Effect of Tadalafil on the Quality of Life and Sexual Life in Erectile Dysfunction

NCT00422578 | Completed Phase 4

• 2 other identifiers: 9113H6D-HL-LVGD
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Impotence; Erectile Dysfunction

Keywords

erectile dysfunction; tadalafil

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Interventions

tadalafil DRUG

Also known as: LY450190, Cialis, IC351

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• exhibit evidence of clinically significant hepatobiliary disease (including jaundice) at visit 1
• receiving treatment with cancer chemotherapy

Sponsors & Collaborators

• Eli Lilly and Company: lead
• ICOS Corporation: collaborator

Study Sites (1)

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

Location

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 16, 2007
• First Posted: January 17, 2007
• Study Start: October 1, 2004
• Study Completion: September 1, 2005
• Last Updated: October 25, 2007

Record last verified: 2007-10

Locations

FI (1)