Phase 3
Completed N=378
A Study for Patients With Erectile Dysfunction to Test Whether Tadalafil Taken Once a Day Can Better Improve Psychological Outcomes.
Source: ClinicalTrials.gov NCT00734604 ↗Enrolled (actual)
378
Serious AEs
1.0%
Results posted
Nov 2010
Primary outcomePrimary: Change From Baseline Between Tadalafil Once a Day (OaD) and Sildenafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS) — 2.24; 2.23; 0.50; 0.39 units on a scale — p=0.001
Summary
The primary purpose of the study is to help answer whether tadalafil taken once a day can help improve the psychological outcomes (such as sexual self confidence, spontaneity and time concerns) compared to sildenafil taken as needed in patients with erectile dysfunction (ED).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline Between Tadalafil Once a Day (OaD) and Sildenafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS) |
2.24; 2.23; 0.50; 0.39 | 0.001 sig |
| SECONDARY Change From Baseline Between Tadalafil Once a Day (OaD) and Tadalafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS) |
2.24; 2.24; 0.50; 0.50 | 0.872 |
| SECONDARY Change From Baseline to Endpoint in the Spontaneity Domain of PAIRS |
3.06; 3.07; 3.07; 0.10; -0.05; 0.07 | <0.001 sig |
| SECONDARY Change From Baseline to Endpoint in the Time Concerns Domain of PAIRS |
2.43; 2.42; 2.42; -0.30; 0.00; -0.17 | <0.001 sig |
| SECONDARY Change From Baseline to Endpoint in the Erectile Function Domain of the International Index of Erectile Function (IIEF) |
15.60; 15.40; 15.55; 8.68; 9.70; 9.54 | 0.004 sig |
| SECONDARY Change From Baseline to Endpoint in the Proportion of Days With at Least One Morning Erection |
0.28; 0.28; 0.27; 0.26; 0.20; 0.11 | <0.001 sig |
| SECONDARY Change From Baseline to Endpoint in the Intercourse Satisfaction (IS) Domain of the IIEF |
8.35; 8.34; 8.37; 3.33; 3.99; 3.83 | <0.001 sig |
| SECONDARY Change From Baseline to Endpoint in the Overall Satisfaction (OS) Domain of the IIEF |
5.26; 5.22; 5.27; 2.60; 2.87; 2.84 | 0.055 |
| SECONDARY Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Score at Endpoint |
75.81; 75.68; 79.50 | 0.004 sig |
| SECONDARY Number of Participants With at Least One Serious Adverse Event |
4; 5; 2 | — |
| SECONDARY Change From Baseline to Endpoint in the Self-Esteem And Relationship (SEAR) Questionnaire Transformed Total Score |
50.28; 50.50; 50.69; 22.94; 22.87; 24.13 | 0.915 |
| SECONDARY Question 1 "I Felt as if I Did Not Have ED" Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint |
1.83; 1.78; 1.77 | 0.403 |
| SECONDARY Question 2 "I Felt in Control of my Sex Life" Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint |
2.33; 2.14; 2.36 | 0.002 sig |
| SECONDARY Question 3 "I Felt the Drug Was in Control of my Erections" Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint |
1.99; 2.28; 2.50 | <0.001 sig |
| SECONDARY Question 4 "I Felt Like a Whole Man" Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint |
2.53; 2.57; 2.44 | 0.070 |
Eligibility Criteria
Inclusion Criteria
- History of erectile dysfunction (ED).
- Have had satisfactory response to tadalafil, sildenafil citrate, or vardenafil HCl for a period of at least 6 months and expect frequent use (at least one dose per week, on average) when administered as needed.
- Have never used tadalafil 5 mg or 2.5 mg once a day therapy.
- Anticipate having the same adult female sexual partner willing to participate during the study.
- Agree to make at least four sexual intercourse attempts during the first four weeks of the study.
- Agree not to use any other treatment for ED (even herbal treatments) during the study.
- Agree to follow the directions given by the study doctor and staff about using the study drug.
Exclusion Criteria
- Have any other primary sexual disorders present or penile deformity.
- Have history of radical prostatectomy or penile implant.
- Have problems with your kidneys, liver, or nervous system.
- Have uncontrolled diabetes, as measured by a blood test for haemoglobin A1C greater than a value of 11%.
- Are being treated for heart disease with any drug that is called a nitrate (for example, nitroglycerin).
- Have chest pain (called unstable angina or angina) that requires treatment.
- Have heart disease that causes symptoms after you exert yourself.
- Have had any of the following in the past 90 days: Heart attack, also known as a myocardial infarction (MI); Heart bypass surgery (called coronary artery bypass graft surgery); Had a procedure to open up blood vessels in the heart known as angioplasty or stent placement (percutaneous coronary intervention).
- Have a history of loss of vision in one eye because of nonarteritic anterior ischemic optic neuropathy (NAION).
- Have retinitis pigmentosa.
- Have history of human immunodeficiency virus (HIV).
- Have very high or very low blood pressure (your study doctor will discuss the limits with you).
- Have had a stroke or a significant injury to your brain or spinal cord within the last 6 months.
- Have rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption Lactose intolerance.
- Have a scheduled or planned surgery requiring anaesthesia during the course of the study.
- Have a scheduled cataract surgery during the curse of the study.
Data sourced from ClinicalTrials.gov (NCT00734604). 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. Informational only — not medical advice.