A Study of LY900010 in Erectile Dysfunction

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT01160289
Collaborator
(none)
410
36
5
13
11.4
0.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
410 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Study of LY900010 (LY2452473 + Tadalafil) in the Treatment of Men With Erectile Dysfunction
Study Start Date :
Oct 1, 2010
Actual Primary Completion Date :
Nov 1, 2011
Actual Study Completion Date :
Nov 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1 milligram (mg) LY2452473 + 5 mg tadalafil

Drug: LY2452473
Administered orally, once daily for 12 weeks

Drug: tadalafil
Administered orally, once daily for 12 weeks

Drug: placebo (tadalafil)
Administered orally, once daily for 12 weeks

Experimental: 5 mg LY2452473 + 5 mg tadalafil

Drug: LY2452473
Administered orally, once daily for 12 weeks

Drug: tadalafil
Administered orally, once daily for 12 weeks

Drug: placebo (tadalafil)
Administered orally, once daily for 12 weeks

Experimental: 5 mg LY2452473 + placebo

Drug: LY2452473
Administered orally, once daily for 12 weeks

Drug: placebo (tadalafil)
Administered orally, once daily for 12 weeks

Active Comparator: 10 mg tadalafil + placebo

Drug: tadalafil
Administered orally, once daily for 12 weeks

Drug: placebo (tadalafil)
Administered orally, once daily for 12 weeks

Drug: placebo (LY2452473)
Administered orally, once daily for 12 weeks

Active Comparator: 5 mg tadalafil + placebo

Drug: tadalafil
Administered orally, once daily for 12 weeks

Drug: placebo (tadalafil)
Administered orally, once daily for 12 weeks

Drug: placebo (LY2452473)
Administered orally, once daily for 12 weeks

Outcome Measures

Primary Outcome Measures

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

    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.

Secondary Outcome Measures

  1. Change From Baseline to 12 Week Endpoint in the Percentage of "Yes" Responses on the Sexual Encounter Profile (SEP) Diary [Baseline, Week 12]

    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).

  2. Change From Baseline to 12 Week Endpoint in IIEF Domain Scores (Intercourse Satisfaction, Orgasmic Function, Sexual Desire, and Overall Satisfaction) [Baseline, Week 12]

    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).

  3. 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) [Baseline, Week 12]

    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.

  4. Change From Baseline to 12 Week Endpoint in IIEF EF Domain Score Reported by Testosterone Concentration Subgroups [Baseline, Week 12]

    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).

  5. Change From Baseline to 12 Week Endpoint in Prostate-Specific Antigen (PSA) [Baseline, Week 12]

    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).

  6. Change From Baseline to 12 Week Endpoint in Total Cholesterol and Triglycerides [Baseline, Week 12]

    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).

  7. Percent Change From Baseline to 12 Week Endpoint in High-Density Lipoprotein Cholesterol (HDL-C) and Low-Density Lipoprotein Cholesterol (LDL-C) [Baseline, Week 12]

    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).

  8. Change From Baseline to 12 Week Endpoint in Fasting Glucose [Baseline, Week 12]

    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).

  9. Change From Baseline to 12 Week Endpoint in Fasting Insulin [Baseline, Week 12]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 70 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Birmingham Alabama United States 35209
2 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Phoenix Arizona United States 85050
3 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Glendora California United States 91741
4 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Irvine California United States 92618
5 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Long Beach California United States 90806
6 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Newport Beach California United States 92660
7 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Sacramento California United States 95825
8 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. San Diego California United States 92120
9 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Vacaville California United States 95688
10 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Denver Colorado United States 80220
11 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Englewood Colorado United States 80113
12 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Aventura Florida United States 33180
13 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Celebration Florida United States 34747
14 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Coral Springs Florida United States 33065
15 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Jacksonville Florida United States 32209
16 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Plantation Florida United States 33317
17 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Coeur d'Alene Idaho United States 83814
18 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Indianapolis Indiana United States 46256
19 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Des Moines Iowa United States 50314
20 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Overland Park Kansas United States 66215
21 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Topeka Kansas United States 66606
22 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Shreveport Louisiana United States 71106
23 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Troy Michigan United States 48084
24 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Saint Louis Missouri United States 63141
25 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Las Vegas Nevada United States 89117
26 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Cary North Carolina United States 27511
27 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Charlotte North Carolina United States 28207
28 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Raleigh North Carolina United States 27607
29 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Salisbury North Carolina United States 28144
30 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Edmond Oklahoma United States 73034
31 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Knoxville Tennessee United States 37920
32 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Dallas Texas United States 75234
33 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. San Antonio Texas United States 78229
34 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Bellevue Washington United States 98007
35 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Olympia Washington United States 98502
36 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Spokane Washington United States 99202

Sponsors and Collaborators

  • Eli Lilly and Company

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01160289
Other Study ID Numbers:
  • 11888
  • I4K-MC-GPEC
First Posted:
Jul 12, 2010
Last Update Posted:
Apr 9, 2019
Last Verified:
Mar 1, 2019
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail 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.
Arm/Group Title All Screened Subjects 1 mg LY2452473 and 5 mg Tadalafil 5 mg LY2452473 and 5 mg Tadalafil 5 mg LY2452473 10 mg Tadalafil 5 mg Tadalafil
Arm/Group Description 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. 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) 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) 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) 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) 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)
Period Title: Screening, Washout, and Lead-In Period
STARTED 894 0 0 0 0 0
COMPLETED 410 0 0 0 0 0
NOT COMPLETED 484 0 0 0 0 0
Period Title: Screening, Washout, and Lead-In Period
STARTED 0 85 97 52 89 87
Received at Least 1 Dose of Study Drug 0 85 97 52 89 87
COMPLETED 0 65 73 31 80 73
NOT COMPLETED 0 20 24 21 9 14

Baseline Characteristics

Arm/Group Title 1 mg LY2452473 and 5 mg Tadalafil 5 mg LY2452473 and 5 mg Tadalafil 5 mg LY2452473 10 mg Tadalafil 5 mg Tadalafil Total
Arm/Group Description 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. 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. 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. 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. 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. Total of all reporting groups
Overall Participants 85 97 52 89 87 410
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
59.7
(6.57)
60.7
(6.57)
58.7
(6.53)
59.4
(6.54)
60.5
(6.68)
59.9
(6.59)
Sex: Female, Male (Count of Participants)
Female
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Male
85
100%
97
100%
52
100%
89
100%
87
100%
410
100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
9
10.6%
13
13.4%
3
5.8%
13
14.6%
10
11.5%
48
11.7%
Not Hispanic or Latino
76
89.4%
84
86.6%
49
94.2%
76
85.4%
77
88.5%
362
88.3%
Unknown or Not Reported
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
1
1.2%
2
2.1%
0
0%
2
2.2%
0
0%
5
1.2%
Asian
2
2.4%
2
2.1%
0
0%
2
2.2%
0
0%
6
1.5%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Black or African American
14
16.5%
17
17.5%
7
13.5%
13
14.6%
8
9.2%
59
14.4%
White
68
80%
76
78.4%
45
86.5%
72
80.9%
78
89.7%
339
82.7%
More than one race
0
0%
0
0%
0
0%
0
0%
1
1.1%
1
0.2%
Unknown or Not Reported
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Region of Enrollment (Count of Participants)
United States
85
100%
97
100%
52
100%
89
100%
87
100%
410
100%

Outcome Measures

1. Primary Outcome
Title Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain Score
Description 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.
Time Frame Baseline, Week 12

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title 1 mg LY2452473 and 5 mg Tadalafil 5 mg LY2452473 and 5 mg Tadalafil 5 mg LY2452473 10 mg Tadalafil 5 mg Tadalafil
Arm/Group Description 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. 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. 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. 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. 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.
Measure Participants 66 74 34 83 74
Mean (Standard Deviation) [units on a scale]
2.515
(6.019)
2.405
(6.920)
-0.971
(6.699)
3.530
(5.640)
2.054
(4.800)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil
Comments 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.5
Comments The p-value was 1-sided and adjusted for multiple comparisons. The level of significance was 1-sided of 0.04.
Method ANCOVA
Comments Treatment group (tx grp), baseline IIEF EF domain score, baseline testosterone level, tx grp*baseline IIEF, tx grp*testosterone level interactions.
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 5 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil
Comments 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.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.498
Comments The p-value was 1-sided and adjusted for multiple comparisons. The level of significance was 1-sided of 0.04.
Method ANCOVA
Comments The model included tx grp, baseline IIEF EF domain score, baseline testosterone level, tx grp*baseline IIEF, tx grp*testosterone level interactions.
2. Secondary Outcome
Title Change From Baseline to 12 Week Endpoint in the Percentage of "Yes" Responses on the Sexual Encounter Profile (SEP) Diary
Description 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).
Time Frame Baseline, Week 12

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title 1 mg LY2452473 and 5 mg Tadalafil 5 mg LY2452473 and 5 mg Tadalafil 5 mg LY2452473 10 mg Tadalafil 5 mg Tadalafil
Arm/Group Description 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. 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. 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. 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. 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.
Measure Participants 79 86 46 88 80
Question 1
-0.247
(2.378)
-2.976
(2.295)
-10.711
(3.268)
4.427
(2.168)
-1.425
(2.305)
Question 2
3.175
(3.345)
3.689
(3.227)
-7.849
(4.566)
10.267
(3.064)
1.844
(3.240)
Question 3
9.296
(3.808)
11.752
(3.675)
-3.800
(5.195)
14.645
(3.489)
2.593
(3.688)
Question 4
12.935
(3.998)
13.910
(3.854)
-1.570
(5.454)
24.202
(3.656)
8.857
(3.872)
Question 5
13.602
(4.027)
15.196
(3.880)
-1.956
(5.488)
22.410
(3.683)
9.400
(3.897)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.722
Comments 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.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value 1.178
Confidence Interval () 95%
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 3.312
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 5 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.634
Comments 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.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value -1.552
Confidence Interval () 95%
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 3.253
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 1 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.147
Comments 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.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value -4.674
Confidence Interval () 95%
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 3.218
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 5 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.020
Comments 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.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value -7.404
Confidence Interval () 95%
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 3.157
Estimation Comments
Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 1 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.775
Comments 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.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value 1.330
Confidence Interval () 95%
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 4.658
Estimation Comments
Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 5 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.687
Comments 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.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value 1.844
Confidence Interval () 95%
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 4.573
Estimation Comments
Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 1 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.119
Comments 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.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value -7.092
Confidence Interval () 95%
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 4.535
Estimation Comments
Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 5 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.140
Comments 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.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value -6.578
Confidence Interval () 95%
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 4.450
Estimation Comments
Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection 1 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.207
Comments 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.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value 6.703
Confidence Interval () 95%
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 5.302
Estimation Comments
Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection 5 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.079
Comments 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.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value 9.159
Confidence Interval () 95%
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 5.206
Estimation Comments
Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection 1 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.301
Comments 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.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value -5.349
Confidence Interval () 95%
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 5.165
Estimation Comments
Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection 5 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.568
Comments 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.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value -2.893
Confidence Interval () 95%
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 5.067
Estimation Comments
Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection 1 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.464
Comments 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.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value 4.079
Confidence Interval () 95%
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 5.566
Estimation Comments
Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection 5 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.356
Comments 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.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value 5.054
Confidence Interval () 95%
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 5.463
Estimation Comments
Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection 1 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.038
Comments 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.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value -11.266
Confidence Interval () 95%
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 5.418
Estimation Comments
Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection 5 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.054
Comments 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.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value -10.292
Confidence Interval () 95%
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 5.312
Estimation Comments
Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection 1 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.454
Comments 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.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value 4.202
Confidence Interval () 95%
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 5.603
Estimation Comments
Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection 5 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.293
Comments 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.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value 5.796
Confidence Interval () 95%
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 5.499
Estimation Comments
Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection 1 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.107
Comments 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.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value -8.808
Confidence Interval () 95%
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 5.457
Estimation Comments
Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection 5 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.178
Comments 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.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value -7.214
Confidence Interval () 95%
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 5.349
Estimation Comments
3. Secondary Outcome
Title Change From Baseline to 12 Week Endpoint in IIEF Domain Scores (Intercourse Satisfaction, Orgasmic Function, Sexual Desire, and Overall Satisfaction)
Description 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).
Time Frame Baseline, Week 12

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title 1 mg LY2452473 and 5 mg Tadalafil 5 mg LY2452473 and 5 mg Tadalafil 5 mg LY2452473 10 mg Tadalafil 5 mg Tadalafil
Arm/Group Description 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. 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. 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. 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. 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.
Measure Participants 80 88 48 88 81
Intercourse Satisfaction
0.475
(0.340)
0.514
(0.322)
-0.672
(0.463)
1.127
(0.310)
0.554
(0.327)
Orgasmic Function
0.510
(0.289)
0.117
(0.274)
0.160
(0.394)
0.678
(0.264)
0.733
(0.278)
Sexual Desire
0.092
(0.186)
0.001
(0.176)
-0.201
(0.253)
0.392
(0.169)
0.180
(0.178)
Overall Satisfaction
0.477
(0.247)
0.258
(0.235)
-0.378
(0.339)
1.206
(0.226)
0.826
(0.238)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.867
Comments 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.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value -0.079
Confidence Interval () 95%
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.472
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 5 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.931
Comments 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.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value -0.039
Confidence Interval () 95%
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.458
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 1 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.158
Comments 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.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value -0.652
Confidence Interval () 95%
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.460
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 5 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.172
Comments 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.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value -0.612
Confidence Interval () 95%
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.447
Estimation Comments
Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 1 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.579
Comments 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.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value -0.223
Confidence Interval () 95%
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.401
Estimation Comments
Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 5 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.115
Comments 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.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value -0.616
Confidence Interval () 95%
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.390
Estimation Comments
Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 1 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.668
Comments 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.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value -0.168
Confidence Interval () 95%
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.392
Estimation Comments
Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 5 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.141
Comments 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.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value -0.561
Confidence Interval () 95%
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.380
Estimation Comments
Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection 1 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.734
Comments 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.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value -0.088
Confidence Interval () 95%
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.258
Estimation Comments
Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection 5 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.477
Comments 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.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value -0.179
Confidence Interval () 95%
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.251
Estimation Comments
Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection 1 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.235
Comments 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.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value -0.300
Confidence Interval () 95%
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.252
Estimation Comments
Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection 5 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.111
Comments 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.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value -0.391
Confidence Interval () 95%
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.245
Estimation Comments
Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection 1 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.310
Comments 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.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value -0.349
Confidence Interval () 95%
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.343
Estimation Comments
Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection 5 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.090
Comments 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.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value -0.568
Confidence Interval () 95%
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.334
Estimation Comments
Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection 1 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.030
Comments 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.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value -0.729
Confidence Interval () 95%
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.335
Estimation Comments
Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection 5 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.004
Comments 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.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value -0.948
Confidence Interval () 95%
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.326
Estimation Comments
4. Secondary Outcome
Title 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)
Description 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.
Time Frame Baseline, Week 12

Outcome Measure Data

Analysis Population Description
Randomized participants who received at least 1 dose of study drug (ITT population).
Arm/Group Title 1 mg LY2452473 and 5 mg Tadalafil 5 mg LY2452473 and 5 mg Tadalafil 5 mg LY2452473 10 mg Tadalafil 5 mg Tadalafil
Arm/Group Description 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. 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. 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. 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. 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.
Measure Participants 85 97 52 89 87
Number [percentage of participants]
24.7
29.1%
27.8
28.7%
13.5
26%
30.3
34%
27.6
31.7%
5. Secondary Outcome
Title Change From Baseline to 12 Week Endpoint in IIEF EF Domain Score Reported by Testosterone Concentration Subgroups
Description 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).
Time Frame Baseline, Week 12

Outcome Measure Data

Analysis Population Description
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).
Arm/Group Title 1 mg LY2452473 and 5 mg Tadalafil 5 mg LY2452473 and 5 mg Tadalafil 5 mg LY2452473 10 mg Tadalafil 5 mg Tadalafil
Arm/Group Description 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. 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. 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. 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. 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.
Measure Participants 80 88 48 88 81
Testosterone <340 ng/dL
2.523
(0.952)
1.012
(0.848)
-1.055
(1.223)
4.172
(0.852)
1.935
(0.912)
Testosterone ≥340 ng/dL
1.077
(1.019)
3.416
(1.071)
-0.714
(1.387)
2.217
(1.070)
1.703
(1.063)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.656
Comments 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.
Method ANCOVA
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 5 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.460
Comments 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.
Method ANCOVA
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 1 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.198
Comments 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.
Method ANCOVA
Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 5 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.009
Comments 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.
Method ANCOVA
Comments
Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 1 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.671
Comments 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.
Method ANCOVA
Comments
Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 5 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.259
Comments 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.
Method ANCOVA
Comments
Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 1 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.441
Comments 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.
Method ANCOVA
Comments
Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 5 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.433
Comments 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.
Method ANCOVA
Comments
6. Secondary Outcome
Title Change From Baseline to 12 Week Endpoint in Prostate-Specific Antigen (PSA)
Description 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).
Time Frame Baseline, Week 12

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title 1 mg LY2452473 and 5 mg Tadalafil 5 mg LY2452473 and 5 mg Tadalafil 5 mg LY2452473 10 mg Tadalafil 5 mg Tadalafil
Arm/Group Description 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. 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. 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. 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. 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.
Measure Participants 81 89 49 87 82
Least Squares Mean (Standard Error) [nanograms per milliliter (ng/mL)]
0.162
(0.119)
-0.088
(0.109)
0.265
(0.157)
0.246
(0.107)
0.032
(0.111)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.423
Comments Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value 0.130
Confidence Interval () 95%
to
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 5 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.443
Comments Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value -0.120
Confidence Interval () 95%
to
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 1 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.599
Comments Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value -0.084
Confidence Interval () 95%
to
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 5 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.029
Comments Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value -0.334
Confidence Interval () 95%
to
Parameter Dispersion Type:
Value:
Estimation Comments
7. Secondary Outcome
Title Change From Baseline to 12 Week Endpoint in Total Cholesterol and Triglycerides
Description 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).
Time Frame Baseline, Week 12

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title 1 mg LY2452473 and 5 mg Tadalafil 5 mg LY2452473 and 5 mg Tadalafil 5 mg LY2452473 10 mg Tadalafil 5 mg Tadalafil
Arm/Group Description 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. 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. 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. 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. 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.
Measure Participants 81 90 49 88 82
Total Cholesterol
-0.210
(0.076)
-0.275
(0.071)
-0.282
(0.102)
-0.086
(0.069)
-0.059
(0.072)
Triglycerides
-0.155
(0.070)
-0.171
(0.066)
-0.067
(0.096)
-0.139
(0.063)
0.056
(0.067)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.148
Comments 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.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS Mean of treatment difference
Estimated Value -0.152
Confidence Interval () 95%
to
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 5 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.033
Comments 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.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value -0.216
Confidence Interval () 95%
to
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 1 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.224
Comments 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.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value -0.124
Confidence Interval () 95%
to
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 5 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.056
Comments 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.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value -0.189
Confidence Interval () 95%
to
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 1 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.031
Comments 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.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value -0.211
Confidence Interval () 95%
to
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 5 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.017
Comments 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.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value -0.227
Confidence Interval () 95%
to
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 1 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.866
Comments 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.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value -0.016
Confidence Interval () 95%
to
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 5 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.726
Comments 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.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value -0.032
Confidence Interval () 95%
to
Parameter Dispersion Type:
Value:
Estimation Comments
8. Secondary Outcome
Title Percent Change From Baseline to 12 Week Endpoint in High-Density Lipoprotein Cholesterol (HDL-C) and Low-Density Lipoprotein Cholesterol (LDL-C)
Description 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).
Time Frame Baseline, Week 12

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title 1 mg LY2452473 and 5 mg Tadalafil 5 mg LY2452473 and 5 mg Tadalafil 5 mg LY2452473 10 mg Tadalafil 5 mg Tadalafil
Arm/Group Description 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. 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. 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. 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. 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.
Measure Participants 81 90 49 88 82
HDL-C
-7.440
(1.658)
-16.974
(1.556)
-22.230
(2.243)
1.776
(1.505)
1.573
(1.585)
LDL-C
-1.695
(2.479)
0.062
(2.319)
-3.424
(3.365)
-0.066
(2.245)
-0.718
(2.367)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments 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.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS Mean of treatment difference
Estimated Value -9.014
Confidence Interval () 95%
to
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 5 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments 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.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value -18.547
Confidence Interval () 95%
to
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 1 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments 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.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value -9.216
Confidence Interval () 95%
to
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 5 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments 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.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value -18.750
Confidence Interval () 95%
to
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 1 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.776
Comments 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.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value -0.977
Confidence Interval () 95%
to
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 5 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.814
Comments 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.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value 0.780
Confidence Interval () 95%
to
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 1 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.627
Comments 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.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value -1.629
Confidence Interval () 95%
to
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 5 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.968
Comments 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.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value 0.128
Confidence Interval () 95%
to
Parameter Dispersion Type:
Value:
Estimation Comments
9. Secondary Outcome
Title Change From Baseline to 12 Week Endpoint in Fasting Glucose
Description 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).
Time Frame Baseline, Week 12

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title 1 mg LY2452473 and 5 mg Tadalafil 5 mg LY2452473 and 5 mg Tadalafil 5 mg LY2452473 10 mg Tadalafil 5 mg Tadalafil
Arm/Group Description 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. 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. 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. 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. 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.
Measure Participants 81 90 49 88 82
Least Squares Mean (Standard Error) [millimoles per Liter (mmol/L)]
0.153
(0.195)
-0.306
(0.183)
0.070
(0.268)
-0.234
(0.176)
0.158
(0.186)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.984
Comments Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS Mean of treatment difference
Estimated Value -0.006
Confidence Interval () 95%
to
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 5 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.076
Comments Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value -0.465
Confidence Interval () 95%
to
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 1 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.142
Comments Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value 0.387
Confidence Interval () 95%
to
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 5 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.776
Comments Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value -0.072
Confidence Interval () 95%
to
Parameter Dispersion Type:
Value:
Estimation Comments
10. Secondary Outcome
Title Change From Baseline to 12 Week Endpoint in Fasting Insulin
Description 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).
Time Frame Baseline, Week 12

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title 1 mg LY2452473 and 5 mg Tadalafil 5 mg LY2452473 and 5 mg Tadalafil 5 mg LY2452473 10 mg Tadalafil 5 mg Tadalafil
Arm/Group Description 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. 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. 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. 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. 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.
Measure Participants 80 90 49 88 82
Least Squares Mean (Standard Error) [milliunits per Liter (mU/L)]
3.756
(2.235)
-4.501
(2.075)
-0.717
(3.068)
-3.300
(1.976)
-1.276
(2.109)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.103
Comments Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS Mean of treatment difference
Estimated Value 5.031
Confidence Interval () 95%
to
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 5 mg LY2452473 and 5 mg Tadalafil, 5 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.277
Comments Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean treatment difference
Estimated Value -3.225
Confidence Interval () 95%
to
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 1 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.019
Comments Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value 7.056
Confidence Interval () 95%
to
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 5 mg LY2452473 and 5 mg Tadalafil, 10 mg Tadalafil
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.676
Comments Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
Method Mixed model repeated measures analysis
Comments
Method of Estimation Estimation Parameter LS mean of treatment difference
Estimated Value -1.201
Confidence Interval () 95%
to
Parameter Dispersion Type:
Value:
Estimation Comments

Adverse Events

Time Frame
Adverse Event Reporting Description
Arm/Group Title 5 mg Tadalafil, Lead-in Period 1 mg LY2452473 and 5 mg Tadalafil 5 mg LY2452473 and 5 mg Tadalafil 5 mg LY2452473 10 mg Tadalafil 5 mg Tadalafil
Arm/Group Description 5-mg tadalafil tablet, administered orally, once daily, during the 4-week lead-in period. 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) 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) 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) 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) 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)
All Cause Mortality
5 mg Tadalafil, Lead-in Period 1 mg LY2452473 and 5 mg Tadalafil 5 mg LY2452473 and 5 mg Tadalafil 5 mg LY2452473 10 mg Tadalafil 5 mg Tadalafil
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
Serious Adverse Events
5 mg Tadalafil, Lead-in Period 1 mg LY2452473 and 5 mg Tadalafil 5 mg LY2452473 and 5 mg Tadalafil 5 mg LY2452473 10 mg Tadalafil 5 mg Tadalafil
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 2/531 (0.4%) 2/85 (2.4%) 1/97 (1%) 1/52 (1.9%) 0/89 (0%) 0/87 (0%)
Cardiac disorders
Arrhythmia 1/531 (0.2%) 1 0/85 (0%) 0 1/97 (1%) 1 0/52 (0%) 0 0/89 (0%) 0 0/87 (0%) 0
Cardiac arrest 0/531 (0%) 0 0/85 (0%) 0 0/97 (0%) 0 1/52 (1.9%) 1 0/89 (0%) 0 0/87 (0%) 0
Hypertensive cardiomyopathy 1/531 (0.2%) 1 0/85 (0%) 0 0/97 (0%) 0 0/52 (0%) 0 0/89 (0%) 0 0/87 (0%) 0
Infections and infestations
Lobar pneumonia 0/531 (0%) 0 1/85 (1.2%) 1 0/97 (0%) 0 0/52 (0%) 0 0/89 (0%) 0 0/87 (0%) 0
Injury, poisoning and procedural complications
Humerus fracture 0/531 (0%) 0 1/85 (1.2%) 1 0/97 (0%) 0 0/52 (0%) 0 0/89 (0%) 0 0/87 (0%) 0
Renal and urinary disorders
Tubulointerstitial nephritis 0/531 (0%) 0 1/85 (1.2%) 1 0/97 (0%) 0 0/52 (0%) 0 0/89 (0%) 0 0/87 (0%) 0
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism 0/531 (0%) 0 1/85 (1.2%) 1 0/97 (0%) 0 0/52 (0%) 0 0/89 (0%) 0 0/87 (0%) 0
Other (Not Including Serious) Adverse Events
5 mg Tadalafil, Lead-in Period 1 mg LY2452473 and 5 mg Tadalafil 5 mg LY2452473 and 5 mg Tadalafil 5 mg LY2452473 10 mg Tadalafil 5 mg Tadalafil
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 88/531 (16.6%) 27/85 (31.8%) 23/97 (23.7%) 10/52 (19.2%) 34/89 (38.2%) 33/87 (37.9%)
Blood and lymphatic system disorders
Anaemia 0/531 (0%) 0 0/85 (0%) 0 1/97 (1%) 1 0/52 (0%) 0 0/89 (0%) 0 0/87 (0%) 0
Cardiac disorders
Arrhythmia 0/531 (0%) 0 0/85 (0%) 0 0/97 (0%) 0 0/52 (0%) 0 0/89 (0%) 0 1/87 (1.1%) 1
Bradycardia 0/531 (0%) 0 0/85 (0%) 0 1/97 (1%) 1 0/52 (0%) 0 0/89 (0%) 0 0/87 (0%) 0
Bundle branch block right 0/531 (0%) 0 0/85 (0%) 0 1/97 (1%) 1 0/52 (0%) 0 0/89 (0%) 0 1/87 (1.1%) 1
Cardiomegaly 0/531 (0%) 0 1/85 (1.2%) 1 0/97 (0%) 0 0/52 (0%) 0 0/89 (0%) 0 0/87 (0%) 0
Eye disorders
Corneal erosion 0/531 (0%) 0 0/85 (0%) 0 1/97 (1%) 1 0/52 (0%) 0 0/89 (0%) 0 0/87 (0%) 0
Eye swelling 0/531 (0%) 0 0/85 (0%) 0 0/97 (0%) 0 0/52 (0%) 0 1/89 (1.1%) 1 0/87 (0%) 0
Ocular hyperaemia 0/531 (0%) 0 0/85 (0%) 0 0/97 (0%) 0 0/52 (0%) 0 1/89 (1.1%) 1 0/87 (0%) 0
Vision blurred 2/531 (0.4%) 2 0/85 (0%) 0 0/97 (0%) 0 0/52 (0%) 0 0/89 (0%) 0 1/87 (1.1%) 1
Gastrointestinal disorders
Barrett's oesophagus 0/531 (0%) 0 0/85 (0%) 0 0/97 (0%) 0 0/52 (0%) 0 1/89 (1.1%) 1 0/87 (0%) 0
Colonic polyp 0/531 (0%) 0 1/85 (1.2%) 1 0/97 (0%) 0 0/52 (0%) 0 1/89 (1.1%) 1 0/87 (0%) 0
Constipation 3/531 (0.6%) 3 1/85 (1.2%) 1 0/97 (0%) 0 0/52 (0%) 0 0/89 (0%) 0 0/87 (0%) 0
Diarrhoea 4/531 (0.8%) 4 0/85 (0%) 0 1/97 (1%) 1 0/52 (0%) 0 0/89 (0%) 0 1/87 (1.1%) 1
Diverticulum 0/531 (0%) 0 1/85 (1.2%) 1 0/97 (0%) 0 0/52 (0%) 0 0/89 (0%) 0 0/87 (0%) 0
Diverticulum intestinal 0/531 (0%) 0 0/85 (0%) 0 0/97 (0%) 0 0/52 (0%) 0 1/89 (1.1%) 1 0/87 (0%) 0
Dyspepsia 6/531 (1.1%) 6 1/85 (1.2%) 1 1/97 (1%) 1 0/52 (0%) 0 1/89 (1.1%) 1 1/87 (1.1%) 1
Gastrooesophageal reflux disease 7/531 (1.3%) 7 0/85 (0%) 0 1/97 (1%) 1 0/52 (0%) 0 3/89 (3.4%) 3 2/87 (2.3%) 2
Hiatus hernia 0/531 (0%) 0 0/85 (0%) 0 0/97 (0%) 0 0/52 (0%) 0 1/89 (1.1%) 1 0/87 (0%) 0
Inguinal hernia 0/531 (0%) 0 0/85 (0%) 0 0/97 (0%) 0 0/52 (0%) 0 1/89 (1.1%) 1 0/87 (0%) 0
Nausea 2/531 (0.4%) 2 0/85 (0%) 0 0/97 (0%) 0 0/52 (0%) 0 1/89 (1.1%) 1 0/87 (0%) 0
Oesophagitis 0/531 (0%) 0 0/85 (0%) 0 1/97 (1%) 1 0/52 (0%) 0 0/89 (0%) 0 0/87 (0%) 0
General disorders
Chest discomfort 1/531 (0.2%) 1 0/85 (0%) 0 1/97 (1%) 1 0/52 (0%) 0 0/89 (0%) 0 1/87 (1.1%) 1
Chest pain 0/531 (0%) 0 1/85 (1.2%) 1 0/97 (0%) 0 0/52 (0%) 0 0/89 (0%) 0 1/87 (1.1%) 1
Fatigue 4/531 (0.8%) 4 0/85 (0%) 0 2/97 (2.1%) 2 0/52 (0%) 0 2/89 (2.2%) 2 1/87 (1.1%) 1
Irritability 0/531 (0%) 0 0/85 (0%) 0 0/97 (0%) 0 0/52 (0%) 0 1/89 (1.1%) 1 0/87 (0%) 0
Oedema peripheral 0/531 (0%) 0 1/85 (1.2%) 1 0/97 (0%) 0 1/52 (1.9%) 1 0/89 (0%) 0 1/87 (1.1%) 1
Pain 0/531 (0%) 0 1/85 (1.2%) 1 0/97 (0%) 0 0/52 (0%) 0 1/89 (1.1%) 1 0/87 (0%) 0
Pyrexia 0/531 (0%) 0 0/85 (0%) 0 0/97 (0%) 0 0/52 (0%) 0 1/89 (1.1%) 1 0/87 (0%) 0
Immune system disorders
Seasonal allergy 0/531 (0%) 0 1/85 (1.2%) 1 0/97 (0%) 0 0/52 (0%) 0 0/89 (0%) 0 1/87 (1.1%) 1
Infections and infestations
Bronchitis 0/531 (0%) 0 0/85 (0%) 0 1/97 (1%) 1 0/52 (0%) 0 0/89 (0%) 0 0/87 (0%) 0
Candidiasis 0/531 (0%) 0 0/85 (0%) 0 0/97 (0%) 0 1/52 (1.9%) 1 0/89 (0%) 0 0/87 (0%) 0
Ear infection 0/531 (0%) 0 0/85 (0%) 0 0/97 (0%) 0 0/52 (0%) 0 2/89 (2.2%) 2 0/87 (0%) 0
Herpes zoster 0/531 (0%) 0 0/85 (0%) 0 0/97 (0%) 0 0/52 (0%) 0 1/89 (1.1%) 1 0/87 (0%) 0
Influenza 1/531 (0.2%) 1 1/85 (1.2%) 1 0/97 (0%) 0 1/52 (1.9%) 1 1/89 (1.1%) 1 0/87 (0%) 0
Nail infection 0/531 (0%) 0 0/85 (0%) 0 0/97 (0%) 0 0/52 (0%) 0 0/89 (0%) 0 1/87 (1.1%) 1
Nasopharyngitis 5/531 (0.9%) 5 3/85 (3.5%) 3 1/97 (1%) 1 1/52 (1.9%) 1 0/89 (0%) 0 0/87 (0%) 0
Oral herpes 0/531 (0%) 0 0/85 (0%) 0 1/97 (1%) 2 0/52 (0%) 0 0/89 (0%) 0 0/87 (0%) 0
Pharyngitis streptococcal 0/531 (0%) 0 0/85 (0%) 0 0/97 (0%) 0 0/52 (0%) 0 1/89 (1.1%) 1 0/87 (0%) 0
Pneumonia 0/531 (0%) 0 2/85 (2.4%) 2 0/97 (0%) 0 0/52 (0%) 0 0/89 (0%) 0 0/87 (0%) 0
Rhinitis 0/531 (0%) 0 0/85 (0%) 0 0/97 (0%) 0 0/52 (0%) 0 0/89 (0%) 0 1/87 (1.1%) 1
Sinusitis 0/531 (0%) 0 0/85 (0%) 0 1/97 (1%) 1 0/52 (0%) 0 1/89 (1.1%) 1 1/87 (1.1%) 1
Subcutaneous abscess 0/531 (0%) 0 0/85 (0%) 0 1/97 (1%) 1 0/52 (0%) 0 0/89 (0%) 0 0/87 (0%) 0
Tinea infection 0/531 (0%) 0 0/85 (0%) 0 0/97 (0%) 0 1/52 (1.9%) 1 0/89 (0%) 0 0/87 (0%) 0
Tonsillitis 0/531 (0%) 0 0/85 (0%) 0 0/97 (0%) 0 0/52 (0%) 0 1/89 (1.1%) 1 0/87 (0%) 0
Tooth abscess 0/531 (0%) 0 0/85 (0%) 0 0/97 (0%) 0 0/52 (0%) 0 0/89 (0%) 0 1/87 (1.1%) 1
Upper respiratory tract infection 2/531 (0.4%) 2 1/85 (1.2%) 1 2/97 (2.1%) 2 0/52 (0%) 0 4/89 (4.5%) 4 3/87 (3.4%) 3
Urinary tract infection 0/531 (0%) 0 0/85 (0%) 0 0/97 (0%) 0 2/52 (3.8%) 2 0/89 (0%) 0 1/87 (1.1%) 1
Wound infection 0/531 (0%) 0 1/85 (1.2%) 1 0/97 (0%) 0 0/52 (0%) 0 0/89 (0%) 0 0/87 (0%) 0
Injury, poisoning and procedural complications
Contusion 0/531 (0%) 0 1/85 (1.2%) 1 0/97 (0%) 0 0/52 (0%) 0 1/89 (1.1%) 1 0/87 (0%) 0
Corneal abrasion 0/531 (0%) 0 0/85 (0%) 0 1/97 (1%) 1 0/52 (0%) 0 0/89 (0%) 0 0/87 (0%) 0
Excoriation 0/531 (0%) 0 0/85 (0%) 0 1/97 (1%) 2 0/52 (0%) 0 0/89 (0%) 0 0/87 (0%) 0
Laceration 0/531 (0%) 0 0/85 (0%) 0 0/97 (0%) 0 0/52 (0%) 0 1/89 (1.1%) 1 0/87 (0%) 0
Ligament sprain 2/531 (0.4%) 2 0/85 (0%) 0 0/97 (0%) 0 0/52 (0%) 0 1/89 (1.1%) 1 2/87 (2.3%) 2
Limb injury 0/531 (0%) 0 0/85 (0%) 0 0/97 (0%) 0 0/52 (0%) 0 0/89 (0%) 0 1/87 (1.1%) 1
Muscle rupture 0/531 (0%) 0 1/85 (1.2%) 1 0/97 (0%) 0 0/52 (0%) 0 0/89 (0%) 0 0/87 (0%) 0
Muscle strain 0/531 (0%) 0 0/85 (0%) 0 0/97 (0%) 0 1/52 (1.9%) 1 2/89 (2.2%) 2 1/87 (1.1%) 1
Radius fracture 0/531 (0%) 0 0/85 (0%) 0 0/97 (0%) 0 0/52 (0%) 0 1/89 (1.1%) 1 0/87 (0%) 0
Rib fracture 0/531 (0%) 0 1/85 (1.2%) 1 0/97 (0%) 0 0/52 (0%) 0 0/89 (0%) 0 0/87 (0%) 0
Sunburn 0/531 (0%) 0 0/85 (0%) 0 0/97 (0%) 0 0/52 (0%) 0 0/89 (0%) 0 1/87 (1.1%) 1
Investigations
Aspartate aminotransferase increased 0/531 (0%) 0 0/85 (0%) 0 0/97 (0%) 0 0/52 (0%) 0 0/89 (0%) 0 2/87 (2.3%) 2
Blood creatine phosphokinase abnormal 0/531 (0%) 0 1/85 (1.2%) 1 0/97 (0%) 0 0/52 (0%) 0 0/89 (0%) 0 0/87 (0%) 0
Blood creatine phosphokinase increased 2/531 (0.4%) 2 0/85 (0%) 0 1/97 (1%) 1 0/52 (0%) 0 1/89 (1.1%) 1 2/87 (2.3%) 2
Blood creatinine abnormal 0/531 (0%) 0 0/85 (0%) 0 0/97 (0%) 0 0/52 (0%) 0 0/89 (0%) 0 1/87 (1.1%) 1
Blood creatinine increased 1/531 (0.2%) 1 0/85 (0%) 0 1/97 (1%) 1 0/52 (0%) 0 2/89 (2.2%) 2 0/87 (0%) 0
Blood glucose increased 0/531 (0%) 0 1/85 (1.2%) 1 1/97 (1%) 1 0/52 (0%) 0 0/89 (0%) 0 0/87 (0%) 0
Blood insulin increased 0/531 (0%) 0 1/85 (1.2%) 1 0/97 (0%) 0 0/52 (0%) 0 0/89 (0%) 0 0/87 (0%) 0
Blood testosterone abnormal 0/531 (0%) 0 1/85 (1.2%) 1 0/97 (0%) 0 0/52 (0%) 0 0/89 (0%) 0 0/87 (0%) 0
Blood urea abnormal 0/531 (0%) 0 0/85 (0%) 0 0/97 (0%) 0 0/52 (0%) 0 0/89 (0%) 0 1/87 (1.1%) 1
Blood urea increased 0/531 (0%) 0 0/85 (0%) 0 0/97 (0%) 0 0/52 (0%) 0 1/89 (1.1%) 1 0/87 (0%) 0
C-reactive protein increased 0/531 (0%) 0 0/85 (0%) 0 1/97 (1%) 1 0/52 (0%) 0 0/89 (0%) 0 0/87 (0%) 0
Colonoscopy 0/531 (0%) 0 0/85 (0%) 0 0/97 (0%) 0 0/52 (0%) 0 1/89 (1.1%) 1 0/87 (0%) 0
Electrocardiogram qrs complex prolonged 0/531 (0%) 0 1/85 (1.2%) 1 0/97 (0%) 0 0/52 (0%) 0 0/89 (0%) 0 0/87 (0%) 0
High density lipoprotein decreased 0/531 (0%) 0 0/85 (0%) 0 0/97 (0%) 0 1/52 (1.9%) 1 0/89 (0%) 0 0/87 (0%) 0
Oestradiol increased 0/531 (0%) 0 1/85 (1.2%) 1 0/97 (0%) 0 0/52 (0%) 0 0/89 (0%) 0 0/87 (0%) 0
Prostatic specific antigen increased 1/531 (0.2%) 1 1/85 (1.2%) 1 0/97 (0%) 0 0/52 (0%) 0 1/89 (1.1%) 1 0/87 (0%) 0
Qrs axis abnormal 0/531 (0%) 0 0/85 (0%) 0 0/97 (0%) 0 0/52 (0%) 0 0/89 (0%) 0 1/87 (1.1%) 1
Weight decreased 1/531 (0.2%) 1 0/85 (0%) 0 0/97 (0%) 0 0/52 (0%) 0 1/89 (1.1%) 1 0/87 (0%) 0
Weight increased 1/531 (0.2%) 1 1/85 (1.2%) 1 0/97 (0%) 0 0/52 (0%) 0 0/89 (0%) 0 0/87 (0%) 0
Metabolism and nutrition disorders
Gout 0/531 (0%) 0 0/85 (0%) 0 0/97 (0%) 0 0/52 (0%) 0 0/89 (0%) 0 1/87 (1.1%) 1
Hyperlipidaemia 0/531 (0%) 0 0/85 (0%) 0 0/97 (0%) 0 0/52 (0%) 0 1/89 (1.1%) 1 0/87 (0%) 0
Vitamin d deficiency 0/531 (0%) 0 0/85 (0%) 0 1/97 (1%) 1 0/52 (0%) 0 0/89 (0%) 0 0/87 (0%) 0
Musculoskeletal and connective tissue disorders
Arthralgia 1/531 (0.2%) 1 1/85 (1.2%) 1 2/97 (2.1%) 2 1/52 (1.9%) 1 3/89 (3.4%) 3 0/87 (0%) 0
Arthritis 0/531 (0%) 0 1/85 (1.2%) 1 0/97 (0%) 0 0/52 (0%) 0 0/89 (0%) 0 1/87 (1.1%) 1
Back pain 4/531 (0.8%) 4 3/85 (3.5%) 3 1/97 (1%) 1 0/52 (0%) 0 3/89 (3.4%) 3 1/87 (1.1%) 1
Flank pain 0/531 (0%) 0 0/85 (0%) 0 0/97 (0%) 0 0/52 (0%) 0 0/89 (0%) 0 1/87 (1.1%) 1
Muscle spasms 0/531 (0%) 0 0/85 (0%) 0 0/97 (0%) 0 0/52 (0%) 0 0/89 (0%) 0 1/87 (1.1%) 1
Musculoskeletal pain 1/531 (0.2%) 1 0/85 (0%) 0 0/97 (0%) 0 1/52 (1.9%) 1 1/89 (1.1%) 1 1/87 (1.1%) 1
Myalgia 3/531 (0.6%) 3 2/85 (2.4%) 3 0/97 (0%) 0 0/52 (0%) 0 0/89 (0%) 0 0/87 (0%) 0
Osteopenia 3/531 (0.6%) 4 0/85 (0%) 0 0/97 (0%) 0 1/52 (1.9%) 1 0/89 (0%) 0 2/87 (2.3%) 2
Osteoporosis 1/531 (0.2%) 1 0/85 (0%) 0 0/97 (0%) 0 0/52 (0%) 0 0/89 (0%) 0 2/87 (2.3%) 2
Pain in extremity 4/531 (0.8%) 4 1/85 (1.2%) 1 0/97 (0%) 0 0/52 (0%) 0 0/89 (0%) 0 0/87 (0%) 0
Sensation of heaviness 0/531 (0%) 0 0/85 (0%) 0 0/97 (0%) 0 0/52 (0%) 0 1/89 (1.1%) 1 0/87 (0%) 0
Spinal disorder 0/531 (0%) 0 0/85 (0%) 0 0/97 (0%) 0 0/52 (0%) 0 0/89 (0%) 0 1/87 (1.1%) 1
Tendonitis 0/531 (0%) 0 0/85 (0%) 0 0/97 (0%) 0 0/52 (0%) 0 1/89 (1.1%) 1 0/87 (0%) 0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma 0/531 (0%) 0 0/85 (0%) 0 0/97 (0%) 0 0/52 (0%) 0 0/89 (0%) 0 1/87 (1.1%) 1
Squamous cell carcinoma of skin 0/531 (0%) 0 1/85 (1.2%) 1 0/97 (0%) 0 0/52 (0%) 0 0/89 (0%) 0 0/87 (0%) 0
Nervous system disorders
Burning sensation 0/531 (0%) 0 0/85 (0%) 0 0/97 (0%) 0 0/52 (0%) 0 0/89 (0%) 0 1/87 (1.1%) 1
Dizziness 3/531 (0.6%) 3 2/85 (2.4%) 3 1/97 (1%) 1 0/52 (0%) 0 2/89 (2.2%) 2 0/87 (0%) 0
Headache 9/531 (1.7%) 9 3/85 (3.5%) 3 1/97 (1%) 1 0/52 (0%) 0 3/89 (3.4%) 3 2/87 (2.3%) 2
Hypoaesthesia 0/531 (0%) 0 0/85 (0%) 0 1/97 (1%) 1 0/52 (0%) 0 0/89 (0%) 0 0/87 (0%) 0
Lethargy 1/531 (0.2%) 1 0/85 (0%) 0 1/97 (1%) 1 0/52 (0%) 0 0/89 (0%) 0 0/87 (0%) 0
Sinus headache 0/531 (0%) 0 0/85 (0%) 0 0/97 (0%) 0 1/52 (1.9%) 1 0/89 (0%) 0 0/87 (0%) 0
Renal and urinary disorders
Dysuria 0/531 (0%) 0 0/85 (0%) 0 0/97 (0%) 0 0/52 (0%) 0 1/89 (1.1%) 1 0/87 (0%) 0
Haematuria 0/531 (0%) 0 1/85 (1.2%) 1 0/97 (0%) 0 0/52 (0%) 0 1/89 (1.1%) 1 0/87 (0%) 0
Nephrolithiasis 2/531 (0.4%) 2 1/85 (1.2%) 1 0/97 (0%) 0 0/52 (0%) 0 0/89 (0%) 0 0/87 (0%) 0
Renal failure 0/531 (0%) 0 0/85 (0%) 0 0/97 (0%) 0 0/52 (0%) 0 0/89 (0%) 0 1/87 (1.1%) 1
Renal failure acute 0/531 (0%) 0 1/85 (1.2%) 1 0/97 (0%) 0 0/52 (0%) 0 0/89 (0%) 0 0/87 (0%) 0
Reproductive system and breast disorders
Epididymitis 0/531 (0%) 0 1/85 (1.2%) 1 0/97 (0%) 0 0/52 (0%) 0 0/89 (0%) 0 0/87 (0%) 0
Haematospermia 0/531 (0%) 0 0/85 (0%) 0 0/97 (0%) 0 0/52 (0%) 0 0/89 (0%) 0 2/87 (2.3%) 2
Prostatitis 1/531 (0.2%) 1 0/85 (0%) 0 0/97 (0%) 0 0/52 (0%) 0 1/89 (1.1%) 1 0/87 (0%) 0
Varicocele 0/531 (0%) 0 0/85 (0%) 0 1/97 (1%) 1 0/52 (0%) 0 0/89 (0%) 0 0/87 (0%) 0
Respiratory, thoracic and mediastinal disorders
Asthma 0/531 (0%) 0 0/85 (0%) 0 0/97 (0%) 0 0/52 (0%) 0 1/89 (1.1%) 1 0/87 (0%) 0
Bronchial hyperreactivity 0/531 (0%) 0 1/85 (1.2%) 1 0/97 (0%) 0 0/52 (0%) 0 0/89 (0%) 0 0/87 (0%) 0
Cough 1/531 (0.2%) 1 0/85 (0%) 0 1/97 (1%) 1 0/52 (0%) 0 0/89 (0%) 0 0/87 (0%) 0
Dyspnoea 0/531 (0%) 0 0/85 (0%) 0 1/97 (1%) 1 0/52 (0%) 0 0/89 (0%) 0 0/87 (0%) 0
Dyspnoea exertional 0/531 (0%) 0 0/85 (0%) 0 0/97 (0%) 0 0/52 (0%) 0 1/89 (1.1%) 1 0/87 (0%) 0
Nasal congestion 3/531 (0.6%) 3 0/85 (0%) 0 0/97 (0%) 0 0/52 (0%) 0 2/89 (2.2%) 2 2/87 (2.3%) 2
Obstructive airways disorder 0/531 (0%) 0 0/85 (0%) 0 0/97 (0%) 0 0/52 (0%) 0 1/89 (1.1%) 1 0/87 (0%) 0
Oropharyngeal pain 1/531 (0.2%) 1 0/85 (0%) 0 1/97 (1%) 1 0/52 (0%) 0 0/89 (0%) 0 0/87 (0%) 0
Paranasal sinus hypersecretion 2/531 (0.4%) 2 0/85 (0%) 0 0/97 (0%) 0 0/52 (0%) 0 1/89 (1.1%) 1 0/87 (0%) 0
Rhinitis allergic 0/531 (0%) 0 0/85 (0%) 0 0/97 (0%) 0 0/52 (0%) 0 1/89 (1.1%) 1 0/87 (0%) 0
Sinus congestion 1/531 (0.2%) 1 0/85 (0%) 0 1/97 (1%) 1 0/52 (0%) 0 2/89 (2.2%) 2 0/87 (0%) 0
Sinus disorder 0/531 (0%) 0 0/85 (0%) 0 0/97 (0%) 0 1/52 (1.9%) 1 1/89 (1.1%) 1 0/87 (0%) 0
Throat irritation 0/531 (0%) 0 0/85 (0%) 0 1/97 (1%) 1 0/52 (0%) 0 0/89 (0%) 0 0/87 (0%) 0
Skin and subcutaneous tissue disorders
Dermatitis 0/531 (0%) 0 0/85 (0%) 0 0/97 (0%) 0 0/52 (0%) 0 1/89 (1.1%) 1 0/87 (0%) 0
Dermatitis contact 0/531 (0%) 0 0/85 (0%) 0 0/97 (0%) 0 0/52 (0%) 0 1/89 (1.1%) 1 0/87 (0%) 0
Diabetic bullosis 0/531 (0%) 0 1/85 (1.2%) 1 0/97 (0%) 0 0/52 (0%) 0 0/89 (0%) 0 0/87 (0%) 0
Rash 0/531 (0%) 0 0/85 (0%) 0 2/97 (2.1%) 2 0/52 (0%) 0 2/89 (2.2%) 2 0/87 (0%) 0
Skin lesion 1/531 (0.2%) 1 1/85 (1.2%) 1 0/97 (0%) 0 0/52 (0%) 0 0/89 (0%) 0 0/87 (0%) 0
Surgical and medical procedures
Tooth extraction 0/531 (0%) 0 0/85 (0%) 0 0/97 (0%) 0 0/52 (0%) 0 1/89 (1.1%) 1 0/87 (0%) 0
Vascular disorders
Flushing 1/531 (0.2%) 1 1/85 (1.2%) 1 1/97 (1%) 1 0/52 (0%) 0 1/89 (1.1%) 1 1/87 (1.1%) 1
Haematoma 0/531 (0%) 0 1/85 (1.2%) 1 0/97 (0%) 0 0/52 (0%) 0 0/89 (0%) 0 0/87 (0%) 0
Hypotension 0/531 (0%) 0 0/85 (0%) 0 0/97 (0%) 0 0/52 (0%) 0 0/89 (0%) 0 1/87 (1.1%) 1
Spider vein 0/531 (0%) 0 0/85 (0%) 0 0/97 (0%) 0 0/52 (0%) 0 0/89 (0%) 0 1/87 (1.1%) 1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

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

Results Point of Contact

Name/Title Chief Medical Officer
Organization Eli Lilly and Company
Phone 800-545-5979
Email
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01160289
Other Study ID Numbers:
  • 11888
  • I4K-MC-GPEC
First Posted:
Jul 12, 2010
Last Update Posted:
Apr 9, 2019
Last Verified:
Mar 1, 2019