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

  Show 36 Study Locations
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
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Tadalafil
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014