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

July 8, 2010
February 10, 2012
October 2010
November 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01160289 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study of LY900010 in Erectile Dysfunction
A Study of LY900010 (LY2452473 + Tadalafil) in the Treatment of Men With Erectile Dysfunction

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Erectile Dysfunction
  • 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
  • Drug: placebo (LY2452473)
    Administered orally, once daily for 12 weeks
  • Experimental: 1 mg LY2452473 + 5 mg tadalafil
    Interventions:
    • Drug: LY2452473
    • Drug: tadalafil
    • Drug: placebo (tadalafil)
  • Experimental: 5 mg LY2452473 + 5 mg tadalafil
    Interventions:
    • Drug: LY2452473
    • Drug: tadalafil
    • Drug: placebo (tadalafil)
  • Experimental: 5 mg LY2452473 + placebo
    Interventions:
    • Drug: LY2452473
    • Drug: placebo (tadalafil)
  • Active Comparator: 10 mg tadalafil + placebo
    Interventions:
    • Drug: tadalafil
    • Drug: placebo (tadalafil)
    • Drug: placebo (LY2452473)
  • Active Comparator: 5 mg tadalafil + placebo
    Interventions:
    • Drug: tadalafil
    • Drug: placebo (tadalafil)
    • Drug: placebo (LY2452473)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
378
November 2011
November 2011   (final data collection date for primary outcome measure)

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
Male
45 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01160289
11888, I4K-MC-GPEC
No
Eli Lilly and Company
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP