| August 12, 2008 |
| October 1, 2009 |
| August 2008 |
| September 2009 (final data collection date for primary outcome measure) |
| Change in Sexual Self-Confidence domain of Psychological and Interpersonal Relationship Scales (PAIRS). [ Time Frame: 26 weeks (including two washout periods of 1 week each) ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00734604 on ClinicalTrials.gov Archive Site |
- Psychosocial outcomes, as measured by Sexual Self-Confidence, Spontaneity, and Time Concerns domains of PAIRS. [ Time Frame: 26 weeks (including two washout periods of 1 week each) ] [ Designated as safety issue: No ]
- Efficacy, as measured by the Erectile Function domain (sum of Items 1 through 5 and Item 15) of the International Index of Erectile Function (IIEF) and the frequency of morning erection. [ Time Frame: 26 weeks (including two washout periods of 1 week each) ] [ Designated as safety issue: No ]
- Sexual satisfaction, as measured by the Intercourse Satisfaction and Overall Satisfaction domains of the IIEF. [ Time Frame: 26 weeks (including two washout periods of 1 week each) ] [ Designated as safety issue: No ]
- Treatment satisfaction, as measured by the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS). [ Time Frame: 26 weeks (including two washout periods of 1 week each) ] [ Designated as safety issue: No ]
- Safety and tolerability. [ Time Frame: 26 weeks (including two washout periods of 1 week each) ] [ Designated as safety issue: Yes ]
- Psychosocial outcomes, as measured by the Self-Esteem And Relationship (SEAR) questionnaire; and Questions 1 to 4 of the Patient Perception and Feelings Questions (PPF-Q). [ Time Frame: 26 weeks (including two washout periods of 1 week each) ] [ Designated as safety issue: No ]
|
| Same as current |
| |
| A Study for Patients With Erectile Dysfunction to Test Whether Tadalafil Taken Once a Day Can Better Improve Psychological Outcomes. |
| A Comparison of Psychosocial Outcomes Following Tadalafil Once a Day or PDE5 Inhibitor As Needed in Men With Erectile Dysfunction. |
The primary purpose of the study is to help answer whether tadalafil taken once a day can help improve the psychological outcomes (such as sexual self confidence, spontaneity and time concerns) compared to sildenafil taken as needed in patients with erectile dysfunction. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study |
| Erectile Dysfunction |
- Drug: tadalafil
- Drug: sildenafil citrate
|
- Experimental: Tadalafil 5 mg OaD, sildenafil citrate 100 mg PRN, tadalafil 20 mg PRN
- Experimental: Tadalafil 5 mg OaD, tadalafil 20 mg PRN, sildenafil citrate 100 mg PRN
- Experimental: Sildenafil citrate 100 mg PRN, tadalafil 5 mg OaD, tadalafil 20 mg PRN
- Experimental: Sildenafil citrate 100 mg PRN, tadalafil 20 mg PRN, tadalafil 5 mg OaD
- Experimental: Tadalafil 20 mg PRN, tadalafil 5 mg OaD, sildenafil citrate 100 mg PRN
- Experimental: Tadalafil 20 mg PRN, sildenafil citrate 100 mg PRN, tadalafil 5 mg OaD
|
| |
| |
| Completed |
| 377 |
| September 2009 |
| September 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- History of erectile dysfunction.
- Have had satisfactory response to tadalafil, sildenafil citrate, or vardenafil HCl for a period of at least 6 months and expect frequent use (at least one dose per week, on average) when administered as needed.
- Have never used tadalafil 5 mg or 2.5 mg once a day therapy.
- Anticipate having the same adult female sexual partner willing to participate during the study.
- Agree to make at least four sexual intercourse attempts during the first four weeks of the study.
- Agree not to use any other treatment for ED (even herbal treatments) during the study.
- Agree to follow the directions given by the study doctor and staff about using the study drug.
Exclusion Criteria:
- Have any other primary sexual disorders present or penile deformity.
- Have history of radical prostatectomy or penile implant.
- Have problems with your kidneys, liver, or nervous system.
- Have uncontrolled diabetes, as measured by a blood test for haemoglobin A1C greater than a value of 11%.
- Are being treated for heart disease with any drug that is called a nitrate (for example, nitroglycerin).
- Have chest pain (called unstable angina or angina) that requires treatment.
- Have heart disease that causes symptoms after you exert yourself.
- Have had any of the following in the past 90 days: Heart attack, also known as a myocardial infarction (MI); Heart bypass surgery (called coronary artery bypass graft surgery); Had a procedure to open up blood vessels in the heart known as angioplasty or stent placement (percutaneous coronary intervention).
- Have a history of loss of vision in one eye because of nonarteritic anterior ischemic optic neuropathy (NAION).
- Have retinitis pigmentosa.
- Have history of HIV.
- Have very high or very low blood pressure (your study doctor will discuss the limits with you).
- Have had a stroke or a significant injury to your brain or spinal cord within the last 6 months.
- Have rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption Lactose intolerance.
- Have a scheduled or planned surgery requiring anaesthesia during the course of the study.
- Have a scheduled cataract surgery during the curse of the study.
|
| Male |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Australia, Brazil, Germany, Italy, Mexico, Puerto Rico, Spain, United Kingdom |
| |
| NCT00734604 |
| Chief Medical Officer, Eli Lilly |
| 12313, H6D-CR-S024 |
| Eli Lilly and Company |
|
| Study Director: |
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Easter Time (UTC/GMT - 5 hours, EST) |
Eli Lilly and Company |
|
|
| Eli Lilly and Company |
| October 2009 |