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CompletedNCT01160289Updated Apr 9, 2019Results posted

A Study of LY900010 in Erectile Dysfunction

A Phase 2 interventional study of LY2452473 and tadalafil in Erectile Dysfunction, sponsored by Eli Lilly and Company. Completed at 36 sites in United States. Open to male participants aged 45 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-04-09.

Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
410
Allocation
Randomized
Ages
45 Years to 70 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Erectile Dysfunction

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03

In context

Erectile Dysfunction

683 studies on the registry are indexed under Erectile Dysfunction; 117 are open to participants now.

This study's enrollment of 410 is above the median of 72 across 542 interventional studies indexed under Erectile Dysfunction.

Browse Erectile Dysfunction studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 70 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • 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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
410 participants (actual)

Study arms

  • Experimental
    1 milligram (mg) LY2452473 + 5 mg tadalafil

    Drug: LY2452473 · Drug: tadalafil · Drug: placebo (tadalafil)

  • Experimental
    5 mg LY2452473 + 5 mg tadalafil

    Drug: LY2452473 · Drug: tadalafil · Drug: placebo (tadalafil)

  • Experimental
    5 mg LY2452473 + placebo

    Drug: LY2452473 · Drug: placebo (tadalafil)

  • Active comparator
    10 mg tadalafil + placebo

    Drug: tadalafil · Drug: placebo (tadalafil) · Drug: placebo (LY2452473)

  • Active comparator
    5 mg tadalafil + placebo

    Drug: tadalafil · Drug: placebo (tadalafil) · Drug: placebo (LY2452473)

Interventions

  • DrugLY2452473

    Administered orally, once daily for 12 weeks

  • Drugtadalafil

    Administered orally, once daily for 12 weeks

  • Drugplacebo (tadalafil)

    Administered orally, once daily for 12 weeks

  • Drugplacebo (LY2452473)

    Administered orally, once daily for 12 weeks

06

What researchers measure

Primary outcomes

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

    The IIEF EF domain score was the sum of Questions (Q) 1 to Q5 and Q15 of the IIEF self-reported questionnaire. Q1 to Q5 were rated 0 (low/no EF) to 5 (high EF) and Q15 was rated 1 (no/low confidence) to 5 (high confidence). IIEF EF domain scores ranged from 1 to 30. Higher scores denoted better EF.

    Time frame: Baseline, Week 12

Secondary outcomes

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

    The SEP diary was a participant-assessed diary with 5 questions (Q): Q1 (erection achievement), Q2 (successful penetration), Q3 (successful intercourse), Q4 (satisfied with erection), and Q5 (satisfied with sexual experience) for each sexual encounter made over a specified period of time. SEP Q1 to Q5 scores were determined as a percentage of "Yes" responses to each of the 5 questions out of all sexual attempts recorded during the time period. A higher percentage of "Yes" responses indicated better EF. Assessed was the mean change from baseline in the percentage of "Yes" responses to the SEP diary Q1 to Q5. The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment\*visit, baseline, baseline\*treatment (if p-value \<0.25).

    Time frame: Baseline, Week 12

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

    Intercourse Satisfaction (IS) domain score: sum of Questions (Q) 6, Q7, and Q8, each rated 0 (low/no satisfaction) to 5 (high satisfaction). IS domain score range: 0 to 15; lower scores denoted lower satisfaction. Orgasmic Function (OF) domain score: sum of Q9 and Q10, each rated 0 (no sexual stimulation) to 5 (almost always/always). OF domain score range: 0 to 10; lower scores denoted lower OF. Sexual Desire (SD) domain score: sum of Q11 and Q12, each rated 1 (almost never or low/no sexual desire) to 5 (almost always or very high sexual desire). SD domain score range: 2 to 10; lower scores denoted lower SD. Overall Satisfaction (OS) domain score: sum of Q13 and Q14, each rated 1 (low/no satisfaction) to 5 (high satisfaction). OS domain score range: 2 to 10; lower scores denoted lower OS. Least squares (LS) mean estimated from repeated measures analysis of variance model that included terms for treatment, visit, treatment\*visit, baseline, baseline\*treatment (if p-value\<0.25).

    Time frame: Baseline, Week 12

  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)

    The percentage of participants whose IIEF Erectile Function (EF) domain scores changed from ≤25 at baseline to \>25 (normal) at Week 12. The IIEF EF domain score was the sum of IIEF Question (Q) 1 to Q5 and Q15. Q1 to Q5 were rated 0 (low/no EF) to 5 (high EF) and Q15 was rated 1 (no/low confidence) to 5 (high confidence). IIEF EF domain scores ranged from 1 to 30. Higher scores denoted better EF.

    Time frame: Baseline, Week 12

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

    The International Index of Erectile Function (IIEF) EF was the sum of Questions (Q) 1 to Q5 and Q15 of the IIEF Self-reported questionnaire. Q1 to Q5 were rated 0 (low/no erectile function) to 5 (high erectile function) and Q15 was rated 1 (no/low confidence) to 5 (high confidence). IIEF EF domain scores ranged from 1 to 30. Higher scores denoted better EF. Testosterone concentration subgroups were based on optimal baseline testosterone levels (\<340 nanograms per deciliter \[ng/dL\] or ≥340 ng/dL). The least squares (LS) mean was estimated from an analysis of covariance (ANCOVA) model that included terms for treatment group, baseline, and baseline\*treatment interaction (if p-value\<0.25).

    Time frame: Baseline, Week 12

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

    The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment\*visit, baseline, baseline\*treatment (if p-value\<0.25).

    Time frame: Baseline, Week 12

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

    The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment\*visit, baseline, baseline\*treatment (if p-value\<0.25).

    Time frame: Baseline, Week 12

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

    The least squares (LS) was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment\*visit, baseline, baseline\*treatment (if p-value\<0.25).

    Time frame: Baseline, Week 12

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

    The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment\*visit, baseline, baseline\*treatment (if p-value\<0.25).

    Time frame: Baseline, Week 12

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

    Change from baseline to 12 Week endpoint in fasting blood insulin concentration. The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment\*visit, baseline, baseline\*treatment (if p-value\<0.25).

    Time frame: Baseline, Week 12

07

Results

Posted Apr 9, 2019

Participant flow

Screening, Washout, and Lead-In Period
Participant flow — Screening, Washout, and Lead-In Period
MilestoneAll Screened Subjects1 mg LY2452473 and 5 mg Tadalafil5 mg LY2452473 and 5 mg Tadalafil5 mg LY245247310 mg Tadalafil5 mg Tadalafil
Started89400000
Completed41000000
Not completed48400000
Withdrew: Adverse event800000
Withdrew: Entry criteria not met30800000
Withdrew: Lack of efficacy100000
Withdrew: Lost to follow-up900000
Withdrew: Physician decision2600000
Withdrew: Protocol violation100000
Withdrew: Randomization criteria not met6700000
Withdrew: Withdrawal by subject6400000
Post-Randomization Period
Participant flow — Post-Randomization Period
MilestoneAll Screened Subjects1 mg LY2452473 and 5 mg Tadalafil5 mg LY2452473 and 5 mg Tadalafil5 mg LY245247310 mg Tadalafil5 mg Tadalafil
Started08597528987
Received at least 1 dose of study drug08597528987
Completed06573318073
Not completed0202421914
Withdrew: Adverse event044200
Withdrew: Death000100
Withdrew: Lack of efficacy010300
Withdrew: Lost to follow-up032534
Withdrew: Physician decision001000
Withdrew: Protocol violation042013
Withdrew: Withdrawal by subject0513857
Withdrew: Entry criteria not met022200
Withdrew: Sponsor decision010000

Outcome measures

PrimaryChange From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain Score

The IIEF EF domain score was the sum of Questions (Q) 1 to Q5 and Q15 of the IIEF self-reported questionnaire. Q1 to Q5 were rated 0 (low/no EF) to 5 (high EF) and Q15 was rated 1 (no/low confidence) to 5 (high confidence). IIEF EF domain scores ranged from 1 to 30. Higher scores denoted better EF.

Time frame:
Baseline, Week 12
Reported as:
Mean · units on a scale
Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain Score
units on a scale1 mg LY2452473 and 5 mg Tadalafil5 mg LY2452473 and 5 mg Tadalafil5 mg LY245247310 mg Tadalafil5 mg Tadalafil
Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain Score2.515 ± 6.0192.405 ± 6.920-0.971 ± 6.6993.530 ± 5.6402.054 ± 4.800
Statistical analysis
  • 1 mg LY2452473 and 5 mg Tadalafil vs 5 mg Tadalafil · ANCOVA · p = 0.5 (The p-value was 1-sided and adjusted for multiple comparisons. The level of significance was 1-sided of 0.04.)Treatment group (tx grp), baseline IIEF EF domain score, baseline testosterone level, tx grp\*baseline IIEF, tx grp\*testosterone level interactions.
  • 5 mg LY2452473 and 5 mg Tadalafil vs 5 mg Tadalafil · ANCOVA · p = 0.498 (The p-value was 1-sided and adjusted for multiple comparisons. The level of significance was 1-sided of 0.04.)The model included tx grp, baseline IIEF EF domain score, baseline testosterone level, tx grp\*baseline IIEF, tx grp\*testosterone level interactions.
SecondaryChange From Baseline to 12 Week Endpoint in the Percentage of "Yes" Responses on the Sexual Encounter Profile (SEP) Diary

The SEP diary was a participant-assessed diary with 5 questions (Q): Q1 (erection achievement), Q2 (successful penetration), Q3 (successful intercourse), Q4 (satisfied with erection), and Q5 (satisfied with sexual experience) for each sexual encounter made over a specified period of time. SEP Q1 to Q5 scores were determined as a percentage of "Yes" responses to each of the 5 questions out of all sexual attempts recorded during the time period. A higher percentage of "Yes" responses indicated better EF. Assessed was the mean change from baseline in the percentage of "Yes" responses to the SEP diary Q1 to Q5. The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment\*visit, baseline, baseline\*treatment (if p-value \<0.25).

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · percentage of "yes" responses
Change From Baseline to 12 Week Endpoint in the Percentage of "Yes" Responses on the Sexual Encounter Profile (SEP) Diary
percentage of "yes" responses1 mg LY2452473 and 5 mg Tadalafil5 mg LY2452473 and 5 mg Tadalafil5 mg LY245247310 mg Tadalafil5 mg Tadalafil
Question 1-0.247 ± 2.378-2.976 ± 2.295-10.711 ± 3.2684.427 ± 2.168-1.425 ± 2.305
Question 23.175 ± 3.3453.689 ± 3.227-7.849 ± 4.56610.267 ± 3.0641.844 ± 3.240
Question 39.296 ± 3.80811.752 ± 3.675-3.800 ± 5.19514.645 ± 3.4892.593 ± 3.688
Question 412.935 ± 3.99813.910 ± 3.854-1.570 ± 5.45424.202 ± 3.6568.857 ± 3.872
Question 513.602 ± 4.02715.196 ± 3.880-1.956 ± 5.48822.410 ± 3.6839.400 ± 3.897
Statistical analysis
  • 1 mg LY2452473 and 5 mg Tadalafil vs 5 mg Tadalafil · Mixed model repeated measures analysis · p = 0.722 (The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q1; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: 1.178
  • 5 mg LY2452473 and 5 mg Tadalafil vs 5 mg Tadalafil · Mixed model repeated measures analysis · p = 0.634 (The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q1; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: -1.552
  • 1 mg LY2452473 and 5 mg Tadalafil vs 10 mg Tadalafil · Mixed model repeated measures analysis · p = 0.147 (The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q1; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: -4.674
  • 5 mg LY2452473 and 5 mg Tadalafil vs 10 mg Tadalafil · Mixed model repeated measures analysis · p = 0.020 (The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q1; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: -7.404
  • 1 mg LY2452473 and 5 mg Tadalafil vs 5 mg Tadalafil · Mixed model repeated measures analysis · p = 0.775 (The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q2; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: 1.330
  • 5 mg LY2452473 and 5 mg Tadalafil vs 5 mg Tadalafil · Mixed model repeated measures analysis · p = 0.687 (The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q2; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: 1.844
  • 1 mg LY2452473 and 5 mg Tadalafil vs 10 mg Tadalafil · Mixed model repeated measures analysis · p = 0.119 (The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q2; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: -7.092
  • 5 mg LY2452473 and 5 mg Tadalafil vs 10 mg Tadalafil · Mixed model repeated measures analysis · p = 0.140 (The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q2; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: -6.578
  • 1 mg LY2452473 and 5 mg Tadalafil vs 5 mg Tadalafil · Mixed model repeated measures analysis · p = 0.207 (The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q3; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: 6.703
  • 5 mg LY2452473 and 5 mg Tadalafil vs 5 mg Tadalafil · Mixed model repeated measures analysis · p = 0.079 (The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q3; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: 9.159
  • 1 mg LY2452473 and 5 mg Tadalafil vs 10 mg Tadalafil · Mixed model repeated measures analysis · p = 0.301 (The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q3; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: -5.349
  • 5 mg LY2452473 and 5 mg Tadalafil vs 10 mg Tadalafil · Mixed model repeated measures analysis · p = 0.568 (The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q3; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: -2.893
  • 1 mg LY2452473 and 5 mg Tadalafil vs 5 mg Tadalafil · Mixed model repeated measures analysis · p = 0.464 (The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q4; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: 4.079
  • 5 mg LY2452473 and 5 mg Tadalafil vs 5 mg Tadalafil · Mixed model repeated measures analysis · p = 0.356 (The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q4; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: 5.054
  • 1 mg LY2452473 and 5 mg Tadalafil vs 10 mg Tadalafil · Mixed model repeated measures analysis · p = 0.038 (The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q4; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: -11.266
  • 5 mg LY2452473 and 5 mg Tadalafil vs 10 mg Tadalafil · Mixed model repeated measures analysis · p = 0.054 (The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q4; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: -10.292
  • 1 mg LY2452473 and 5 mg Tadalafil vs 5 mg Tadalafil · Mixed model repeated measures analysis · p = 0.454 (The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q5; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: 4.202
  • 5 mg LY2452473 and 5 mg Tadalafil vs 5 mg Tadalafil · Mixed model repeated measures analysis · p = 0.293 (The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q5; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: 5.796
  • 1 mg LY2452473 and 5 mg Tadalafil vs 10 mg Tadalafil · Mixed model repeated measures analysis · p = 0.107 (The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q5; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: -8.808
  • 5 mg LY2452473 and 5 mg Tadalafil vs 10 mg Tadalafil · Mixed model repeated measures analysis · p = 0.178 (The p-value is for the change from baseline to Week 12 in the percentage of "Yes" responses on the SEP diary, Q5; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: -7.214
SecondaryChange From Baseline to 12 Week Endpoint in IIEF Domain Scores (Intercourse Satisfaction, Orgasmic Function, Sexual Desire, and Overall Satisfaction)

Intercourse Satisfaction (IS) domain score: sum of Questions (Q) 6, Q7, and Q8, each rated 0 (low/no satisfaction) to 5 (high satisfaction). IS domain score range: 0 to 15; lower scores denoted lower satisfaction. Orgasmic Function (OF) domain score: sum of Q9 and Q10, each rated 0 (no sexual stimulation) to 5 (almost always/always). OF domain score range: 0 to 10; lower scores denoted lower OF. Sexual Desire (SD) domain score: sum of Q11 and Q12, each rated 1 (almost never or low/no sexual desire) to 5 (almost always or very high sexual desire). SD domain score range: 2 to 10; lower scores denoted lower SD. Overall Satisfaction (OS) domain score: sum of Q13 and Q14, each rated 1 (low/no satisfaction) to 5 (high satisfaction). OS domain score range: 2 to 10; lower scores denoted lower OS. Least squares (LS) mean estimated from repeated measures analysis of variance model that included terms for treatment, visit, treatment\*visit, baseline, baseline\*treatment (if p-value\<0.25).

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · units on a scale
Change From Baseline to 12 Week Endpoint in IIEF Domain Scores (Intercourse Satisfaction, Orgasmic Function, Sexual Desire, and Overall Satisfaction)
units on a scale1 mg LY2452473 and 5 mg Tadalafil5 mg LY2452473 and 5 mg Tadalafil5 mg LY245247310 mg Tadalafil5 mg Tadalafil
Intercourse Satisfaction0.475 ± 0.3400.514 ± 0.322-0.672 ± 0.4631.127 ± 0.3100.554 ± 0.327
Orgasmic Function0.510 ± 0.2890.117 ± 0.2740.160 ± 0.3940.678 ± 0.2640.733 ± 0.278
Sexual Desire0.092 ± 0.1860.001 ± 0.176-0.201 ± 0.2530.392 ± 0.1690.180 ± 0.178
Overall Satisfaction0.477 ± 0.2470.258 ± 0.235-0.378 ± 0.3391.206 ± 0.2260.826 ± 0.238
Statistical analysis
  • 1 mg LY2452473 and 5 mg Tadalafil vs 5 mg Tadalafil · Mixed model repeated measures analysis · p = 0.867 (The p-value is for the change from baseline to Week 12 in the IIEF IS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: -0.079
  • 5 mg LY2452473 and 5 mg Tadalafil vs 5 mg Tadalafil · Mixed model repeated measures analysis · p = 0.931 (The p-value is for the change from baseline to Week 12 in the IIEF IS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: -0.039
  • 1 mg LY2452473 and 5 mg Tadalafil vs 10 mg Tadalafil · Mixed model repeated measures analysis · p = 0.158 (The p-value is for the change from baseline to Week 12 in the IIEF IS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: -0.652
  • 5 mg LY2452473 and 5 mg Tadalafil vs 10 mg Tadalafil · Mixed model repeated measures analysis · p = 0.172 (The p-value is for the change from baseline to Week 12 in the IIEF IS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: -0.612
  • 1 mg LY2452473 and 5 mg Tadalafil vs 5 mg Tadalafil · Mixed model repeated measures analysis · p = 0.579 (The p-value is for the change from baseline to Week 12 in the IIEF OF domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: -0.223
  • 5 mg LY2452473 and 5 mg Tadalafil vs 5 mg Tadalafil · Mixed model repeated measures analysis · p = 0.115 (The p-value is for the change from baseline to Week 12 in the IIEF OF domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: -0.616
  • 1 mg LY2452473 and 5 mg Tadalafil vs 10 mg Tadalafil · Mixed model repeated measures analysis · p = 0.668 (The p-value is for the change from baseline to Week 12 in the IIEF OF domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: -0.168
  • 5 mg LY2452473 and 5 mg Tadalafil vs 10 mg Tadalafil · Mixed model repeated measures analysis · p = 0.141 (The p-value is for the change from baseline to Week 12 in the IIEF OF domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: -0.561
  • 1 mg LY2452473 and 5 mg Tadalafil vs 5 mg Tadalafil · Mixed model repeated measures analysis · p = 0.734 (The p-value is for the change from baseline to Week 12 in the IIEF SD domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: -0.088
  • 5 mg LY2452473 and 5 mg Tadalafil vs 5 mg Tadalafil · Mixed model repeated measures analysis · p = 0.477 (The p-value is for the change from baseline to Week 12 in the IIEF SD domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: -0.179
  • 1 mg LY2452473 and 5 mg Tadalafil vs 10 mg Tadalafil · Mixed model repeated measures analysis · p = 0.235 (The p-value is for the change from baseline to Week 12 in the IIEF SD domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: -0.300
  • 5 mg LY2452473 and 5 mg Tadalafil vs 10 mg Tadalafil · Mixed model repeated measures analysis · p = 0.111 (The p-value is for the change from baseline to Week 12 in the IIEF SD domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: -0.391
  • 1 mg LY2452473 and 5 mg Tadalafil vs 5 mg Tadalafil · Mixed model repeated measures analysis · p = 0.310 (The p-value is for the change from baseline to Week 12 in the IIEF OS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: -0.349
  • 5 mg LY2452473 and 5 mg Tadalafil vs 5 mg Tadalafil · Mixed model repeated measures analysis · p = 0.090 (The p-value is for the change from baseline to Week 12 in the IIEF OS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: -0.568
  • 1 mg LY2452473 and 5 mg Tadalafil vs 10 mg Tadalafil · Mixed model repeated measures analysis · p = 0.030 (The p-value is for the change from baseline to Week 12 in the IIEF OS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: -0.729
  • 5 mg LY2452473 and 5 mg Tadalafil vs 10 mg Tadalafil · Mixed model repeated measures analysis · p = 0.004 (The p-value is for the change from baseline to Week 12 in the IIEF OS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: -0.948
SecondaryChange From Baseline to 12 Week Endpoint in the Percentage of Participants Who Return to "Normal" on the International Index of Erectile Function (IIEF) Scale (EF>25)

The percentage of participants whose IIEF Erectile Function (EF) domain scores changed from ≤25 at baseline to \>25 (normal) at Week 12. The IIEF EF domain score was the sum of IIEF Question (Q) 1 to Q5 and Q15. Q1 to Q5 were rated 0 (low/no EF) to 5 (high EF) and Q15 was rated 1 (no/low confidence) to 5 (high confidence). IIEF EF domain scores ranged from 1 to 30. Higher scores denoted better EF.

Time frame:
Baseline, Week 12
Reported as:
Number · percentage of participants
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)
percentage of participants1 mg LY2452473 and 5 mg Tadalafil5 mg LY2452473 and 5 mg Tadalafil5 mg LY245247310 mg Tadalafil5 mg Tadalafil
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)24.727.813.530.327.6
SecondaryChange From Baseline to 12 Week Endpoint in IIEF EF Domain Score Reported by Testosterone Concentration Subgroups

The International Index of Erectile Function (IIEF) EF was the sum of Questions (Q) 1 to Q5 and Q15 of the IIEF Self-reported questionnaire. Q1 to Q5 were rated 0 (low/no erectile function) to 5 (high erectile function) and Q15 was rated 1 (no/low confidence) to 5 (high confidence). IIEF EF domain scores ranged from 1 to 30. Higher scores denoted better EF. Testosterone concentration subgroups were based on optimal baseline testosterone levels (\<340 nanograms per deciliter \[ng/dL\] or ≥340 ng/dL). The least squares (LS) mean was estimated from an analysis of covariance (ANCOVA) model that included terms for treatment group, baseline, and baseline\*treatment interaction (if p-value\<0.25).

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · units on a scale
Change From Baseline to 12 Week Endpoint in IIEF EF Domain Score Reported by Testosterone Concentration Subgroups
units on a scale1 mg LY2452473 and 5 mg Tadalafil5 mg LY2452473 and 5 mg Tadalafil5 mg LY245247310 mg Tadalafil5 mg Tadalafil
Testosterone <340 ng/dL2.523 ± 0.9521.012 ± 0.848-1.055 ± 1.2234.172 ± 0.8521.935 ± 0.912
Testosterone ≥340 ng/dL1.077 ± 1.0193.416 ± 1.071-0.714 ± 1.3872.217 ± 1.0701.703 ± 1.063
Statistical analysis
  • 1 mg LY2452473 and 5 mg Tadalafil vs 5 mg Tadalafil · ANCOVA · p = 0.656 (The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level \<340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.)
  • 5 mg LY2452473 and 5 mg Tadalafil vs 5 mg Tadalafil · ANCOVA · p = 0.460 (The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level \<340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.)
  • 1 mg LY2452473 and 5 mg Tadalafil vs 10 mg Tadalafil · ANCOVA · p = 0.198 (The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level \<340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.)
  • 5 mg LY2452473 and 5 mg Tadalafil vs 10 mg Tadalafil · ANCOVA · p = 0.009 (The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level ≥340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.)
  • 1 mg LY2452473 and 5 mg Tadalafil vs 5 mg Tadalafil · ANCOVA · p = 0.671 (The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level ≥340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.)
  • 5 mg LY2452473 and 5 mg Tadalafil vs 5 mg Tadalafil · ANCOVA · p = 0.259 (The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level ≥340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.)
  • 1 mg LY2452473 and 5 mg Tadalafil vs 10 mg Tadalafil · ANCOVA · p = 0.441 (The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level ≥340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.)
  • 5 mg LY2452473 and 5 mg Tadalafil vs 10 mg Tadalafil · ANCOVA · p = 0.433 (The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level ≥340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.)
SecondaryChange From Baseline to 12 Week Endpoint in Prostate-Specific Antigen (PSA)

The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment\*visit, baseline, baseline\*treatment (if p-value\<0.25).

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · nanograms per milliliter (ng/mL)
Change From Baseline to 12 Week Endpoint in Prostate-Specific Antigen (PSA)
nanograms per milliliter (ng/mL)1 mg LY2452473 and 5 mg Tadalafil5 mg LY2452473 and 5 mg Tadalafil5 mg LY245247310 mg Tadalafil5 mg Tadalafil
Change From Baseline to 12 Week Endpoint in Prostate-Specific Antigen (PSA)0.162 ± 0.119-0.088 ± 0.1090.265 ± 0.1570.246 ± 0.1070.032 ± 0.111
Statistical analysis
  • 1 mg LY2452473 and 5 mg Tadalafil vs 5 mg Tadalafil · Mixed model repeated measures analysis · p = 0.423 (Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: 0.130
  • 5 mg LY2452473 and 5 mg Tadalafil vs 5 mg Tadalafil · Mixed model repeated measures analysis · p = 0.443 (Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: -0.120
  • 1 mg LY2452473 and 5 mg Tadalafil vs 10 mg Tadalafil · Mixed model repeated measures analysis · p = 0.599 (Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: -0.084
  • 5 mg LY2452473 and 5 mg Tadalafil vs 10 mg Tadalafil · Mixed model repeated measures analysis · p = 0.029 (Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: -0.334
SecondaryChange From Baseline to 12 Week Endpoint in Total Cholesterol and Triglycerides

The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment\*visit, baseline, baseline\*treatment (if p-value\<0.25).

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · millimoles per Liter (mmol/L)
Change From Baseline to 12 Week Endpoint in Total Cholesterol and Triglycerides
millimoles per Liter (mmol/L)1 mg LY2452473 and 5 mg Tadalafil5 mg LY2452473 and 5 mg Tadalafil5 mg LY245247310 mg Tadalafil5 mg Tadalafil
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 ± 0.0630.056 ± 0.067
Statistical analysis
  • 1 mg LY2452473 and 5 mg Tadalafil vs 5 mg Tadalafil · Mixed model repeated measures analysis · p = 0.148 (The p-value is for the change from baseline to Week 12 in total cholesterol; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: -0.152
  • 5 mg LY2452473 and 5 mg Tadalafil vs 5 mg Tadalafil · Mixed model repeated measures analysis · p = 0.033 (The p-value is for the change from baseline to Week 12 in total cholesterol; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: -0.216
  • 1 mg LY2452473 and 5 mg Tadalafil vs 10 mg Tadalafil · Mixed model repeated measures analysis · p = 0.224 (The p-value is for the change from baseline to Week 12 in total cholesterol; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: -0.124
  • 5 mg LY2452473 and 5 mg Tadalafil vs 10 mg Tadalafil · Mixed model repeated measures analysis · p = 0.056 (The p-value is for the change from baseline to Week 12 in total cholesterol; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: -0.189
  • 1 mg LY2452473 and 5 mg Tadalafil vs 5 mg Tadalafil · Mixed model repeated measures analysis · p = 0.031 (The p-value is for the change from baseline to Week 12 in triglycerides; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: -0.211
  • 5 mg LY2452473 and 5 mg Tadalafil vs 5 mg Tadalafil · Mixed model repeated measures analysis · p = 0.017 (The p-value is for the change from baseline to Week 12 in triglycerides; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: -0.227
  • 1 mg LY2452473 and 5 mg Tadalafil vs 10 mg Tadalafil · Mixed model repeated measures analysis · p = 0.866 (The p-value is for the change from baseline to Week 12 in triglycerides; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: -0.016
  • 5 mg LY2452473 and 5 mg Tadalafil vs 10 mg Tadalafil · Mixed model repeated measures analysis · p = 0.726 (The p-value is for the change from baseline to Week 12 in triglycerides; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: -0.032
SecondaryPercent Change From Baseline to 12 Week Endpoint in High-Density Lipoprotein Cholesterol (HDL-C) and Low-Density Lipoprotein Cholesterol (LDL-C)

The least squares (LS) was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment\*visit, baseline, baseline\*treatment (if p-value\<0.25).

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · percent change
Percent Change From Baseline to 12 Week Endpoint in High-Density Lipoprotein Cholesterol (HDL-C) and Low-Density Lipoprotein Cholesterol (LDL-C)
percent change1 mg LY2452473 and 5 mg Tadalafil5 mg LY2452473 and 5 mg Tadalafil5 mg LY245247310 mg Tadalafil5 mg Tadalafil
HDL-C-7.440 ± 1.658-16.974 ± 1.556-22.230 ± 2.2431.776 ± 1.5051.573 ± 1.585
LDL-C-1.695 ± 2.4790.062 ± 2.319-3.424 ± 3.365-0.066 ± 2.245-0.718 ± 2.367
Statistical analysis
  • 1 mg LY2452473 and 5 mg Tadalafil vs 5 mg Tadalafil · Mixed model repeated measures analysis · p = <0.001 (The p-value is for the percent change from baseline to Week 12 in HDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: -9.014
  • 5 mg LY2452473 and 5 mg Tadalafil vs 5 mg Tadalafil · Mixed model repeated measures analysis · p = <0.001 (The p-value is for the percent change from baseline to Week 12 in HDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: -18.547
  • 1 mg LY2452473 and 5 mg Tadalafil vs 10 mg Tadalafil · Mixed model repeated measures analysis · p = <0.001 (The p-value is for the percent change from baseline to Week 12 in HDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: -9.216
  • 5 mg LY2452473 and 5 mg Tadalafil vs 10 mg Tadalafil · Mixed model repeated measures analysis · p = <0.001 (The p-value is for the percent change from baseline to Week 12 in HDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: -18.750
  • 1 mg LY2452473 and 5 mg Tadalafil vs 5 mg Tadalafil · Mixed model repeated measures analysis · p = 0.776 (The p-value is for the percent change from baseline to Week 12 in LDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: -0.977
  • 5 mg LY2452473 and 5 mg Tadalafil vs 5 mg Tadalafil · Mixed model repeated measures analysis · p = 0.814 (The p-value is for the percent change from baseline to Week 12 in LDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: 0.780
  • 1 mg LY2452473 and 5 mg Tadalafil vs 10 mg Tadalafil · Mixed model repeated measures analysis · p = 0.627 (The p-value is for the percent change from baseline to Week 12 in LDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: -1.629
  • 5 mg LY2452473 and 5 mg Tadalafil vs 10 mg Tadalafil · Mixed model repeated measures analysis · p = 0.968 (The p-value is for the percent change from baseline to Week 12 in LDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: 0.128
SecondaryChange From Baseline to 12 Week Endpoint in Fasting Glucose

The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment\*visit, baseline, baseline\*treatment (if p-value\<0.25).

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · millimoles per Liter (mmol/L)
Change From Baseline to 12 Week Endpoint in Fasting Glucose
millimoles per Liter (mmol/L)1 mg LY2452473 and 5 mg Tadalafil5 mg LY2452473 and 5 mg Tadalafil5 mg LY245247310 mg Tadalafil5 mg Tadalafil
Change From Baseline to 12 Week Endpoint in Fasting Glucose0.153 ± 0.195-0.306 ± 0.1830.070 ± 0.268-0.234 ± 0.1760.158 ± 0.186
Statistical analysis
  • 1 mg LY2452473 and 5 mg Tadalafil vs 5 mg Tadalafil · Mixed model repeated measures analysis · p = 0.984 (Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: -0.006
  • 5 mg LY2452473 and 5 mg Tadalafil vs 5 mg Tadalafil · Mixed model repeated measures analysis · p = 0.076 (Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: -0.465
  • 1 mg LY2452473 and 5 mg Tadalafil vs 10 mg Tadalafil · Mixed model repeated measures analysis · p = 0.142 (Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: 0.387
  • 5 mg LY2452473 and 5 mg Tadalafil vs 10 mg Tadalafil · Mixed model repeated measures analysis · p = 0.776 (Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: -0.072
SecondaryChange From Baseline to 12 Week Endpoint in Fasting Insulin

Change from baseline to 12 Week endpoint in fasting blood insulin concentration. The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment\*visit, baseline, baseline\*treatment (if p-value\<0.25).

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · milliunits per Liter (mU/L)
Change From Baseline to 12 Week Endpoint in Fasting Insulin
milliunits per Liter (mU/L)1 mg LY2452473 and 5 mg Tadalafil5 mg LY2452473 and 5 mg Tadalafil5 mg LY245247310 mg Tadalafil5 mg Tadalafil
Change From Baseline to 12 Week Endpoint in Fasting Insulin3.756 ± 2.235-4.501 ± 2.075-0.717 ± 3.068-3.300 ± 1.976-1.276 ± 2.109
Statistical analysis
  • 1 mg LY2452473 and 5 mg Tadalafil vs 5 mg Tadalafil · Mixed model repeated measures analysis · p = 0.103 (Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: 5.031
  • 5 mg LY2452473 and 5 mg Tadalafil vs 5 mg Tadalafil · Mixed model repeated measures analysis · p = 0.277 (Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean treatment difference: -3.225
  • 1 mg LY2452473 and 5 mg Tadalafil vs 10 mg Tadalafil · Mixed model repeated measures analysis · p = 0.019 (Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: 7.056
  • 5 mg LY2452473 and 5 mg Tadalafil vs 10 mg Tadalafil · Mixed model repeated measures analysis · p = 0.676 (Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.) · Ls mean of treatment difference: -1.201

Adverse events

Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
5 mg Tadalafil, Lead-in Period—2/531 (0.4%)88/531 (16.6%)
1 mg LY2452473 and 5 mg Tadalafil—2/85 (2.4%)27/85 (31.8%)
5 mg LY2452473 and 5 mg Tadalafil—1/97 (1%)23/97 (23.7%)
5 mg LY2452473—1/52 (1.9%)10/52 (19.2%)
10 mg Tadalafil—0/89 (0%)34/89 (38.2%)
5 mg Tadalafil—0/87 (0%)33/87 (37.9%)
Most frequent serious events
Most frequent serious events
Event5 mg Tadalafil, Lead-in Period1 mg LY2452473 and 5 mg Tadalafil5 mg LY2452473 and 5 mg Tadalafil5 mg LY245247310 mg Tadalafil5 mg Tadalafil
Cardiac arrestCardiac disorders0/5310/850/971/520/890/87
Lobar pneumoniaInfections and infestations0/5311/850/970/520/890/87
Humerus fractureInjury, poisoning and procedural complications0/5311/850/970/520/890/87
Tubulointerstitial nephritisRenal and urinary disorders0/5311/850/970/520/890/87
Pulmonary embolismRespiratory, thoracic and mediastinal disorders0/5311/850/970/520/890/87
ArrhythmiaCardiac disorders1/5310/851/970/520/890/87
Hypertensive cardiomyopathyCardiac disorders1/5310/850/970/520/890/87
Most frequent other events
Showing 10 of 134
Most frequent other events
Event5 mg Tadalafil, Lead-in Period1 mg LY2452473 and 5 mg Tadalafil5 mg LY2452473 and 5 mg Tadalafil5 mg LY245247310 mg Tadalafil5 mg Tadalafil
Upper respiratory tract infectionInfections and infestations2/5311/852/970/524/893/87
Urinary tract infectionInfections and infestations0/5310/850/972/520/891/87
NasopharyngitisInfections and infestations5/5313/851/971/520/890/87
Back painMusculoskeletal and connective tissue disorders4/5313/851/970/523/891/87
HeadacheNervous system disorders9/5313/851/970/523/892/87
Gastrooesophageal reflux diseaseGastrointestinal disorders7/5310/851/970/523/892/87
ArthralgiaMusculoskeletal and connective tissue disorders1/5311/852/971/523/890/87
PneumoniaInfections and infestations0/5312/850/970/520/890/87
MyalgiaMusculoskeletal and connective tissue disorders3/5312/850/970/520/890/87
DizzinessNervous system disorders3/5312/851/970/522/890/87

Baseline characteristics

All randomized participants.

Age, Continuous
Age, Continuous(years)1 mg LY2452473 and 5 mg Tadalafil5 mg LY2452473 and 5 mg Tadalafil5 mg LY245247310 mg Tadalafil5 mg TadalafilTotal
Mean59.7 ± 6.5760.7 ± 6.5758.7 ± 6.5359.4 ± 6.5460.5 ± 6.6859.9 ± 6.59
Sex: Female, Male
Sex: Female, Male(Participants)1 mg LY2452473 and 5 mg Tadalafil5 mg LY2452473 and 5 mg Tadalafil5 mg LY245247310 mg Tadalafil5 mg TadalafilTotal
Female000000
Male8597528987410
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)1 mg LY2452473 and 5 mg Tadalafil5 mg LY2452473 and 5 mg Tadalafil5 mg LY245247310 mg Tadalafil5 mg TadalafilTotal
Hispanic or Latino9133131048
Not Hispanic or Latino7684497677362
Unknown or Not Reported000000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)1 mg LY2452473 and 5 mg Tadalafil5 mg LY2452473 and 5 mg Tadalafil5 mg LY245247310 mg Tadalafil5 mg TadalafilTotal
American Indian or Alaska Native120205
Asian220206
Native Hawaiian or Other Pacific Islander000000
Black or African American1417713859
White6876457278339
More than one race000011
Unknown or Not Reported000000
Region of Enrollment
Region of Enrollment(Participants)1 mg LY2452473 and 5 mg Tadalafil5 mg LY2452473 and 5 mg Tadalafil5 mg LY245247310 mg Tadalafil5 mg TadalafilTotal
United States8597528987410
08

Study locations

36 sites
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Birmingham, Alabama 35209, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Phoenix, Arizona 85050, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Glendora, California 91741, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Irvine, California 92618, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Long Beach, California 90806, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Newport Beach, California 92660, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Sacramento, California 95825, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    San Diego, California 92120, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Vacaville, California 95688, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Denver, Colorado 80220, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Englewood, Colorado 80113, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Aventura, Florida 33180, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Celebration, Florida 34747, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Coral Springs, Florida 33065, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Jacksonville, Florida 32209, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Plantation, Florida 33317, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Coeur d'Alene, Idaho 83814, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Indianapolis, Indiana 46256, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Des Moines, Iowa 50314, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Overland Park, Kansas 66215, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Topeka, Kansas 66606, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Shreveport, Louisiana 71106, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Troy, Michigan 48084, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Saint Louis, Missouri 63141, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Las Vegas, Nevada 89117, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Cary, North Carolina 27511, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Charlotte, North Carolina 28207, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Raleigh, North Carolina 27607, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Salisbury, North Carolina 28144, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Edmond, Oklahoma 73034, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Knoxville, Tennessee 37920, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Dallas, Texas 75234, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    San Antonio, Texas 78229, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Bellevue, Washington 98007, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Olympia, Washington 98502, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Spokane, Washington 99202, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 9, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01160289
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Jul 12, 2010
Start date
Oct 2010
Primary completion
Nov 2011
Completion
Nov 2011
Results posted
Apr 9, 2019
Last update
Apr 9, 2019

Study contacts

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)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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