A Study in Patients With Erectile Dysfunction

Impact of Tadalafil (LY450190) Once a Day or Tadalafil on Demand Compared to Sildenafil Citrate on Demand on Treatment Discontinuation in Patients With Erectile Dysfunction Who Are naïve to PDE5 Inhibitors

The purpose of this study is to investigate if treatment in erectile dysfunction with a long-acting drug (Tadalafil) taken once a day or taken as needed results in a longer treatment adherence and better long term outcomes (over 24 weeks), compared with a short-acting drug (Sildenafil Citrate) taken as needed.

Study Overview

• Status: Completed
• Conditions: Erectile Dysfunction
• Intervention / Treatment: Drug: Tadalafil; Drug: Sildenafil Citrate

• Study Type: Interventional
• Enrollment (Actual): 770
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Carpentras, France, 84200
    • 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.
  • Chambery, France, 73000
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  • La Bouexiere, France, 35340
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  • Lille, France, 59000
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  • Lyon, France, 69437
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  • Marseille, France, 13009
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  • Montpellier, France, 34090
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  • Murs-Erigne, France, 49610
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  • Nantes, France, 44300
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  • Rennes, France, 35 700
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  • Toulouse, France, 31000
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• Germany
  • Giengen, Germany, 89537
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  • Grevenbroich, Germany, 41515
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  • Holzminden, Germany, D-37603
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  • Koblenz, Germany, 56068
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  • Leipzig, Germany, 04109
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  • Leverkusen, Germany, 51375
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  • Luebeck, Germany, 23552
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  • Marburg, Germany, 35039
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  • Muehlacker, Germany, D-75417
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  • Warburg, Germany, 34414
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• Greece
  • Heraklion, Greece, 71110
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  • Larissa, Greece, 41221
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  • Patras, Greece, 26500
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  • Thessaloniki, Greece, 56429
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• Poland
  • Kutno, Poland, 99-300
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  • Legionowo, Poland, 05-120
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  • Lublin, Poland, 20-008
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  • Warsaw, Poland, 00-909
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  • Wroclaw, Poland, 53-532
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• Portugal
  • Porto, Portugal, 4202-451
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• Romania
  • Bucharest, Romania, 050653
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  • Cluj-Napoca, Romania, 400046
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• Spain
  • Alcorcon, Spain, 28922
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  • Aravaca, Spain, 28023
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  • Barcelona, Spain, 08025
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  • Coslada, Spain, 28820
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  • Gijon, Spain
    • 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.
  • Madrid, Spain, 28040
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  • Málaga, Spain, 29007
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  • San Sebastian De Los Reyes, Spain, 28702
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  • Vigo, Spain, 36211
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• United Kingdom
  • Cornwall
    • Fowey, Cornwall, United Kingdom, PL23 1DT
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  • County Durham
    • Durham, County Durham, United Kingdom, DH1 2QW
      • 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.
  • Devon
    • Plymouth, Devon, United Kingdom, PL6 7TH
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Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• History of Erectile Dysfunction (ED) of at least 3 months duration.
• Anticipate having the same adult female sexual partner during the study.
• Agree not to use any other treatment for ED and to participate in recording responses to questionnaires and other instruments used in this study.

Exclusion Criteria:

• Previous or current treatment with tadalafil or any other phosphodiesterase type 5 (PDE5) inhibitor.
• ED caused by other primary sexual disorders, history of radical prostatectomy or other pelvic surgery with subsequent failure to achieve any erection, or history of penile implant or clinically significant penile deformity.
• ED caused by untreated or inadequately treated endocrine disease.
• Current treatment with doxazosin, nitrates, cancer chemotherapy, or anti-androgens.
• Severe renal or hepatic impairment, history of malignant hypertension.
• Presence or history of specific heart conditions.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tadalafil on demand; 10 milligrams (mg) or 20 mg on demand	Drug: Tadalafil; Administered orally for 24 weeks.; Other Names: LY450190; Cialis
Experimental: Tadalafil once a day; 5 mg or 2.5 mg once a day	Drug: Tadalafil; Administered orally for 24 weeks.; Other Names: LY450190; Cialis
Active Comparator: Sildenafil Citrate; 50 mg, 100 mg, or 25 mg on demand	Drug: Sildenafil Citrate; Administered orally for 24 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Discontinuation of Randomized Treatment	Time to discontinuation of randomized treatment was defined as the number of days from randomization until the day the participant discontinued the randomized treatment. Discontinuation of randomized treatment was defined as switching between the 3 study treatments (tadalafil on demand, tadalafil once a day, or sildenafil citrate on demand) or discontinuing from all treatments. A change of dose within the same treatment was not considered switching of treatment. This outcome measure was estimated using the Kaplan-Meier product-limit method.	Baseline up to 334 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Erectile Function (EF) Domain	Self-reported EF score over past 4 weeks. Items 1-5 scores range from 0 (no sexual activity) to 5 (high EF). Item 15 score ranges from 1 (very low confidence to get/keep erection) to 5 (very high confidence). Total scores range from 1 to 30; lower scores denote greater erectile dysfunction severity. Least Squares Mean changes from baseline to endpoint for each visit from repeated measures analysis included terms for baseline score, treatment group, country, baseline*treatment (if p<0.10), visit, and visit*treatment. Correlation matrix for repeated observations assumed to be unstructured.	Baseline, 4, 8, 16, and 24 weeks
Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Orgasmic Function Domain	Self-reported orgasmic function on the IIEF over past 4 weeks and consists of 2 questions (items 9 and 10). Each question is rated on a scale from 0 (no sexual stimulation) to 5 (almost always/always). Total scores range from 0 to 10; lower scores represent lower orgasmic function. Least Squares Mean changes from baseline to endpoint for each visit were from a repeated measures analysis and included terms for baseline score, treatment group, country, baseline*treatment (if p<0.10), visit, and visit*treatment. The correlation matrix for the repeated observations was assumed to be unstructured.	Baseline, 4, 8, 16, and 24 weeks
Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Sexual Desire Domain	Self-reported sexual desire on IIEF over past 4 weeks; comprises 2 questions (items 11 and 12). Each question rated on a scale from 1 (almost never or low/no sexual desire) to 5 (almost always or very high sexual desire). Total scores range: 2 to 10; lower numerical scores denote lower sexual desire. Least Squares Mean changes from baseline to endpoint for each visit from repeated measures analysis and included terms for baseline score, treatment group, country, baseline*treatment (if p<0.10), visit, and visit*treatment. Correlation matrix for repeated observations assumed to be unstructured.	Baseline, 4, 8, 16, and 24 weeks
Change From Baseline to 4, 8, 16 and 24 Weeks of the Sexual Encounter Profile (SEP)	Participant-assessed diary. Has 5 questions (Question[Q]1:erection achievement, Q2:successful penetration, Q3:successful intercourse, Q4:satisfied with erection, and Q5:satisfied with sexual experience) for each sexual encounter made over specified period of time. SEP Q1-Q5 scores determined as percentage of 'Yes' responses to each of 5 questions out of all sexual attempts recorded during the time period. Least Squares Mean changes from baseline to endpoint for each visit from a repeated measures analysis included terms for baseline score, treatment group, country, visit, and visit*treatment.	Baseline, 4, 8, 16, and 24 weeks
Global Assessment Questions (GAQ)	The GAQ consists of 2 Yes/No/No Response (No Respo) questions. GAQ Question (Q)1: Has the treatment you have been taking during this study improved your erections? GAQ Q2: Has the treatment improved your ability to engage in sexual activity?	24 weeks
Number of Treatment Switches	The number of times participants switched erectile dysfunction medication within the 3 treatments being studied (tadalafil on demand, tadalafil once a day, or sildenafil citrate on demand).	Baseline through 24 weeks
Patterns of Erectile Dysfunction Treatment Change	Results are reported as the number of participants per sequence of study medications (tadalafil on demand, tadalafil once a day, or sildenafil citrate on demand) that were taken as a result of switching treatments. The Other Treatment Sequence reports the number of participants per sequence of study medications that were taken as a result of switching treatments more than once. The number of participants who did not switch is also reported.	Baseline through 24 weeks
Reasons for Discontinuation of Randomized Erectile Dysfunction Treatment	The reported reasons for a decision to discontinue from initial randomized treatment prior to Week 24 are reported. Discontinuation of randomized treatment was defined as switching between the 3 study treatments (tadalafil on demand, tadalafil once a day, or sildenafil citrate on demand) or discontinuing from all treatments. A change of dose within the same treatment was not considered as switching of treatment.	Baseline through 24 weeks
Number of Days From the 8-Week Study Visit to the Time the Participant Discontinues From All Phosphodiesterase Type 5 (PDE5) Inhibitor Treatments	The differences in time between the 8-week time point and the discontinuation of all study treatments (that is, discontinuation from the study and not switching to another treatment) are reported by the median (95% confidence interval). Duration was measured as the number of days from Week 8 to the date of the last dose of the study drug. This outcome measure was estimated using the Kaplan-Meier product-limit method.	8 weeks up to 334 days
Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Intercourse Satisfaction Domain	Self-reported intercourse satisfaction score over past 4 weeks (1 intercourse attempt item, 2 intercourse satisfaction items). Each item range: 0 (no intercourse attempts/no satisfaction) to 5 (more attempts/high satisfaction). Total scores range: 0-15; lower scores=lower intercourse satisfaction. Least Squares Mean changes from baseline to endpoint for each visit from repeated measures analysis and included terms for baseline score, treatment group, country, baseline*treatment (if p<0.10), visit, and visit*treatment. Correlation matrix for repeated observations assumed to be unstructured.	Baseline, 4, 8, 16, and 24 weeks
Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Overall Satisfaction Domain	Self-reported overall satisfaction on the IIEF over past 4 weeks and consists of 2 questions (items 13 and 14), each rated on a scale from 1 (very dissatisfied) to 5 (very satisfied). Total scores range from 2 to 10; lower numerical scores represent lower overall satisfaction. Least Squares Mean changes from baseline to endpoint for each visit were from a repeated measures analysis and included terms for baseline score, treatment group, country, baseline*treatment (if p<0.10), visit, and visit*treatment. The correlation matrix for the repeated observations was assumed to be unstructured.	Baseline, 4, 8, 16, and 24 weeks
Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire at 4, 8, 16, and 24 Weeks	The participant questionnaire consists of 11 questions. Each question is rated on a scale of 0 (extremely low treatment satisfaction) to 4 (extremely high treatment satisfaction). The EDITS summary score was obtained by adding each individual result for all questions, dividing by the number of questions answered (mean satisfaction score), then multiplying by 25, thus obtaining a score range from 0 (extremely low treatment satisfaction) to 100 (extremely high satisfaction). Least Squares Mean changes were adjusted for treatment group, country, visit, and visit*treatment.	4, 8, 16, and 24 weeks
Change From Baseline to 24 Week Endpoint of the Sexual Self-Confidence, Spontaneity, and Time Concerns Domains (23-items) of the Psychological and Interpersonal Relationships Scale (PAIRS)	The PAIRS is a 23-item scale that assesses broader psychological/interpersonal outcomes associated with erectile dysfunction and its treatment. Each question is rated on a Likert scale from 1 (strongly disagree) to 4 (strongly agree). The scale consists of 3 domains: Sexual Self-Confidence (items 1-6), Spontaneity domain (items 7-15), and Time Concerns (items 16-23). The average domain score for each domain was calculated by adding the nonmissing items for the respective domain, then dividing by the number of nonmissing items for the respective domain. Each average domain score ranged from 1 to 4. Higher scores represent the following: greater sexual self-confidence (better outcome); greater spontaneity (better outcome); higher time concerns (worse outcome). The Least Squares Mean changes were adjusted for treatment group, country, baseline IIEF-EF severity, baseline domain score, and baseline domain score*treatment (if p<0.10).	Baseline, 24 weeks
Change From Baseline to 4, 8, 16, and 24 Weeks of the Sexual Relationship Domain of the Self-Esteem and Relationship (SEAR) Questionnaire	SEAR assesses psychosocial outcomes in men with erectile dysfunction. Sexual Relationship domain consists of 8 items (items 1-8). Items 2-8 are rated on a scale of 1 (Never) to 5 (Always), whereas item 1 is reverse scored (1=Always and 5=Never). The domain score was computed by summing its respective items, then transforming it into a 0 (least favorable) to 100 (most favorable) scale. Transformed score = 100 x [(actual raw score - lowest possible raw score)/possible raw score range]. Least Squares Mean changes adjusted for baseline score, treatment group, country, visit, and visit*treatment.	Baseline, 4, 8, 16, and 24 weeks
Change From Baseline to 4, 8, 16, and 24 Weeks of the Confidence Domain of the Self-Esteem and Relationship (SEAR) Questionnaire	SEAR assesses psychosocial outcomes in men with erectile dysfunction. Confidence domain measures improvement in confidence; 2 subscales (6 items: Self-Esteem [items 9-12]; Overall Relationship [items 13-14]). Each item range: 1 (Never) to 5 (Always); item 11 reverse scored. Domain score=sum of domain's respective items, then transformed into 0 (least favorable) to 100 (most favorable) scale. Transformed score=100x[(actual raw score-lowest possible raw score)/possible raw score range]. Least Squares Mean change adjusted for baseline score, treatment group, country, visit, and visit*treatment.	Baseline, 4, 8, 16, and 24 weeks
Change From Baseline to 4, 8, 16, and 24 Weeks of the Self Esteem Domain of the Self-Esteem and Relationship (SEAR) Questionnaire	SEAR assesses psychosocial outcomes in men with erectile dysfunction. The Self-Esteem domain consists of 4 items (items 9-12), each rated on a scale of 1 (Never) to 5 (Always). Item 11 is reverse scored (1=Always and 5=Never). The domain score was computed by summing its respective items, then transforming it into a 0 (least favorable) to 100 (most favorable) scale. The transformed score = 100 x [(actual raw score - lowest possible raw score)/possible raw score range]. Least Squares Mean changes were adjusted for baseline score, treatment group, country, visit, and visit*treatment.	Baseline, 4, 8, 16, and 24 weeks
Change From Baseline to 4, 8, 16, and 24 Weeks of the Overall Relationship Domain of the Self-Esteem and Relationship (SEAR) Questionnaire	SEAR assesses psychosocial outcomes in men with erectile dysfunction. The Overall Relationship domain consists of 2 items (items 13-14), each rated on a scale of 1 (Never) to 5 (Always). The domain score was computed by summing its respective items, then transforming it into a 0 (least favorable) to 100 (most favorable) scale. The transformed score = 100 x [(actual raw score - lowest possible raw score)/possible raw score range]. Least Squares Mean changes were adjusted for baseline score, treatment group, country, visit, and visit*treatment.	Baseline, 4, 8, 16, and 24 weeks

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Publications and helpful links

General Publications

• Buvat J, Buttner H, Hatzimouratidis K, Vendeira PA, Moncada I, Boehmer M, Henneges C, Boess FG. Adherence to initial PDE-5 inhibitor treatment: randomized open-label study comparing tadalafil once a day, tadalafil on demand, and sildenafil on demand in patients with erectile dysfunction. J Sex Med. 2013 Jun;10(6):1592-602. doi: 10.1111/jsm.12130. Epub 2013 Apr 2.

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: May 5, 2010
• First Submitted That Met QC Criteria: May 11, 2010
• First Posted (Estimate): May 13, 2010

Study Record Updates

• Last Update Posted (Estimate): October 19, 2012
• Last Update Submitted That Met QC Criteria: September 18, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: Erectile Dysfunction
• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Erectile Dysfunction; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate; Tadalafil
• Other Study ID Numbers: 13085; H6D-EW-LVIJ (Other Identifier: Eli Lilly and Company)