Phase 3
N=342
Tadalafil Taken Daily Compared to Placebo on Improvement of Getting and Maintaining an Erection and Sexual Quality of Life
Impotence
Bottom Line
View on ClinicalTrials.gov: NCT00422734 ↗Enrolled (actual)
342
Serious AEs
—
Results posted
Jun 2009
Primary outcome: 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) — 0.49; 8.03 units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- tadalafil (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Eli Lilly and Company
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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) |
0.49; 8.03 | <0.001 sig |
| 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) |
12.59; 39.37; 7.93; 32.87 | <0.001 sig |
| PRIMARY Change From Baseline to Endpoint in the Percent of "Yes" Responses to Sexual Encounter Profile (SEP) Diary Questions 2 (SEP2) and 3 (SEP3). |
2.19; 28.80; 10.80; 46.46 | <0.001 sig |
| SECONDARY Change From Baseline to Week 12 Endpoint in the International Index of Erectile Function - Intercourse Satisfaction Domain - Subject Response |
0.09; 2.74 | <0.001 sig |
| SECONDARY Change From Baseline to 12 Week Endpoint in Overall Satisfaction Domain of the International Index of Erectile Function (IIEF-OS) - Subject Response |
0.44; 2.57 | <0.001 sig |
| SECONDARY Sexual Life Quality Questionnaire (SLQQ) Treatment Satisfaction Domain |
51.58; 75.04; 55.25; 73.42 | <0.001 sig |
| SECONDARY Change From Baseline to 12 Week Endpoint in Percent of "Yes" Responses to Sexual Encounter Profile (SEP) Questions 4 and 5 - Subject Response |
12.08; 50.05; 11.47; 48.78 | <0.001 sig |
| SECONDARY Change From Baseline to 12 Week Endpoint in Percent of "Yes" Responses to Partner-Sexual Encounter Profile (SEP) Question 3 - Partner Response |
10.21; 43.16 | <0.001 sig |
| SECONDARY Change From Baseline to 12 Week Endpoint in the Satisfaction Domain of the Female Sexual Function Index (FSFI) - Partner Response |
-0.40; 0.32 | <0.001 sig |
| SECONDARY Percent of Subjects With "Yes" Responses to Global Assessment Questionnaire (GAQ) - Subject Response |
26; 81; 22; 79 | <0.001 sig |
| SECONDARY Percent of Partners With "Yes" Responses to Global Assessment Questionnaire (GAQ) - Partner Response |
30; 79; 24; 76 | <0.001 sig |
| 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 |
1.25; 18.34; 6.97; 30.69 | <0.001 sig |
| SECONDARY Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire |
3.07; 30.44; 4.61; 34.28; 0.91; 25.35 | <0.001 sig |
| SECONDARY Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire - Confidence Domain Subscales |
3.26; 29.56; -4.04; 16.97 | <0.001 sig |
Summary
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
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00422734). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.