A Study of LY900010 in Erectile Dysfunction | NCT01160289 | Trialant
NCT01160289
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Apr 9, 2019Actual
Enrollment
410Actual
Phase
Phase 2
Conditions
Erectile Dysfunction
Interventions
LY2452473
tadalafil
placebo (tadalafil)
placebo (LY2452473)
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT01160289
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
11888
Secondary IDs
ID
Type
Description
Link
I4K-MC-GPEC
Other Identifier
Eli Lilly and Company
Brief Title
A Study of LY900010 in Erectile Dysfunction
Official Title
A Study of LY900010 (LY2452473 + Tadalafil) in the Treatment of Men With Erectile Dysfunction
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Mar 2019
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 2010
Primary Completion Date
Nov 2011Actual
Completion Date
Nov 2011Actual
First Submitted Date
Jul 8, 2010
First Submission Date that Met QC Criteria
Jul 8, 2010
First Posted Date
Jul 12, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 11, 2019
Results First Submitted that Met QC Criteria
Mar 11, 2019
Results First Posted Date
Apr 9, 2019Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Feb 10, 2012
Certification/Extension First Submitted that Passed QC Review
Feb 10, 2012
Certification/Extension First Posted Date
Feb 14, 2012Estimated
Last Update Submitted Date
Mar 11, 2019
Last Update Posted Date
Apr 9, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The primary purpose of the study is to compare the efficacy of LY2452473 + tadalafil to tadalafil alone in improving the erectile function (EF) of men with erectile dysfunction (ED) who incompletely respond to tadalafil alone.
Detailed Description
Not provided
Conditions Module
Conditions
Erectile Dysfunction
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
410Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
1 milligram (mg) LY2452473 + 5 mg tadalafil
Experimental
Drug: LY2452473
Drug: tadalafil
Drug: placebo (tadalafil)
5 mg LY2452473 + 5 mg tadalafil
Experimental
Drug: LY2452473
Drug: tadalafil
Drug: placebo (tadalafil)
5 mg LY2452473 + placebo
Experimental
Drug: LY2452473
Drug: placebo (tadalafil)
10 mg tadalafil + placebo
Active Comparator
Drug: tadalafil
Drug: placebo (tadalafil)
Drug: placebo (LY2452473)
5 mg tadalafil + placebo
Active Comparator
Drug: tadalafil
Drug: placebo (tadalafil)
Drug: placebo (LY2452473)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
LY2452473
Drug
Administered orally, once daily for 12 weeks
1 milligram (mg) LY2452473 + 5 mg tadalafil
5 mg LY2452473 + 5 mg tadalafil
5 mg LY2452473 + placebo
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain Score
The IIEF EF domain score was the sum of Questions (Q) 1 to Q5 and Q15 of the IIEF self-reported questionnaire. Q1 to Q5 were rated 0 (low/no EF) to 5 (high EF) and Q15 was rated 1 (no/low confidence) to 5 (high confidence). IIEF EF domain scores ranged from 1 to 30. Higher scores denoted better EF.
Baseline, Week 12
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline to 12 Week Endpoint in the Percentage of "Yes" Responses on the Sexual Encounter Profile (SEP) Diary
The SEP diary was a participant-assessed diary with 5 questions (Q): Q1 (erection achievement), 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 to Q5 scores were determined as a percentage of "Yes" responses to each of the 5 questions out of all sexual attempts recorded during the time period. A higher percentage of "Yes" responses indicated better EF. Assessed was the mean change from baseline in the percentage of "Yes" responses to the SEP diary Q1 to Q5. The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment*visit, baseline, baseline*treatment (if p-value <0.25).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria include:
Ambulatory men
History of erectile dysfunction of at least 3 months duration
History of incomplete response to any phosphodiesterase type 5 inhibitor (PDE5i) at the maximum tolerated dose within the label
Anticipate having the same female sexual partner throughout the duration of the study
Are willing and able to make at least 4 sexual intercourse attempts with the female sexual partner during each 4-week segment of the study
Agree to use birth control during the study and for 60 days after the study, unless the female partner is postmenopausal
Agree not to use any other erectile dysfunction treatment, including herbal treatment, during the study and for 96 hours after the last dose of study drug
Screening laboratory tests within normal limits except for testosterone
Without a language barrier, are reliable and willing to follow study procedures
Prostate-specific antigen (PSA) less than 10 nanograms per milliliter (ng/ml). Men with PSA greater than 4 and less than 10 ng/ml must have documentation of a negative histological biopsy of carcinoma of prostate within 12 months prior to screening
Exclusion Criteria include:
History of penile implant
History of no response to injection therapy for erectile dysfunction
History of radical prostatectomy or other pelvic surgery with subsequent failure to achieve any erection
Exhibit the presence of clinically significant penile deformity in the opinion of the investigator
History of prior sexual legal convictions
Bilateral hip replacements
History of cancer within the previous 5 years, except for excised superficial lesions such as basal cell carcinoma and squamous cell carcinoma of the skin
Chronic stable angina currently treated with long-acting nitrates
Chronic stable angina requiring treatment with short-acting nitrates within 90 days prior to screening
Angina occurring during sexual intercourse in the 6 months prior to screening
Unstable angina within 6 months prior to screening
Myocardial infarction or coronary artery bypass graft surgery within 90 days prior to screening
Angioplasty or stent placement within 90 days prior to screening
Congestive heart failure within 6 months prior to screening
History of sudden cardiac arrest
Supraventricular arrhythmia with an uncontrolled ventricular response at rest, or any history of spontaneous or induced sustained ventricular tachycardia, or use an automatic internal cardioverter-defibrillator
An abnormality in the 12-lead electrocardiogram (ECG) that in the opinion of the investigator places the subject in an unacceptable risk for study participation
Systolic blood pressure greater than 170 or less than 90 millimeters of mercury (mm Hg) or diastolic blood pressure greater than 100 or less than 50 mm Hg at screening
Hepatic, renal, human immunodeficiency virus (HIV), or clinically significant active neuropsychiatric disease
History of central nervous system injuries (including stroke or spinal cord injury) within 6 months prior to screening
Alcohol intake of 5 units or greater per day (1 unit = 12 ounces beer, 5 ounces wine, or 1.5 ounces of 80-proof distilled spirits)
Receiving treatment with antiandrogens or 5-alpha reductase inhibitor
Anabolic steroids, calcitonin, oral bisphosphonates, Vitamin D greater than 50,000 international units per week (IU/week), dehydroepiandrosterone (DHEA), steroidal supplements, nutritional products intended to have weight reduction or performance enhancing effects, herbal supplements within 7 days prior to screening
Currently treated with a potent cytochrome P450 (CYP) 3A4 inhibitor, such as systemic ketoconazole or ritonavir, or a CYP3A4 inducer such as rifampicin
Accepts Healthy Volunteers
No
Sex
Male
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
45 Years
Maximum Age
70 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
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 Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
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.
Birmingham
Alabama
35209
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
The study had 2 periods. Period 1: a screening, a 4-week washout, and a 4-week lead-in period prior to randomization. Period 2: a 12-week treatment and a 4-week follow-up period, post-randomization.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
All Screened Subjects
After screening but prior to randomization, subjects completed a 4-week washout and a 4-week tadalafil [5-milligram (mg) tablet, administered orally, once daily] lead-in period.
FG001
1 mg LY2452473 and 5 mg Tadalafil
Periods
Title
Milestones
Reasons Not Completed
Screening, Washout, and Lead-In Period
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
1
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
tadalafil
Drug
Administered orally, once daily for 12 weeks
1 milligram (mg) LY2452473 + 5 mg tadalafil
10 mg tadalafil + placebo
5 mg LY2452473 + 5 mg tadalafil
5 mg tadalafil + placebo
placebo (tadalafil)
Drug
Administered orally, once daily for 12 weeks
1 milligram (mg) LY2452473 + 5 mg tadalafil
10 mg tadalafil + placebo
5 mg LY2452473 + 5 mg tadalafil
5 mg LY2452473 + placebo
5 mg tadalafil + placebo
placebo (LY2452473)
Drug
Administered orally, once daily for 12 weeks
10 mg tadalafil + placebo
5 mg tadalafil + placebo
Baseline, Week 12
Change From Baseline to 12 Week Endpoint in IIEF Domain Scores (Intercourse Satisfaction, Orgasmic Function, Sexual Desire, and Overall Satisfaction)
Intercourse Satisfaction (IS) domain score: sum of Questions (Q) 6, Q7, and Q8, each rated 0 (low/no satisfaction) to 5 (high satisfaction). IS domain score range: 0 to 15; lower scores denoted lower satisfaction. Orgasmic Function (OF) domain score: sum of Q9 and Q10, each rated 0 (no sexual stimulation) to 5 (almost always/always). OF domain score range: 0 to 10; lower scores denoted lower OF. Sexual Desire (SD) domain score: sum of Q11 and Q12, each rated 1 (almost never or low/no sexual desire) to 5 (almost always or very high sexual desire). SD domain score range: 2 to 10; lower scores denoted lower SD. Overall Satisfaction (OS) domain score: sum of Q13 and Q14, each rated 1 (low/no satisfaction) to 5 (high satisfaction). OS domain score range: 2 to 10; lower scores denoted lower OS. Least squares (LS) mean estimated from repeated measures analysis of variance model that included terms for treatment, visit, treatment*visit, baseline, baseline*treatment (if p-value<0.25).
Baseline, Week 12
Change From Baseline to 12 Week Endpoint in the Percentage of Participants Who Return to "Normal" on the International Index of Erectile Function (IIEF) Scale (EF>25)
The percentage of participants whose IIEF Erectile Function (EF) domain scores changed from ≤25 at baseline to >25 (normal) at Week 12. The IIEF EF domain score was the sum of IIEF Question (Q) 1 to Q5 and Q15. Q1 to Q5 were rated 0 (low/no EF) to 5 (high EF) and Q15 was rated 1 (no/low confidence) to 5 (high confidence). IIEF EF domain scores ranged from 1 to 30. Higher scores denoted better EF.
Baseline, Week 12
Change From Baseline to 12 Week Endpoint in IIEF EF Domain Score Reported by Testosterone Concentration Subgroups
The International Index of Erectile Function (IIEF) EF was the sum of Questions (Q) 1 to Q5 and Q15 of the IIEF Self-reported questionnaire. Q1 to Q5 were rated 0 (low/no erectile function) to 5 (high erectile function) and Q15 was rated 1 (no/low confidence) to 5 (high confidence). IIEF EF domain scores ranged from 1 to 30. Higher scores denoted better EF. Testosterone concentration subgroups were based on optimal baseline testosterone levels (<340 nanograms per deciliter [ng/dL] or ≥340 ng/dL). The least squares (LS) mean was estimated from an analysis of covariance (ANCOVA) model that included terms for treatment group, baseline, and baseline*treatment interaction (if p-value<0.25).
Baseline, Week 12
Change From Baseline to 12 Week Endpoint in Prostate-Specific Antigen (PSA)
The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment*visit, baseline, baseline*treatment (if p-value<0.25).
Baseline, Week 12
Change From Baseline to 12 Week Endpoint in Total Cholesterol and Triglycerides
The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment*visit, baseline, baseline*treatment (if p-value<0.25).
Baseline, Week 12
Percent Change From Baseline to 12 Week Endpoint in High-Density Lipoprotein Cholesterol (HDL-C) and Low-Density Lipoprotein Cholesterol (LDL-C)
The least squares (LS) was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment*visit, baseline, baseline*treatment (if p-value<0.25).
Baseline, Week 12
Change From Baseline to 12 Week Endpoint in Fasting Glucose
The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment*visit, baseline, baseline*treatment (if p-value<0.25).
Baseline, Week 12
Change From Baseline to 12 Week Endpoint in Fasting Insulin
Change from baseline to 12 Week endpoint in fasting blood insulin concentration. The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment*visit, baseline, baseline*treatment (if p-value<0.25).
Baseline, Week 12
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Phoenix
Arizona
85050
United States
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Glendora
California
91741
United States
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Irvine
California
92618
United States
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Long Beach
California
90806
United States
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Newport Beach
California
92660
United States
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Sacramento
California
95825
United States
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San Diego
California
92120
United States
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Vacaville
California
95688
United States
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Denver
Colorado
80220
United States
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Englewood
Colorado
80113
United States
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Aventura
Florida
33180
United States
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Celebration
Florida
34747
United States
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Coral Springs
Florida
33065
United States
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Jacksonville
Florida
32209
United States
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Plantation
Florida
33317
United States
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Coeur d'Alene
Idaho
83814
United States
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Indianapolis
Indiana
46256
United States
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Des Moines
Iowa
50314
United States
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Overland Park
Kansas
66215
United States
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Topeka
Kansas
66606
United States
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Shreveport
Louisiana
71106
United States
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Troy
Michigan
48084
United States
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St Louis
Missouri
63141
United States
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Las Vegas
Nevada
89117
United States
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Cary
North Carolina
27511
United States
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Charlotte
North Carolina
28207
United States
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Raleigh
North Carolina
27607
United States
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Salisbury
North Carolina
28144
United States
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Edmond
Oklahoma
73034
United States
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Knoxville
Tennessee
37920
United States
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Dallas
Texas
75234
United States
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San Antonio
Texas
78229
United States
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Bellevue
Washington
98007
United States
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Olympia
Washington
98502
United States
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Spokane
Washington
99202
United States
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
LY2452473 1-mg capsule
tadalafil 5-mg tablet
placebo 10-mg tablet (matching tadalafil)
FG002
5 mg LY2452473 and 5 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
LY2452473 5-mg capsule
tadalafil 5-mg tablet
placebo 10-mg tablet (matching tadalafil)
FG003
5 mg LY2452473
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
LY2452473 5-mg capsule
placebo 5-mg tablet (matching tadalafil)
placebo 10-mg tablet (matching tadalafil)
FG004
10 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
tadalafil 10-mg tablet
placebo 5-mg capsule (matching LY2452473)
placebo 5-mg tablet (matching tadalafil)
FG005
5 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
tadalafil 5-mg tablet
placebo 5-mg capsule (matching LY2452473)
placebo 10-mg tablet (matching tadalafil)
FG000894 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
COMPLETED
FG000410 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
NOT COMPLETED
FG000484 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Type
Comment
Reasons
Adverse Event
FG0008 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Entry Criteria Not Met
FG000308 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lack of Efficacy
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0009 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG00026 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Randomization Criteria Not Met
FG00067 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG00064 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Post-Randomization Period
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG00185 subjects
FG00297 subjects
FG00352 subjects
FG00489 subjects
FG00587 subjects
Received at Least 1 Dose of Study Drug
FG0000 subjects
FG00185 subjects
FG00297 subjects
FG00352 subjects
COMPLETED
FG0000 subjects
FG00165 subjects
FG00273 subjects
FG00331 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG00120 subjects
FG00224 subjects
FG00321 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0014 subjects
FG0024 subjects
FG003
All randomized participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
1 mg LY2452473 and 5 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
LY2452473 1-mg capsule
tadalafil 5-mg tablet
placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
BG001
5 mg LY2452473 and 5 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
LY2452473 5-mg capsule
tadalafil 5-mg tablet
placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
BG002
5 mg LY2452473
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
LY2452473 5-mg capsule
placebo 5-mg tablet (matching tadalafil)
placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
BG003
10 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
tadalafil 10-mg tablet
placebo 5-mg capsule (matching LY2452473)
placebo 5-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
BG004
5 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
tadalafil 5-mg tablet
placebo 5-mg capsule (matching LY2452473)
placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00085
BG00197
BG00252
BG00389
BG00487
BG005410
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00059.7± 6.57
BG00160.7± 6.57
BG00258.7± 6.53
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0010
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0009
BG00113
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0001
BG0012
BG002
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
United States
Title
Measurements
BG00085
BG00197
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain Score
The IIEF EF domain score was the sum of Questions (Q) 1 to Q5 and Q15 of the IIEF self-reported questionnaire. Q1 to Q5 were rated 0 (low/no EF) to 5 (high EF) and Q15 was rated 1 (no/low confidence) to 5 (high confidence). IIEF EF domain scores ranged from 1 to 30. Higher scores denoted better EF.
Randomized participants who received at least 1 dose of study drug [intention-to-treat (ITT) population] and had non-missing IIEF EF domain scores at baseline and at Week 12; Last observation carried forward (LOCF) applied to statistical analyses.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Week 12
ID
Title
Description
OG000
1 mg LY2452473 and 5 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
LY2452473 1-mg capsule
tadalafil 5-mg tablet
placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
OG001
5 mg LY2452473 and 5 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
LY2452473 5-mg capsule
tadalafil 5-mg tablet
placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
OG002
5 mg LY2452473
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
LY2452473 5-mg capsule
placebo 5-mg tablet (matching tadalafil)
placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
OG003
10 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
tadalafil 10-mg tablet
placebo 5-mg capsule (matching LY2452473)
placebo 5-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
OG004
5 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
tadalafil 5-mg tablet
placebo 5-mg capsule (matching LY2452473)
placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
Units
Counts
Participants
OG00066
OG00174
OG00234
OG003
Title
Denominators
Categories
Title
Measurements
OG0002.515± 6.019(0.75 to 3.28)
OG0012.405± 6.920(0.88 to 3.27)
OG002-0.971± 6.699(0.7 to 3.27)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Only the treatment effects of 1 mg LY2452473 and 5 mg tadalafil versus 5 mg tadalafil and the treatment effects of 5 mg LY2452473 and 5 mg tadalafil versus 5 mg tadalafil were analyzed.
ANCOVA
Treatment group (tx grp), baseline IIEF EF domain score, baseline testosterone level, tx grp*baseline IIEF, tx grp*testosterone level interactions.
0.5
The p-value was 1-sided and adjusted for multiple comparisons. The level of significance was 1-sided of 0.04.
95
Superiority or Other
Secondary
Change From Baseline to 12 Week Endpoint in the Percentage of "Yes" Responses on the Sexual Encounter Profile (SEP) Diary
The SEP diary was a participant-assessed diary with 5 questions (Q): Q1 (erection achievement), 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 to Q5 scores were determined as a percentage of "Yes" responses to each of the 5 questions out of all sexual attempts recorded during the time period. A higher percentage of "Yes" responses indicated better EF. Assessed was the mean change from baseline in the percentage of "Yes" responses to the SEP diary Q1 to Q5. The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment*visit, baseline, baseline*treatment (if p-value <0.25).
Randomized participants who received at least 1 dose of study drug (ITT population) and had non-missing SEP diary data at baseline and at a post-baseline visit.
Posted
Least Squares Mean
Standard Error
percentage of "yes" responses
Baseline, Week 12
ID
Title
Description
OG000
1 mg LY2452473 and 5 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
LY2452473 1-mg capsule
tadalafil 5-mg tablet
placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
OG001
Secondary
Change From Baseline to 12 Week Endpoint in IIEF Domain Scores (Intercourse Satisfaction, Orgasmic Function, Sexual Desire, and Overall Satisfaction)
Intercourse Satisfaction (IS) domain score: sum of Questions (Q) 6, Q7, and Q8, each rated 0 (low/no satisfaction) to 5 (high satisfaction). IS domain score range: 0 to 15; lower scores denoted lower satisfaction. Orgasmic Function (OF) domain score: sum of Q9 and Q10, each rated 0 (no sexual stimulation) to 5 (almost always/always). OF domain score range: 0 to 10; lower scores denoted lower OF. Sexual Desire (SD) domain score: sum of Q11 and Q12, each rated 1 (almost never or low/no sexual desire) to 5 (almost always or very high sexual desire). SD domain score range: 2 to 10; lower scores denoted lower SD. Overall Satisfaction (OS) domain score: sum of Q13 and Q14, each rated 1 (low/no satisfaction) to 5 (high satisfaction). OS domain score range: 2 to 10; lower scores denoted lower OS. Least squares (LS) mean estimated from repeated measures analysis of variance model that included terms for treatment, visit, treatment*visit, baseline, baseline*treatment (if p-value<0.25).
Randomized participants who received at least 1 dose of study drug (ITT population) and had non-missing IIEF domain scores at baseline and at a post-baseline visit.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 12
ID
Title
Description
OG000
1 mg LY2452473 and 5 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
LY2452473 1-mg capsule
tadalafil 5-mg tablet
placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
Secondary
Change From Baseline to 12 Week Endpoint in the Percentage of Participants Who Return to "Normal" on the International Index of Erectile Function (IIEF) Scale (EF>25)
The percentage of participants whose IIEF Erectile Function (EF) domain scores changed from ≤25 at baseline to >25 (normal) at Week 12. The IIEF EF domain score was the sum of IIEF Question (Q) 1 to Q5 and Q15. Q1 to Q5 were rated 0 (low/no EF) to 5 (high EF) and Q15 was rated 1 (no/low confidence) to 5 (high confidence). IIEF EF domain scores ranged from 1 to 30. Higher scores denoted better EF.
Randomized participants who received at least 1 dose of study drug (ITT population).
Posted
Number
percentage of participants
Baseline, Week 12
ID
Title
Description
OG000
1 mg LY2452473 and 5 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
LY2452473 1-mg capsule
tadalafil 5-mg tablet
placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
OG001
5 mg LY2452473 and 5 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
LY2452473 5-mg capsule
tadalafil 5-mg tablet
placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
Secondary
Change From Baseline to 12 Week Endpoint in IIEF EF Domain Score Reported by Testosterone Concentration Subgroups
The International Index of Erectile Function (IIEF) EF was the sum of Questions (Q) 1 to Q5 and Q15 of the IIEF Self-reported questionnaire. Q1 to Q5 were rated 0 (low/no erectile function) to 5 (high erectile function) and Q15 was rated 1 (no/low confidence) to 5 (high confidence). IIEF EF domain scores ranged from 1 to 30. Higher scores denoted better EF. Testosterone concentration subgroups were based on optimal baseline testosterone levels (<340 nanograms per deciliter [ng/dL] or ≥340 ng/dL). The least squares (LS) mean was estimated from an analysis of covariance (ANCOVA) model that included terms for treatment group, baseline, and baseline*treatment interaction (if p-value<0.25).
Randomized participants who received at least 1 dose of study drug (ITT population) and had non-missing IIEF EF domain scores at baseline and at a post-baseline visit; Last observation carried forward (LOCF).
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 12
ID
Title
Description
OG000
1 mg LY2452473 and 5 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
LY2452473 1-mg capsule
tadalafil 5-mg tablet
placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
OG001
5 mg LY2452473 and 5 mg Tadalafil
Secondary
Change From Baseline to 12 Week Endpoint in Prostate-Specific Antigen (PSA)
The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment*visit, baseline, baseline*treatment (if p-value<0.25).
Randomized participants who received at least 1 dose of study drug (ITT population) and had non-missing PSA data at baseline and at a post-baseline visit.
Posted
Least Squares Mean
Standard Error
nanograms per milliliter (ng/mL)
Baseline, Week 12
ID
Title
Description
OG000
1 mg LY2452473 and 5 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
LY2452473 1-mg capsule
tadalafil 5-mg tablet
placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
OG001
5 mg LY2452473 and 5 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
LY2452473 5-mg capsule
tadalafil 5-mg tablet
placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
OG002
5 mg LY2452473
Secondary
Change From Baseline to 12 Week Endpoint in Total Cholesterol and Triglycerides
The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment*visit, baseline, baseline*treatment (if p-value<0.25).
Randomized participants who received at least 1 dose of study drug (ITT population) and had non-missing laboratory data (total cholesterol and triglycerides) at baseline and at a post-baseline visit.
Posted
Least Squares Mean
Standard Error
millimoles per Liter (mmol/L)
Baseline, Week 12
ID
Title
Description
OG000
1 mg LY2452473 and 5 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
LY2452473 1-mg capsule
tadalafil 5-mg tablet
placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
OG001
5 mg LY2452473 and 5 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
LY2452473 5-mg capsule
tadalafil 5-mg tablet
placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
OG002
Secondary
Percent Change From Baseline to 12 Week Endpoint in High-Density Lipoprotein Cholesterol (HDL-C) and Low-Density Lipoprotein Cholesterol (LDL-C)
The least squares (LS) was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment*visit, baseline, baseline*treatment (if p-value<0.25).
Randomized participants who received at least 1 dose of study drug (ITT population) and had non-missing laboratory data (HDL-C and LDL-C) at baseline and at a post-baseline visit.
Posted
Least Squares Mean
Standard Error
percent change
Baseline, Week 12
ID
Title
Description
OG000
1 mg LY2452473 and 5 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
LY2452473 1-mg capsule
tadalafil 5-mg tablet
placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
OG001
5 mg LY2452473 and 5 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
LY2452473 5-mg capsule
tadalafil 5-mg tablet
placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
Secondary
Change From Baseline to 12 Week Endpoint in Fasting Glucose
The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment*visit, baseline, baseline*treatment (if p-value<0.25).
All randomized participants who received at least 1 dose of study drug (ITT population) and had non-missing laboratory data (fasting glucose) at baseline and at a post-baseline visit.
Posted
Least Squares Mean
Standard Error
millimoles per Liter (mmol/L)
Baseline, Week 12
ID
Title
Description
OG000
1 mg LY2452473 and 5 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
LY2452473 1-mg capsule
tadalafil 5-mg tablet
placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
OG001
5 mg LY2452473 and 5 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
LY2452473 5-mg capsule
tadalafil 5-mg tablet
placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
OG002
Secondary
Change From Baseline to 12 Week Endpoint in Fasting Insulin
Change from baseline to 12 Week endpoint in fasting blood insulin concentration. The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment*visit, baseline, baseline*treatment (if p-value<0.25).
Randomized participants who received at least 1 dose of study drug (ITT population) and had non-missing laboratory data (fasting insulin) at baseline and at a post-baseline visit.
Posted
Least Squares Mean
Standard Error
milliunits per Liter (mU/L)
Baseline, Week 12
ID
Title
Description
OG000
1 mg LY2452473 and 5 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
LY2452473 1-mg capsule
tadalafil 5-mg tablet
placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
OG001
5 mg LY2452473 and 5 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
LY2452473 5-mg capsule
tadalafil 5-mg tablet
placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
Time Frame
Not provided
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
5 mg Tadalafil, Lead-in Period
5-mg tadalafil tablet, administered orally, once daily, during the 4-week lead-in period.
2
531
88
531
EG001
1 mg LY2452473 and 5 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
LY2452473 1-mg capsule
tadalafil 5-mg tablet
placebo 10-mg tablet (matching tadalafil)
2
85
27
85
EG002
5 mg LY2452473 and 5 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
LY2452473 5-mg capsule
tadalafil 5-mg tablet
placebo 10-mg tablet (matching tadalafil)
1
97
23
97
EG003
5 mg LY2452473
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
LY2452473 5-mg capsule
placebo 5-mg tablet (matching tadalafil)
placebo 10-mg tablet (matching tadalafil)
1
52
10
52
EG004
10 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
tadalafil 10-mg tablet
placebo 5-mg capsule (matching LY2452473)
placebo 5-mg tablet (matching tadalafil)
0
89
34
89
EG005
5 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
tadalafil 5-mg tablet
placebo 5-mg capsule (matching LY2452473)
placebo 10-mg tablet (matching tadalafil)
0
87
33
87
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Arrhythmia
Cardiac disorders
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected531 at risk
EG0010 events0 affected85 at risk
EG0021 events1 affected97 at risk
EG0030 events0 affected52 at risk
EG0040 events0 affected89 at risk
EG0050 events0 affected87 at risk
Cardiac arrest
Cardiac disorders
MedDRA 14.1
Systematic Assessment
Event resulted in death
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Hypertensive cardiomyopathy
Cardiac disorders
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Lobar pneumonia
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0011 events1 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0011 events1 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Tubulointerstitial nephritis
Renal and urinary disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0011 events1 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0011 events1 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0021 events1 affected97 at risk
EG0030 events0 affected52 at risk
EG0040 events0 affected89 at risk
EG0050 events0 affected87 at risk
Arrhythmia
Cardiac disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0021 events1 affected97 at risk
EG003
Bundle branch block right
Cardiac disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0021 events1 affected97 at risk
EG003
Cardiomegaly
Cardiac disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0011 events1 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Corneal erosion
Eye disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0021 events1 affected97 at risk
EG003
Eye swelling
Eye disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Vision blurred
Eye disorders
MedDRA 14.1
Systematic Assessment
EG0002 events2 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Barrett's oesophagus
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Colonic polyp
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0011 events1 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0003 events3 affected531 at risk
EG0011 events1 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0004 events4 affected531 at risk
EG0010 events0 affected85 at risk
EG0021 events1 affected97 at risk
EG003
Diverticulum
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0011 events1 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Diverticulum intestinal
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0006 events6 affected531 at risk
EG0011 events1 affected85 at risk
EG0021 events1 affected97 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0007 events7 affected531 at risk
EG0010 events0 affected85 at risk
EG0021 events1 affected97 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0002 events2 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0021 events1 affected97 at risk
EG003
Chest discomfort
General disorders
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected531 at risk
EG0010 events0 affected85 at risk
EG0021 events1 affected97 at risk
EG003
Chest pain
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0011 events1 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Fatigue
General disorders
MedDRA 14.1
Systematic Assessment
EG0004 events4 affected531 at risk
EG0010 events0 affected85 at risk
EG0022 events2 affected97 at risk
EG003
Irritability
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Oedema peripheral
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0011 events1 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Pain
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0011 events1 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Pyrexia
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0011 events1 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0021 events1 affected97 at risk
EG003
Candidiasis
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Ear infection
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Influenza
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected531 at risk
EG0011 events1 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Nail infection
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0005 events5 affected531 at risk
EG0013 events3 affected85 at risk
EG0021 events1 affected97 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0022 events1 affected97 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0012 events2 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0021 events1 affected97 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0021 events1 affected97 at risk
EG003
Tinea infection
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0002 events2 affected531 at risk
EG0011 events1 affected85 at risk
EG0022 events2 affected97 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Wound infection
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0011 events1 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0011 events1 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Corneal abrasion
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0021 events1 affected97 at risk
EG003
Excoriation
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0022 events1 affected97 at risk
EG003
Laceration
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0002 events2 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Muscle rupture
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0011 events1 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0011 events1 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Sunburn
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Blood creatine phosphokinase abnormal
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0011 events1 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 14.1
Systematic Assessment
EG0002 events2 affected531 at risk
EG0010 events0 affected85 at risk
EG0021 events1 affected97 at risk
EG003
Blood creatinine abnormal
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected531 at risk
EG0010 events0 affected85 at risk
EG0021 events1 affected97 at risk
EG003
Blood glucose increased
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0011 events1 affected85 at risk
EG0021 events1 affected97 at risk
EG003
Blood insulin increased
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0011 events1 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Blood testosterone abnormal
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0011 events1 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Blood urea abnormal
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Blood urea increased
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
C-reactive protein increased
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0021 events1 affected97 at risk
EG003
Colonoscopy
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Electrocardiogram qrs complex prolonged
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0011 events1 affected85 at risk
EG0020 events0 affected97 at risk
EG003
High density lipoprotein decreased
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Oestradiol increased
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0011 events1 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Prostatic specific antigen increased
Investigations
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected531 at risk
EG0011 events1 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Qrs axis abnormal
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Weight decreased
Investigations
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Weight increased
Investigations
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected531 at risk
EG0011 events1 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Vitamin d deficiency
Metabolism and nutrition disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0021 events1 affected97 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected531 at risk
EG0011 events1 affected85 at risk
EG0022 events2 affected97 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0011 events1 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0004 events4 affected531 at risk
EG0013 events3 affected85 at risk
EG0021 events1 affected97 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0003 events3 affected531 at risk
EG0013 events2 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Osteopenia
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0004 events3 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Osteoporosis
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0004 events4 affected531 at risk
EG0011 events1 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Sensation of heaviness
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Spinal disorder
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0011 events1 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Burning sensation
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0003 events3 affected531 at risk
EG0013 events2 affected85 at risk
EG0021 events1 affected97 at risk
EG003
Headache
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0009 events9 affected531 at risk
EG0013 events3 affected85 at risk
EG0021 events1 affected97 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0021 events1 affected97 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected531 at risk
EG0010 events0 affected85 at risk
EG0021 events1 affected97 at risk
EG003
Sinus headache
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0011 events1 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 14.1
Systematic Assessment
EG0002 events2 affected531 at risk
EG0011 events1 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0011 events1 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Epididymitis
Reproductive system and breast disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0011 events1 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Haematospermia
Reproductive system and breast disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Prostatitis
Reproductive system and breast disorders
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Varicocele
Reproductive system and breast disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0021 events1 affected97 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Bronchial hyperreactivity
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0011 events1 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected531 at risk
EG0010 events0 affected85 at risk
EG0021 events1 affected97 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0021 events1 affected97 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0003 events3 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Obstructive airways disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected531 at risk
EG0010 events0 affected85 at risk
EG0021 events1 affected97 at risk
EG003
Paranasal sinus hypersecretion
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0002 events2 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected531 at risk
EG0010 events0 affected85 at risk
EG0021 events1 affected97 at risk
EG003
Sinus disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Throat irritation
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0021 events1 affected97 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Diabetic bullosis
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0011 events1 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0022 events2 affected97 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected531 at risk
EG0011 events1 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Tooth extraction
Surgical and medical procedures
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Flushing
Vascular disorders
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected531 at risk
EG0011 events1 affected85 at risk
EG0021 events1 affected97 at risk
EG003
Haematoma
Vascular disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0011 events1 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Hypotension
Vascular disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Spider vein
Vascular disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected85 at risk
EG0020 events0 affected97 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
GT60
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Chief Medical Officer
Eli Lilly and Company
800-545-5979
ID
Term
D007172
Erectile Dysfunction
Ancestor Terms
ID
Term
D005832
Genital Diseases, Male
D000091662
Genital Diseases
D000091642
Urogenital Diseases
D012735
Sexual Dysfunction, Physiological
D052801
Male Urogenital Diseases
D020018
Sexual Dysfunctions, Psychological
D001523
Mental Disorders
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C582633
LY2452473
D000068581
Tadalafil
Ancestor Terms
ID
Term
D002243
Carbolines
D011725
Pyridines
D006573
Heterocyclic Compounds, 1-Ring
D006571
Heterocyclic Compounds
D026121
Indole Alkaloids
D007211
Indoles
D006574
Heterocyclic Compounds, 2-Ring
D000072471
Heterocyclic Compounds, Fused-Ring
D006575
Heterocyclic Compounds, 3-Ring
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
0 subjects
FG0050 subjects
0 subjects
FG0050 subjects
0 subjects
FG0050 subjects
0 subjects
FG0050 subjects
0 subjects
FG0050 subjects
0 subjects
FG0050 subjects
FG004
89 subjects
FG00587 subjects
80 subjects
FG00573 subjects
9 subjects
FG00514 subjects
2 subjects
FG0040 subjects
FG0050 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
Lack of Efficacy
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0033 subjects
FG0040 subjects
FG0050 subjects
Lost to Follow-up
FG0000 subjects
FG0013 subjects
FG0022 subjects
FG0035 subjects
FG0043 subjects
FG0054 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Protocol Violation
FG0000 subjects
FG0014 subjects
FG0022 subjects
FG0030 subjects
FG0041 subjects
FG0053 subjects
Withdrawal by Subject
FG0000 subjects
FG0015 subjects
FG00213 subjects
FG0038 subjects
FG0045 subjects
FG0057 subjects
Entry Criteria Not Met
FG0000 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG0040 subjects
FG0050 subjects
Sponsor Decision
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
59.4
± 6.54
BG00460.5± 6.68
BG00559.9± 6.59
0
BG0030
BG0040
BG0050
Male
BG00085
BG00197
BG00252
BG00389
BG00487
BG005410
3
BG00313
BG00410
BG00548
Not Hispanic or Latino
BG00076
BG00184
BG00249
BG00376
BG00477
BG005362
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
0
BG0032
BG0040
BG0055
Asian
BG0002
BG0012
BG0020
BG0032
BG0040
BG0056
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
Black or African American
BG00014
BG00117
BG0027
BG00313
BG0048
BG00559
White
BG00068
BG00176
BG00245
BG00372
BG00478
BG005339
More than one race
BG0000
BG0010
BG0020
BG0030
BG0041
BG0051
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
52
BG00389
BG00487
BG005410
83
OG00474
OG0033.530± 5.640
OG0042.054± 4.800(0.7 to 3.27)
OG001
OG004
Only the treatment effects of the treatment effects of 5 mg LY2452473 and 5 mg tadalafil versus 5 mg tadalafil and 1 mg LY2452473 and 5 mg tadalafil versus 5 mg tadalafil were analyzed.
ANCOVA
The model included tx grp, baseline IIEF EF domain score, baseline testosterone level, tx grp*baseline IIEF, tx grp*testosterone level interactions.
0.498
The p-value was 1-sided and adjusted for multiple comparisons. The level of significance was 1-sided of 0.04.
95
Superiority or Other
5 mg LY2452473 and 5 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
LY2452473 5-mg capsule
tadalafil 5-mg tablet
placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
OG002
5 mg LY2452473
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
LY2452473 5-mg capsule
placebo 5-mg tablet (matching tadalafil)
placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
OG003
10 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
tadalafil 10-mg tablet
placebo 5-mg capsule (matching LY2452473)
placebo 5-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
OG004
5 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
tadalafil 5-mg tablet
placebo 5-mg capsule (matching LY2452473)
placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
Units
Counts
Participants
OG00079
OG00186
OG00246
OG00388
OG00480
Title
Denominators
Categories
Question 1
Title
Measurements
OG000-0.247± 2.378
OG001-2.976± 2.295
OG002-10.711± 3.268
OG0034.427± 2.168
OG004-1.425± 2.305
Question 2
Title
Measurements
OG0003.175± 3.345
OG0013.689± 3.227
OG002-7.849± 4.566
OG003
Question 3
Title
Measurements
OG0009.296± 3.808
OG00111.752± 3.675
OG002-3.800± 5.195
OG003
Question 4
Title
Measurements
OG00012.935± 3.998
OG00113.910± 3.854
OG002-1.570± 5.454
OG003
Question 5
Title
Measurements
OG00013.602± 4.027
OG00115.196± 3.880
OG002-1.956± 5.488
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Mixed model repeated measures analysis
0.722
The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q1; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
1.178
Standard Error of the Mean
3.312
95
Superiority or Other
OG001
OG004
Mixed model repeated measures analysis
0.634
The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q1; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
-1.552
Standard Error of the Mean
3.253
95
Superiority or Other
OG000
OG003
Mixed model repeated measures analysis
0.147
The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q1; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
-4.674
Standard Error of the Mean
3.218
95
Superiority or Other
OG001
OG003
Mixed model repeated measures analysis
0.020
The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q1; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
-7.404
Standard Error of the Mean
3.157
95
Superiority or Other
OG000
OG004
Mixed model repeated measures analysis
0.775
The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q2; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
1.330
Standard Error of the Mean
4.658
95
Superiority or Other
OG001
OG004
Mixed model repeated measures analysis
0.687
The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q2; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
1.844
Standard Error of the Mean
4.573
95
Superiority or Other
OG000
OG003
Mixed model repeated measures analysis
0.119
The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q2; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
-7.092
Standard Error of the Mean
4.535
95
Superiority or Other
OG001
OG003
Mixed model repeated measures analysis
0.140
The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q2; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
-6.578
Standard Error of the Mean
4.450
95
Superiority or Other
OG000
OG004
Mixed model repeated measures analysis
0.207
The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q3; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
6.703
Standard Error of the Mean
5.302
95
Superiority or Other
OG001
OG004
Mixed model repeated measures analysis
0.079
The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q3; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
9.159
Standard Error of the Mean
5.206
95
Superiority or Other
OG000
OG003
Mixed model repeated measures analysis
0.301
The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q3; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
-5.349
Standard Error of the Mean
5.165
95
Superiority or Other
OG001
OG003
Mixed model repeated measures analysis
0.568
The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q3; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
-2.893
Standard Error of the Mean
5.067
95
Superiority or Other
OG000
OG004
Mixed model repeated measures analysis
0.464
The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q4; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
4.079
Standard Error of the Mean
5.566
95
Superiority or Other
OG001
OG004
Mixed model repeated measures analysis
0.356
The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q4; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
5.054
Standard Error of the Mean
5.463
95
Superiority or Other
OG000
OG003
Mixed model repeated measures analysis
0.038
The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q4; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
-11.266
Standard Error of the Mean
5.418
95
Superiority or Other
OG001
OG003
Mixed model repeated measures analysis
0.054
The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q4; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
-10.292
Standard Error of the Mean
5.312
95
Superiority or Other
OG000
OG004
Mixed model repeated measures analysis
0.454
The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q5; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
4.202
Standard Error of the Mean
5.603
95
Superiority or Other
OG001
OG004
Mixed model repeated measures analysis
0.293
The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q5; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
5.796
Standard Error of the Mean
5.499
95
Superiority or Other
OG000
OG003
Mixed model repeated measures analysis
0.107
The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q5; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
-8.808
Standard Error of the Mean
5.457
95
Superiority or Other
OG001
OG003
Mixed model repeated measures analysis
0.178
The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q5; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
-7.214
Standard Error of the Mean
5.349
95
Superiority or Other
OG001
5 mg LY2452473 and 5 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
LY2452473 5-mg capsule
tadalafil 5-mg tablet
placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
OG002
5 mg LY2452473
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
LY2452473 5-mg capsule
placebo 5-mg tablet (matching tadalafil)
placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
OG003
10 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
tadalafil 10-mg tablet
placebo 5-mg capsule (matching LY2452473)
placebo 5-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
OG004
5 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
tadalafil 5-mg tablet
placebo 5-mg capsule (matching LY2452473)
placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
Units
Counts
Participants
OG00080
OG00188
OG00248
OG00388
OG00481
Title
Denominators
Categories
Intercourse Satisfaction
ParticipantsOG00080
ParticipantsOG00188
ParticipantsOG00248
ParticipantsOG00388
ParticipantsOG00481
Title
Measurements
OG0000.475± 0.340
OG0010.514± 0.322
OG002-0.672± 0.463
OG003
Orgasmic Function
ParticipantsOG00080
ParticipantsOG00188
ParticipantsOG00248
ParticipantsOG00388
Sexual Desire
ParticipantsOG00080
ParticipantsOG00187
ParticipantsOG00248
ParticipantsOG00388
Overall Satisfaction
ParticipantsOG00080
ParticipantsOG00188
ParticipantsOG00248
ParticipantsOG00388
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Mixed model repeated measures analysis
0.867
The p-value is for the change from baseline to Week 12 in the IIEF IS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
-0.079
Standard Error of the Mean
0.472
95
Superiority or Other
OG001
OG004
Mixed model repeated measures analysis
0.931
The p-value is for the change from baseline to Week 12 in the IIEF IS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
-0.039
Standard Error of the Mean
0.458
95
Superiority or Other
OG000
OG003
Mixed model repeated measures analysis
0.158
The p-value is for the change from baseline to Week 12 in the IIEF IS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
-0.652
Standard Error of the Mean
0.460
95
Superiority or Other
OG001
OG003
Mixed model repeated measures analysis
0.172
The p-value is for the change from baseline to Week 12 in the IIEF IS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
-0.612
Standard Error of the Mean
0.447
95
Superiority or Other
OG000
OG004
Mixed model repeated measures analysis
0.579
The p-value is for the change from baseline to Week 12 in the IIEF OF domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
-0.223
Standard Error of the Mean
0.401
95
Superiority or Other
OG001
OG004
Mixed model repeated measures analysis
0.115
The p-value is for the change from baseline to Week 12 in the IIEF OF domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
-0.616
Standard Error of the Mean
0.390
95
Superiority or Other
OG000
OG003
Mixed model repeated measures analysis
0.668
The p-value is for the change from baseline to Week 12 in the IIEF OF domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
-0.168
Standard Error of the Mean
0.392
95
Superiority or Other
OG001
OG003
Mixed model repeated measures analysis
0.141
The p-value is for the change from baseline to Week 12 in the IIEF OF domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
-0.561
Standard Error of the Mean
0.380
95
Superiority or Other
OG000
OG004
Mixed model repeated measures analysis
0.734
The p-value is for the change from baseline to Week 12 in the IIEF SD domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
-0.088
Standard Error of the Mean
0.258
95
Superiority or Other
OG001
OG004
Mixed model repeated measures analysis
0.477
The p-value is for the change from baseline to Week 12 in the IIEF SD domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
-0.179
Standard Error of the Mean
0.251
95
Superiority or Other
OG000
OG003
Mixed model repeated measures analysis
0.235
The p-value is for the change from baseline to Week 12 in the IIEF SD domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
-0.300
Standard Error of the Mean
0.252
95
Superiority or Other
OG001
OG003
Mixed model repeated measures analysis
0.111
The p-value is for the change from baseline to Week 12 in the IIEF SD domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
-0.391
Standard Error of the Mean
0.245
95
Superiority or Other
OG000
OG004
Mixed model repeated measures analysis
0.310
The p-value is for the change from baseline to Week 12 in the IIEF OS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
-0.349
Standard Error of the Mean
0.343
95
Superiority or Other
OG001
OG004
Mixed model repeated measures analysis
0.090
The p-value is for the change from baseline to Week 12 in the IIEF OS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
-0.568
Standard Error of the Mean
0.334
95
Superiority or Other
OG000
OG003
Mixed model repeated measures analysis
0.030
The p-value is for the change from baseline to Week 12 in the IIEF OS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
-0.729
Standard Error of the Mean
0.335
95
Superiority or Other
OG001
OG003
Mixed model repeated measures analysis
0.004
The p-value is for the change from baseline to Week 12 in the IIEF OS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
-0.948
Standard Error of the Mean
0.326
95
Superiority or Other
OG002
5 mg LY2452473
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
LY2452473 5-mg capsule
placebo 5-mg tablet (matching tadalafil)
placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
OG003
10 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
tadalafil 10-mg tablet
placebo 5-mg capsule (matching LY2452473)
placebo 5-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
OG004
5 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
tadalafil 5-mg tablet
placebo 5-mg capsule (matching LY2452473)
placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
Units
Counts
Participants
OG00085
OG00197
OG00252
OG00389
OG00487
Title
Denominators
Categories
Title
Measurements
OG00024.7
OG00127.8
OG00213.5
OG00330.3
OG00427.6
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
LY2452473 5-mg capsule
tadalafil 5-mg tablet
placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
OG002
5 mg LY2452473
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
LY2452473 5-mg capsule
placebo 5-mg tablet (matching tadalafil)
placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
OG003
10 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
tadalafil 10-mg tablet
placebo 5-mg capsule (matching LY2452473)
placebo 5-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
OG004
5 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
tadalafil 5-mg tablet
placebo 5-mg capsule (matching LY2452473)
placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
Units
Counts
Participants
OG00080
OG00188
OG00248
OG00388
OG00481
Title
Denominators
Categories
Testosterone <340 ng/dL
ParticipantsOG00043
ParticipantsOG00154
ParticipantsOG00228
ParticipantsOG00354
ParticipantsOG00447
Title
Measurements
OG0002.523± 0.952
OG0011.012± 0.848
OG002-1.055± 1.223
OG003
Testosterone ≥340 ng/dL
ParticipantsOG00037
ParticipantsOG00134
ParticipantsOG00220
ParticipantsOG00334
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
ANCOVA
0.656
The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level <340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
Superiority or Other
OG001
OG004
ANCOVA
0.460
The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level <340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
Superiority or Other
OG000
OG003
ANCOVA
0.198
The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level <340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
95
Superiority or Other
OG001
OG003
ANCOVA
0.009
The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level ≥340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
95
Superiority or Other
OG000
OG004
ANCOVA
0.671
The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level ≥340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
Superiority or Other
OG001
OG004
ANCOVA
0.259
The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level ≥340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
Superiority or Other
OG000
OG003
ANCOVA
0.441
The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level ≥340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
95
Superiority or Other
OG001
OG003
ANCOVA
0.433
The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level ≥340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
95
Superiority or Other
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
LY2452473 5-mg capsule
placebo 5-mg tablet (matching tadalafil)
placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
OG003
10 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
tadalafil 10-mg tablet
placebo 5-mg capsule (matching LY2452473)
placebo 5-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
OG004
5 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
tadalafil 5-mg tablet
placebo 5-mg capsule (matching LY2452473)
placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
Units
Counts
Participants
OG00081
OG00189
OG00249
OG00387
OG00482
Title
Denominators
Categories
Title
Measurements
OG0000.162± 0.119
OG001-0.088± 0.109
OG0020.265± 0.157
OG0030.246± 0.107
OG0040.032± 0.111
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Mixed model repeated measures analysis
0.423
Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
0.130
95
Superiority or Other
OG001
OG004
Mixed model repeated measures analysis
0.443
Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
-0.120
95
Superiority or Other
OG000
OG003
Mixed model repeated measures analysis
0.599
Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
-0.084
95
Superiority or Other
OG001
OG003
Mixed model repeated measures analysis
0.029
Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
-0.334
95
Superiority or Other
5 mg LY2452473
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
LY2452473 5-mg capsule
placebo 5-mg tablet (matching tadalafil)
placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
OG003
10 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
tadalafil 10-mg tablet
placebo 5-mg capsule (matching LY2452473)
placebo 5-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
OG004
5 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
tadalafil 5-mg tablet
placebo 5-mg capsule (matching LY2452473)
placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
Units
Counts
Participants
OG00081
OG00190
OG00249
OG00388
OG00482
Title
Denominators
Categories
Total Cholesterol
Title
Measurements
OG000-0.210± 0.076
OG001-0.275± 0.071
OG002-0.282± 0.102
OG003-0.086± 0.069
OG004-0.059± 0.072
Triglycerides
Title
Measurements
OG000-0.155± 0.070
OG001-0.171± 0.066
OG002-0.067± 0.096
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Mixed model repeated measures analysis
0.148
The p-value is for the change from baseline to Week 12 in total cholesterol; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS Mean of treatment difference
-0.152
95
Superiority or Other
OG001
OG004
Mixed model repeated measures analysis
0.033
The p-value is for the change from baseline to Week 12 in total cholesterol; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
-0.216
95
Superiority or Other
OG000
OG003
Mixed model repeated measures analysis
0.224
The p-value is for the change from baseline to Week 12 in total cholesterol; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
-0.124
95
Superiority or Other
OG001
OG003
Mixed model repeated measures analysis
0.056
The p-value is for the change from baseline to Week 12 in total cholesterol; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
-0.189
95
Superiority or Other
OG000
OG004
Mixed model repeated measures analysis
0.031
The p-value is for the change from baseline to Week 12 in triglycerides; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
-0.211
95
Superiority or Other
OG001
OG004
Mixed model repeated measures analysis
0.017
The p-value is for the change from baseline to Week 12 in triglycerides; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
-0.227
95
Superiority or Other
OG000
OG003
Mixed model repeated measures analysis
0.866
The p-value is for the change from baseline to Week 12 in triglycerides; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
-0.016
95
Superiority or Other
OG001
OG003
Mixed model repeated measures analysis
0.726
The p-value is for the change from baseline to Week 12 in triglycerides; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
-0.032
95
Superiority or Other
OG002
5 mg LY2452473
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
LY2452473 5-mg capsule
placebo 5-mg tablet (matching tadalafil)
placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
OG003
10 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
tadalafil 10-mg tablet
placebo 5-mg capsule (matching LY2452473)
placebo 5-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
OG004
5 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
tadalafil 5-mg tablet
placebo 5-mg capsule (matching LY2452473)
placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
Units
Counts
Participants
OG00081
OG00190
OG00249
OG00388
OG00482
Title
Denominators
Categories
HDL-C
Title
Measurements
OG000-7.440± 1.658
OG001-16.974± 1.556
OG002-22.230± 2.243
OG0031.776± 1.505
OG0041.573± 1.585
LDL-C
Title
Measurements
OG000-1.695± 2.479
OG0010.062± 2.319
OG002-3.424± 3.365
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Mixed model repeated measures analysis
<0.001
The p-value is for the percent change from baseline to Week 12 in HDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS Mean of treatment difference
-9.014
95
Superiority or Other
OG001
OG004
Mixed model repeated measures analysis
<0.001
The p-value is for the percent change from baseline to Week 12 in HDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
-18.547
95
Superiority or Other
OG000
OG003
Mixed model repeated measures analysis
<0.001
The p-value is for the percent change from baseline to Week 12 in HDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
-9.216
95
Superiority or Other
OG001
OG003
Mixed model repeated measures analysis
<0.001
The p-value is for the percent change from baseline to Week 12 in HDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
-18.750
95
Superiority or Other
OG000
OG004
Mixed model repeated measures analysis
0.776
The p-value is for the percent change from baseline to Week 12 in LDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
-0.977
95
Superiority or Other
OG001
OG004
Mixed model repeated measures analysis
0.814
The p-value is for the percent change from baseline to Week 12 in LDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
0.780
95
Superiority or Other
OG000
OG003
Mixed model repeated measures analysis
0.627
The p-value is for the percent change from baseline to Week 12 in LDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
-1.629
95
Superiority or Other
OG001
OG003
Mixed model repeated measures analysis
0.968
The p-value is for the percent change from baseline to Week 12 in LDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
0.128
95
Superiority or Other
5 mg LY2452473
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
LY2452473 5-mg capsule
placebo 5-mg tablet (matching tadalafil)
placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
OG003
10 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
tadalafil 10-mg tablet
placebo 5-mg capsule (matching LY2452473)
placebo 5-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
OG004
5 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
tadalafil 5-mg tablet
placebo 5-mg capsule (matching LY2452473)
placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
Units
Counts
Participants
OG00081
OG00190
OG00249
OG00388
OG00482
Title
Denominators
Categories
Title
Measurements
OG0000.153± 0.195
OG001-0.306± 0.183
OG0020.070± 0.268
OG003-0.234± 0.176
OG0040.158± 0.186
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Mixed model repeated measures analysis
0.984
Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS Mean of treatment difference
-0.006
95
Superiority or Other
OG001
OG004
Mixed model repeated measures analysis
0.076
Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
-0.465
95
Superiority or Other
OG000
OG003
Mixed model repeated measures analysis
0.142
Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
0.387
95
Superiority or Other
OG001
OG003
Mixed model repeated measures analysis
0.776
Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
-0.072
95
Superiority or Other
OG002
5 mg LY2452473
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
LY2452473 5-mg capsule
placebo 5-mg tablet (matching tadalafil)
placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
OG003
10 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
tadalafil 10-mg tablet
placebo 5-mg capsule (matching LY2452473)
placebo 5-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
OG004
5 mg Tadalafil
The following study drugs, administered orally, once daily for 12 weeks post-randomization:
tadalafil 5-mg tablet
placebo 5-mg capsule (matching LY2452473)
placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period.
Units
Counts
Participants
OG00080
OG00190
OG00249
OG00388
OG00482
Title
Denominators
Categories
Title
Measurements
OG0003.756± 2.235
OG001-4.501± 2.075
OG002-0.717± 3.068
OG003-3.300± 1.976
OG004-1.276± 2.109
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Mixed model repeated measures analysis
0.103
Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS Mean of treatment difference
5.031
95
Superiority or Other
OG001
OG004
Mixed model repeated measures analysis
0.277
Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean treatment difference
-3.225
95
Superiority or Other
OG000
OG003
Mixed model repeated measures analysis
0.019
Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
LS mean of treatment difference
7.056
95
Superiority or Other
OG001
OG003
Mixed model repeated measures analysis
0.676
Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.