Impotence Clinical Trial
Official title:
Tadalafil 5 mg Once a Day Compared to Placebo in Improving Erectile Dysfunction and Sexual Quality of Life
| Verified date | June 2009 |
| Source | Eli Lilly and Company |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
To determine if tadalafil 5 mg daily compared to placebo when given for 12 weeks improves getting and maintaining an erection in men with erectile dysfunction and if there are improvements in the sexual quality of life of the man and his female study partner
| Status | Completed |
| Enrollment | 342 |
| Est. completion date | January 2008 |
| Est. primary completion date | January 2008 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: Male - History of erectile dysfunction (ED) for at least 3 months duration - Anticipate having the same female partner willing to participate throughout the study - At least 18 years of age at Visit 1 and agree to make at least 4 sexual attempts during the early phase of the study - Adequate partner sexual function as determined by a Female Sexual Function Index - Willing to record responses to efficacy questionnaires, sexual quality of life questionnaires and other instruments used in the study Exclusion Criteria: - May not participate in the study if you have taken tadalafil previously. - History of cardiac conditions including angina requiring treatment with nitrates, heart disease of coronary conditions including myocardial infarction, bypass surgery, angioplasty or stent placement for specified time before starting the study. - Have sexual partner not willing to complete the scales. - Use of nitrates. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Austria | 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. | Salzburg | |
| France | 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. | Lille | |
| France | 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. | Marseille | |
| France | 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. | Rennes | |
| Germany | 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. | Augsburg | |
| Germany | 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. | Berlin | |
| Germany | 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. | Hamburg | |
| Germany | 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. | Leverkusen | |
| Mexico | 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. | La Joya | |
| United States | 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. | Cleveland | Ohio |
| United States | 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. | Des Moines | Iowa |
| United States | 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. | Huntsville | Alabama |
| United States | 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. | Knoxville | Tennessee |
| United States | 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. | Little Rock | Arkansas |
| United States | 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. | Newport Beach | California |
| United States | 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. | San Antonio | Texas |
| United States | 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. | Stuart | Florida |
| United States | 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. | Tampa | Florida |
| United States | 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. | Virginia Beach | Virginia |
| Lead Sponsor | Collaborator |
|---|---|
| Eli Lilly and Company | ICOS Corporation |
United States, Austria, France, Germany, Mexico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF)- Erectile Function Domain Score (Sum of IIEF Questions 1-5 and 15) | Baseline and 12 weeks | No | |
| Primary | Improvement in the Sexual Quality of Life in the Subject and His Study Partner as Measured by the Sexual Quality of Life (SQoL) Domain of the Sexual Life Quality Questionnaire (SLQQ) | Baseline and 12 weeks | No | |
| Primary | Change From Baseline to Endpoint in the Percent of "Yes" Responses to Sexual Encounter Profile (SEP) Diary Questions 2 (SEP2) and 3 (SEP3). | Baseline and 12 weeks | No | |
| Secondary | Change From Baseline to Week 12 Endpoint in the International Index of Erectile Function - Intercourse Satisfaction Domain - Subject Response | Baseline and 12 weeks | No | |
| Secondary | Change From Baseline to 12 Week Endpoint in Overall Satisfaction Domain of the International Index of Erectile Function (IIEF-OS) - Subject Response | Baseline and 12 weeks | No | |
| Secondary | Sexual Life Quality Questionnaire (SLQQ) Treatment Satisfaction Domain | 12 weeks | No | |
| Secondary | Change From Baseline to 12 Week Endpoint in Percent of "Yes" Responses to Sexual Encounter Profile (SEP) Questions 4 and 5 - Subject Response | Baseline and 12 weeks | No | |
| Secondary | Change From Baseline to 12 Week Endpoint in Percent of "Yes" Responses to Partner-Sexual Encounter Profile (SEP) Question 3 - Partner Response | Baseline and 12 weeks | No | |
| Secondary | Change From Baseline to 12 Week Endpoint in the Satisfaction Domain of the Female Sexual Function Index (FSFI) - Partner Response | Baseline and 12 weeks | No | |
| Secondary | Percent of Subjects With "Yes" Responses to Global Assessment Questionnaire (GAQ) - Subject Response | 12 weeks | No | |
| Secondary | Percent of Partners With "Yes" Responses to Global Assessment Questionnaire (GAQ) - Partner Response | 12 weeks | No | |
| Secondary | Change From Baseline to 12 Week Endpoint in Percent of "Yes" Responses to Partner-Sexual Encounter Profile (SEP) Questions 1 and 2 - Partner Response | Baseline and 12 weeks | No | |
| Secondary | Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire | Baseline and 12 weeks | No | |
| Secondary | Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire - Confidence Domain Subscales | Baseline and 12 weeks | No |
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