A Study of LY900010 in Erectile Dysfunction

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT01160289
Collaborator
(none)
410
Enrollment
36
Locations
5
Arms
13
Duration (Months)
11.4
Patients Per Site
0.9
Patients Per Site Per Month

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 DiseaseIntervention/TreatmentPhase
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

ArmIntervention/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

SiteCityStateCountryPostal Code
1For 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.BirminghamAlabamaUnited States35209
2For 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.PhoenixArizonaUnited States85050
3For 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.GlendoraCaliforniaUnited States91741
4For 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.IrvineCaliforniaUnited States92618
5For 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 BeachCaliforniaUnited States90806
6For 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 BeachCaliforniaUnited States92660
7For 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.SacramentoCaliforniaUnited States95825
8For 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 DiegoCaliforniaUnited States92120
9For 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.VacavilleCaliforniaUnited States95688
10For 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.DenverColoradoUnited States80220
11For 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.EnglewoodColoradoUnited States80113
12For 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.AventuraFloridaUnited States33180
13For 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.CelebrationFloridaUnited States34747
14For 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 SpringsFloridaUnited States33065
15For 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.JacksonvilleFloridaUnited States32209
16For 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.PlantationFloridaUnited States33317
17For 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'AleneIdahoUnited States83814
18For 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.IndianapolisIndianaUnited States46256
19For 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 MoinesIowaUnited States50314
20For 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 ParkKansasUnited States66215
21For 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.TopekaKansasUnited States66606
22For 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.ShreveportLouisianaUnited States71106
23For 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.TroyMichiganUnited States48084
24For 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 LouisMissouriUnited States63141
25For 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 VegasNevadaUnited States89117
26For 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.CaryNorth CarolinaUnited States27511
27For 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.CharlotteNorth CarolinaUnited States28207
28For 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.RaleighNorth CarolinaUnited States27607
29For 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.SalisburyNorth CarolinaUnited States28144
30For 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.EdmondOklahomaUnited States73034
31For 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.KnoxvilleTennesseeUnited States37920
32For 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.DallasTexasUnited States75234
33For 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 AntonioTexasUnited States78229
34For 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.BellevueWashingtonUnited States98007
35For 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.OlympiaWashingtonUnited States98502
36For 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.SpokaneWashingtonUnited States99202

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 DetailThe 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 TitleAll Screened Subjects1 mg LY2452473 and 5 mg Tadalafil5 mg LY2452473 and 5 mg Tadalafil5 mg LY245247310 mg Tadalafil5 mg Tadalafil
Arm/Group DescriptionAfter 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
STARTED89400000
COMPLETED41000000
NOT COMPLETED48400000
Period Title: Screening, Washout, and Lead-In Period
STARTED08597528987
Received at Least 1 Dose of Study Drug08597528987
COMPLETED06573318073
NOT COMPLETED0202421914

Baseline Characteristics

Arm/Group Title1 mg LY2452473 and 5 mg Tadalafil5 mg LY2452473 and 5 mg Tadalafil5 mg LY245247310 mg Tadalafil5 mg TadalafilTotal
Arm/Group DescriptionThe 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 Participants8597528987410
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
TitleChange From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain Score
DescriptionThe 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 FrameBaseline, 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 Title1 mg LY2452473 and 5 mg Tadalafil5 mg LY2452473 and 5 mg Tadalafil5 mg LY245247310 mg Tadalafil5 mg Tadalafil
Arm/Group DescriptionThe 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 Participants6674348374
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 Hypothesisp-Value0.5
CommentsThe p-value was 1-sided and adjusted for multiple comparisons. The level of significance was 1-sided of 0.04.
MethodANCOVA
CommentsTreatment 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 Hypothesisp-Value0.498
CommentsThe p-value was 1-sided and adjusted for multiple comparisons. The level of significance was 1-sided of 0.04.
MethodANCOVA
CommentsThe model included tx grp, baseline IIEF EF domain score, baseline testosterone level, tx grp*baseline IIEF, tx grp*testosterone level interactions.
2. Secondary Outcome
TitleChange From Baseline to 12 Week Endpoint in the Percentage of "Yes" Responses on the Sexual Encounter Profile (SEP) Diary
DescriptionThe 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 FrameBaseline, 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 Title1 mg LY2452473 and 5 mg Tadalafil5 mg LY2452473 and 5 mg Tadalafil5 mg LY245247310 mg Tadalafil5 mg Tadalafil
Arm/Group DescriptionThe 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 Participants7986468880
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 Hypothesisp-Value0.722
CommentsThe 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.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS mean of treatment difference
Estimated Value1.178
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 Hypothesisp-Value0.634
CommentsThe 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.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS 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 Hypothesisp-Value0.147
CommentsThe 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.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS 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 Hypothesisp-Value0.020
CommentsThe 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.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS 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 Hypothesisp-Value0.775
CommentsThe 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.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS mean of treatment difference
Estimated Value1.330
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 Hypothesisp-Value0.687
CommentsThe 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.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS mean of treatment difference
Estimated Value1.844
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 Hypothesisp-Value0.119
CommentsThe 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.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS 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 Hypothesisp-Value0.140
CommentsThe 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.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS 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 Hypothesisp-Value0.207
CommentsThe 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.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS mean of treatment difference
Estimated Value6.703
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 Hypothesisp-Value0.079
CommentsThe 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.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS mean of treatment difference
Estimated Value9.159
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 Hypothesisp-Value0.301
CommentsThe 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.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS 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 Hypothesisp-Value0.568
CommentsThe 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.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS 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 Hypothesisp-Value0.464
CommentsThe 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.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS mean of treatment difference
Estimated Value4.079
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 Hypothesisp-Value0.356
CommentsThe 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.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS mean of treatment difference
Estimated Value5.054
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 Hypothesisp-Value0.038
CommentsThe 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.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS 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 Hypothesisp-Value0.054
CommentsThe 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.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS 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 Hypothesisp-Value0.454
CommentsThe 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.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS mean of treatment difference
Estimated Value4.202
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 Hypothesisp-Value0.293
CommentsThe 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.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS mean of treatment difference
Estimated Value5.796
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 Hypothesisp-Value0.107
CommentsThe 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.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS 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 Hypothesisp-Value0.178
CommentsThe 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.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS 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
TitleChange From Baseline to 12 Week Endpoint in IIEF Domain Scores (Intercourse Satisfaction, Orgasmic Function, Sexual Desire, and Overall Satisfaction)
DescriptionIntercourse 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 FrameBaseline, 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 Title1 mg LY2452473 and 5 mg Tadalafil5 mg LY2452473 and 5 mg Tadalafil5 mg LY245247310 mg Tadalafil5 mg Tadalafil
Arm/Group DescriptionThe 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 Participants8088488881
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 Hypothesisp-Value0.867
CommentsThe 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.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS 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 Hypothesisp-Value0.931
CommentsThe 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.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS 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 Hypothesisp-Value0.158
CommentsThe 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.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS 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 Hypothesisp-Value0.172
CommentsThe 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.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS 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 Hypothesisp-Value0.579
CommentsThe 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.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS 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 Hypothesisp-Value0.115
CommentsThe 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.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS 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 Hypothesisp-Value0.668
CommentsThe 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.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS 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 Hypothesisp-Value0.141
CommentsThe 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.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS 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 Hypothesisp-Value0.734
CommentsThe 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.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS 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 Hypothesisp-Value0.477
CommentsThe 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.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS 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 Hypothesisp-Value0.235
CommentsThe 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.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS 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 Hypothesisp-Value0.111
CommentsThe 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.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS 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 Hypothesisp-Value0.310
CommentsThe 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.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS 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 Hypothesisp-Value0.090
CommentsThe 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.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS 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 Hypothesisp-Value0.030
CommentsThe 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.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS 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 Hypothesisp-Value0.004
CommentsThe 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.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS 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
TitleChange 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)
DescriptionThe 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 FrameBaseline, Week 12

Outcome Measure Data

Analysis Population Description
Randomized participants who received at least 1 dose of study drug (ITT population).
Arm/Group Title1 mg LY2452473 and 5 mg Tadalafil5 mg LY2452473 and 5 mg Tadalafil5 mg LY245247310 mg Tadalafil5 mg Tadalafil
Arm/Group DescriptionThe 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 Participants8597528987
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
TitleChange From Baseline to 12 Week Endpoint in IIEF EF Domain Score Reported by Testosterone Concentration Subgroups
DescriptionThe 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 FrameBaseline, 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 Title1 mg LY2452473 and 5 mg Tadalafil5 mg LY2452473 and 5 mg Tadalafil5 mg LY245247310 mg Tadalafil5 mg Tadalafil
Arm/Group DescriptionThe 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 Participants8088488881
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 Hypothesisp-Value0.656
CommentsThe 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.
MethodANCOVA
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 Hypothesisp-Value0.460
CommentsThe 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.
MethodANCOVA
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 Hypothesisp-Value0.198
CommentsThe 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.
MethodANCOVA
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 Hypothesisp-Value0.009
CommentsThe 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.
MethodANCOVA
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 Hypothesisp-Value0.671
CommentsThe 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.
MethodANCOVA
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 Hypothesisp-Value0.259
CommentsThe 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.
MethodANCOVA
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 Hypothesisp-Value0.441
CommentsThe 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.
MethodANCOVA
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 Hypothesisp-Value0.433
CommentsThe 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.
MethodANCOVA
Comments
6. Secondary Outcome
TitleChange From Baseline to 12 Week Endpoint in Prostate-Specific Antigen (PSA)
DescriptionThe 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 FrameBaseline, 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 Title1 mg LY2452473 and 5 mg Tadalafil5 mg LY2452473 and 5 mg Tadalafil5 mg LY245247310 mg Tadalafil5 mg Tadalafil
Arm/Group DescriptionThe 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 Participants8189498782
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 Hypothesisp-Value0.423
CommentsConducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS mean of treatment difference
Estimated Value0.130
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 Hypothesisp-Value0.443
CommentsConducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS 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 Hypothesisp-Value0.599
CommentsConducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS 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 Hypothesisp-Value0.029
CommentsConducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS mean of treatment difference
Estimated Value-0.334
Confidence Interval () 95%
to
Parameter Dispersion Type:
Value:
Estimation Comments
7. Secondary Outcome
TitleChange From Baseline to 12 Week Endpoint in Total Cholesterol and Triglycerides
DescriptionThe 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 FrameBaseline, 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 Title1 mg LY2452473 and 5 mg Tadalafil5 mg LY2452473 and 5 mg Tadalafil5 mg LY245247310 mg Tadalafil5 mg Tadalafil
Arm/Group DescriptionThe 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 Participants8190498882
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 Hypothesisp-Value0.148
CommentsThe 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.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS 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 Hypothesisp-Value0.033
CommentsThe 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.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS 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 Hypothesisp-Value0.224
CommentsThe 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.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS 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 Hypothesisp-Value0.056
CommentsThe 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.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS 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 Hypothesisp-Value0.031
CommentsThe 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.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS 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 Hypothesisp-Value0.017
CommentsThe 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.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS 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 Hypothesisp-Value0.866
CommentsThe 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.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS 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 Hypothesisp-Value0.726
CommentsThe 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.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS mean of treatment difference
Estimated Value-0.032
Confidence Interval () 95%
to
Parameter Dispersion Type:
Value:
Estimation Comments
8. Secondary Outcome
TitlePercent Change From Baseline to 12 Week Endpoint in High-Density Lipoprotein Cholesterol (HDL-C) and Low-Density Lipoprotein Cholesterol (LDL-C)
DescriptionThe 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 FrameBaseline, 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 Title1 mg LY2452473 and 5 mg Tadalafil5 mg LY2452473 and 5 mg Tadalafil5 mg LY245247310 mg Tadalafil5 mg Tadalafil
Arm/Group DescriptionThe 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 Participants8190498882
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 Hypothesisp-Value<0.001
CommentsThe 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.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS 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 Hypothesisp-Value<0.001
CommentsThe 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.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS 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 Hypothesisp-Value<0.001
CommentsThe 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.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS 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 Hypothesisp-Value<0.001
CommentsThe 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.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS 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 Hypothesisp-Value0.776
CommentsThe 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.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS 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 Hypothesisp-Value0.814
CommentsThe 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.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS mean of treatment difference
Estimated Value0.780
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 Hypothesisp-Value0.627
CommentsThe 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.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS 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 Hypothesisp-Value0.968
CommentsThe 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.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS mean of treatment difference
Estimated Value0.128
Confidence Interval () 95%
to
Parameter Dispersion Type:
Value:
Estimation Comments
9. Secondary Outcome
TitleChange From Baseline to 12 Week Endpoint in Fasting Glucose
DescriptionThe 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 FrameBaseline, 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 Title1 mg LY2452473 and 5 mg Tadalafil5 mg LY2452473 and 5 mg Tadalafil5 mg LY245247310 mg Tadalafil5 mg Tadalafil
Arm/Group DescriptionThe 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 Participants8190498882
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 Hypothesisp-Value0.984
CommentsConducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS 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 Hypothesisp-Value0.076
CommentsConducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS 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 Hypothesisp-Value0.142
CommentsConducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS mean of treatment difference
Estimated Value0.387
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 Hypothesisp-Value0.776
CommentsConducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS mean of treatment difference
Estimated Value-0.072
Confidence Interval () 95%
to
Parameter Dispersion Type:
Value:
Estimation Comments
10. Secondary Outcome
TitleChange From Baseline to 12 Week Endpoint in Fasting Insulin
DescriptionChange 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 FrameBaseline, 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 Title1 mg LY2452473 and 5 mg Tadalafil5 mg LY2452473 and 5 mg Tadalafil5 mg LY245247310 mg Tadalafil5 mg Tadalafil
Arm/Group DescriptionThe 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 Participants8090498882
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 Hypothesisp-Value0.103
CommentsConducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS Mean of treatment difference
Estimated Value5.031
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 Hypothesisp-Value0.277
CommentsConducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS 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 Hypothesisp-Value0.019
CommentsConducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS mean of treatment difference
Estimated Value7.056
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 Hypothesisp-Value0.676
CommentsConducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.
MethodMixed model repeated measures analysis
Comments
Method of EstimationEstimation ParameterLS 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 Title5 mg Tadalafil, Lead-in Period1 mg LY2452473 and 5 mg Tadalafil5 mg LY2452473 and 5 mg Tadalafil5 mg LY245247310 mg Tadalafil5 mg Tadalafil
Arm/Group Description5-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 Period1 mg LY2452473 and 5 mg Tadalafil5 mg LY2452473 and 5 mg Tadalafil5 mg LY245247310 mg Tadalafil5 mg Tadalafil
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total/ (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
Serious Adverse Events
5 mg Tadalafil, Lead-in Period1 mg LY2452473 and 5 mg Tadalafil5 mg LY2452473 and 5 mg Tadalafil5 mg LY245247310 mg Tadalafil5 mg Tadalafil
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total2/531 (0.4%) 2/85 (2.4%) 1/97 (1%) 1/52 (1.9%) 0/89 (0%) 0/87 (0%)
Cardiac disorders
Arrhythmia1/531 (0.2%) 10/85 (0%) 01/97 (1%) 10/52 (0%) 00/89 (0%) 00/87 (0%) 0
Cardiac arrest0/531 (0%) 00/85 (0%) 00/97 (0%) 01/52 (1.9%) 10/89 (0%) 00/87 (0%) 0
Hypertensive cardiomyopathy1/531 (0.2%) 10/85 (0%) 00/97 (0%) 00/52 (0%) 00/89 (0%) 00/87 (0%) 0
Infections and infestations
Lobar pneumonia0/531 (0%) 01/85 (1.2%) 10/97 (0%) 00/52 (0%) 00/89 (0%) 00/87 (0%) 0
Injury, poisoning and procedural complications
Humerus fracture0/531 (0%) 01/85 (1.2%) 10/97 (0%) 00/52 (0%) 00/89 (0%) 00/87 (0%) 0
Renal and urinary disorders
Tubulointerstitial nephritis0/531 (0%) 01/85 (1.2%) 10/97 (0%) 00/52 (0%) 00/89 (0%) 00/87 (0%) 0
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism0/531 (0%) 01/85 (1.2%) 10/97 (0%) 00/52 (0%) 00/89 (0%) 00/87 (0%) 0
Other (Not Including Serious) Adverse Events
5 mg Tadalafil, Lead-in Period1 mg LY2452473 and 5 mg Tadalafil5 mg LY2452473 and 5 mg Tadalafil5 mg LY245247310 mg Tadalafil5 mg Tadalafil
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total88/531 (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
Anaemia0/531 (0%) 00/85 (0%) 01/97 (1%) 10/52 (0%) 00/89 (0%) 00/87 (0%) 0
Cardiac disorders
Arrhythmia0/531 (0%) 00/85 (0%) 00/97 (0%) 00/52 (0%) 00/89 (0%) 01/87 (1.1%) 1
Bradycardia0/531 (0%) 00/85 (0%) 01/97 (1%) 10/52 (0%) 00/89 (0%) 00/87 (0%) 0
Bundle branch block right0/531 (0%) 00/85 (0%) 01/97 (1%) 10/52 (0%) 00/89 (0%) 01/87 (1.1%) 1
Cardiomegaly0/531 (0%) 01/85 (1.2%) 10/97 (0%) 00/52 (0%) 00/89 (0%) 00/87 (0%) 0
Eye disorders
Corneal erosion0/531 (0%) 00/85 (0%) 01/97 (1%) 10/52 (0%) 00/89 (0%) 00/87 (0%) 0
Eye swelling0/531 (0%) 00/85 (0%) 00/97 (0%) 00/52 (0%) 01/89 (1.1%) 10/87 (0%) 0
Ocular hyperaemia0/531 (0%) 00/85 (0%) 00/97 (0%) 00/52 (0%) 01/89 (1.1%) 10/87 (0%) 0
Vision blurred2/531 (0.4%) 20/85 (0%) 00/97 (0%) 00/52 (0%) 00/89 (0%) 01/87 (1.1%) 1
Gastrointestinal disorders
Barrett's oesophagus0/531 (0%) 00/85 (0%) 00/97 (0%) 00/52 (0%) 01/89 (1.1%) 10/87 (0%) 0
Colonic polyp0/531 (0%) 01/85 (1.2%) 10/97 (0%) 00/52 (0%) 01/89 (1.1%) 10/87 (0%) 0
Constipation3/531 (0.6%) 31/85 (1.2%) 10/97 (0%) 00/52 (0%) 00/89 (0%) 00/87 (0%) 0
Diarrhoea4/531 (0.8%) 40/85 (0%) 01/97 (1%) 10/52 (0%) 00/89 (0%) 01/87 (1.1%) 1
Diverticulum0/531 (0%) 01/85 (1.2%) 10/97 (0%) 00/52 (0%) 00/89 (0%) 00/87 (0%) 0
Diverticulum intestinal0/531 (0%) 00/85 (0%) 00/97 (0%) 00/52 (0%) 01/89 (1.1%) 10/87 (0%) 0
Dyspepsia6/531 (1.1%) 61/85 (1.2%) 11/97 (1%) 10/52 (0%) 01/89 (1.1%) 11/87 (1.1%) 1
Gastrooesophageal reflux disease7/531 (1.3%) 70/85 (0%) 01/97 (1%) 10/52 (0%) 03/89 (3.4%) 32/87 (2.3%) 2
Hiatus hernia0/531 (0%) 00/85 (0%) 00/97 (0%) 00/52 (0%) 01/89 (1.1%) 10/87 (0%) 0
Inguinal hernia0/531 (0%) 00/85 (0%) 00/97 (0%) 00/52 (0%) 01/89 (1.1%) 10/87 (0%) 0
Nausea2/531 (0.4%) 20/85 (0%) 00/97 (0%) 00/52 (0%) 01/89 (1.1%) 10/87 (0%) 0
Oesophagitis0/531 (0%) 00/85 (0%) 01/97 (1%) 10/52 (0%) 00/89 (0%) 00/87 (0%) 0
General disorders
Chest discomfort1/531 (0.2%) 10/85 (0%) 01/97 (1%) 10/52 (0%) 00/89 (0%) 01/87 (1.1%) 1
Chest pain0/531 (0%) 01/85 (1.2%) 10/97 (0%) 00/52 (0%) 00/89 (0%) 01/87 (1.1%) 1
Fatigue4/531 (0.8%) 40/85 (0%) 02/97 (2.1%) 20/52 (0%) 02/89 (2.2%) 21/87 (1.1%) 1
Irritability0/531 (0%) 00/85 (0%) 00/97 (0%) 00/52 (0%) 01/89 (1.1%) 10/87 (0%) 0
Oedema peripheral0/531 (0%) 01/85 (1.2%) 10/97 (0%) 01/52 (1.9%) 10/89 (0%) 01/87 (1.1%) 1
Pain0/531 (0%) 01/85 (1.2%) 10/97 (0%) 00/52 (0%) 01/89 (1.1%) 10/87 (0%) 0
Pyrexia0/531 (0%) 00/85 (0%) 00/97 (0%) 00/52 (0%) 01/89 (1.1%) 10/87 (0%) 0
Immune system disorders
Seasonal allergy0/531 (0%) 01/85 (1.2%) 10/97 (0%) 00/52 (0%) 00/89 (0%) 01/87 (1.1%) 1
Infections and infestations
Bronchitis0/531 (0%) 00/85 (0%) 01/97 (1%) 10/52 (0%) 00/89 (0%) 00/87 (0%) 0
Candidiasis0/531 (0%) 00/85 (0%) 00/97 (0%) 01/52 (1.9%) 10/89 (0%) 00/87 (0%) 0
Ear infection0/531 (0%) 00/85 (0%) 00/97 (0%) 00/52 (0%) 02/89 (2.2%) 20/87 (0%) 0
Herpes zoster0/531 (0%) 00/85 (0%) 00/97 (0%) 00/52 (0%) 01/89 (1.1%) 10/87 (0%) 0
Influenza1/531 (0.2%) 11/85 (1.2%) 10/97 (0%) 01/52 (1.9%) 11/89 (1.1%) 10/87 (0%) 0
Nail infection0/531 (0%) 00/85 (0%) 00/97 (0%) 00/52 (0%) 00/89 (0%) 01/87 (1.1%) 1
Nasopharyngitis5/531 (0.9%) 53/85 (3.5%) 31/97 (1%) 11/52 (1.9%) 10/89 (0%) 00/87 (0%) 0
Oral herpes0/531 (0%) 00/85 (0%) 01/97 (1%) 20/52 (0%) 00/89 (0%) 00/87 (0%) 0
Pharyngitis streptococcal0/531 (0%) 00/85 (0%) 00/97 (0%) 00/52 (0%) 01/89 (1.1%) 10/87 (0%) 0
Pneumonia0/531 (0%) 02/85 (2.4%) 20/97 (0%) 00/52 (0%) 00/89 (0%) 00/87 (0%) 0
Rhinitis0/531 (0%) 00/85 (0%) 00/97 (0%) 00/52 (0%) 00/89 (0%) 01/87 (1.1%) 1
Sinusitis0/531 (0%) 00/85 (0%) 01/97 (1%) 10/52 (0%) 01/89 (1.1%) 11/87 (1.1%) 1
Subcutaneous abscess0/531 (0%) 00/85 (0%) 01/97 (1%) 10/52 (0%) 00/89 (0%) 00/87 (0%) 0
Tinea infection0/531 (0%) 00/85 (0%) 00/97 (0%) 01/52 (1.9%) 10/89 (0%) 00/87 (0%) 0
Tonsillitis0/531 (0%) 00/85 (0%) 00/97 (0%) 00/52 (0%) 01/89 (1.1%) 10/87 (0%) 0
Tooth abscess0/531 (0%) 00/85 (0%) 00/97 (0%) 00/52 (0%) 00/89 (0%) 01/87 (1.1%) 1
Upper respiratory tract infection2/531 (0.4%) 21/85 (1.2%) 12/97 (2.1%) 20/52 (0%) 04/89 (4.5%) 43/87 (3.4%) 3
Urinary tract infection0/531 (0%) 00/85 (0%) 00/97 (0%) 02/52 (3.8%) 20/89 (0%) 01/87 (1.1%) 1
Wound infection0/531 (0%) 01/85 (1.2%) 10/97 (0%) 00/52 (0%) 00/89 (0%) 00/87 (0%) 0
Injury, poisoning and procedural complications
Contusion0/531 (0%) 01/85 (1.2%) 10/97 (0%) 00/52 (0%) 01/89 (1.1%) 10/87 (0%) 0
Corneal abrasion0/531 (0%) 00/85 (0%) 01/97 (1%) 10/52 (0%) 00/89 (0%) 00/87 (0%) 0
Excoriation0/531 (0%) 00/85 (0%) 01/97 (1%) 20/52 (0%) 00/89 (0%) 00/87 (0%) 0
Laceration0/531 (0%) 00/85 (0%) 00/97 (0%) 00/52 (0%) 01/89 (1.1%) 10/87 (0%) 0
Ligament sprain2/531 (0.4%) 20/85 (0%) 00/97 (0%) 00/52 (0%) 01/89 (1.1%) 12/87 (2.3%) 2
Limb injury0/531 (0%) 00/85 (0%) 00/97 (0%) 00/52 (0%) 00/89 (0%) 01/87 (1.1%) 1
Muscle rupture0/531 (0%) 01/85 (1.2%) 10/97 (0%) 00/52 (0%) 00/89 (0%) 00/87 (0%) 0
Muscle strain0/531 (0%) 00/85 (0%) 00/97 (0%) 01/52 (1.9%) 12/89 (2.2%) 21/87 (1.1%) 1
Radius fracture0/531 (0%) 00/85 (0%) 00/97 (0%) 00/52 (0%) 01/89 (1.1%) 10/87 (0%) 0
Rib fracture0/531 (0%) 01/85 (1.2%) 10/97 (0%) 00/52 (0%) 00/89 (0%) 00/87 (0%) 0
Sunburn0/531 (0%) 00/85 (0%) 00/97 (0%) 00/52 (0%) 00/89 (0%) 01/87 (1.1%) 1
Investigations
Aspartate aminotransferase increased0/531 (0%) 00/85 (0%) 00/97 (0%) 00/52 (0%) 00/89 (0%) 02/87 (2.3%) 2
Blood creatine phosphokinase abnormal0/531 (0%) 01/85 (1.2%) 10/97 (0%) 00/52 (0%) 00/89 (0%) 00/87 (0%) 0
Blood creatine phosphokinase increased2/531 (0.4%) 20/85 (0%) 01/97 (1%) 10/52 (0%) 01/89 (1.1%) 12/87 (2.3%) 2
Blood creatinine abnormal0/531 (0%) 00/85 (0%) 00/97 (0%) 00/52 (0%) 00/89 (0%) 01/87 (1.1%) 1
Blood creatinine increased1/531 (0.2%) 10/85 (0%) 01/97 (1%) 10/52 (0%) 02/89 (2.2%) 20/87 (0%) 0
Blood glucose increased0/531 (0%) 01/85 (1.2%) 11/97 (1%) 10/52 (0%) 00/89 (0%) 00/87 (0%) 0
Blood insulin increased0/531 (0%) 01/85 (1.2%) 10/97 (0%) 00/52 (0%) 00/89 (0%) 00/87 (0%) 0
Blood testosterone abnormal0/531 (0%) 01/85 (1.2%) 10/97 (0%) 00/52 (0%) 00/89 (0%) 00/87 (0%) 0
Blood urea abnormal0/531 (0%) 00/85 (0%) 00/97 (0%) 00/52 (0%) 00/89 (0%) 01/87 (1.1%) 1
Blood urea increased0/531 (0%) 00/85 (0%) 00/97 (0%) 00/52 (0%) 01/89 (1.1%) 10/87 (0%) 0
C-reactive protein increased0/531 (0%) 00/85 (0%) 01/97 (1%) 10/52 (0%) 00/89 (0%) 00/87 (0%) 0
Colonoscopy0/531 (0%) 00/85 (0%) 00/97 (0%) 00/52 (0%) 01/89 (1.1%) 10/87 (0%) 0
Electrocardiogram qrs complex prolonged0/531 (0%) 01/85 (1.2%) 10/97 (0%) 00/52 (0%) 00/89 (0%) 00/87 (0%) 0
High density lipoprotein decreased0/531 (0%) 00/85 (0%) 00/97 (0%) 01/52 (1.9%) 10/89 (0%) 00/87 (0%) 0
Oestradiol increased0/531 (0%) 01/85 (1.2%) 10/97 (0%) 00/52 (0%) 00/89 (0%) 00/87 (0%) 0
Prostatic specific antigen increased1/531 (0.2%) 11/85 (1.2%) 10/97 (0%) 00/52 (0%) 01/89 (1.1%) 10/87 (0%) 0
Qrs axis abnormal0/531 (0%) 00/85 (0%) 00/97 (0%) 00/52 (0%) 00/89 (0%) 01/87 (1.1%) 1
Weight decreased1/531 (0.2%) 10/85 (0%) 00/97 (0%) 00/52 (0%) 01/89 (1.1%) 10/87 (0%) 0
Weight increased1/531 (0.2%) 11/85 (1.2%) 10/97 (0%) 00/52 (0%) 00/89 (0%) 00/87 (0%) 0
Metabolism and nutrition disorders
Gout0/531 (0%) 00/85 (0%) 00/97 (0%) 00/52 (0%) 00/89 (0%) 01/87 (1.1%) 1
Hyperlipidaemia0/531 (0%) 00/85 (0%) 00/97 (0%) 00/52 (0%) 01/89 (1.1%) 10/87 (0%) 0
Vitamin d deficiency0/531 (0%) 00/85 (0%) 01/97 (1%) 10/52 (0%) 00/89 (0%) 00/87 (0%) 0
Musculoskeletal and connective tissue disorders
Arthralgia1/531 (0.2%) 11/85 (1.2%) 12/97 (2.1%) 21/52 (1.9%) 13/89 (3.4%) 30/87 (0%) 0
Arthritis0/531 (0%) 01/85 (1.2%) 10/97 (0%) 00/52 (0%) 00/89 (0%) 01/87 (1.1%) 1
Back pain4/531 (0.8%) 43/85 (3.5%) 31/97 (1%) 10/52 (0%) 03/89 (3.4%) 31/87 (1.1%) 1
Flank pain0/531 (0%) 00/85 (0%) 00/97 (0%) 00/52 (0%) 00/89 (0%) 01/87 (1.1%) 1
Muscle spasms0/531 (0%) 00/85 (0%) 00/97 (0%) 00/52 (0%) 00/89 (0%) 01/87 (1.1%) 1
Musculoskeletal pain1/531 (0.2%) 10/85 (0%) 00/97 (0%) 01/52 (1.9%) 11/89 (1.1%) 11/87 (1.1%) 1
Myalgia3/531 (0.6%) 32/85 (2.4%) 30/97 (0%) 00/52 (0%) 00/89 (0%) 00/87 (0%) 0
Osteopenia3/531 (0.6%) 40/85 (0%) 00/97 (0%) 01/52 (1.9%) 10/89 (0%) 02/87 (2.3%) 2
Osteoporosis1/531 (0.2%) 10/85 (0%) 00/97 (0%) 00/52 (0%) 00/89 (0%) 02/87 (2.3%) 2
Pain in extremity4/531 (0.8%) 41/85 (1.2%) 10/97 (0%) 00/52 (0%) 00/89 (0%) 00/87 (0%) 0
Sensation of heaviness0/531 (0%) 00/85 (0%) 00/97 (0%) 00/52 (0%) 01/89 (1.1%) 10/87 (0%) 0
Spinal disorder0/531 (0%) 00/85 (0%) 00/97 (0%) 00/52 (0%) 00/89 (0%) 01/87 (1.1%) 1
Tendonitis0/531 (0%) 00/85 (0%) 00/97 (0%) 00/52 (0%) 01/89 (1.1%) 10/87 (0%) 0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma0/531 (0%) 00/85 (0%) 00/97 (0%) 00/52 (0%) 00/89 (0%) 01/87 (1.1%) 1
Squamous cell carcinoma of skin0/531 (0%) 01/85 (1.2%) 10/97 (0%) 00/52 (0%) 00/89 (0%) 00/87 (0%) 0
Nervous system disorders
Burning sensation0/531 (0%) 00/85 (0%) 00/97 (0%) 00/52 (0%) 00/89 (0%) 01/87 (1.1%) 1
Dizziness3/531 (0.6%) 32/85 (2.4%) 31/97 (1%) 10/52 (0%) 02/89 (2.2%) 20/87 (0%) 0
Headache9/531 (1.7%) 93/85 (3.5%) 31/97 (1%) 10/52 (0%) 03/89 (3.4%) 32/87 (2.3%) 2
Hypoaesthesia0/531 (0%) 00/85 (0%) 01/97 (1%) 10/52 (0%) 00/89 (0%) 00/87 (0%) 0
Lethargy1/531 (0.2%) 10/85 (0%) 01/97 (1%) 10/52 (0%) 00/89 (0%) 00/87 (0%) 0
Sinus headache0/531 (0%) 00/85 (0%) 00/97 (0%) 01/52 (1.9%) 10/89 (0%) 00/87 (0%) 0
Renal and urinary disorders
Dysuria0/531 (0%) 00/85 (0%) 00/97 (0%) 00/52 (0%) 01/89 (1.1%) 10/87 (0%) 0
Haematuria0/531 (0%) 01/85 (1.2%) 10/97 (0%) 00/52 (0%) 01/89 (1.1%) 10/87 (0%) 0
Nephrolithiasis2/531 (0.4%) 21/85 (1.2%) 10/97 (0%) 00/52 (0%) 00/89 (0%) 00/87 (0%) 0
Renal failure0/531 (0%) 00/85 (0%) 00/97 (0%) 00/52 (0%) 00/89 (0%) 01/87 (1.1%) 1
Renal failure acute0/531 (0%) 01/85 (1.2%) 10/97 (0%) 00/52 (0%) 00/89 (0%) 00/87 (0%) 0
Reproductive system and breast disorders
Epididymitis0/531 (0%) 01/85 (1.2%) 10/97 (0%) 00/52 (0%) 00/89 (0%) 00/87 (0%) 0
Haematospermia0/531 (0%) 00/85 (0%) 00/97 (0%) 00/52 (0%) 00/89 (0%) 02/87 (2.3%) 2
Prostatitis1/531 (0.2%) 10/85 (0%) 00/97 (0%) 00/52 (0%) 01/89 (1.1%) 10/87 (0%) 0
Varicocele0/531 (0%) 00/85 (0%) 01/97 (1%) 10/52 (0%) 00/89 (0%) 00/87 (0%) 0
Respiratory, thoracic and mediastinal disorders
Asthma0/531 (0%) 00/85 (0%) 00/97 (0%) 00/52 (0%) 01/89 (1.1%) 10/87 (0%) 0
Bronchial hyperreactivity0/531 (0%) 01/85 (1.2%) 10/97 (0%) 00/52 (0%) 00/89 (0%) 00/87 (0%) 0
Cough1/531 (0.2%) 10/85 (0%) 01/97 (1%) 10/52 (0%) 00/89 (0%) 00/87 (0%) 0
Dyspnoea0/531 (0%) 00/85 (0%) 01/97 (1%) 10/52 (0%) 00/89 (0%) 00/87 (0%) 0
Dyspnoea exertional0/531 (0%) 00/85 (0%) 00/97 (0%) 00/52 (0%) 01/89 (1.1%) 10/87 (0%) 0
Nasal congestion3/531 (0.6%) 30/85 (0%) 00/97 (0%) 00/52 (0%) 02/89 (2.2%) 22/87 (2.3%) 2
Obstructive airways disorder0/531 (0%) 00/85 (0%) 00/97 (0%) 00/52 (0%) 01/89 (1.1%) 10/87 (0%) 0
Oropharyngeal pain1/531 (0.2%) 10/85 (0%) 01/97 (1%) 10/52 (0%) 00/89 (0%) 00/87 (0%) 0
Paranasal sinus hypersecretion2/531 (0.4%) 20/85 (0%) 00/97 (0%) 00/52 (0%) 01/89 (1.1%) 10/87 (0%) 0
Rhinitis allergic0/531 (0%) 00/85 (0%) 00/97 (0%) 00/52 (0%) 01/89 (1.1%) 10/87 (0%) 0
Sinus congestion1/531 (0.2%) 10/85 (0%) 01/97 (1%) 10/52 (0%) 02/89 (2.2%) 20/87 (0%) 0
Sinus disorder0/531 (0%) 00/85 (0%) 00/97 (0%) 01/52 (1.9%) 11/89 (1.1%) 10/87 (0%) 0
Throat irritation0/531 (0%) 00/85 (0%) 01/97 (1%) 10/52 (0%) 00/89 (0%) 00/87 (0%) 0
Skin and subcutaneous tissue disorders
Dermatitis0/531 (0%) 00/85 (0%) 00/97 (0%) 00/52 (0%) 01/89 (1.1%) 10/87 (0%) 0
Dermatitis contact0/531 (0%) 00/85 (0%) 00/97 (0%) 00/52 (0%) 01/89 (1.1%) 10/87 (0%) 0
Diabetic bullosis0/531 (0%) 01/85 (1.2%) 10/97 (0%) 00/52 (0%) 00/89 (0%) 00/87 (0%) 0
Rash0/531 (0%) 00/85 (0%) 02/97 (2.1%) 20/52 (0%) 02/89 (2.2%) 20/87 (0%) 0
Skin lesion1/531 (0.2%) 11/85 (1.2%) 10/97 (0%) 00/52 (0%) 00/89 (0%) 00/87 (0%) 0
Surgical and medical procedures
Tooth extraction0/531 (0%) 00/85 (0%) 00/97 (0%) 00/52 (0%) 01/89 (1.1%) 10/87 (0%) 0
Vascular disorders
Flushing1/531 (0.2%) 11/85 (1.2%) 11/97 (1%) 10/52 (0%) 01/89 (1.1%) 11/87 (1.1%) 1
Haematoma0/531 (0%) 01/85 (1.2%) 10/97 (0%) 00/52 (0%) 00/89 (0%) 00/87 (0%) 0
Hypotension0/531 (0%) 00/85 (0%) 00/97 (0%) 00/52 (0%) 00/89 (0%) 01/87 (1.1%) 1
Spider vein0/531 (0%) 00/85 (0%) 00/97 (0%) 00/52 (0%) 00/89 (0%) 01/87 (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/TitleChief Medical Officer
OrganizationEli Lilly and Company
Phone800-545-5979
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