Clincosm LogoSign in Get a demo

Tadalafil Taken Daily Compared to Placebo on Improvement of Getting and Maintaining an Erection and Sexual Quality of Life

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00422734
Collaborator
ICOS Corporation (Industry)
342
Enrollment
19
Locations
2
Arms
14
Duration (Months)
18
Patients Per Site
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To determine if tadalafil 5 mg daily compared to placebo when given for 12 weeks improves getting and maintaining an erection in men with erectile dysfunction and if there are improvements in the sexual quality of life of the man and his female study partner

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
342 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Tadalafil 5 mg Once a Day Compared to Placebo in Improving Erectile Dysfunction and Sexual Quality of Life
Study Start Date :
Nov 1, 2006
Actual Primary Completion Date :
Jan 1, 2008
Actual Study Completion Date :
Jan 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: 1

Placebo

Drug: Placebo
placebo tablet taken by mouth once a day for 12 weeks
Active Comparator: 2

5 mg tadalafil

Drug: tadalafil
5 mg tadalafil tablet taken by mouth once a day for 12 weeks
Other Names:
  • LY450190
  • Cialis
  • IC351

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF)- Erectile Function Domain Score (Sum of IIEF Questions 1-5 and 15) [Baseline and 12 weeks]

      Measures erectile function over the past 4 weeks on Questions 1-5 and 15 (6 questions) of the International Index of Erecile Function (IIEF) questionnaire. Scores range from 0 (low/no erectile function) to 5 (high erectile function), thus the 6 questions of the IIEF-EF domain range from 0 to 30.

    2. Improvement in the Sexual Quality of Life in the Subject and His Study Partner as Measured by the Sexual Quality of Life (SQoL) Domain of the Sexual Life Quality Questionnaire (SLQQ) [Baseline and 12 weeks]

      The original item scores (-4 to 4 range) were converted to 0 to 8 scale score by adding 4 to each recorded responses. Each transformed score was multiplied by 12.5 for a total range of 0 to 100. Higher scores are indicative of a higher sexual quality of life.

    3. Change From Baseline to Endpoint in the Percent of "Yes" Responses to Sexual Encounter Profile (SEP) Diary Questions 2 (SEP2) and 3 (SEP3). [Baseline and 12 weeks]

      The baseline and endpoint score for each SEP question 2 (Insert penis into vagina) and 3 (Successful intercourse) are the subject's percentage of "yes" responses to those questions during the run-in period and postbaseline period, respectively.

    Secondary Outcome Measures

    1. Change From Baseline to Week 12 Endpoint in the International Index of Erectile Function - Intercourse Satisfaction Domain - Subject Response [Baseline and 12 weeks]

      Self-reported intercourse satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 3 questions of the IIEF-IS domain range from 0 to 15.

    2. Change From Baseline to 12 Week Endpoint in Overall Satisfaction Domain of the International Index of Erectile Function (IIEF-OS) - Subject Response [Baseline and 12 weeks]

      Self-reported overall satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 2 questions of the IIEF-OS domain range from 0 to 10.

    3. Sexual Life Quality Questionnaire (SLQQ) Treatment Satisfaction Domain [12 weeks]

      The 6 SLQQ-treatment satisfaction questions were answered by subject and partner at Visit 4/Final Visit. Original item scores (1 to 6 range) were converted to 0 to 5 scale by subtracting 1 to each recorded responses. Each transformed score was multiplied by 20. Total range of scores: 0 (low satisfaction) to 100 (high satisfaction).

    4. Change From Baseline to 12 Week Endpoint in Percent of "Yes" Responses to Sexual Encounter Profile (SEP) Questions 4 and 5 - Subject Response [Baseline and 12 weeks]

      The baseline and endpoint score for each SEP question 4 (Satisfied with hardness) and 5 (Satisfied overall) are the subject's percentage of "yes" responses to those questions during the run-in period and postbaseline period, respectively.

    5. Change From Baseline to 12 Week Endpoint in Percent of "Yes" Responses to Partner-Sexual Encounter Profile (SEP) Question 3 - Partner Response [Baseline and 12 weeks]

      The baseline and endpoint score for partner SEP question 3 (Satisfied overall) are the partner's percentage of "yes" responses to the question during the run-in period and postbaseline period, respectively.

    6. Change From Baseline to 12 Week Endpoint in the Satisfaction Domain of the Female Sexual Function Index (FSFI) - Partner Response [Baseline and 12 weeks]

      The FSFI Satisfaction Domain (items 14-16) measures satisfaction with emotional closeness, sexual relationship, and overall sexual life. Each question is scored on a 0/1 to 5 scale and domain score is calculated by multiplying the total points by 0.4, for a total score range of 0.8 to 6, with higher scores indicating greater satisfaction.

    7. Percent of Subjects With "Yes" Responses to Global Assessment Questionnaire (GAQ) - Subject Response [12 weeks]

      Percent of subjects with "Yes" responses to Question 1 (Improvement in Erections) and Question 2 (Improvement in the Ability to Engage in Sexual Activity)

    8. Percent of Partners With "Yes" Responses to Global Assessment Questionnaire (GAQ) - Partner Response [12 weeks]

      Percent of Partners with "Yes" responses to Question 1 (Improvement in Erections) and Question 2 (Improvement in the Ability to Engage in Sexual Activity)

    9. Change From Baseline to 12 Week Endpoint in Percent of "Yes" Responses to Partner-Sexual Encounter Profile (SEP) Questions 1 and 2 - Partner Response [Baseline and 12 weeks]

      The baseline and endpoint score for each SEP question 1 (Achieve some erection) and 2 (Insert penis into vagina) are the partner's percentage of "yes" responses to those questions during the run-in period and postbaseline period, respectively.

    10. Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire [Baseline and 12 weeks]

      Measures improvement in self-esteem and relationship satisfaction. Questionnaire consists of two domains, Sexual Relationship (items 1-8) and Confidence (items 9-14). Overall score is transformed onto a 0 (least favorable) to 100 (most favorable) scale. Overall score was calculated from two domains and subscales scores.

    11. Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire - Confidence Domain Subscales [Baseline and 12 weeks]

      Measures improvement in confidence (items 9-14). Confidence domain consists of two subscales (Self-Esteem, items 9-12; Overall Relationship, items 13 and 14). Each domain score, subscale score, and overall score are transformed onto a 0 (least favorable) to 100 (most favorable) scale.

    Eligibility Criteria

    Criteria

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

    Male

    • History of erectile dysfunction (ED) for at least 3 months duration

    • Anticipate having the same female partner willing to participate throughout the study

    • At least 18 years of age at Visit 1 and agree to make at least 4 sexual attempts during the early phase of the study

    • Adequate partner sexual function as determined by a Female Sexual Function Index

    • Willing to record responses to efficacy questionnaires, sexual quality of life questionnaires and other instruments used in the study

    Exclusion Criteria:

    • May not participate in the study if you have taken tadalafil previously.

    • History of cardiac conditions including angina requiring treatment with nitrates, heart disease of coronary conditions including myocardial infarction, bypass surgery, angioplasty or stent placement for specified time before starting the study.

    • Have sexual partner not willing to complete the scales.

    • Use of nitrates.

    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. Little Rock Arkansas United States 72211
    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. Stuart Florida United States 34996
    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. Tampa Florida United States 33607
    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. Des Moines Iowa United States 50309
    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. Cleveland Ohio United States 44106
    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. Knoxville Tennessee United States 37920
    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. San Antonio Texas United States 78229
    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. Virginia Beach Virginia United States 23454
    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. Salzburg Austria 5020
    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. Lille France 59000
    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. Marseille France 13009
    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. Rennes France 35 700
    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. Augsburg Germany D-86150
    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. Berlin Germany 13465
    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. Hamburg Germany D-20354
    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. Leverkusen Germany 51375
    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. La Joya Mexico 14000

    Sponsors and Collaborators

    • Eli Lilly and Company
    • ICOS Corporation

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00422734
    Other Study ID Numbers:
    • 9501
    • H6D-MC-LVGH
    First Posted:
    Jan 17, 2007
    Last Update Posted:
    Jun 10, 2009
    Last Verified:
    Jun 1, 2009
    Additional relevant MeSH terms:
    Erectile Dysfunction
    Tadalafil

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Placebo Tadalafil
    Arm/Group Description Placebo tablet taken by mouth once a day for 12 weeks 5 mg tadalafil tablet taken by mouth once a day for 12 weeks
    Period Title: Overall Study
    STARTED 78 264
    COMPLETED 64 243
    NOT COMPLETED 14 21

    Baseline Characteristics

    Arm/Group Title Placebo Tadalafil Total
    Arm/Group Description Placebo tablet taken by mouth once a day for 12 weeks 5 mg tadalafil tablet taken by mouth once a day for 12 weeks Total of all reporting groups
    Overall Participants 78 264 342
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    53.82
    (10.72)
    54.42
    (10.04)
    54.29
    (10.18)
    Sex: Female, Male (Count of Participants)
    Female
    0
    0%
    0
    0%
    0
    0%
    Male
    78
    100%
    264
    100%
    342
    100%
    Region of Enrollment (participants) [Number]
    France
    11
    14.1%
    41
    15.5%
    52
    15.2%
    United States
    29
    37.2%
    107
    40.5%
    136
    39.8%
    Mexico
    19
    24.4%
    63
    23.9%
    82
    24%
    Austria
    8
    10.3%
    17
    6.4%
    25
    7.3%
    Germany
    11
    14.1%
    36
    13.6%
    47
    13.7%
    Erectile Dysfunction History - Duration (participants) [Number]
    >= 1 year
    73
    93.6%
    240
    90.9%
    313
    91.5%
    >= 3 months and < 6 months
    1
    1.3%
    8
    3%
    9
    2.6%
    >= 6 months and < 1 year
    4
    5.1%
    16
    6.1%
    20
    5.8%
    Erectile Dysfunction History - Etiology (participants) [Number]
    Mixed
    34
    43.6%
    114
    43.2%
    148
    43.3%
    Organic
    29
    37.2%
    91
    34.5%
    120
    35.1%
    Psychogenic
    12
    15.4%
    30
    11.4%
    42
    12.3%
    Unknown
    3
    3.8%
    29
    11%
    32
    9.4%
    International Index of Erectile Function (IIEF) - Erectile Dysfunction Severity (participants) [Number]
    Mild (17-30)
    35
    44.9%
    123
    46.6%
    158.0
    46.2%
    Moderate (11-16)
    22
    28.2%
    71
    26.9%
    93.0
    27.2%
    Severe (1-10)
    20
    25.6%
    63
    23.9%
    83.0
    24.3%
    Missing
    1
    1.3%
    7
    2.7%
    8.0
    2.3%
    Race/Ethnicity (participants) [Number]
    African
    0
    0%
    6
    2.3%
    6
    1.8%
    Caucasian
    57
    73.1%
    188
    71.2%
    245
    71.6%
    Hispanic
    21
    26.9%
    69
    26.1%
    90
    26.3%
    Native American
    0
    0%
    1
    0.4%
    1
    0.3%
    International Index of Erectile Function (IIEF) - Erectile Function Domain (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    15.27
    (6.49)
    15.73
    (6.13)
    15.62
    (6.21)

    Outcome Measures

    1. Primary Outcome
    Title Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF)- Erectile Function Domain Score (Sum of IIEF Questions 1-5 and 15)
    Description Measures erectile function over the past 4 weeks on Questions 1-5 and 15 (6 questions) of the International Index of Erecile Function (IIEF) questionnaire. Scores range from 0 (low/no erectile function) to 5 (high erectile function), thus the 6 questions of the IIEF-EF domain range from 0 to 30.
    Time Frame Baseline and 12 weeks

    Outcome Measure Data

    Analysis Population Description
    last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement
    Arm/Group Title Placebo Tadalafil
    Arm/Group Description Placebo tablet taken by mouth once a day for 12 weeks 5 mg tadalafil tablet taken by mouth once a day for 12 weeks
    Measure Participants 72 244
    Least Squares Mean (Standard Error) [units on a scale]
    0.49
    (0.781)
    8.03
    (0.449)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Tadalafil
    Comments The null hypotheses (no treatment effect with respect to IIEF EF domain or SEP2 or SEP3) were each tested at a specified level of 0.05. In order to pass a serial gatekeeper, it was necessary to reject all three hypotheses. The two null hypotheses (no treatment effect with respect to subject SLQQ-SQoL domain and no treatment effect with respect to partner SLQQ-SQoL domain) were then each tested at a significance level of 0.025.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments Hypotheses were tested in a sequential fashion using a gatekeeping strategy and adjusted for multiplicity. Statistical significance at 0.05 level was required for this variable
    Method ANCOVA
    Comments Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p<0.10.
    2. Primary Outcome
    Title Improvement in the Sexual Quality of Life in the Subject and His Study Partner as Measured by the Sexual Quality of Life (SQoL) Domain of the Sexual Life Quality Questionnaire (SLQQ)
    Description The original item scores (-4 to 4 range) were converted to 0 to 8 scale score by adding 4 to each recorded responses. Each transformed score was multiplied by 12.5 for a total range of 0 to 100. Higher scores are indicative of a higher sexual quality of life.
    Time Frame Baseline and 12 weeks

    Outcome Measure Data

    Analysis Population Description
    last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement
    Arm/Group Title Placebo Tadalafil
    Arm/Group Description Placebo tablet taken by mouth once a day for 12 weeks 5 mg tadalafil tablet taken by mouth once a day for 12 weeks
    Measure Participants 72 244
    SQoL - Subject (change from baseline)
    12.59
    (2.866)
    39.37
    (1.651)
    SQoL-Partner (change from baseline) (n=70, n=238)
    7.93
    (2.861)
    32.87
    (1.638)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Tadalafil
    Comments The null hypotheses (no treatment effect with respect to IIEF EF domain or SEP2 or SEP3) were each tested at a specified level of 0.05. In order to pass a serial gatekeeper, it was necessary to reject all three hypotheses. The two null hypotheses (no treatment effect with respect to subject SLQQ-SQoL domain and no treatment effect with respect to partner SLQQ-SQoL domain) were then each tested at a significance level of 0.025.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value for Subject. Hypotheses were tested in a sequential fashion using a gatekeeping strategy and adjusted for multiplicity. To adjust for multiplicity, statistical significance at 0.025 level was required for this variable.
    Method ANCOVA
    Comments Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p<0.10.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Tadalafil
    Comments The null hypotheses (no treatment effect with respect to IIEF EF domain or SEP2 or SEP3) were each tested at a specified level of 0.05. In order to pass a serial gatekeeper, it was necessary to reject all three hypotheses. The two null hypotheses (no treatment effect with respect to subject SLQQ-SQoL domain and no treatment effect with respect to partner SLQQ-SQoL domain) were then each tested at a significance level of 0.025.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value for Partner. Hypotheses were tested in a sequential fashion using a gatekeeping strategy and adjusted for multiplicity. To adjust for multiplicity, statistical significance at 0.025 level was required for this variable.
    Method ANCOVA
    Comments Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p<0.10.
    3. Secondary Outcome
    Title Change From Baseline to Week 12 Endpoint in the International Index of Erectile Function - Intercourse Satisfaction Domain - Subject Response
    Description Self-reported intercourse satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 3 questions of the IIEF-IS domain range from 0 to 15.
    Time Frame Baseline and 12 weeks

    Outcome Measure Data

    Analysis Population Description
    last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement
    Arm/Group Title Placebo Tadalafil
    Arm/Group Description Placebo tablet taken by mouth once a day for 12 weeks 5 mg tadalafil tablet taken by mouth once a day for 12 weeks
    Measure Participants 72 244
    Least Squares Mean (Standard Error) [units on a scale]
    0.09
    (0.356)
    2.74
    (0.205)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Tadalafil
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method ANCOVA
    Comments Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p<0.10.
    4. Secondary Outcome
    Title Change From Baseline to 12 Week Endpoint in Overall Satisfaction Domain of the International Index of Erectile Function (IIEF-OS) - Subject Response
    Description Self-reported overall satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 2 questions of the IIEF-OS domain range from 0 to 10.
    Time Frame Baseline and 12 weeks

    Outcome Measure Data

    Analysis Population Description
    last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement
    Arm/Group Title Placebo Tadalafil
    Arm/Group Description Placebo tablet taken by mouth once a day for 12 weeks 5 mg tadalafil tablet taken by mouth once a day for 12 weeks
    Measure Participants 72 244
    Least Squares Mean (Standard Error) [units on a scale]
    0.44
    (0.257)
    2.57
    (0.148)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Tadalafil
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method ANCOVA
    Comments Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p<0.10.
    5. Secondary Outcome
    Title Sexual Life Quality Questionnaire (SLQQ) Treatment Satisfaction Domain
    Description The 6 SLQQ-treatment satisfaction questions were answered by subject and partner at Visit 4/Final Visit. Original item scores (1 to 6 range) were converted to 0 to 5 scale by subtracting 1 to each recorded responses. Each transformed score was multiplied by 20. Total range of scores: 0 (low satisfaction) to 100 (high satisfaction).
    Time Frame 12 weeks

    Outcome Measure Data

    Analysis Population Description
    all randomized participants having post-baseline data measurement on this variable
    Arm/Group Title Placebo Tadalafil
    Arm/Group Description Placebo tablet taken by mouth once a day for 12 weeks 5 mg tadalafil tablet taken by mouth once a day for 12 weeks
    Measure Participants 72 244
    SLQQ - Subject (n=72, n=244)
    51.58
    (2.246)
    75.04
    (1.293)
    SLQQ - Partner (n=70, n=238)
    55.25
    (2.115)
    73.42
    (1.214)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Tadalafil
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments p-value is for subject scores
    Method ANCOVA
    Comments ANCOVA included:treatment, baseline value of IIEF EF Domain, pooled site. Baseline-value-by-treatment interaction included if interaction at p<0.10
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Tadalafil
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments p-value is for partner scores
    Method ANCOVA
    Comments ANCOVA included:treatment, baseline value of IIEF EF Domain, pooled site. Baseline-value-by-treatment interaction included if interaction at p<0.10
    6. Primary Outcome
    Title Change From Baseline to Endpoint in the Percent of "Yes" Responses to Sexual Encounter Profile (SEP) Diary Questions 2 (SEP2) and 3 (SEP3).
    Description The baseline and endpoint score for each SEP question 2 (Insert penis into vagina) and 3 (Successful intercourse) are the subject's percentage of "yes" responses to those questions during the run-in period and postbaseline period, respectively.
    Time Frame Baseline and 12 weeks

    Outcome Measure Data

    Analysis Population Description
    all randomized participants having both baseline and at least one post-baseline data measurement
    Arm/Group Title Placebo Tadalafil
    Arm/Group Description Placebo tablet taken by mouth once a day for 12 weeks 5 mg tadalafil tablet taken by mouth once a day for 12 weeks
    Measure Participants 74 251
    Question 2 change from baseline in percent "yes"
    2.19
    (2.833)
    28.80
    (1.644)
    Question 3 change from baseline in percent "yes"
    10.80
    (3.767)
    46.46
    (2.185)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Tadalafil
    Comments The null hypotheses (no treatment effect with respect to IIEF EF domain or SEP2 or SEP3) were each tested at a specified level of 0.05. In order to pass a serial gatekeeper, it was necessary to reject all three hypotheses. The two null hypotheses (no treatment effect with respect to subject SLQQ-SQoL domain and no treatment effect with respect to partner SLQQ-SQoL domain) were then each tested at a significance level of 0.025.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value for SEP Question 2. Hypotheses were tested in a sequential fashion using a gatekeeping strategy and adjusted for multiplicity. Statistical significance at 0.05 level was required for this variable.
    Method ANCOVA
    Comments Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p<0.10.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Tadalafil
    Comments The null hypotheses (no treatment effect with respect to IIEF EF domain or SEP2 or SEP3) were each tested at a specified level of 0.05. In order to pass a serial gatekeeper, it was necessary to reject all three hypotheses. The two null hypotheses (no treatment effect with respect to subject SLQQ-SQoL domain and no treatment effect with respect to partner SLQQ-SQoL domain) were then each tested at a significance level of 0.025.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value for SEP Question 3. Hypotheses were tested in a sequential fashion using a gatekeeping strategy and adjusted for multiplicity. Statistical significance at 0.05 level was required for this variable.
    Method ANCOVA
    Comments Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p<0.10.
    7. Secondary Outcome
    Title Change From Baseline to 12 Week Endpoint in Percent of "Yes" Responses to Sexual Encounter Profile (SEP) Questions 4 and 5 - Subject Response
    Description The baseline and endpoint score for each SEP question 4 (Satisfied with hardness) and 5 (Satisfied overall) are the subject's percentage of "yes" responses to those questions during the run-in period and postbaseline period, respectively.
    Time Frame Baseline and 12 weeks

    Outcome Measure Data

    Analysis Population Description
    all randomized participants having both baseline and at least one post-baseline data measurement
    Arm/Group Title Placebo Tadalafil
    Arm/Group Description Placebo tablet taken by mouth once a day for 12 weeks 5 mg tadalafil tablet taken by mouth once a day for 12 weeks
    Measure Participants 74 251
    Question 4 change from baseline in percent "Yes"
    12.08
    (3.936)
    50.05
    (2.283)
    Question 5 change from baseline in percent "Yes"
    11.47
    (3.951)
    48.78
    (2.292)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Tadalafil
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments p-value for SEP Question 4
    Method ANCOVA
    Comments Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p<0.10.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Tadalafil
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments p-value for SEP Question 5
    Method ANCOVA
    Comments Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p<0.10.
    8. Secondary Outcome
    Title Change From Baseline to 12 Week Endpoint in Percent of "Yes" Responses to Partner-Sexual Encounter Profile (SEP) Question 3 - Partner Response
    Description The baseline and endpoint score for partner SEP question 3 (Satisfied overall) are the partner's percentage of "yes" responses to the question during the run-in period and postbaseline period, respectively.
    Time Frame Baseline and 12 weeks

    Outcome Measure Data

    Analysis Population Description
    all randomized participants having both baseline and at least one post-baseline data measurement
    Arm/Group Title Placebo Tadalafil
    Arm/Group Description Placebo tablet taken by mouth once a day for 12 weeks 5 mg tadalafil tablet taken by mouth once a day for 12 weeks
    Measure Participants 73 250
    Least Squares Mean (Standard Error) [percent]
    10.21
    (3.595)
    43.16
    (2.072)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Tadalafil
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method ANCOVA
    Comments Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p<0.10.
    9. Secondary Outcome
    Title Change From Baseline to 12 Week Endpoint in the Satisfaction Domain of the Female Sexual Function Index (FSFI) - Partner Response
    Description The FSFI Satisfaction Domain (items 14-16) measures satisfaction with emotional closeness, sexual relationship, and overall sexual life. Each question is scored on a 0/1 to 5 scale and domain score is calculated by multiplying the total points by 0.4, for a total score range of 0.8 to 6, with higher scores indicating greater satisfaction.
    Time Frame Baseline and 12 weeks

    Outcome Measure Data

    Analysis Population Description
    last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement
    Arm/Group Title Placebo Tadalafil
    Arm/Group Description Placebo tablet taken by mouth once a day for 12 weeks 5 mg tadalafil tablet taken by mouth once a day for 12 weeks
    Measure Participants 70 238
    Least Squares Mean (Standard Error) [units on a scale]
    -0.40
    (0.130)
    0.32
    (0.075)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Tadalafil
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method ANCOVA
    Comments Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p<0.10.
    10. Secondary Outcome
    Title Percent of Subjects With "Yes" Responses to Global Assessment Questionnaire (GAQ) - Subject Response
    Description Percent of subjects with "Yes" responses to Question 1 (Improvement in Erections) and Question 2 (Improvement in the Ability to Engage in Sexual Activity)
    Time Frame 12 weeks

    Outcome Measure Data

    Analysis Population Description
    all randomized participants having post-baseline data measurement on this variable
    Arm/Group Title Placebo Tadalafil
    Arm/Group Description Placebo tablet taken by mouth once a day for 12 weeks 5 mg tadalafil tablet taken by mouth once a day for 12 weeks
    Measure Participants 72 244
    GAQ Question 1
    26
    81
    GAQ Question 2
    22
    79
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Tadalafil
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for GAQ Question 1
    Method Regression, Logistic
    Comments Model included:treatment, baseline value of IIEF EF Domain, pooled site. Baseline-value-by-treatment interaction included if interaction at p<0.10
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Tadalafil
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for GAQ Question 2
    Method Regression, Logistic
    Comments Model included:treatment, baseline value of IIEF EF Domain, pooled site. Baseline-value-by-treatment interaction included if interaction at p<0.10
    11. Secondary Outcome
    Title Percent of Partners With "Yes" Responses to Global Assessment Questionnaire (GAQ) - Partner Response
    Description Percent of Partners with "Yes" responses to Question 1 (Improvement in Erections) and Question 2 (Improvement in the Ability to Engage in Sexual Activity)
    Time Frame 12 weeks

    Outcome Measure Data

    Analysis Population Description
    all randomized participants having post-baseline data measurement on this variable
    Arm/Group Title Placebo Tadalafil
    Arm/Group Description Placebo tablet taken by mouth once a day for 12 weeks 5 mg tadalafil tablet taken by mouth once a day for 12 weeks
    Measure Participants 70 238
    GAQ Question 1
    30
    79
    GAQ Question 2
    24
    76
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Tadalafil
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for GAQ Question 1
    Method Regression, Logistic
    Comments Model included:treatment, baseline value of IIEF EF Domain, pooled site. Baseline-value-by-treatment interaction included if interaction at p<0.10
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Tadalafil
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for GAQ Question 2
    Method Regression, Logistic
    Comments Model included:treatment, baseline value of IIEF EF Domain, pooled site. Baseline-value-by-treatment interaction included if interaction at p<0.10
    12. Secondary Outcome
    Title Change From Baseline to 12 Week Endpoint in Percent of "Yes" Responses to Partner-Sexual Encounter Profile (SEP) Questions 1 and 2 - Partner Response
    Description The baseline and endpoint score for each SEP question 1 (Achieve some erection) and 2 (Insert penis into vagina) are the partner's percentage of "yes" responses to those questions during the run-in period and postbaseline period, respectively.
    Time Frame Baseline and 12 weeks

    Outcome Measure Data

    Analysis Population Description
    all randomized participants having both baseline and at least one post-baseline data measurement
    Arm/Group Title Placebo Tadalafil
    Arm/Group Description Placebo tablet taken by mouth once a day for 12 weeks 5 mg tadalafil tablet taken by mouth once a day for 12 weeks
    Measure Participants 73 250
    Question 1 change from baseline in percent "Yes"
    1.25
    (2.224)
    18.34
    (1.270)
    Question 2 change from baseline in percent "Yes"
    6.97
    (2.896)
    30.69
    (1.662)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Tadalafil
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for SEP Question 1
    Method ANCOVA
    Comments Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p<0.10.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Tadalafil
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for SEP Question 2
    Method ANCOVA
    Comments Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p<0.10.
    13. Secondary Outcome
    Title Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire
    Description Measures improvement in self-esteem and relationship satisfaction. Questionnaire consists of two domains, Sexual Relationship (items 1-8) and Confidence (items 9-14). Overall score is transformed onto a 0 (least favorable) to 100 (most favorable) scale. Overall score was calculated from two domains and subscales scores.
    Time Frame Baseline and 12 weeks

    Outcome Measure Data

    Analysis Population Description
    last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement
    Arm/Group Title Placebo Tadalafil
    Arm/Group Description Placebo tablet taken by mouth once a day for 12 weeks 5 mg tadalafil tablet taken by mouth once a day for 12 weeks
    Measure Participants 72 244
    Total Score change from baseline
    3.07
    (2.616)
    30.44
    (1.506)
    Sexual Relationship change from baseline
    4.61
    (2.903)
    34.28
    (1.673)
    Confidence change from baseline
    0.91
    (2.567)
    25.35
    (1.475)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Tadalafil
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for SEAR Total Score
    Method ANCOVA
    Comments Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p<0.10.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Tadalafil
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for SEAR Sexual Relationship
    Method ANCOVA
    Comments Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p<0.10.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Tadalafil
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for SEAR Confidence
    Method ANCOVA
    Comments Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p<0.10.
    14. Secondary Outcome
    Title Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire - Confidence Domain Subscales
    Description Measures improvement in confidence (items 9-14). Confidence domain consists of two subscales (Self-Esteem, items 9-12; Overall Relationship, items 13 and 14). Each domain score, subscale score, and overall score are transformed onto a 0 (least favorable) to 100 (most favorable) scale.
    Time Frame Baseline and 12 weeks

    Outcome Measure Data

    Analysis Population Description
    last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement
    Arm/Group Title Placebo Tadalafil
    Arm/Group Description Placebo tablet taken by mouth once a day for 12 weeks 5 mg tadalafil tablet taken by mouth once a day for 12 weeks
    Measure Participants 72 244
    Self-Esteem change from baseline
    3.26
    (2.743)
    29.56
    (1.579)
    Overall Relationship change from baseline
    -4.04
    (2.792)
    16.97
    (1.603)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Tadalafil
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for SEAR Self-Esteem
    Method ANCOVA
    Comments Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p<0.10.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Tadalafil
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value is for SEAR Overall Relationship
    Method ANCOVA
    Comments Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p<0.10.

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Placebo Tadalafil
    Arm/Group Description Placebo tablet taken by mouth once a day for 12 weeks 5 mg tadalafil tablet taken by mouth once a day for 12 weeks
    All Cause Mortality
    Placebo Tadalafil
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Placebo Tadalafil
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/ (NaN) 3/ (NaN)
    Gastrointestinal disorders
    Pancreatitis 1/78 (1.3%) 1 0/264 (0%) 0
    Immune system disorders
    Hypersensitivity 0/78 (0%) 0 1/264 (0.4%) 1
    Infections and infestations
    Gastroenteritis 0/78 (0%) 0 1/264 (0.4%) 1
    Nervous system disorders
    Cerebrovascular accident 0/78 (0%) 0 1/264 (0.4%) 1
    Other (Not Including Serious) Adverse Events
    Placebo Tadalafil
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 21/ (NaN) 77/ (NaN)
    Ear and labyrinth disorders
    Hypoacusis 0/78 (0%) 0 1/264 (0.4%) 1
    Endocrine disorders
    Hypogonadism 0/78 (0%) 0 1/264 (0.4%) 1
    Eye disorders
    Blepharitis 0/78 (0%) 0 1/264 (0.4%) 1
    Conjunctivitis 0/78 (0%) 0 1/264 (0.4%) 1
    Gastrointestinal disorders
    Abdominal pain upper 0/78 (0%) 0 1/264 (0.4%) 1
    Constipation 1/78 (1.3%) 1 0/264 (0%) 0
    Diarrhoea 1/78 (1.3%) 1 5/264 (1.9%) 5
    Dry mouth 1/78 (1.3%) 1 0/264 (0%) 0
    Dyspepsia 0/78 (0%) 0 12/264 (4.5%) 13
    Dysphagia 0/78 (0%) 0 1/264 (0.4%) 1
    Gastritis 0/78 (0%) 0 2/264 (0.8%) 2
    Gastrooesophageal reflux disease 0/78 (0%) 0 5/264 (1.9%) 5
    Hiatus hernia 0/78 (0%) 0 1/264 (0.4%) 1
    Nausea 0/78 (0%) 0 3/264 (1.1%) 3
    Toothache 0/78 (0%) 0 1/264 (0.4%) 1
    Vomiting 1/78 (1.3%) 1 2/264 (0.8%) 2
    General disorders
    Chest pain 0/78 (0%) 0 1/264 (0.4%) 1
    Discomfort 0/78 (0%) 0 1/264 (0.4%) 1
    Fatigue 2/78 (2.6%) 2 0/264 (0%) 0
    Oedema mucosal 0/78 (0%) 0 1/264 (0.4%) 1
    Pyrexia 0/78 (0%) 0 1/264 (0.4%) 1
    Immune system disorders
    Drug hypersensitivity 1/78 (1.3%) 1 0/264 (0%) 0
    Infections and infestations
    Amoebic dysentery 0/78 (0%) 0 1/264 (0.4%) 1
    Anogenital warts 0/78 (0%) 0 1/264 (0.4%) 1
    Bronchitis 1/78 (1.3%) 1 0/264 (0%) 0
    Gastroenteritis 3/78 (3.8%) 3 2/264 (0.8%) 3
    Herpes simplex 1/78 (1.3%) 1 0/264 (0%) 0
    Herpes zoster 0/78 (0%) 0 1/264 (0.4%) 1
    Influenza 0/78 (0%) 0 2/264 (0.8%) 2
    Nasopharyngitis 0/78 (0%) 0 2/264 (0.8%) 2
    Onychomycosis 0/78 (0%) 0 1/264 (0.4%) 1
    Oral herpes 0/78 (0%) 0 1/264 (0.4%) 1
    Pharyngitis 1/78 (1.3%) 1 3/264 (1.1%) 4
    Rhinitis 0/78 (0%) 0 3/264 (1.1%) 3
    Sinusitis 1/78 (1.3%) 1 0/264 (0%) 0
    Tonsillitis 1/78 (1.3%) 1 3/264 (1.1%) 3
    Tooth infection 1/78 (1.3%) 1 0/264 (0%) 0
    Injury, poisoning and procedural complications
    Wound 0/78 (0%) 0 1/264 (0.4%) 1
    Metabolism and nutrition disorders
    Diabetes mellitus 1/78 (1.3%) 1 0/264 (0%) 0
    Diabetes mellitus non-insulin-dependent 1/78 (1.3%) 1 0/264 (0%) 0
    Gout 0/78 (0%) 0 1/264 (0.4%) 1
    Hypertriglyceridaemia 1/78 (1.3%) 1 0/264 (0%) 0
    Obesity 0/78 (0%) 0 1/264 (0.4%) 1
    Musculoskeletal and connective tissue disorders
    Arthralgia 0/78 (0%) 0 1/264 (0.4%) 1
    Back pain 1/78 (1.3%) 2 5/264 (1.9%) 5
    Muscle spasms 1/78 (1.3%) 1 3/264 (1.1%) 3
    Musculoskeletal pain 1/78 (1.3%) 1 0/264 (0%) 0
    Myalgia 0/78 (0%) 0 4/264 (1.5%) 4
    Osteoarthritis 0/78 (0%) 0 1/264 (0.4%) 1
    Pain in extremity 0/78 (0%) 0 5/264 (1.9%) 5
    Nervous system disorders
    Dizziness 1/78 (1.3%) 1 1/264 (0.4%) 1
    Headache 3/78 (3.8%) 4 22/264 (8.3%) 26
    Hypoaesthesia 0/78 (0%) 0 1/264 (0.4%) 1
    Sciatica 0/78 (0%) 0 1/264 (0.4%) 1
    Pregnancy, puerperium and perinatal conditions
    Pregnancy 0/78 (0%) 0 1/264 (0.4%) 1
    Psychiatric disorders
    Anxiety 0/78 (0%) 0 1/264 (0.4%) 1
    Insomnia 1/78 (1.3%) 1 0/264 (0%) 0
    Libido decreased 0/78 (0%) 0 1/264 (0.4%) 1
    Renal and urinary disorders
    Pollakiuria 0/78 (0%) 0 1/264 (0.4%) 1
    Reproductive system and breast disorders
    Ejaculation delayed 0/78 (0%) 0 1/264 (0.4%) 1
    Gynaecomastia 0/78 (0%) 0 1/264 (0.4%) 1
    Hypoaesthesia of genital male 0/78 (0%) 0 1/264 (0.4%) 1
    Painful erection 0/78 (0%) 0 1/264 (0.4%) 2
    Testicular pain 1/78 (1.3%) 1 0/264 (0%) 0
    Varicocele 0/78 (0%) 0 1/264 (0.4%) 1
    Respiratory, thoracic and mediastinal disorders
    Cough 1/78 (1.3%) 1 1/264 (0.4%) 1
    Dyspnoea 0/78 (0%) 0 1/264 (0.4%) 1
    Hiccups 0/78 (0%) 0 1/264 (0.4%) 1
    Nasal congestion 0/78 (0%) 0 7/264 (2.7%) 9
    Skin and subcutaneous tissue disorders
    Erythema 1/78 (1.3%) 1 1/264 (0.4%) 1
    Hyperhidrosis 1/78 (1.3%) 1 0/264 (0%) 0
    Rash 0/78 (0%) 0 1/264 (0.4%) 1
    Surgical and medical procedures
    Dental prosthesis placement 0/78 (0%) 0 1/264 (0.4%) 1
    Vascular disorders
    Hot flush 0/78 (0%) 0 2/264 (0.8%) 2
    Hypertension 0/78 (0%) 0 3/264 (1.1%) 3
    Hypotension 1/78 (1.3%) 1 0/264 (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 1-800-545-5979
    Email
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00422734
    Other Study ID Numbers:
    • 9501
    • H6D-MC-LVGH
    First Posted:
    Jan 17, 2007
    Last Update Posted:
    Jun 10, 2009
    Last Verified:
    Jun 1, 2009