Official Title: “Tadalafil 5 mg Once a Day Compared to Placebo in Improving Erectile Dysfunction and Sexual Quality of Life”

To determine if tadalafil 5 mg daily compared to placebo when given for 12 weeks improves getting and maintaining an erection in men with erectile dysfunction and if there are improvements in the sexual quality of life of the man and his female study partner

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2008

Intervention(s) in this Clinical Trial

• Drug: tadalafil
  • 5 mg tadalafil tablet taken by mouth once a day for 12 weeks
• Drug: Placebo
  • placebo tablet taken by mouth once a day for 12 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: 1
  • Placebo
• Active Comparator: 2
  • 5 mg tadalafil

Primary Measures

• Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF)- Erectile Function Domain Score (Sum of IIEF Questions 1-5 and 15)
  • Time Frame: Baseline and 12 weeks
    Safety Issue?: No
• Improvement in the Sexual Quality of Life in the Subject and His Study Partner as Measured by the Sexual Quality of Life (SQoL) Domain of the Sexual Life Quality Questionnaire (SLQQ)
  • Time Frame: Baseline and 12 weeks
    Safety Issue?: No
• Change From Baseline to Endpoint in the Percent of "Yes" Responses to Sexual Encounter Profile (SEP) Diary Questions 2 (SEP2) and 3 (SEP3).
  • Time Frame: Baseline and 12 weeks
    Safety Issue?: No

Secondary Measures

• Change From Baseline to Week 12 Endpoint in the International Index of Erectile Function - Intercourse Satisfaction Domain - Subject Response
  • Time Frame: Baseline and 12 weeks
    Safety Issue?: No
• Change From Baseline to 12 Week Endpoint in Overall Satisfaction Domain of the International Index of Erectile Function (IIEF-OS) - Subject Response
  • Time Frame: Baseline and 12 weeks
    Safety Issue?: No
• Sexual Life Quality Questionnaire (SLQQ) Treatment Satisfaction Domain
  • Time Frame: 12 weeks
    Safety Issue?: No
• Change From Baseline to 12 Week Endpoint in Percent of "Yes" Responses to Sexual Encounter Profile (SEP) Questions 4 and 5 - Subject Response
  • Time Frame: Baseline and 12 weeks
    Safety Issue?: No
• Change From Baseline to 12 Week Endpoint in Percent of "Yes" Responses to Partner-Sexual Encounter Profile (SEP) Question 3 - Partner Response
  • Time Frame: Baseline and 12 weeks
    Safety Issue?: No
• Change From Baseline to 12 Week Endpoint in the Satisfaction Domain of the Female Sexual Function Index (FSFI) - Partner Response
  • Time Frame: Baseline and 12 weeks
    Safety Issue?: No
• Percent of Subjects With "Yes" Responses to Global Assessment Questionnaire (GAQ) - Subject Response
  • Time Frame: 12 weeks
    Safety Issue?: No
• Percent of Partners With "Yes" Responses to Global Assessment Questionnaire (GAQ) - Partner Response
  • Time Frame: 12 weeks
    Safety Issue?: No
• Change From Baseline to 12 Week Endpoint in Percent of "Yes" Responses to Partner-Sexual Encounter Profile (SEP) Questions 1 and 2 - Partner Response
  • Time Frame: Baseline and 12 weeks
    Safety Issue?: No
• Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire
  • Time Frame: Baseline and 12 weeks
    Safety Issue?: No
• Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire - Confidence Domain Subscales
  • Time Frame: Baseline and 12 weeks
    Safety Issue?: No

Inclusion Criteria:

• Male
• History of erectile dysfunction (ED) for at least 3 months duration
• Anticipate having the same female partner willing to participate throughout the study
• At least 18 years of age at Visit 1 and agree to make at least 4 sexual attempts during the early phase of the study
• Adequate partner sexual function as determined by a Female Sexual Function Index
• Willing to record responses to efficacy questionnaires, sexual quality of life questionnaires and other instruments used in the study

Exclusion Criteria:

• May not participate in the study if you have taken tadalafil previously.
• History of cardiac conditions including angina requiring treatment with nitrates, heart disease of coronary conditions including myocardial infarction, bypass surgery, angioplasty or stent placement for specified time before starting the study.
• Have sexual partner not willing to complete the scales.
• Use of nitrates.

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Eli Lilly and Company

Overall Clinical Trial Officials and Contacts

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) Study Director Eli Lilly and Company  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00422734

Study ID Number: 9501

ClinicalTrials.gov Identifier: NCT00422734

Health Authority: United States: Food and Drug Administration

Lilly Clinical Trial Registry