Effect of Tadalafil on the Quality of Life and Sexual Life in Erectile Dysfunction
Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Impotence; Erectile Dysfunction
Intervention: tadalafil (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Eli Lilly and Company Official(s) and/or principal investigator(s): Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study Director, Affiliation: Eli Lilly and Company
Summary
Study is a clinical study assessing the effect of oral tadalafil 10mg or 20 mg on
psychosocial aspects and quality of life of erectile dysfunction patients and to compare
tadalafil with previous oral erectile dysfunction medication. Study period is 13 weeks.
Study patients fill in quality of life questionnaires and treatment satisfaction
questionnaires.
Clinical Details
Official title: Effect of Tadalafil on the Quality of Life and Sexual Life in Erectile Dysfunction (ED) Patients Previously Treated With Other Oral ED Therapy
Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: On-demand therapy with tadalafil, as measured by the spontaneity domain of the PAIRS questionnaire increases the possibility to spontaneous sexual activity in ED patients compared with any other previous oral ED treatment.
Secondary outcome: Estimate the level of quality of life (15D and LiSat-11)in treated ED patients in order to be able to compare it with existing data of the general population and patients suffering from other diseases and symptoms.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- have a history of erectile dysfunction (defined as a consistent change in the quality
of erection that adversely affects the patient's satisfaction with sexual
intercourse)of at least 3 months duration
- have been using any oral prescription medication,but not tadalafil, for erectile
dysfunction for a minimum period of 3 months before visit 1
- have responded to previous erectile dysfunction medication as assessed by the
investigator
Exclusion Criteria:
- exhibit evidence of clinically significant hepatobiliary disease (including jaundice)
at visit 1
- cardiovascular exclusion criteria: history of chronic stable angina treated with
nitrates, recent acute cardiovascular events or procedures (myocardial infarction,
coronary interventions, stroke, etc.), history of other serious cardiovascular events
(e. g. arrhythmias, sudden cardiac arrest, congestive heart failure, etc.), systolic
blood pressure <90mmHg or diastolic blood pressure <50mmHg at screening
- receiving treatment with cancer chemotherapy
Locations and Contacts
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., Tampere, Finland
Additional Information
Lilly Clinical Trial Registry
Starting date: October 2004
Last updated: October 23, 2007
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