Status:
COMPLETED
A Study of LY900010 in Erectile Dysfunction
Lead Sponsor:
Eli Lilly and Company
Conditions:
Erectile Dysfunction
Eligibility:
MALE
45-70 years
Phase:
PHASE2
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 r...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
410 Patients enrolled
Trial Details
Trial ID
NCT01160289
Start Date
October 1 2010
End Date
November 1 2011
Last Update
April 9 2019
Active Locations (36)
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1
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Birmingham, Alabama, United States, 35209
2
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Phoenix, Arizona, United States, 85050
3
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Glendora, California, United States, 91741
4
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Irvine, California, United States, 92618