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A Study of LY900010 in Erectile Dysfunction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01160289
First received: July 8, 2010
Last updated: February 10, 2012
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Erectile Dysfunction
Drug: LY2452473
Drug: tadalafil
Drug: placebo (tadalafil)
Drug: placebo (LY2452473)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Study of LY900010 (LY2452473 + Tadalafil) in the Treatment of Men With Erectile Dysfunction

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change from baseline to 12 week endpoint in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of "Yes" responses to Questions 1 through 5 of the Patient Sexual Encounter (SEP) diary [ Time Frame: Baseline through 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 12 week endpoint in International Index of Erectile Function (IIEF) Domain scores (Intercourse Satisfaction, Orgasmic Function, Sexual Desire, and Overall Satisfaction) [ Time Frame: Baseline through 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 12 week endpoint in the percentage of subjects who return to "normal" on the International Index of Erectile Function (IIEF) scale (EF>25) [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 12 week endpoint in Erectile Function (EF) Domain of International Index or Erectile Function (IIEF) in different baseline testosterone concentration subgroups [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 12 week endpoint in Prostate-Specific Antigen (PSA) [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 12 week endpoint in lipid profile [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 12 week endpoint in fasting glucose [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 12 week endpoint in fasting insulin [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 378
Study Start Date: October 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 mg LY2452473 + 5 mg tadalafil Drug: LY2452473
Administered orally, once daily for 12 weeks
Drug: tadalafil
Administered orally, once daily for 12 weeks
Drug: placebo (tadalafil)
Administered orally, once daily for 12 weeks
Experimental: 5 mg LY2452473 + 5 mg tadalafil Drug: LY2452473
Administered orally, once daily for 12 weeks
Drug: tadalafil
Administered orally, once daily for 12 weeks
Drug: placebo (tadalafil)
Administered orally, once daily for 12 weeks
Experimental: 5 mg LY2452473 + placebo Drug: LY2452473
Administered orally, once daily for 12 weeks
Drug: placebo (tadalafil)
Administered orally, once daily for 12 weeks
Active Comparator: 10 mg tadalafil + placebo Drug: tadalafil
Administered orally, once daily for 12 weeks
Drug: placebo (tadalafil)
Administered orally, once daily for 12 weeks
Drug: placebo (LY2452473)
Administered orally, once daily for 12 weeks
Active Comparator: 5 mg tadalafil + placebo Drug: tadalafil
Administered orally, once daily for 12 weeks
Drug: placebo (tadalafil)
Administered orally, once daily for 12 weeks
Drug: placebo (LY2452473)
Administered orally, once daily for 12 weeks

  Eligibility

Ages Eligible for Study:   45 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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 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 arrythmia 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 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 mm Hg or diastolic blood pressure greater than 100 or less than 50 mm Hg at screening
  • Hepatic, renal, 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 IU/week, 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01160289

  Hide Study Locations
Locations
United States, Alabama
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
United States, Arizona
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Phoenix, Arizona, United States, 85050
United States, California
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Glendora, California, United States, 91741
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Irvine, California, United States, 92618
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Long Beach, California, United States, 90806
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Newport Beach, California, United States, 92660
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Sacramento, California, United States, 95825
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San Diego, California, United States, 92120
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Vacaville, California, United States, 95688
United States, Colorado
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Denver, Colorado, United States, 80220
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Englewood, Colorado, United States, 80113
United States, Florida
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Aventura, Florida, United States, 33180
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Celebration, Florida, United States, 34747
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Coral Springs, Florida, United States, 33065
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Jacksonville, Florida, United States, 32209
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Plantation, Florida, United States, 33317
United States, Idaho
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Coeur D' Alene, Idaho, United States, 83814
United States, Indiana
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Indianapolis, Indiana, United States, 46256
United States, Iowa
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Des Moines, Iowa, United States, 50314
United States, Kansas
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Overland Park, Kansas, United States, 66215
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Topeka, Kansas, United States, 66606
United States, Louisiana
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Shreveport, Louisiana, United States, 71106
United States, Michigan
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Troy, Michigan, United States, 48084
United States, Missouri
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St Louis, Missouri, United States, 63141
United States, Nevada
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Las Vegas, Nevada, United States, 89117
United States, North Carolina
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Cary, North Carolina, United States, 27511
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Charlotte, North Carolina, United States, 28207
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Raleigh, North Carolina, United States, 27607
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Salisbury, North Carolina, United States, 28144
United States, Oklahoma
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Edmond, Oklahoma, United States, 73034
United States, Tennessee
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Knoxville, Tennessee, United States, 37920
United States, Texas
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Dallas, Texas, United States, 75234
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San Antonio, Texas, United States, 78229
United States, Washington
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Bellevue, Washington, United States, 98007
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Olympia, Washington, United States, 98502
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Spokane, Washington, United States, 99202
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01160289     History of Changes
Other Study ID Numbers: 11888, I4K-MC-GPEC
Study First Received: July 8, 2010
Last Updated: February 10, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Erectile Dysfunction
Genital Diseases, Male
Mental Disorders
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Tadalafil
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Therapeutic Uses
Urological Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on November 20, 2014