A Study for Patients With Erectile Dysfunction to Test Whether Tadalafil Taken Once a Day Can Better Improve Psychological Outcomes. - Full Text View

Sponsor:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00734604

Purpose

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 (ED).

Condition	Intervention	Phase
Erectile Dysfunction	Drug: tadalafil once a day [T(OaD)] Drug: sildenafil citrate as needed [S(PRN)] Drug: tadalafil as needed [T(PRN)]	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Comparison of Psychosocial Outcomes Following Tadalafil Once a Day or PDE5 Inhibitor As Needed in Men With Erectile Dysfunction.

Resource links provided by NLM:

MedlinePlus related topics: Erectile Dysfunction

Drug Information available for: Citric acid Sodium Citrate Sildenafil Tadalafil Sildenafil citrate

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Change From Baseline Between Tadalafil Once a Day (OaD) and Sildenafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS) [ Time Frame: baseline, 8 weeks of each treatment ] [ Designated as safety issue: No ]
The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Sexual Self-Confidence score is the average of responses on 6 PAIRS item scores. Sexual Self-Confidence scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater sexual self-confidence.

Secondary Outcome Measures:

Change From Baseline Between Tadalafil Once a Day (OaD) and Tadalafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS) [ Time Frame: baseline, 8 weeks of each treatment ] [ Designated as safety issue: No ]
The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Sexual Self-Confidence score is the average of responses on 6 PAIRS item scores. Sexual Self-Confidence scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater sexual self-confidence.
Change From Baseline to Endpoint in the Spontaneity Domain of PAIRS [ Time Frame: baseline, 8 weeks of each treatment ] [ Designated as safety issue: No ]
The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Spontaneity score is the average of responses on 9 PAIRS item scores. Spontaneity scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater spontaneity.
Change From Baseline to Endpoint in the Time Concerns Domain of PAIRS [ Time Frame: baseline, 8 weeks of each treatment ] [ Designated as safety issue: No ]
The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Time Concerns score is the average of responses on 8 PAIRS item scores. Time Concerns scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater sexual self-confidence.
Change From Baseline to Endpoint in the Erectile Function Domain of the International Index of Erectile Function (IIEF) [ Time Frame: baseline, 8 weeks of each treatment ] [ Designated as safety issue: No ]
Self-reported erectile function over the past 4 weeks. Scores range from 0 (low or no erectile function) to 5 (high erectile function) on 6 questions (1-5, 15 of the IIEF). Total Erectile Function Domain scores range from 0 to 30.
Change From Baseline to Endpoint in the Proportion of Days With at Least One Morning Erection [ Time Frame: baseline, 8 weeks of each treatment ] [ Designated as safety issue: No ]
Change From Baseline to Endpoint in the Intercourse Satisfaction (IS) Domain of the IIEF [ Time Frame: baseline, 8 weeks of each treatment ] [ Designated as safety issue: No ]
Self-reported intercourse satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 3 questions of the IIEF-IS domain range from 0 to 15.
Change From Baseline to Endpoint in the Overall Satisfaction (OS) Domain of the IIEF [ Time Frame: baseline, 8 weeks of each treatment ] [ Designated as safety issue: No ]
Self-reported overall satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 2 questions of the IIEF-OS domain range from 0 to 10.
Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Score at Endpoint [ Time Frame: 8 weeks of each treatment ] [ Designated as safety issue: No ]
EDITS is a questionnaire-based inventory capturing a participant's subjective evaluation of treatment for the participant's erection problems. All items on the 11-item Patient EDITS were scored from zero (no satisfaction or dissatisfaction) to four (high satisfaction). The EDITS Summary Score (transformed) is obtained by adding each individual score for all questions, dividing by the number of questions, and multiplying by 25, so that EDITS scores could range from a low of 0 (extremely low treatment satisfaction) to a high of 100 (extremely high treatment satisfaction).
Number of Participants With at Least One Serious Adverse Event [ Time Frame: baseline through 26 weeks (including two washout periods of 1 week each) ] [ Designated as safety issue: Yes ]
Serious adverse events are listed in the Reported Adverse Event module.
Change From Baseline to Endpoint in the Self-Esteem And Relationship (SEAR) Questionnaire Transformed Total Score [ Time Frame: baseline, 8 weeks of each treatment ] [ Designated as safety issue: No ]
Measures improvement in self-esteem and relationship satisfaction. Questionnaire consists of two domains, Sexual Relationship (items 1-8) and Confidence (items 9-14). Overall score is transformed onto a 0 (least favorable) to 100 (most favorable) scale. Overall score was calculated from two domains and subscales scores.
Question 1 "I Felt as if I Did Not Have ED" Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint [ Time Frame: 8 weeks of each treatment ] [ Designated as safety issue: No ]
Scores for Question 1 range from 0 (not at all) to 4 (extremely).
Question 2 "I Felt in Control of my Sex Life" Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint [ Time Frame: 8 weeks of each treatment ] [ Designated as safety issue: No ]
Scores for Question 2 range from 0 (not at all) to 4 (extremely).
Question 3 "I Felt the Drug Was in Control of my Erections" Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint [ Time Frame: 8 weeks of each treatment ] [ Designated as safety issue: No ]
Scores for Question 3 range from 0 (not at all) to 4 (extremely).
Question 4 "I Felt Like a Whole Man" Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint [ Time Frame: 8 weeks of each treatment ] [ Designated as safety issue: No ]
Scores for Question 4 range from 0 (not at all) to 4 (extremely).

Enrollment:	378
Study Start Date:	August 2008
Study Completion Date:	September 2009
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: T(OaD)/S(PRN)/T(PRN) Tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks	Drug: tadalafil once a day [T(OaD)] 5 mg tablet taken once a day (OaD) by mouth for 8 weeks Other Names: Cialis LY450190 Drug: sildenafil citrate as needed [S(PRN)] 100 mg tablet taken as needed (PRN) by mouth for 8 weeks Drug: tadalafil as needed [T(PRN)] 20 mg tablet taken as needed (PRN) by mouth for 8 weeks Other Names: Cialis LY450190
Experimental: T(OaD)/T(PRN)/S(PRN) Tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks	Drug: tadalafil once a day [T(OaD)] 5 mg tablet taken once a day (OaD) by mouth for 8 weeks Other Names: Cialis LY450190 Drug: sildenafil citrate as needed [S(PRN)] 100 mg tablet taken as needed (PRN) by mouth for 8 weeks Drug: tadalafil as needed [T(PRN)] 20 mg tablet taken as needed (PRN) by mouth for 8 weeks Other Names: Cialis LY450190
Experimental: S(PRN)/T(OaD)/T(PRN) Sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks	Drug: tadalafil once a day [T(OaD)] 5 mg tablet taken once a day (OaD) by mouth for 8 weeks Other Names: Cialis LY450190 Drug: sildenafil citrate as needed [S(PRN)] 100 mg tablet taken as needed (PRN) by mouth for 8 weeks Drug: tadalafil as needed [T(PRN)] 20 mg tablet taken as needed (PRN) by mouth for 8 weeks Other Names: Cialis LY450190
Experimental: S(PRN)/T(PRN)/T(OaD) Sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks	Drug: tadalafil once a day [T(OaD)] 5 mg tablet taken once a day (OaD) by mouth for 8 weeks Other Names: Cialis LY450190 Drug: sildenafil citrate as needed [S(PRN)] 100 mg tablet taken as needed (PRN) by mouth for 8 weeks Drug: tadalafil as needed [T(PRN)] 20 mg tablet taken as needed (PRN) by mouth for 8 weeks Other Names: Cialis LY450190
Experimental: T(PRN)/T(OaD)/S(PRN) Tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks	Drug: tadalafil once a day [T(OaD)] 5 mg tablet taken once a day (OaD) by mouth for 8 weeks Other Names: Cialis LY450190 Drug: sildenafil citrate as needed [S(PRN)] 100 mg tablet taken as needed (PRN) by mouth for 8 weeks Drug: tadalafil as needed [T(PRN)] 20 mg tablet taken as needed (PRN) by mouth for 8 weeks Other Names: Cialis LY450190
Experimental: T(PRN)/S(PRN)/T(OaD) Tadalafil 20 mg as needed [T(PRN)] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed [S(PRN)] for 8 weeks, 1 week washout, tadalafil 5 mg once a day [T(OaD)] for 8 weeks	Drug: tadalafil once a day [T(OaD)] 5 mg tablet taken once a day (OaD) by mouth for 8 weeks Other Names: Cialis LY450190 Drug: sildenafil citrate as needed [S(PRN)] 100 mg tablet taken as needed (PRN) by mouth for 8 weeks Drug: tadalafil as needed [T(PRN)] 20 mg tablet taken as needed (PRN) by mouth for 8 weeks Other Names: Cialis LY450190

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

History of erectile dysfunction (ED).
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 human immunodeficiency virus (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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00734604

Show 37 Study Locations

Sponsors and Collaborators

Eli Lilly and Company

Investigators

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

More Information

No publications provided

Responsible Party:	Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier:	NCT00734604 History of Changes
Other Study ID Numbers:	12313, H6D-CR-S024
Study First Received:	August 12, 2008
Results First Received:	September 20, 2010
Last Updated:	October 21, 2010
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration Brazil: Ministry of Health Germany: Federal Institute for Drugs and Medical Devices Italy: Ministry of Health Mexico: Federal Commission for Sanitary Risks Protection Mexico: Ethics Committee Mexico: Ministry of Health Spain: Ethics Committee Spain: Spanish Agency of Medicines United Kingdom: Medicines and Healthcare Products Regulatory Agency United Kingdom: Research Ethics Committee United States: Food and Drug Administration

Additional relevant MeSH terms:

Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Sildenafil
Tadalafil

Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 24, 2012