Erectile Dysfunction, Impotence
Conditions
Keywords
erectile dysfunction, tadalafil
Brief 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.
Interventions
DRUGtadalafil
Sponsors
ICOS Corporation
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Finland
Outcome results
None listed