A Study of LY900010 in Erectile Dysfunction

Lilly

Status and phase: Completed; Phase 2

Conditions: Erectile Dysfunction

Treatments: Drug: placebo (LY2452473); Drug: LY2452473; Drug: tadalafil; Drug: placebo (tadalafil)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01160289

11888

I4K-MC-GPEC (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 410 patients

Sex: Male

Ages: 45 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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410 participants in 5 patient groups

1 milligram (mg) LY2452473 + 5 mg tadalafil

Experimental group

Treatment:

Drug: LY2452473

Drug: placebo (tadalafil)

Drug: tadalafil

5 mg LY2452473 + 5 mg tadalafil

Experimental group

Treatment:

Drug: LY2452473

Drug: placebo (tadalafil)

Drug: tadalafil

5 mg LY2452473 + placebo

Experimental group

Treatment:

Drug: LY2452473

Drug: placebo (tadalafil)

10 mg tadalafil + placebo

Active Comparator group

Treatment:

Drug: placebo (LY2452473)

Drug: placebo (tadalafil)

Drug: tadalafil

5 mg tadalafil + placebo

Active Comparator group

Treatment:

Drug: placebo (LY2452473)

Drug: placebo (tadalafil)

Drug: tadalafil