The purpose of this trial is to evaluate if treatment with tadalafil once daily will allow
men to return to normal erectile function in those who did not have normal erectile function
following as-needed (PRN) Phosphodiesterase Type 5 (PDE5) Inhibitor treatment.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
Inclusion Criteria:
- At least a 3-month history of erectile dysfunction (ED).
- Are able to read, understand and provide signed informed consent.
- Have an International Index of Erectile Function-Erectile Function (IIEF-EF) domain
score that is greater than or equal to 17 and less than 26 at screening.
- Have been taking a maximum dose of sildenafil citrate (100 milligram [mg]),
vardenafil (20 mg), or tadalafil (20 mg) on as needed basis for at least one month
prior to screening.
- Anticipate having the same female sexual partner during the study who is willing to
participate in the required number of sexual intercourse attempts and complete study
measures during the study.
- Agree to make at least four sexual intercourse attempts during both the 4-week as
needed run-in period and the 4-week non-drug run-in period.
- Agree not to use any other erectile dysfunction (ED) treatment, including herbal
therapy during the 4-week non-drug, run-in, the double-blind treatment period, the
open label period and for 96 hours after the end of the study.
Partner Inclusion Criteria:
- Are female and at least 18 years of age at screening.
- Anticipate having the same male study subject as her sexual partner during the study.
- Able to read, understand and provide signed informed consent.
- Agree to make the required number of sexual intercourse attempts with the male sexual
study partner during the study.
- Willing to participate in recording responses to the treatment satisfaction scale.
Exclusion Criteria:
- Have an IIEF-EF domain score of greater than or equal to 26 at screening.
- Prior ineffective treatment with (or nonresponder to) any PDE5 Inhibitor
- Have previously used or are currently using any PDE5 inhibitor once daily.
- Present with ED caused by other primary disorders or ED caused by
untreated/inadequately treated endocrine disease.
- Partner unwilling to complete all study requirements.
- History of radical prostatectomy or other pelvic surgery or penile implant, or a
clinically significant penile deformity, in the opinion of the investigator
- Exhibit evidence of clinically significant renal insufficiency or hepatobiliary
disease, or significant cardiac history as determined by the investigator
- Currently receive treatment with nitrates, cancer chemotherapy, or antiandrogens
- Have previously completed or withdrawn from this study or any other study
investigating tadalafil for once-daily use.
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., Huntsville, Alabama 35801, United States
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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., Victoria, British Columbia V8T 5G1, Canada
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., Lancaster, California 93534, United States
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., Newport Beach, California 92660, United States
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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., Saskatoon, Saskatchewan S7K 7H9, Canada
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., Anderson, South Carolina 29621, United States
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