Erectile Dysfunction
Conditions
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.
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
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
45 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
| 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). |
| 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). |
| 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). |
| 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). |
| 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). |
| 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). |
| 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). |
Countries
United States
Participant flow
Pre-assignment details
The study had 2 periods. Period 1: a screening, a 4-week washout, and a 4-week lead-in period prior to randomization. Period 2: a 12-week treatment and a 4-week follow-up period, post-randomization.
Participants by arm
| Arm | Count |
|---|---|
| 1 mg LY2452473 and 5 mg Tadalafil The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* LY2452473 1-mg capsule
* tadalafil 5-mg tablet
* placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout and a 4-week tadalafil (5-mg tablet, daily) lead-in period. | 85 |
| 5 mg LY2452473 and 5 mg Tadalafil The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* LY2452473 5-mg capsule
* tadalafil 5-mg tablet
* placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period. | 97 |
| 5 mg LY2452473 The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* LY2452473 5-mg capsule
* placebo 5-mg tablet (matching tadalafil)
* placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period. | 52 |
| 10 mg Tadalafil The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* tadalafil 10-mg tablet
* placebo 5-mg capsule (matching LY2452473)
* placebo 5-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period. | 89 |
| 5 mg Tadalafil The following study drugs, administered orally, once daily for 12 weeks post-randomization:
* tadalafil 5-mg tablet
* placebo 5-mg capsule (matching LY2452473)
* placebo 10-mg tablet (matching tadalafil)
Prior to randomization, participants successfully completed a 4-week washout period and a 4-week tadalafil (5-mg tablet, daily) lead-in period. | 87 |
| Total | 410 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Post-Randomization Period | Adverse Event | 0 | 4 | 4 | 2 | 0 | 0 |
| Post-Randomization Period | Death | 0 | 0 | 0 | 1 | 0 | 0 |
| Post-Randomization Period | Entry Criteria Not Met | 0 | 2 | 2 | 2 | 0 | 0 |
| Post-Randomization Period | Lack of Efficacy | 0 | 1 | 0 | 3 | 0 | 0 |
| Post-Randomization Period | Lost to Follow-up | 0 | 3 | 2 | 5 | 3 | 4 |
| Post-Randomization Period | Physician Decision | 0 | 0 | 1 | 0 | 0 | 0 |
| Post-Randomization Period | Protocol Violation | 0 | 4 | 2 | 0 | 1 | 3 |
| Post-Randomization Period | Sponsor Decision | 0 | 1 | 0 | 0 | 0 | 0 |
| Post-Randomization Period | Withdrawal by Subject | 0 | 5 | 13 | 8 | 5 | 7 |
| Screening, Washout, and Lead-In Period | Adverse Event | 8 | 0 | 0 | 0 | 0 | 0 |
| Screening, Washout, and Lead-In Period | Entry Criteria Not Met | 308 | 0 | 0 | 0 | 0 | 0 |
| Screening, Washout, and Lead-In Period | Lack of Efficacy | 1 | 0 | 0 | 0 | 0 | 0 |
| Screening, Washout, and Lead-In Period | Lost to Follow-up | 9 | 0 | 0 | 0 | 0 | 0 |
| Screening, Washout, and Lead-In Period | Physician Decision | 26 | 0 | 0 | 0 | 0 | 0 |
| Screening, Washout, and Lead-In Period | Protocol Violation | 1 | 0 | 0 | 0 | 0 | 0 |
| Screening, Washout, and Lead-In Period | Randomization Criteria Not Met | 67 | 0 | 0 | 0 | 0 | 0 |
| Screening, Washout, and Lead-In Period | Withdrawal by Subject | 64 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | 1 mg LY2452473 and 5 mg Tadalafil | Total | 5 mg Tadalafil | 10 mg Tadalafil | 5 mg LY2452473 | 5 mg LY2452473 and 5 mg Tadalafil |
|---|---|---|---|---|---|---|
| Age, Continuous | 59.7 years STANDARD_DEVIATION 6.57 | 59.9 years STANDARD_DEVIATION 6.59 | 60.5 years STANDARD_DEVIATION 6.68 | 59.4 years STANDARD_DEVIATION 6.54 | 58.7 years STANDARD_DEVIATION 6.53 | 60.7 years STANDARD_DEVIATION 6.57 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 48 Participants | 10 Participants | 13 Participants | 3 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 76 Participants | 362 Participants | 77 Participants | 76 Participants | 49 Participants | 84 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 5 Participants | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 6 Participants | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 59 Participants | 8 Participants | 13 Participants | 7 Participants | 17 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 68 Participants | 339 Participants | 78 Participants | 72 Participants | 45 Participants | 76 Participants |
| Region of Enrollment United States | 85 Participants | 410 Participants | 87 Participants | 89 Participants | 52 Participants | 97 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 85 Participants | 410 Participants | 87 Participants | 89 Participants | 52 Participants | 97 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 88 / 531 | 27 / 85 | 23 / 97 | 10 / 52 | 34 / 89 | 33 / 87 |
| serious Total, serious adverse events | 2 / 531 | 2 / 85 | 1 / 97 | 1 / 52 | 0 / 89 | 0 / 87 |
Outcome results
Primary
Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain Score
The IIEF EF domain score was the sum of Questions (Q) 1 to Q5 and Q15 of the IIEF self-reported questionnaire. Q1 to Q5 were rated 0 (low/no EF) to 5 (high EF) and Q15 was rated 1 (no/low confidence) to 5 (high confidence). IIEF EF domain scores ranged from 1 to 30. Higher scores denoted better EF.
Time frame: Baseline, Week 12
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1 mg LY2452473 and 5 mg Tadalafil | Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain Score | 2.515 units on a scale | Standard Deviation 6.019 |
| 5 mg LY2452473 and 5 mg Tadalafil | Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain Score | 2.405 units on a scale | Standard Deviation 6.92 |
| 5 mg LY2452473 | Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain Score | -0.971 units on a scale | Standard Deviation 6.699 |
| 10 mg Tadalafil | Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain Score | 3.530 units on a scale | Standard Deviation 5.64 |
| 5 mg Tadalafil | Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain Score | 2.054 units on a scale | Standard Deviation 4.8 |
Comparison: 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.p-value: 0.5ANCOVA
Comparison: 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.p-value: 0.498ANCOVA
Secondary
Change From Baseline to 12 Week Endpoint in Fasting Glucose
The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment\*visit, baseline, baseline\*treatment (if p-value\<0.25).
Time frame: Baseline, Week 12
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 1 mg LY2452473 and 5 mg Tadalafil | Change From Baseline to 12 Week Endpoint in Fasting Glucose | 0.153 millimoles per Liter (mmol/L) | Standard Error 0.195 |
| 5 mg LY2452473 and 5 mg Tadalafil | Change From Baseline to 12 Week Endpoint in Fasting Glucose | -0.306 millimoles per Liter (mmol/L) | Standard Error 0.183 |
| 5 mg LY2452473 | Change From Baseline to 12 Week Endpoint in Fasting Glucose | 0.070 millimoles per Liter (mmol/L) | Standard Error 0.268 |
| 10 mg Tadalafil | Change From Baseline to 12 Week Endpoint in Fasting Glucose | -0.234 millimoles per Liter (mmol/L) | Standard Error 0.176 |
| 5 mg Tadalafil | Change From Baseline to 12 Week Endpoint in Fasting Glucose | 0.158 millimoles per Liter (mmol/L) | Standard Error 0.186 |
p-value: 0.984Mixed model repeated measures analysis
p-value: 0.076Mixed model repeated measures analysis
p-value: 0.142Mixed model repeated measures analysis
p-value: 0.776Mixed model repeated measures analysis
Secondary
Change From Baseline to 12 Week Endpoint in Fasting Insulin
Change from baseline to 12 Week endpoint in fasting blood insulin concentration. The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment\*visit, baseline, baseline\*treatment (if p-value\<0.25).
Time frame: Baseline, Week 12
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 1 mg LY2452473 and 5 mg Tadalafil | Change From Baseline to 12 Week Endpoint in Fasting Insulin | 3.756 milliunits per Liter (mU/L) | Standard Error 2.235 |
| 5 mg LY2452473 and 5 mg Tadalafil | Change From Baseline to 12 Week Endpoint in Fasting Insulin | -4.501 milliunits per Liter (mU/L) | Standard Error 2.075 |
| 5 mg LY2452473 | Change From Baseline to 12 Week Endpoint in Fasting Insulin | -0.717 milliunits per Liter (mU/L) | Standard Error 3.068 |
| 10 mg Tadalafil | Change From Baseline to 12 Week Endpoint in Fasting Insulin | -3.300 milliunits per Liter (mU/L) | Standard Error 1.976 |
| 5 mg Tadalafil | Change From Baseline to 12 Week Endpoint in Fasting Insulin | -1.276 milliunits per Liter (mU/L) | Standard Error 2.109 |
p-value: 0.103Mixed model repeated measures analysis
p-value: 0.277Mixed model repeated measures analysis
p-value: 0.019Mixed model repeated measures analysis
p-value: 0.676Mixed model repeated measures analysis
Secondary
Change From Baseline to 12 Week Endpoint in IIEF Domain Scores (Intercourse Satisfaction, Orgasmic Function, Sexual Desire, and Overall Satisfaction)
Intercourse Satisfaction (IS) domain score: sum of Questions (Q) 6, Q7, and Q8, each rated 0 (low/no satisfaction) to 5 (high satisfaction). IS domain score range: 0 to 15; lower scores denoted lower satisfaction. Orgasmic Function (OF) domain score: sum of Q9 and Q10, each rated 0 (no sexual stimulation) to 5 (almost always/always). OF domain score range: 0 to 10; lower scores denoted lower OF. Sexual Desire (SD) domain score: sum of Q11 and Q12, each rated 1 (almost never or low/no sexual desire) to 5 (almost always or very high sexual desire). SD domain score range: 2 to 10; lower scores denoted lower SD. Overall Satisfaction (OS) domain score: sum of Q13 and Q14, each rated 1 (low/no satisfaction) to 5 (high satisfaction). OS domain score range: 2 to 10; lower scores denoted lower OS. Least squares (LS) mean estimated from repeated measures analysis of variance model that included terms for treatment, visit, treatment\*visit, baseline, baseline\*treatment (if p-value\<0.25).
Time frame: Baseline, Week 12
Population: 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 | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| 1 mg LY2452473 and 5 mg Tadalafil | Change From Baseline to 12 Week Endpoint in IIEF Domain Scores (Intercourse Satisfaction, Orgasmic Function, Sexual Desire, and Overall Satisfaction) | Intercourse Satisfaction | 0.475 units on a scale | Standard Error 0.34 |
| 1 mg LY2452473 and 5 mg Tadalafil | Change From Baseline to 12 Week Endpoint in IIEF Domain Scores (Intercourse Satisfaction, Orgasmic Function, Sexual Desire, and Overall Satisfaction) | Overall Satisfaction | 0.477 units on a scale | Standard Error 0.247 |
| 1 mg LY2452473 and 5 mg Tadalafil | Change From Baseline to 12 Week Endpoint in IIEF Domain Scores (Intercourse Satisfaction, Orgasmic Function, Sexual Desire, and Overall Satisfaction) | Orgasmic Function | 0.510 units on a scale | Standard Error 0.289 |
| 1 mg LY2452473 and 5 mg Tadalafil | Change From Baseline to 12 Week Endpoint in IIEF Domain Scores (Intercourse Satisfaction, Orgasmic Function, Sexual Desire, and Overall Satisfaction) | Sexual Desire | 0.092 units on a scale | Standard Error 0.186 |
| 5 mg LY2452473 and 5 mg Tadalafil | Change From Baseline to 12 Week Endpoint in IIEF Domain Scores (Intercourse Satisfaction, Orgasmic Function, Sexual Desire, and Overall Satisfaction) | Sexual Desire | 0.001 units on a scale | Standard Error 0.176 |
| 5 mg LY2452473 and 5 mg Tadalafil | Change From Baseline to 12 Week Endpoint in IIEF Domain Scores (Intercourse Satisfaction, Orgasmic Function, Sexual Desire, and Overall Satisfaction) | Overall Satisfaction | 0.258 units on a scale | Standard Error 0.235 |
| 5 mg LY2452473 and 5 mg Tadalafil | Change From Baseline to 12 Week Endpoint in IIEF Domain Scores (Intercourse Satisfaction, Orgasmic Function, Sexual Desire, and Overall Satisfaction) | Intercourse Satisfaction | 0.514 units on a scale | Standard Error 0.322 |
| 5 mg LY2452473 and 5 mg Tadalafil | Change From Baseline to 12 Week Endpoint in IIEF Domain Scores (Intercourse Satisfaction, Orgasmic Function, Sexual Desire, and Overall Satisfaction) | Orgasmic Function | 0.117 units on a scale | Standard Error 0.274 |
| 5 mg LY2452473 | Change From Baseline to 12 Week Endpoint in IIEF Domain Scores (Intercourse Satisfaction, Orgasmic Function, Sexual Desire, and Overall Satisfaction) | Sexual Desire | -0.201 units on a scale | Standard Error 0.253 |
| 5 mg LY2452473 | Change From Baseline to 12 Week Endpoint in IIEF Domain Scores (Intercourse Satisfaction, Orgasmic Function, Sexual Desire, and Overall Satisfaction) | Orgasmic Function | 0.160 units on a scale | Standard Error 0.394 |
| 5 mg LY2452473 | Change From Baseline to 12 Week Endpoint in IIEF Domain Scores (Intercourse Satisfaction, Orgasmic Function, Sexual Desire, and Overall Satisfaction) | Overall Satisfaction | -0.378 units on a scale | Standard Error 0.339 |
| 5 mg LY2452473 | Change From Baseline to 12 Week Endpoint in IIEF Domain Scores (Intercourse Satisfaction, Orgasmic Function, Sexual Desire, and Overall Satisfaction) | Intercourse Satisfaction | -0.672 units on a scale | Standard Error 0.463 |
| 10 mg Tadalafil | Change From Baseline to 12 Week Endpoint in IIEF Domain Scores (Intercourse Satisfaction, Orgasmic Function, Sexual Desire, and Overall Satisfaction) | Orgasmic Function | 0.678 units on a scale | Standard Error 0.264 |
| 10 mg Tadalafil | Change From Baseline to 12 Week Endpoint in IIEF Domain Scores (Intercourse Satisfaction, Orgasmic Function, Sexual Desire, and Overall Satisfaction) | Intercourse Satisfaction | 1.127 units on a scale | Standard Error 0.31 |
| 10 mg Tadalafil | Change From Baseline to 12 Week Endpoint in IIEF Domain Scores (Intercourse Satisfaction, Orgasmic Function, Sexual Desire, and Overall Satisfaction) | Sexual Desire | 0.392 units on a scale | Standard Error 0.169 |
| 10 mg Tadalafil | Change From Baseline to 12 Week Endpoint in IIEF Domain Scores (Intercourse Satisfaction, Orgasmic Function, Sexual Desire, and Overall Satisfaction) | Overall Satisfaction | 1.206 units on a scale | Standard Error 0.226 |
| 5 mg Tadalafil | Change From Baseline to 12 Week Endpoint in IIEF Domain Scores (Intercourse Satisfaction, Orgasmic Function, Sexual Desire, and Overall Satisfaction) | Orgasmic Function | 0.733 units on a scale | Standard Error 0.278 |
| 5 mg Tadalafil | Change From Baseline to 12 Week Endpoint in IIEF Domain Scores (Intercourse Satisfaction, Orgasmic Function, Sexual Desire, and Overall Satisfaction) | Intercourse Satisfaction | 0.554 units on a scale | Standard Error 0.327 |
| 5 mg Tadalafil | Change From Baseline to 12 Week Endpoint in IIEF Domain Scores (Intercourse Satisfaction, Orgasmic Function, Sexual Desire, and Overall Satisfaction) | Overall Satisfaction | 0.826 units on a scale | Standard Error 0.238 |
| 5 mg Tadalafil | Change From Baseline to 12 Week Endpoint in IIEF Domain Scores (Intercourse Satisfaction, Orgasmic Function, Sexual Desire, and Overall Satisfaction) | Sexual Desire | 0.180 units on a scale | Standard Error 0.178 |
p-value: 0.867Mixed model repeated measures analysis
p-value: 0.931Mixed model repeated measures analysis
p-value: 0.158Mixed model repeated measures analysis
p-value: 0.172Mixed model repeated measures analysis
p-value: 0.579Mixed model repeated measures analysis
p-value: 0.115Mixed model repeated measures analysis
p-value: 0.668Mixed model repeated measures analysis
p-value: 0.141Mixed model repeated measures analysis
p-value: 0.734Mixed model repeated measures analysis
p-value: 0.477Mixed model repeated measures analysis
p-value: 0.235Mixed model repeated measures analysis
p-value: 0.111Mixed model repeated measures analysis
p-value: 0.31Mixed model repeated measures analysis
p-value: 0.09Mixed model repeated measures analysis
p-value: 0.03Mixed model repeated measures analysis
p-value: 0.004Mixed model repeated measures analysis
Secondary
Change From Baseline to 12 Week Endpoint in IIEF EF Domain Score Reported by Testosterone Concentration Subgroups
The International Index of Erectile Function (IIEF) EF was the sum of Questions (Q) 1 to Q5 and Q15 of the IIEF Self-reported questionnaire. Q1 to Q5 were rated 0 (low/no erectile function) to 5 (high erectile function) and Q15 was rated 1 (no/low confidence) to 5 (high confidence). IIEF EF domain scores ranged from 1 to 30. Higher scores denoted better EF. Testosterone concentration subgroups were based on optimal baseline testosterone levels (\<340 nanograms per deciliter \[ng/dL\] or ≥340 ng/dL). The least squares (LS) mean was estimated from an analysis of covariance (ANCOVA) model that included terms for treatment group, baseline, and baseline\*treatment interaction (if p-value\<0.25).
Time frame: Baseline, Week 12
Population: 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 | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| 1 mg LY2452473 and 5 mg Tadalafil | Change From Baseline to 12 Week Endpoint in IIEF EF Domain Score Reported by Testosterone Concentration Subgroups | Testosterone <340 ng/dL | 2.523 units on a scale | Standard Error 0.952 |
| 1 mg LY2452473 and 5 mg Tadalafil | Change From Baseline to 12 Week Endpoint in IIEF EF Domain Score Reported by Testosterone Concentration Subgroups | Testosterone ≥340 ng/dL | 1.077 units on a scale | Standard Error 1.019 |
| 5 mg LY2452473 and 5 mg Tadalafil | Change From Baseline to 12 Week Endpoint in IIEF EF Domain Score Reported by Testosterone Concentration Subgroups | Testosterone ≥340 ng/dL | 3.416 units on a scale | Standard Error 1.071 |
| 5 mg LY2452473 and 5 mg Tadalafil | Change From Baseline to 12 Week Endpoint in IIEF EF Domain Score Reported by Testosterone Concentration Subgroups | Testosterone <340 ng/dL | 1.012 units on a scale | Standard Error 0.848 |
| 5 mg LY2452473 | Change From Baseline to 12 Week Endpoint in IIEF EF Domain Score Reported by Testosterone Concentration Subgroups | Testosterone ≥340 ng/dL | -0.714 units on a scale | Standard Error 1.387 |
| 5 mg LY2452473 | Change From Baseline to 12 Week Endpoint in IIEF EF Domain Score Reported by Testosterone Concentration Subgroups | Testosterone <340 ng/dL | -1.055 units on a scale | Standard Error 1.223 |
| 10 mg Tadalafil | Change From Baseline to 12 Week Endpoint in IIEF EF Domain Score Reported by Testosterone Concentration Subgroups | Testosterone ≥340 ng/dL | 2.217 units on a scale | Standard Error 1.07 |
| 10 mg Tadalafil | Change From Baseline to 12 Week Endpoint in IIEF EF Domain Score Reported by Testosterone Concentration Subgroups | Testosterone <340 ng/dL | 4.172 units on a scale | Standard Error 0.852 |
| 5 mg Tadalafil | Change From Baseline to 12 Week Endpoint in IIEF EF Domain Score Reported by Testosterone Concentration Subgroups | Testosterone <340 ng/dL | 1.935 units on a scale | Standard Error 0.912 |
| 5 mg Tadalafil | Change From Baseline to 12 Week Endpoint in IIEF EF Domain Score Reported by Testosterone Concentration Subgroups | Testosterone ≥340 ng/dL | 1.703 units on a scale | Standard Error 1.063 |
p-value: 0.656ANCOVA
p-value: 0.46ANCOVA
p-value: 0.198ANCOVA
p-value: 0.009ANCOVA
p-value: 0.671ANCOVA
p-value: 0.259ANCOVA
p-value: 0.441ANCOVA
p-value: 0.433ANCOVA
Secondary
Change From Baseline to 12 Week Endpoint in Prostate-Specific Antigen (PSA)
The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment\*visit, baseline, baseline\*treatment (if p-value\<0.25).
Time frame: Baseline, Week 12
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 1 mg LY2452473 and 5 mg Tadalafil | Change From Baseline to 12 Week Endpoint in Prostate-Specific Antigen (PSA) | 0.162 nanograms per milliliter (ng/mL) | Standard Error 0.119 |
| 5 mg LY2452473 and 5 mg Tadalafil | Change From Baseline to 12 Week Endpoint in Prostate-Specific Antigen (PSA) | -0.088 nanograms per milliliter (ng/mL) | Standard Error 0.109 |
| 5 mg LY2452473 | Change From Baseline to 12 Week Endpoint in Prostate-Specific Antigen (PSA) | 0.265 nanograms per milliliter (ng/mL) | Standard Error 0.157 |
| 10 mg Tadalafil | Change From Baseline to 12 Week Endpoint in Prostate-Specific Antigen (PSA) | 0.246 nanograms per milliliter (ng/mL) | Standard Error 0.107 |
| 5 mg Tadalafil | Change From Baseline to 12 Week Endpoint in Prostate-Specific Antigen (PSA) | 0.032 nanograms per milliliter (ng/mL) | Standard Error 0.111 |
p-value: 0.423Mixed model repeated measures analysis
p-value: 0.443Mixed model repeated measures analysis
p-value: 0.599Mixed model repeated measures analysis
p-value: 0.029Mixed model repeated measures analysis
Secondary
Change From Baseline to 12 Week Endpoint in the Percentage of Participants Who Return to Normal on the International Index of Erectile Function (IIEF) Scale (EF>25)
The percentage of participants whose IIEF Erectile Function (EF) domain scores changed from ≤25 at baseline to \>25 (normal) at Week 12. The IIEF EF domain score was the sum of IIEF Question (Q) 1 to Q5 and Q15. Q1 to Q5 were rated 0 (low/no EF) to 5 (high EF) and Q15 was rated 1 (no/low confidence) to 5 (high confidence). IIEF EF domain scores ranged from 1 to 30. Higher scores denoted better EF.
Time frame: Baseline, Week 12
Population: Randomized participants who received at least 1 dose of study drug (ITT population).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1 mg LY2452473 and 5 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) | 24.7 percentage of participants |
| 5 mg LY2452473 and 5 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) | 27.8 percentage of participants |
| 5 mg LY2452473 | 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) | 13.5 percentage of participants |
| 10 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) | 30.3 percentage of participants |
| 5 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) | 27.6 percentage of participants |
Secondary
Change From Baseline to 12 Week Endpoint in the Percentage of Yes Responses on the Sexual Encounter Profile (SEP) Diary
The SEP diary was a participant-assessed diary with 5 questions (Q): Q1 (erection achievement), Q2 (successful penetration), Q3 (successful intercourse), Q4 (satisfied with erection), and Q5 (satisfied with sexual experience) for each sexual encounter made over a specified period of time. SEP Q1 to Q5 scores were determined as a percentage of Yes responses to each of the 5 questions out of all sexual attempts recorded during the time period. A higher percentage of Yes responses indicated better EF. Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Q1 to Q5. The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment\*visit, baseline, baseline\*treatment (if p-value \<0.25).
Time frame: Baseline, Week 12
Population: 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 | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| 1 mg LY2452473 and 5 mg Tadalafil | Change From Baseline to 12 Week Endpoint in the Percentage of Yes Responses on the Sexual Encounter Profile (SEP) Diary | Question 2 | 3.175 percentage of yes responses | Standard Error 3.345 |
| 1 mg LY2452473 and 5 mg Tadalafil | Change From Baseline to 12 Week Endpoint in the Percentage of Yes Responses on the Sexual Encounter Profile (SEP) Diary | Question 1 | -0.247 percentage of yes responses | Standard Error 2.378 |
| 1 mg LY2452473 and 5 mg Tadalafil | Change From Baseline to 12 Week Endpoint in the Percentage of Yes Responses on the Sexual Encounter Profile (SEP) Diary | Question 4 | 12.935 percentage of yes responses | Standard Error 3.998 |
| 1 mg LY2452473 and 5 mg Tadalafil | Change From Baseline to 12 Week Endpoint in the Percentage of Yes Responses on the Sexual Encounter Profile (SEP) Diary | Question 5 | 13.602 percentage of yes responses | Standard Error 4.027 |
| 1 mg LY2452473 and 5 mg Tadalafil | Change From Baseline to 12 Week Endpoint in the Percentage of Yes Responses on the Sexual Encounter Profile (SEP) Diary | Question 3 | 9.296 percentage of yes responses | Standard Error 3.808 |
| 5 mg LY2452473 and 5 mg Tadalafil | Change From Baseline to 12 Week Endpoint in the Percentage of Yes Responses on the Sexual Encounter Profile (SEP) Diary | Question 5 | 15.196 percentage of yes responses | Standard Error 3.88 |
| 5 mg LY2452473 and 5 mg Tadalafil | Change From Baseline to 12 Week Endpoint in the Percentage of Yes Responses on the Sexual Encounter Profile (SEP) Diary | Question 2 | 3.689 percentage of yes responses | Standard Error 3.227 |
| 5 mg LY2452473 and 5 mg Tadalafil | Change From Baseline to 12 Week Endpoint in the Percentage of Yes Responses on the Sexual Encounter Profile (SEP) Diary | Question 1 | -2.976 percentage of yes responses | Standard Error 2.295 |
| 5 mg LY2452473 and 5 mg Tadalafil | Change From Baseline to 12 Week Endpoint in the Percentage of Yes Responses on the Sexual Encounter Profile (SEP) Diary | Question 4 | 13.910 percentage of yes responses | Standard Error 3.854 |
| 5 mg LY2452473 and 5 mg Tadalafil | Change From Baseline to 12 Week Endpoint in the Percentage of Yes Responses on the Sexual Encounter Profile (SEP) Diary | Question 3 | 11.752 percentage of yes responses | Standard Error 3.675 |
| 5 mg LY2452473 | Change From Baseline to 12 Week Endpoint in the Percentage of Yes Responses on the Sexual Encounter Profile (SEP) Diary | Question 4 | -1.570 percentage of yes responses | Standard Error 5.454 |
| 5 mg LY2452473 | Change From Baseline to 12 Week Endpoint in the Percentage of Yes Responses on the Sexual Encounter Profile (SEP) Diary | Question 2 | -7.849 percentage of yes responses | Standard Error 4.566 |
| 5 mg LY2452473 | Change From Baseline to 12 Week Endpoint in the Percentage of Yes Responses on the Sexual Encounter Profile (SEP) Diary | Question 5 | -1.956 percentage of yes responses | Standard Error 5.488 |
| 5 mg LY2452473 | Change From Baseline to 12 Week Endpoint in the Percentage of Yes Responses on the Sexual Encounter Profile (SEP) Diary | Question 1 | -10.711 percentage of yes responses | Standard Error 3.268 |
| 5 mg LY2452473 | Change From Baseline to 12 Week Endpoint in the Percentage of Yes Responses on the Sexual Encounter Profile (SEP) Diary | Question 3 | -3.800 percentage of yes responses | Standard Error 5.195 |
| 10 mg Tadalafil | Change From Baseline to 12 Week Endpoint in the Percentage of Yes Responses on the Sexual Encounter Profile (SEP) Diary | Question 2 | 10.267 percentage of yes responses | Standard Error 3.064 |
| 10 mg Tadalafil | Change From Baseline to 12 Week Endpoint in the Percentage of Yes Responses on the Sexual Encounter Profile (SEP) Diary | Question 1 | 4.427 percentage of yes responses | Standard Error 2.168 |
| 10 mg Tadalafil | Change From Baseline to 12 Week Endpoint in the Percentage of Yes Responses on the Sexual Encounter Profile (SEP) Diary | Question 3 | 14.645 percentage of yes responses | Standard Error 3.489 |
| 10 mg Tadalafil | Change From Baseline to 12 Week Endpoint in the Percentage of Yes Responses on the Sexual Encounter Profile (SEP) Diary | Question 4 | 24.202 percentage of yes responses | Standard Error 3.656 |
| 10 mg Tadalafil | Change From Baseline to 12 Week Endpoint in the Percentage of Yes Responses on the Sexual Encounter Profile (SEP) Diary | Question 5 | 22.410 percentage of yes responses | Standard Error 3.683 |
| 5 mg Tadalafil | Change From Baseline to 12 Week Endpoint in the Percentage of Yes Responses on the Sexual Encounter Profile (SEP) Diary | Question 4 | 8.857 percentage of yes responses | Standard Error 3.872 |
| 5 mg Tadalafil | Change From Baseline to 12 Week Endpoint in the Percentage of Yes Responses on the Sexual Encounter Profile (SEP) Diary | Question 1 | -1.425 percentage of yes responses | Standard Error 2.305 |
| 5 mg Tadalafil | Change From Baseline to 12 Week Endpoint in the Percentage of Yes Responses on the Sexual Encounter Profile (SEP) Diary | Question 3 | 2.593 percentage of yes responses | Standard Error 3.688 |
| 5 mg Tadalafil | Change From Baseline to 12 Week Endpoint in the Percentage of Yes Responses on the Sexual Encounter Profile (SEP) Diary | Question 5 | 9.400 percentage of yes responses | Standard Error 3.897 |
| 5 mg Tadalafil | Change From Baseline to 12 Week Endpoint in the Percentage of Yes Responses on the Sexual Encounter Profile (SEP) Diary | Question 2 | 1.844 percentage of yes responses | Standard Error 3.24 |
p-value: 0.722Mixed model repeated measures analysis
p-value: 0.634Mixed model repeated measures analysis
p-value: 0.147Mixed model repeated measures analysis
p-value: 0.02Mixed model repeated measures analysis
p-value: 0.775Mixed model repeated measures analysis
p-value: 0.687Mixed model repeated measures analysis
p-value: 0.119Mixed model repeated measures analysis
p-value: 0.14Mixed model repeated measures analysis
p-value: 0.207Mixed model repeated measures analysis
p-value: 0.079Mixed model repeated measures analysis
p-value: 0.301Mixed model repeated measures analysis
p-value: 0.568Mixed model repeated measures analysis
p-value: 0.464Mixed model repeated measures analysis
p-value: 0.356Mixed model repeated measures analysis
p-value: 0.038Mixed model repeated measures analysis
p-value: 0.054Mixed model repeated measures analysis
p-value: 0.454Mixed model repeated measures analysis
p-value: 0.293Mixed model repeated measures analysis
p-value: 0.107Mixed model repeated measures analysis
p-value: 0.178Mixed model repeated measures analysis
Secondary
Change From Baseline to 12 Week Endpoint in Total Cholesterol and Triglycerides
The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment\*visit, baseline, baseline\*treatment (if p-value\<0.25).
Time frame: Baseline, Week 12
Population: 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 | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| 1 mg LY2452473 and 5 mg Tadalafil | Change From Baseline to 12 Week Endpoint in Total Cholesterol and Triglycerides | Triglycerides | -0.155 millimoles per Liter (mmol/L) | Standard Error 0.07 |
| 1 mg LY2452473 and 5 mg Tadalafil | Change From Baseline to 12 Week Endpoint in Total Cholesterol and Triglycerides | Total Cholesterol | -0.210 millimoles per Liter (mmol/L) | Standard Error 0.076 |
| 5 mg LY2452473 and 5 mg Tadalafil | Change From Baseline to 12 Week Endpoint in Total Cholesterol and Triglycerides | Triglycerides | -0.171 millimoles per Liter (mmol/L) | Standard Error 0.066 |
| 5 mg LY2452473 and 5 mg Tadalafil | Change From Baseline to 12 Week Endpoint in Total Cholesterol and Triglycerides | Total Cholesterol | -0.275 millimoles per Liter (mmol/L) | Standard Error 0.071 |
| 5 mg LY2452473 | Change From Baseline to 12 Week Endpoint in Total Cholesterol and Triglycerides | Triglycerides | -0.067 millimoles per Liter (mmol/L) | Standard Error 0.096 |
| 5 mg LY2452473 | Change From Baseline to 12 Week Endpoint in Total Cholesterol and Triglycerides | Total Cholesterol | -0.282 millimoles per Liter (mmol/L) | Standard Error 0.102 |
| 10 mg Tadalafil | Change From Baseline to 12 Week Endpoint in Total Cholesterol and Triglycerides | Total Cholesterol | -0.086 millimoles per Liter (mmol/L) | Standard Error 0.069 |
| 10 mg Tadalafil | Change From Baseline to 12 Week Endpoint in Total Cholesterol and Triglycerides | Triglycerides | -0.139 millimoles per Liter (mmol/L) | Standard Error 0.063 |
| 5 mg Tadalafil | Change From Baseline to 12 Week Endpoint in Total Cholesterol and Triglycerides | Triglycerides | 0.056 millimoles per Liter (mmol/L) | Standard Error 0.067 |
| 5 mg Tadalafil | Change From Baseline to 12 Week Endpoint in Total Cholesterol and Triglycerides | Total Cholesterol | -0.059 millimoles per Liter (mmol/L) | Standard Error 0.072 |
p-value: 0.148Mixed model repeated measures analysis
p-value: 0.033Mixed model repeated measures analysis
p-value: 0.224Mixed model repeated measures analysis
p-value: 0.056Mixed model repeated measures analysis
p-value: 0.031Mixed model repeated measures analysis
p-value: 0.017Mixed model repeated measures analysis
p-value: 0.866Mixed model repeated measures analysis
p-value: 0.726Mixed model repeated measures analysis
Secondary
Percent Change From Baseline to 12 Week Endpoint in High-Density Lipoprotein Cholesterol (HDL-C) and Low-Density Lipoprotein Cholesterol (LDL-C)
The least squares (LS) was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment\*visit, baseline, baseline\*treatment (if p-value\<0.25).
Time frame: Baseline, Week 12
Population: 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 | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| 1 mg LY2452473 and 5 mg Tadalafil | Percent Change From Baseline to 12 Week Endpoint in High-Density Lipoprotein Cholesterol (HDL-C) and Low-Density Lipoprotein Cholesterol (LDL-C) | HDL-C | -7.440 percent change | Standard Error 1.658 |
| 1 mg LY2452473 and 5 mg Tadalafil | Percent Change From Baseline to 12 Week Endpoint in High-Density Lipoprotein Cholesterol (HDL-C) and Low-Density Lipoprotein Cholesterol (LDL-C) | LDL-C | -1.695 percent change | Standard Error 2.479 |
| 5 mg LY2452473 and 5 mg Tadalafil | Percent Change From Baseline to 12 Week Endpoint in High-Density Lipoprotein Cholesterol (HDL-C) and Low-Density Lipoprotein Cholesterol (LDL-C) | HDL-C | -16.974 percent change | Standard Error 1.556 |
| 5 mg LY2452473 and 5 mg Tadalafil | Percent Change From Baseline to 12 Week Endpoint in High-Density Lipoprotein Cholesterol (HDL-C) and Low-Density Lipoprotein Cholesterol (LDL-C) | LDL-C | 0.062 percent change | Standard Error 2.319 |
| 5 mg LY2452473 | Percent Change From Baseline to 12 Week Endpoint in High-Density Lipoprotein Cholesterol (HDL-C) and Low-Density Lipoprotein Cholesterol (LDL-C) | HDL-C | -22.230 percent change | Standard Error 2.243 |
| 5 mg LY2452473 | Percent Change From Baseline to 12 Week Endpoint in High-Density Lipoprotein Cholesterol (HDL-C) and Low-Density Lipoprotein Cholesterol (LDL-C) | LDL-C | -3.424 percent change | Standard Error 3.365 |
| 10 mg Tadalafil | Percent Change From Baseline to 12 Week Endpoint in High-Density Lipoprotein Cholesterol (HDL-C) and Low-Density Lipoprotein Cholesterol (LDL-C) | LDL-C | -0.066 percent change | Standard Error 2.245 |
| 10 mg Tadalafil | Percent Change From Baseline to 12 Week Endpoint in High-Density Lipoprotein Cholesterol (HDL-C) and Low-Density Lipoprotein Cholesterol (LDL-C) | HDL-C | 1.776 percent change | Standard Error 1.505 |
| 5 mg Tadalafil | Percent Change From Baseline to 12 Week Endpoint in High-Density Lipoprotein Cholesterol (HDL-C) and Low-Density Lipoprotein Cholesterol (LDL-C) | HDL-C | 1.573 percent change | Standard Error 1.585 |
| 5 mg Tadalafil | Percent Change From Baseline to 12 Week Endpoint in High-Density Lipoprotein Cholesterol (HDL-C) and Low-Density Lipoprotein Cholesterol (LDL-C) | LDL-C | -0.718 percent change | Standard Error 2.367 |
p-value: <0.001Mixed model repeated measures analysis
p-value: <0.001Mixed model repeated measures analysis
p-value: <0.001Mixed model repeated measures analysis
p-value: <0.001Mixed model repeated measures analysis
p-value: 0.776Mixed model repeated measures analysis
p-value: 0.814Mixed model repeated measures analysis
p-value: 0.627Mixed model repeated measures analysis
p-value: 0.968Mixed model repeated measures analysis