Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
410 participants
INTERVENTIONAL
2010-10-31
2011-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1 milligram (mg) LY2452473 + 5 mg tadalafil
LY2452473
Administered orally, once daily for 12 weeks
tadalafil
Administered orally, once daily for 12 weeks
placebo (tadalafil)
Administered orally, once daily for 12 weeks
5 mg LY2452473 + 5 mg tadalafil
LY2452473
Administered orally, once daily for 12 weeks
tadalafil
Administered orally, once daily for 12 weeks
placebo (tadalafil)
Administered orally, once daily for 12 weeks
5 mg LY2452473 + placebo
LY2452473
Administered orally, once daily for 12 weeks
placebo (tadalafil)
Administered orally, once daily for 12 weeks
10 mg tadalafil + placebo
tadalafil
Administered orally, once daily for 12 weeks
placebo (tadalafil)
Administered orally, once daily for 12 weeks
placebo (LY2452473)
Administered orally, once daily for 12 weeks
5 mg tadalafil + placebo
tadalafil
Administered orally, once daily for 12 weeks
placebo (tadalafil)
Administered orally, once daily for 12 weeks
placebo (LY2452473)
Administered orally, once daily for 12 weeks
Interventions
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LY2452473
Administered orally, once daily for 12 weeks
tadalafil
Administered orally, once daily for 12 weeks
placebo (tadalafil)
Administered orally, once daily for 12 weeks
placebo (LY2452473)
Administered orally, once daily for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
45 Years
70 Years
MALE
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Birmingham, Alabama, United States
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Phoenix, Arizona, United States
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Glendora, California, United States
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Irvine, California, United States
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Long Beach, California, United States
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Newport Beach, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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Vacaville, California, United States
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Denver, Colorado, United States
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Englewood, Colorado, United States
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Aventura, Florida, United States
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Celebration, Florida, United States
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Coral Springs, Florida, United States
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Jacksonville, Florida, United States
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Plantation, Florida, United States
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Coeur d'Alene, Idaho, United States
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Indianapolis, Indiana, United States
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Des Moines, Iowa, United States
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Overland Park, Kansas, United States
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Topeka, Kansas, United States
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Shreveport, Louisiana, United States
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Troy, Michigan, United States
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St Louis, Missouri, United States
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Las Vegas, Nevada, United States
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Cary, North Carolina, United States
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Charlotte, North Carolina, United States
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Raleigh, North Carolina, United States
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Salisbury, North Carolina, United States
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Edmond, Oklahoma, United States
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Knoxville, Tennessee, United States
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Dallas, Texas, United States
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San Antonio, Texas, United States
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Bellevue, Washington, United States
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Olympia, Washington, United States
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Spokane, Washington, United States
Countries
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Other Identifiers
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I4K-MC-GPEC
Identifier Type: OTHER
Identifier Source: secondary_id
11888
Identifier Type: -
Identifier Source: org_study_id
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