The primary aim of this study is to assess the efficacy and safety of tadalafil 5 mg
administered once a day in patients with erectile dysfunction (ED) who are naļve to PDE5
(phosphodiesterase type 5) inhibitors. Patients may be dose reduced to 2. 5mg based on
tolerability.
Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Number of Erectile Events Per NightChange From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Duration of Erectile Events Per Night
Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Percentage Volumetric Change
Change From Baseline to 12 Week Endpoint in the Frequency of Spontaneous Morning Erections Captured by Patient Diary
The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire at 12 Week Endpoint
Change From Baseline to 12 Week Endpoint in Total and Subdomain Scores of the Self-Esteem and Relationship (SEAR) Questionnaire
Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Orgasmic Functions (OF)
Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Sexual Desire (SD)
Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Intercourse Satisfaction (IS)
Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Overall Satisfaction (OS)
Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 1 Percentage of "Yes" Responses
Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 4 Percentage of "Yes" Responses
Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 5 Percentage of "Yes" Responses
Global Assessment Question (GAQ) Question 1 at 12 Week Endpoint
Global Assessment Question (GAQ) Question 2 at 12 Week Endpoint
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
Inclusion Criteria:
- You are male and aged at least 18 years.
- Have a history of erectile dysfunction (ED)(defined as the consistent inability to
achieve and/or maintain an erection sufficient to permit satisfactory sexual
intercourse) of at least 3 months duration.
- Agree not to use any other treatment for ED, including herbal and over-the-counter
(OTC) medications, during the study
- You agree to make at least four sexual intercourse attempts with the female sexual
study partner during the 4-week run-in period without medication
- Your entry laboratory test results and medical tests meet study requirements
- You agree to use the study drug only as instructed by your study doctor and staff and
to return any unused study drug and containers at the end of the study or as
otherwise instructed by the study doctor.
- If currently using cholesterol lowering medications (for example: statins) or
medications to lower blood pressure (example: angiotensin-converting enzyme (ACE)
inhibitors or calcium channel blocker medications), you need to be on a stable dose
and you and your study doctor do not expect any dose change during the study.
Exclusion Criteria:
- You have received previous or current treatment with tadalafil or any other PDE5
inhibitor.
- Currently receives treatment with doxazosin, nitrates, cancer chemotherapy, or
anti-androgens (except finasteride e. g. Propeciaā¢ or ProscarĀ®, or dutasteride e. g.
AvodartĀ®).
- You have had significant heart disease as determined by your doctor in charge of this
study or a member of the doctor's staff.
- Have a history of significant central nervous system injuries (including stroke or
spinal cord injury) within the last 6 months.
- Have a history of loss of vision in one eye because of nonarteritic anterior ischemic
optic neuropathy (NAION), regardless of whether this episode was in connection or not
with previous PDE5 inhibitor exposure.
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., Bad Wiessee D-83707, Germany
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., Berlin 13465, Germany
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., Hamburg 20354, Germany
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., Koblenz D-56068, Germany
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., Leipzig 04109, Germany
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., Athens 11527, Greece
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., Patras 26500, Greece
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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., Bialystok 15-223, Poland
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