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A Study for Patients With Erectile Dysfunction to Test Whether Tadalafil Taken Once a Day Can Better Improve Psychological Outcomes.
This study has been completed.
Study NCT00734604   Information provided by Eli Lilly and Company
First Received: August 12, 2008   Last Updated: October 1, 2009   History of Changes

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
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
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

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