuation. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.

    Secondary Outcome Measures

    1. Change From Baseline in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain Questionnaire Score [Baseline, Month 1; Baseline, Month 3]

      IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) 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 is from Mixed effect Model Repeat Measurement (MMRM) model. The model included covariates baseline + visit + pooled investigator + baseline*visit, where participant is a random effect.

    2. Change From Baseline in the IIEF-EF Domain Questionnaire Score of 5 mg Tadalafil Treatments [Baseline, Month 6; Baseline, Month 12;Baseline, Month 18; Baseline, Month 24]

      IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) 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 is from Mixed effect Model Repeat Measurement (MMRM) model. The model included covariates baseline + visit + pooled investigator + baseline*visit, where participant is a random effect.

    3. Percentage of Participants With "Yes" Responses to Sexual Encounter Profile (SEP) Diary [Month 1, Month 3]

      Participant-assessed diary has 5 questions(QI-Q5): 4 of the 5 questions were analyzed. Q2: successful penetration, Q3: successful intercourse, Q4: satisfied with erection, and Q5: satisfied with sexual experience) for each sexual encounter made over a specified period of time. SEP Q1-Q5 scores were determined as the percentage of 'Yes' responses to each of the 5 questions out of all sexual attempts recorded during the time period.

    4. Percentage of Participants Achieving Normal Erectile Functioning [Month 1, Month 3]

      Participants achieving a normal erectile functioning (defined as having an IIEF-EF Domain score of >=26) at Month 1 and Month 3.

    5. Percentage of Participants Achieving Normal Erectile Functioning of 5 mg Tadalafil Treatments [Month 6, Month 12, Month 18, Month 24]

      Participants achieving a normal erectile functioning (defined as having an IIEF-EF Domain score of >=26) at Month 6 and Month 12.

    6. Percentage of Participants With "Yes" Responses to Global Assessment Questions (GAQ)1 and GAQ2 [Month 3, Month12, Month 24]

      Participants with "yes" responses to GAQ Question 1 (GAQ1) and GAQ Question 2 (GAQ2) of the GAQ questionnaire at Month 3 and Month 12. GAQ1: Has the treatment you have been taking during this study improved your erections? GAQ2: If yes, has the treatment improved your ability to engage in sexual activity?

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    22 Years to 69 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Have a history of erectile dysfunction for at least 3 months.

    • Are sexually active and willing to remain sexually active with the same female partner during the study.

    • Are willing to have 4 or more attempts of sexual intercourse with female partner between screening and first treatment start day.

    • Are willing to stay away from any other medicines that the participants were already taking for erectile dysfunction during this study period.

    Exclusion Criteria:

    • Have erectile dysfunction, which is caused by any other primary sexual disorder.

    • Have certain problems with kidneys, liver, heart, blood sugar levels, eyes, or central nervous system (study doctor will discuss with participants).

    • Have a penis deformity or penile implant that in the opinion of the participants' doctor is significant.

    • Have human immunodeficiency virus (HIV) infection.

    • Are using certain kinds of medicines, which are not allowed in this study.

    • Are allergic to tadalafil.

    • Are planning to father a baby or are in a relationship with a pregnant partner.

    • Are participating or discontinued participation in the past 30 days from any another clinical trial, which is not compatible with this trial.

    • Have participated or discontinued from any other tadalafil clinical trial.

    • Have a history of drug, alcohol, or substance abuse within the past 6 months.

    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. Beijing China 100020
    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. Changchun China 130021
    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. Changsha China 410011
    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. Chengdu China 610083
    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. Chongqing China 400037
    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. Fuzhou China 350001
    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. Guangzhou China 510180
    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. Hangzhou China 310003
    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. Hefei China 230022
    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. Nanjing China 210008
    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. Qingdao China 266071
    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. Shanghai China 200092
    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. Suzhou City China 215004
    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. Wenzhou China 325035
    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. Wu Han China 430030
    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. Wuhan China 430022
    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. Yinchuan China 750004

    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:
    NCT02224846
    Other Study ID Numbers:
    • 15382
    • H6D-GH-B022
    First Posted:
    Aug 25, 2014
    Last Update Posted:
    Sep 23, 2019
    Last Verified:
    Sep 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:
    Erectile Dysfunction
    Tadalafil

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title 2.5 mg/5 mg Tadalafil 5 mg Tadalafil
    Arm/Group Description 2.5 mg tadalafil orally once daily for 3 months (Period 1) and then 5 mg tadalafil orally once daily for 21 months (Period 2). 5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).
    Period Title: Period 1 (Month 3)
    STARTED 211 424
    Received at Least One Dose of Study Drug 210 421
    COMPLETED 192 388
    NOT COMPLETED 19 36
    Period Title: Period 1 (Month 3)
    STARTED 192 388
    COMPLETED 173 357
    NOT COMPLETED 19 31
    Period Title: Period 1 (Month 3)
    STARTED 173 357
    COMPLETED 131 283
    NOT COMPLETED 42 74

    Baseline Characteristics

    Arm/Group Title 2.5 mg/5 mg Tadalafil 5 mg Tadalafil Total
    Arm/Group Description 2.5 mg tadalafil orally once daily for 3 months (Period 1) and then 5 mg tadalafil orally once daily for 21 months (Period 2). 5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2). Total of all reporting groups
    Overall Participants 211 424 635
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    42.6
    (11.11)
    44.1
    (10.90)
    43.6
    (10.98)
    Sex: Female, Male (Count of Participants)
    Female
    0
    0%
    0
    0%
    0
    0%
    Male
    211
    100%
    424
    100%
    635
    100%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    211
    100%
    424
    100%
    635
    100%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    0
    0%
    0
    0%
    0
    0%
    White
    0
    0%
    0
    0%
    0
    0%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Region of Enrollment (Count of Participants)
    China
    211
    100%
    424
    100%
    635
    100%

    Outcome Measures

    1. Primary Outcome
    Title Percentage of Participants Experiencing at Least One Treatment Emergent Adverse Event (Serious or Non-Serious)
    Description A Treatment Emergent Adverse Event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline, regardless of causality or severity. The percentage of participants with TEAEs was calculated by dividing the number of participants with at least 1 TEAE over the 12-Month treatment period by the total number of participants analyzed, multiplied by 100%. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
    Time Frame Baseline through Month 12

    Outcome Measure Data

    Analysis Population Description
    All enrolled participants who fulfill the study entry criteria and who receive at least one dose of tadalafil.
    Arm/Group Title 2.5 mg/5 mg Tadalafil 5 mg Tadalafil
    Arm/Group Description 2.5 mg tadalafil orally once daily for 3 months (Period 1) and then 5 mg tadalafil orally once daily for 21 months (Period 2). 5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).
    Measure Participants 210 421
    Number [Percentage of participants]
    33.8
    16%
    35.9
    8.5%
    2. Primary Outcome
    Title Percentage of Participants Experiencing at Least One Adverse Event Leading to Discontinuation
    Description Data presented are the number of participants who experienced 1 or more AEs (all causalities and drug-related) and serious AEs (SAEs) that lead to discontinuation. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
    Time Frame Baseline through Month 12

    Outcome Measure Data

    Analysis Population Description
    All enrolled participants who fulfill the study entry criteria and who receive at least one dose of tadalafil.
    Arm/Group Title 2.5 mg/5 mg Tadalafil 5 mg Tadalafil
    Arm/Group Description 2.5 mg tadalafil orally once daily for 3 months (Period 1) and then 5 mg tadalafil orally once daily for 21 months (Period 2). 5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).
    Measure Participants 210 421
    Number [percentage of participants]
    1.4
    0.7%
    0.7
    0.2%
    3. Secondary Outcome
    Title Change From Baseline in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain Questionnaire Score
    Description IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) 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 is from Mixed effect Model Repeat Measurement (MMRM) model. The model included covariates baseline + visit + pooled investigator + baseline*visit, where participant is a random effect.
    Time Frame Baseline, Month 1; Baseline, Month 3

    Outcome Measure Data

    Analysis Population Description
    All enrolled participants who fulfill the study entry criteria, receive at least one dose of tadalafil, and have both baseline and postbaseline data.
    Arm/Group Title 2.5 mg/5 mg Tadalafil 5 mg Tadalafil
    Arm/Group Description 2.5 mg tadalafil orally once daily for 3 months (Period 1) and then 5 mg tadalafil orally once daily for 21 months (Period 2). 5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).
    Measure Participants 203 414
    Month 1
    4.5
    (0.42)
    6.2
    (0.28)
    Month 3
    6.1
    (0.44)
    7.4
    (0.28)
    4. Secondary Outcome
    Title Change From Baseline in the IIEF-EF Domain Questionnaire Score of 5 mg Tadalafil Treatments
    Description IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) 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 is from Mixed effect Model Repeat Measurement (MMRM) model. The model included covariates baseline + visit + pooled investigator + baseline*visit, where participant is a random effect.
    Time Frame Baseline, Month 6; Baseline, Month 12;Baseline, Month 18; Baseline, Month 24

    Outcome Measure Data

    Analysis Population Description
    All enrolled participants who fulfill the study entry criteria, receive at least one dose of tadalafil, and have both baseline and postbaseline data.
    Arm/Group Title 2.5 mg/5 mg Tadalafil 5 mg Tadalafil
    Arm/Group Description 2.5 mg tadalafil orally once daily for 3 months (Period 1) and then 5 mg tadalafil orally once daily for 21 months (Period 2). 5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).
    Measure Participants 203 414
    Month 6
    8.2
    (0.38)
    7.9
    (0.27)
    Month 12
    8.1
    (0.43)
    7.9
    (0.27)
    Month 18
    8.6
    (0.39)
    8.3
    (0.27)
    Month 24
    8.6
    (0.44)
    8.5
    (0.28)
    5. Secondary Outcome
    Title Percentage of Participants With "Yes" Responses to Sexual Encounter Profile (SEP) Diary
    Description Participant-assessed diary has 5 questions(QI-Q5): 4 of the 5 questions were analyzed. Q2: successful penetration, Q3: successful intercourse, Q4: satisfied with erection, and Q5: satisfied with sexual experience) for each sexual encounter made over a specified period of time. SEP Q1-Q5 scores were determined as the percentage of 'Yes' responses to each of the 5 questions out of all sexual attempts recorded during the time period.
    Time Frame Month 1, Month 3

    Outcome Measure Data

    Analysis Population Description
    All enrolled subjects who fulfill the study entry criteria, receive at least one dose of tadalafil, and have both baseline and postbaseline data.
    Arm/Group Title 2.5 mg/5 mg Tadalafil 5 mg Tadalafil
    Arm/Group Description 2.5 mg tadalafil orally once daily for 3 months (Period 1) and then 5 mg tadalafil orally once daily for 21 months (Period 2). 5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).
    Measure Participants 203 412
    Q2: successful penetration,Month 1
    81.3
    (34.58) 38.5%
    86.7
    (27.58) 20.4%
    Q2: successful penetration,Month 3
    88.2
    (28.55) 41.8%
    91.7
    (23.11) 21.6%
    Q3: successful intercourse,Month 1
    41.2
    (41.48) 19.5%
    49.5
    (42.85) 11.7%
    Q3: successful intercourse,Month 3
    55.7
    (43.19) 26.4%
    60.1
    (42.39) 14.2%
    Q4: satisfied with erection, Month 1
    24.8
    (35.62) 11.8%
    35.5
    (41.63) 8.4%
    Q4: satisfied with erection, Month 3
    39.9
    (43.73) 18.9%
    43.5
    (43.46) 10.3%
    Q5: satisfied with sexual experience,Month 1
    20.4
    (32.81) 9.7%
    31.1
    (40.50) 7.3%
    Q5: satisfied with sexual experience,Month 3
    35.7
    (41.93) 16.9%
    39.2
    (43.06) 9.2%
    6. Secondary Outcome
    Title Percentage of Participants Achieving Normal Erectile Functioning
    Description Participants achieving a normal erectile functioning (defined as having an IIEF-EF Domain score of >=26) at Month 1 and Month 3.
    Time Frame Month 1, Month 3

    Outcome Measure Data

    Analysis Population Description
    All enrolled subjects who fulfill the study entry criteria, receive at least one dose of tadalafil, and have both baseline and postbaseline data.
    Arm/Group Title 2.5 mg/5 mg Tadalafil 5 mg Tadalafil
    Arm/Group Description 2.5 mg tadalafil orally once daily for 3 months (Period 1) and then 5 mg tadalafil orally once daily for 21 months (Period 2). 5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).
    Measure Participants 210 421
    Month 1
    22.2
    30.9
    Month 3
    31.6
    37.6
    7. Secondary Outcome
    Title Percentage of Participants Achieving Normal Erectile Functioning of 5 mg Tadalafil Treatments
    Description Participants achieving a normal erectile functioning (defined as having an IIEF-EF Domain score of >=26) at Month 6 and Month 12.
    Time Frame Month 6, Month 12, Month 18, Month 24

    Outcome Measure Data

    Analysis Population Description
    All enrolled subjects who fulfill the study entry criteria, receive at least one dose of tadalafil, and have both baseline and postbaseline data.
    Arm/Group Title 2.5 mg/5 mg Tadalafil 5 mg Tadalafil
    Arm/Group Description 2.5 mg tadalafil orally once daily for 3 months (Period 1) and then 5 mg tadalafil orally once daily for 21 months (Period 2). 5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).
    Measure Participants 210 421
    Month 6
    38.2
    18.1%
    42.3
    10%
    Month 12
    44.1
    20.9%
    43.5
    10.3%
    Month 18
    44.6
    21.1%
    43.7
    10.3%
    Month 24
    45.5
    21.6%
    48.2
    11.4%
    8. Secondary Outcome
    Title Percentage of Participants With "Yes" Responses to Global Assessment Questions (GAQ)1 and GAQ2
    Description Participants with "yes" responses to GAQ Question 1 (GAQ1) and GAQ Question 2 (GAQ2) of the GAQ questionnaire at Month 3 and Month 12. GAQ1: Has the treatment you have been taking during this study improved your erections? GAQ2: If yes, has the treatment improved your ability to engage in sexual activity?
    Time Frame Month 3, Month12, Month 24

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who had evaluable data for Global Assessment Questions (GAQ)1 and GAQ2.
    Arm/Group Title 2.5 mg/5 mg Tadalafil 5 mg Tadalafil
    Arm/Group Description 2.5 mg tadalafil orally once daily for 3 months (Period 1) and then 5 mg tadalafil orally once daily for 21 months (Period 2). 5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).
    Measure Participants 211 424
    Month 3: GAQ1
    89.6
    42.5%
    95.7
    22.6%
    Month 12: GAQ1
    96.6
    45.8%
    97.5
    23%
    Month 24: GAQ1
    96.8
    45.9%
    95.7
    22.6%
    Month 3: GAQ2
    86.5
    41%
    92.1
    21.7%
    Month 12: GAQ2
    95.5
    45.3%
    96.1
    22.7%
    Month 24: GAQ2
    96.2
    45.6%
    94.5
    22.3%

    Adverse Events

    Time Frame
    Adverse Event Reporting Description All the participants who received at least one dose of study drug.
    Arm/Group Title 2.5 mg/5 mg Tadalafil 5 mg Tadalafil
    Arm/Group Description 2.5 mg tadalafil orally once daily for 3 months (Period 1) and then 5 mg tadalafil orally once daily for 21 months (Period 2). 5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).
    All Cause Mortality
    2.5 mg/5 mg Tadalafil 5 mg Tadalafil
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    2.5 mg/5 mg Tadalafil 5 mg Tadalafil
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 15/210 (7.1%) 17/421 (4%)
    Cardiac disorders
    Angina unstable 0/210 (0%) 0 1/421 (0.2%) 1
    Coronary artery disease 0/210 (0%) 0 1/421 (0.2%) 1
    Myocardial infarction 1/210 (0.5%) 1 0/421 (0%) 0
    Palpitations 0/210 (0%) 0 1/421 (0.2%) 1
    Eye disorders
    Maculopathy 1/210 (0.5%) 1 0/421 (0%) 0
    Gastrointestinal disorders
    Duodenal ulcer haemorrhage 1/210 (0.5%) 1 0/421 (0%) 0
    Gastric ulcer 0/210 (0%) 0 1/421 (0.2%) 1
    Large intestine polyp 2/210 (1%) 2 1/421 (0.2%) 1
    Hepatobiliary disorders
    Cholelithiasis 1/210 (0.5%) 1 0/421 (0%) 0
    Hepatic cyst 1/210 (0.5%) 1 0/421 (0%) 0
    Infections and infestations
    Otitis media 0/210 (0%) 0 1/421 (0.2%) 1
    Pneumonia 1/210 (0.5%) 1 0/421 (0%) 0
    Injury, poisoning and procedural complications
    Facial bones fracture 0/210 (0%) 0 1/421 (0.2%) 1
    Urethral stricture postoperative 1/210 (0.5%) 1 0/421 (0%) 0
    Metabolism and nutrition disorders
    Diabetes mellitus 2/210 (1%) 2 0/421 (0%) 0
    Type 2 diabetes mellitus 0/210 (0%) 0 1/421 (0.2%) 1
    Musculoskeletal and connective tissue disorders
    Ankylosing spondylitis 1/210 (0.5%) 1 0/421 (0%) 0
    Lumbar spinal stenosis 0/210 (0%) 0 1/421 (0.2%) 1
    Osteoporosis 0/210 (0%) 0 1/421 (0.2%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lipoma 1/210 (0.5%) 1 0/421 (0%) 0
    Nervous system disorders
    Cerebral infarction 1/210 (0.5%) 1 0/421 (0%) 0
    Transient ischaemic attack 1/210 (0.5%) 1 0/421 (0%) 0
    Pregnancy, puerperium and perinatal conditions
    Pregnancy 0/210 (0%) 0 1/421 (0.2%) 1
    Renal and urinary disorders
    Nephrolithiasis 0/210 (0%) 0 1/421 (0.2%) 1
    Renal cyst 1/210 (0.5%) 1 1/421 (0.2%) 1
    Ureterolithiasis 1/210 (0.5%) 2 1/421 (0.2%) 1
    Reproductive system and breast disorders
    Benign prostatic hyperplasia 0/210 (0%) 0 1/421 (0.2%) 1
    Erectile dysfunction 1/210 (0.5%) 1 0/421 (0%) 0
    Varicocele 1/210 (0.5%) 1 0/421 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Nasal septum deviation 0/210 (0%) 0 1/421 (0.2%) 1
    Pulmonary mass 1/210 (0.5%) 1 0/421 (0%) 0
    Rhinitis allergic 0/210 (0%) 0 1/421 (0.2%) 1
    Sleep apnoea syndrome 0/210 (0%) 0 1/421 (0.2%) 1
    Vascular disorders
    Hypertension 0/210 (0%) 0 1/421 (0.2%) 1
    Other (Not Including Serious) Adverse Events
    2.5 mg/5 mg Tadalafil 5 mg Tadalafil
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 86/210 (41%) 178/421 (42.3%)
    Blood and lymphatic system disorders
    Anaemia 1/210 (0.5%) 1 1/421 (0.2%) 1
    Cardiac disorders
    Angina unstable 0/210 (0%) 0 1/421 (0.2%) 1
    Arrhythmia 1/210 (0.5%) 1 0/421 (0%) 0
    Arteriosclerosis coronary artery 1/210 (0.5%) 1 0/421 (0%) 0
    Atrial fibrillation 1/210 (0.5%) 1 1/421 (0.2%) 1
    Cardiac failure 0/210 (0%) 0 1/421 (0.2%) 1
    Coronary artery disease 0/210 (0%) 0 1/421 (0.2%) 1
    Hypertensive heart disease 0/210 (0%) 0 1/421 (0.2%) 1
    Microvascular coronary artery disease 0/210 (0%) 0 1/421 (0.2%) 1
    Palpitations 0/210 (0%) 0 1/421 (0.2%) 1
    Tachycardia 1/210 (0.5%) 1 0/421 (0%) 0
    Congenital, familial and genetic disorders
    Atrial septal defect 1/210 (0.5%) 1 0/421 (0%) 0
    Ear and labyrinth disorders
    Cerumen impaction 0/210 (0%) 0 1/421 (0.2%) 1
    Ear pain 0/210 (0%) 0 1/421 (0.2%) 1
    Eustachian tube dysfunction 0/210 (0%) 0 1/421 (0.2%) 1
    Excessive cerumen production 0/210 (0%) 0 1/421 (0.2%) 1
    Mixed deafness 0/210 (0%) 0 1/421 (0.2%) 1
    Endocrine disorders
    Hyperthyroidism 0/210 (0%) 0 1/421 (0.2%) 1
    Thyroid mass 0/210 (0%) 0 2/421 (0.5%) 2
    Eye disorders
    Conjunctival haemorrhage 0/210 (0%) 0 1/421 (0.2%) 1
    Conjunctivitis allergic 0/210 (0%) 0 1/421 (0.2%) 1
    Diabetic retinopathy 0/210 (0%) 0 1/421 (0.2%) 1
    Dry eye 1/210 (0.5%) 1 0/421 (0%) 0
    Eye disorder 0/210 (0%) 0 1/421 (0.2%) 1
    Eye swelling 1/210 (0.5%) 1 0/421 (0%) 0
    Ocular discomfort 0/210 (0%) 0 1/421 (0.2%) 1
    Uveitis 0/210 (0%) 0 1/421 (0.2%) 1
    Vision blurred 1/210 (0.5%) 1 2/421 (0.5%) 2
    Xerophthalmia 0/210 (0%) 0 1/421 (0.2%) 2
    Gastrointestinal disorders
    Abdominal discomfort 1/210 (0.5%) 1 3/421 (0.7%) 3
    Abdominal distension 2/210 (1%) 2 3/421 (0.7%) 3
    Abdominal pain 2/210 (1%) 2 1/421 (0.2%) 1
    Abdominal pain upper 4/210 (1.9%) 6 4/421 (1%) 4
    Chronic gastritis 4/210 (1.9%) 4 3/421 (0.7%) 3
    Colitis 0/210 (0%) 0 1/421 (0.2%) 1
    Dental caries 3/210 (1.4%) 4 1/421 (0.2%) 1
    Diarrhoea 3/210 (1.4%) 3 5/421 (1.2%) 6
    Dry mouth 0/210 (0%) 0 2/421 (0.5%) 2
    Duodenal ulcer 1/210 (0.5%) 1 0/421 (0%) 0
    Dyspepsia 0/210 (0%) 0 3/421 (0.7%) 3
    Enteritis 2/210 (1%) 2 2/421 (0.5%) 2
    Gastric dilatation 1/210 (0.5%) 1 2/421 (0.5%) 2
    Gastric polyps 2/210 (1%) 2 0/421 (0%) 0
    Gastric ulcer 1/210 (0.5%) 1 2/421 (0.5%) 2
    Gastritis 3/210 (1.4%) 3 8/421 (1.9%) 10
    Gastritis erosive 0/210 (0%) 0 3/421 (0.7%) 3
    Gastrooesophageal reflux disease 2/210 (1%) 2 4/421 (1%) 5
    Gingival bleeding 1/210 (0.5%) 1 0/421 (0%) 0
    Gingival pain 0/210 (0%) 0 1/421 (0.2%) 1
    Gingival swelling 0/210 (0%) 0 1/421 (0.2%) 1
    Haemorrhoids 0/210 (0%) 0 3/421 (0.7%) 3
    Large intestine polyp 1/210 (0.5%) 1 1/421 (0.2%) 1
    Mouth ulceration 1/210 (0.5%) 1 4/421 (1%) 4
    Nausea 0/210 (0%) 0 3/421 (0.7%) 3
    Tooth disorder 0/210 (0%) 0 1/421 (0.2%) 1
    Toothache 1/210 (0.5%) 1 6/421 (1.4%) 6
    Vomiting 1/210 (0.5%) 1 0/421 (0%) 0
    General disorders
    Asthenia 0/210 (0%) 0 1/421 (0.2%) 1
    Chest discomfort 0/210 (0%) 0 1/421 (0.2%) 1
    Chest pain 1/210 (0.5%) 1 1/421 (0.2%) 1
    Oedema peripheral 0/210 (0%) 0 1/421 (0.2%) 1
    Pain 1/210 (0.5%) 1 1/421 (0.2%) 1
    Pyrexia 3/210 (1.4%) 3 4/421 (1%) 4
    Hepatobiliary disorders
    Cholecystitis 0/210 (0%) 0 1/421 (0.2%) 2
    Cholecystitis acute 0/210 (0%) 0 1/421 (0.2%) 1
    Cholecystitis chronic 1/210 (0.5%) 1 0/421 (0%) 0
    Fatty liver alcoholic 1/210 (0.5%) 1 0/421 (0%) 0
    Gallbladder polyp 1/210 (0.5%) 1 0/421 (0%) 0
    Hepatic cyst 0/210 (0%) 0 1/421 (0.2%) 1
    Hepatic steatosis 1/210 (0.5%) 1 2/421 (0.5%) 2
    Immune system disorders
    Hypersensitivity 0/210 (0%) 0 1/421 (0.2%) 1
    Infections and infestations
    Anal abscess 1/210 (0.5%) 1 0/421 (0%) 0
    Appendicitis 0/210 (0%) 0 1/421 (0.2%) 1
    Bronchitis 1/210 (0.5%) 1 5/421 (1.2%) 6
    Chronic sinusitis 0/210 (0%) 0 1/421 (0.2%) 1
    Conjunctivitis 1/210 (0.5%) 1 3/421 (0.7%) 3
    Conjunctivitis bacterial 0/210 (0%) 0 1/421 (0.2%) 1
    Dermatophytosis 0/210 (0%) 0 1/421 (0.2%) 1
    Ear infection 0/210 (0%) 0 1/421 (0.2%) 1
    Epididymitis 0/210 (0%) 0 1/421 (0.2%) 1
    Folliculitis 0/210 (0%) 0 3/421 (0.7%) 3
    Gastroenteritis 1/210 (0.5%) 1 3/421 (0.7%) 3
    Gingivitis 1/210 (0.5%) 1 0/421 (0%) 0
    Helicobacter infection 1/210 (0.5%) 1 0/421 (0%) 0
    Hepatitis b 0/210 (0%) 0 1/421 (0.2%) 1
    Hordeolum 1/210 (0.5%) 1 0/421 (0%) 0
    Infected dermal cyst 0/210 (0%) 0 1/421 (0.2%) 1
    Influenza 2/210 (1%) 2 3/421 (0.7%) 4
    Laryngitis 1/210 (0.5%) 1 0/421 (0%) 0
    Lung infection 0/210 (0%) 0 1/421 (0.2%) 1
    Mumps 0/210 (0%) 0 1/421 (0.2%) 1
    Otitis media 1/210 (0.5%) 1 4/421 (1%) 4
    Otitis media chronic 0/210 (0%) 0 1/421 (0.2%) 2
    Periodontitis 6/210 (2.9%) 6 3/421 (0.7%) 3
    Pharyngitis 3/210 (1.4%) 3 8/421 (1.9%) 8
    Pneumonia 0/210 (0%) 0 1/421 (0.2%) 1
    Pulpitis dental 1/210 (0.5%) 1 2/421 (0.5%) 2
    Respiratory tract infection 1/210 (0.5%) 1 3/421 (0.7%) 3
    Rhinitis 3/210 (1.4%) 3 5/421 (1.2%) 6
    Sinusitis 0/210 (0%) 0 1/421 (0.2%) 1
    Tinea cruris 0/210 (0%) 0 1/421 (0.2%) 1
    Tinea infection 0/210 (0%) 0 1/421 (0.2%) 1
    Tinea manuum 0/210 (0%) 0 1/421 (0.2%) 2
    Tinea pedis 0/210 (0%) 0 3/421 (0.7%) 3
    Tonsillitis 1/210 (0.5%) 1 1/421 (0.2%) 1
    Upper respiratory tract infection 5/210 (2.4%) 5 21/421 (5%) 25
    Urinary tract infection 3/210 (1.4%) 3 2/421 (0.5%) 2
    Viral upper respiratory tract infection 18/210 (8.6%) 24 39/421 (9.3%) 48
    Wound infection 0/210 (0%) 0 1/421 (0.2%) 1
    Injury, poisoning and procedural complications
    Electrical burn 0/210 (0%) 0 1/421 (0.2%) 1
    Foreign body 0/210 (0%) 0 1/421 (0.2%) 1
    Fracture 1/210 (0.5%) 1 0/421 (0%) 0
    Hand fracture 0/210 (0%) 0 2/421 (0.5%) 2
    Heat stroke 0/210 (0%) 0 1/421 (0.2%) 1
    Joint injury 1/210 (0.5%) 1 1/421 (0.2%) 1
    Ligament sprain 1/210 (0.5%) 1 3/421 (0.7%) 3
    Limb injury 0/210 (0%) 0 3/421 (0.7%) 3
    Lip injury 0/210 (0%) 0 1/421 (0.2%) 1
    Muscle strain 0/210 (0%) 0 1/421 (0.2%) 1
    Peripheral nerve injury 1/210 (0.5%) 1 0/421 (0%) 0
    Skin injury 1/210 (0.5%) 1 0/421 (0%) 0
    Thermal burn 0/210 (0%) 0 2/421 (0.5%) 2
    Investigations
    Alanine aminotransferase increased 5/210 (2.4%) 5 1/421 (0.2%) 1
    Aspartate aminotransferase increased 1/210 (0.5%) 1 0/421 (0%) 0
    Blood cholesterol increased 1/210 (0.5%) 1 1/421 (0.2%) 1
    Blood creatine phosphokinase increased 1/210 (0.5%) 1 0/421 (0%) 0
    Blood glucose increased 1/210 (0.5%) 1 0/421 (0%) 0
    Blood pressure increased 0/210 (0%) 0 3/421 (0.7%) 3
    Blood pressure systolic increased 0/210 (0%) 0 1/421 (0.2%) 1
    Blood triglycerides increased 1/210 (0.5%) 1 2/421 (0.5%) 2
    Blood urea increased 1/210 (0.5%) 1 1/421 (0.2%) 1
    Blood uric acid increased 4/210 (1.9%) 4 1/421 (0.2%) 1
    Gamma-glutamyltransferase increased 2/210 (1%) 2 1/421 (0.2%) 1
    High density lipoprotein increased 1/210 (0.5%) 1 0/421 (0%) 0
    Lipids increased 1/210 (0.5%) 1 1/421 (0.2%) 1
    Low density lipoprotein increased 1/210 (0.5%) 1 0/421 (0%) 0
    Platelet count decreased 0/210 (0%) 0 1/421 (0.2%) 1
    White blood cell count increased 0/210 (0%) 0 1/421 (0.2%) 1
    Metabolism and nutrition disorders
    Diabetes mellitus 1/210 (0.5%) 1 0/421 (0%) 0
    Folate deficiency 0/210 (0%) 0 1/421 (0.2%) 1
    Gout 2/210 (1%) 2 2/421 (0.5%) 2
    Hyperlipidaemia 1/210 (0.5%) 1 4/421 (1%) 5
    Hypertriglyceridaemia 1/210 (0.5%) 1 2/421 (0.5%) 2
    Hypoglycaemia 0/210 (0%) 0 2/421 (0.5%) 2
    Type 2 diabetes mellitus 0/210 (0%) 0 1/421 (0.2%) 1
    Musculoskeletal and connective tissue disorders
    Arthralgia 1/210 (0.5%) 1 3/421 (0.7%) 3
    Arthritis 0/210 (0%) 0 2/421 (0.5%) 2
    Arthropathy 0/210 (0%) 0 1/421 (0.2%) 1
    Back pain 3/210 (1.4%) 3 4/421 (1%) 5
    Bursitis 0/210 (0%) 0 1/421 (0.2%) 1
    Exostosis 0/210 (0%) 0 1/421 (0.2%) 1
    Intervertebral disc degeneration 0/210 (0%) 0 1/421 (0.2%) 1
    Intervertebral disc protrusion 1/210 (0.5%) 1 4/421 (1%) 5
    Musculoskeletal discomfort 0/210 (0%) 0 1/421 (0.2%) 1
    Musculoskeletal pain 0/210 (0%) 0 1/421 (0.2%) 1
    Musculoskeletal stiffness 1/210 (0.5%) 1 1/421 (0.2%) 1
    Myalgia 0/210 (0%) 0 2/421 (0.5%) 2
    Neck pain 1/210 (0.5%) 1 1/421 (0.2%) 1
    Osteoarthritis 1/210 (0.5%) 1 1/421 (0.2%) 1
    Osteoporosis 0/210 (0%) 0 1/421 (0.2%) 2
    Pain in extremity 1/210 (0.5%) 1 1/421 (0.2%) 1
    Periarthritis 1/210 (0.5%) 1 2/421 (0.5%) 2
    Spinal osteoarthritis 1/210 (0.5%) 1 1/421 (0.2%) 1
    Spinal pain 0/210 (0%) 0 1/421 (0.2%) 1
    Vertebral lesion 0/210 (0%) 0 1/421 (0.2%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Skin papilloma 0/210 (0%) 0 3/421 (0.7%) 5
    Nervous system disorders
    Carotid arteriosclerosis 1/210 (0.5%) 1 1/421 (0.2%) 1
    Carotid artery stenosis 1/210 (0.5%) 1 0/421 (0%) 0
    Cerebral artery stenosis 1/210 (0.5%) 1 0/421 (0%) 0
    Cerebral infarction 0/210 (0%) 0 1/421 (0.2%) 1
    Diabetic neuropathy 0/210 (0%) 0 1/421 (0.2%) 1
    Dizziness 3/210 (1.4%) 3 9/421 (2.1%) 9
    Head discomfort 0/210 (0%) 0 1/421 (0.2%) 1
    Headache 2/210 (1%) 2 13/421 (3.1%) 14
    Migraine 0/210 (0%) 0 1/421 (0.2%) 1
    Poor quality sleep 0/210 (0%) 0 1/421 (0.2%) 1
    Radiculopathy 0/210 (0%) 0 1/421 (0.2%) 1
    Tension headache 0/210 (0%) 0 1/421 (0.2%) 1
    Transient ischaemic attack 0/210 (0%) 0 2/421 (0.5%) 2
    Vertebrobasilar insufficiency 0/210 (0%) 0 1/421 (0.2%) 1
    Pregnancy, puerperium and perinatal conditions
    Pregnancy 1/210 (0.5%) 1 0/421 (0%) 0
    Psychiatric disorders
    Agitation 1/210 (0.5%) 1 0/421 (0%) 0
    Insomnia 4/210 (1.9%) 4 1/421 (0.2%) 1
    Irritability 1/210 (0.5%) 1 0/421 (0%) 0
    Premature ejaculation 0/210 (0%) 0 1/421 (0.2%) 1
    Sleep disorder 2/210 (1%) 2 0/421 (0%) 0
    Renal and urinary disorders
    Calculus urinary 1/210 (0.5%) 1 0/421 (0%) 0
    Glomerulonephritis chronic 0/210 (0%) 0 1/421 (0.2%) 1
    Nephrolithiasis 2/210 (1%) 4 1/421 (0.2%) 1
    Renal cyst 2/210 (1%) 2 2/421 (0.5%) 2
    Renal failure 0/210 (0%) 0 1/421 (0.2%) 1
    Renal mass 0/210 (0%) 0 1/421 (0.2%) 1
    Urethral pain 0/210 (0%) 0 1/421 (0.2%) 1
    Urinary retention 1/210 (0.5%) 1 0/421 (0%) 0
    Reproductive system and breast disorders
    Balanoposthitis 1/210 (0.5%) 1 0/421 (0%) 0
    Benign prostatic hyperplasia 0/210 (0%) 0 3/421 (0.7%) 3
    Epididymal cyst 0/210 (0%) 0 1/421 (0.2%) 1
    Prostatitis 7/210 (3.3%) 7 4/421 (1%) 4
    Testicular pain 0/210 (0%) 0 1/421 (0.2%) 1
    Respiratory, thoracic and mediastinal disorders
    Asthma 0/210 (0%) 0 1/421 (0.2%) 1
    Cough 2/210 (1%) 2 5/421 (1.2%) 5
    Dry throat 1/210 (0.5%) 1 0/421 (0%) 0
    Epistaxis 2/210 (1%) 2 2/421 (0.5%) 2
    Haemoptysis 0/210 (0%) 0 1/421 (0.2%) 1
    Interstitial lung disease 0/210 (0%) 0 1/421 (0.2%) 1
    Nasal inflammation 0/210 (0%) 0 1/421 (0.2%) 1
    Nasal obstruction 1/210 (0.5%) 1 0/421 (0%) 0
    Oropharyngeal pain 0/210 (0%) 0 3/421 (0.7%) 3
    Reflux laryngitis 0/210 (0%) 0 1/421 (0.2%) 1
    Rhinitis allergic 3/210 (1.4%) 3 0/421 (0%) 0
    Upper respiratory tract congestion 0/210 (0%) 0 1/421 (0.2%) 1
    Upper-airway cough syndrome 0/210 (0%) 0 1/421 (0.2%) 1
    Skin and subcutaneous tissue disorders
    Acne 0/210 (0%) 0 1/421 (0.2%) 1
    Dermatitis 1/210 (0.5%) 1 3/421 (0.7%) 3
    Dermatitis allergic 0/210 (0%) 0 2/421 (0.5%) 2
    Eczema 3/210 (1.4%) 3 2/421 (0.5%) 2
    Hyperhidrosis 0/210 (0%) 0 1/421 (0.2%) 1
    Papule 0/210 (0%) 0 1/421 (0.2%) 1
    Pruritus 0/210 (0%) 0 1/421 (0.2%) 1
    Rash 1/210 (0.5%) 1 2/421 (0.5%) 2
    Skin disorder 1/210 (0.5%) 1 0/421 (0%) 0
    Skin ulcer 1/210 (0.5%) 1 0/421 (0%) 0
    Stasis dermatitis 1/210 (0.5%) 1 0/421 (0%) 0
    Urticaria 0/210 (0%) 0 2/421 (0.5%) 2
    Social circumstances
    Breast feeding 0/210 (0%) 0 1/421 (0.2%) 1
    Vascular disorders
    Deep vein thrombosis 1/210 (0.5%) 1 0/421 (0%) 0
    Flushing 1/210 (0.5%) 1 2/421 (0.5%) 2
    Hypertension 3/210 (1.4%) 3 8/421 (1.9%) 9
    Peripheral arterial occlusive disease 1/210 (0.5%) 1 0/421 (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 ClinicalTrials.gov@lilly.com
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT02224846
    Other Study ID Numbers:
    • 15382
    • H6D-GH-B022
    First Posted:
    Aug 25, 2014
    Last Update Posted:
    Sep 23, 2019
    Last Verified:
    Sep 1, 2019