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Clinical Trials/NCT01122264
NCT01122264CompletedPhase 4

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

Eli Lilly and Company1 site in 1 country770 target enrollmentStarted: May 2010Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
770
Locations
1
Primary Endpoint
Time to Discontinuation of Randomized Treatment
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Tadalafil on demand

Experimental

10 milligrams (mg) or 20 mg on demand

Intervention: Tadalafil (Drug)

Tadalafil once a day

Experimental

5 mg or 2.5 mg once a day

Intervention: Tadalafil (Drug)

Sildenafil Citrate

Active Comparator

50 mg, 100 mg, or 25 mg on demand

Intervention: Sildenafil Citrate (Drug)

Outcomes

Primary Outcomes

Time to Discontinuation of Randomized Treatment

Time Frame: Baseline up to 334 days

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.

Secondary Outcomes

  • Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Erectile Function (EF) Domain(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(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(Baseline, 4, 8, 16, and 24 weeks)
  • Change From Baseline to 4, 8, 16 and 24 Weeks of the Sexual Encounter Profile (SEP)(Baseline, 4, 8, 16, and 24 weeks)
  • Global Assessment Questions (GAQ)(24 weeks)
  • Number of Treatment Switches(Baseline through 24 weeks)
  • Patterns of Erectile Dysfunction Treatment Change(Baseline through 24 weeks)
  • Reasons for Discontinuation of Randomized Erectile Dysfunction 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(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(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(Baseline, 4, 8, 16, and 24 weeks)
  • Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire at 4, 8, 16, and 24 Weeks(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)(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(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(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(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(Baseline, 4, 8, 16, and 24 weeks)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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