Phase 3
Completed N=217
Effect of Tadalafil Once a Day in Men With Erectile Dysfunction
Source: ClinicalTrials.gov NCT00836693 ↗Enrolled (actual)
217
Serious AEs
1.4%
Results posted
Jan 2011
Primary outcomePrimary: Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 12 — 15.5; 16.0; 7.3; 3.3 units on a scale — p=<0.001
Summary
The primary aim of this study is to assess the efficacy and safety of tadalafil 5 mg administered once a day in patients with erectile dysfunction (ED) who are naïve to PDE5 (phosphodiesterase type 5) inhibitors. Patients may be dose reduced to 2.5mg based on tolerability.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 12 |
15.5; 16.0; 7.3; 3.3 | <0.001 sig |
| PRIMARY Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at Week 12 in Percentage of Yes Responses |
60.1; 59.9; 23.2; 11.6 | <0.001 sig |
| PRIMARY Sexual Encounter Profile (SEP) Diary, Question 3 Change From Baseline to Week 12 in Percentage of Yes Responses |
28.2; 32.2; 39.4; 19.3 | <0.001 sig |
| SECONDARY Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Number of Erectile Events Per Night |
2.75; 2.44; -0.11; -0.09 | — |
| SECONDARY Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Duration of Erectile Events Per Night |
28.487; 26.372; -1.553; -0.398 | — |
| SECONDARY Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Percentage Volumetric Change |
-5.96; -50.30 | — |
| SECONDARY Change From Baseline to 12 Week Endpoint in the Frequency of Spontaneous Morning Erections Captured by Patient Diary |
31.0; 28.9; 27.5; 11.9 | <0.001 sig |
| SECONDARY The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire at 12 Week Endpoint |
72.8; 52.7 | >0.001 |
| SECONDARY Change From Baseline to 12 Week Endpoint in Total and Subdomain Scores of the Self-Esteem and Relationship (SEAR) Questionnaire |
47.3; 47.9; 20.4; 8.3; 43.0; 43.9 | <0.001 sig |
| SECONDARY Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Orgasmic Functions (OF) |
6.5; 7.2; 2.0; 0.5 | <0.001 sig |
| SECONDARY Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Sexual Desire (SD) |
6.7; 6.6; 0.5; -0.1 | 0.0089 sig |
| SECONDARY Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Intercourse Satisfaction (IS) |
8.2; 7.6; 2.1; 1.5 | 0.0461 sig |
| SECONDARY Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Overall Satisfaction (OS) |
5.2; 5.1; 2.0; 0.8 | <0.001 sig |
| SECONDARY Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 1 Percentage of "Yes" Responses |
80.8; 74.2; 12.5; 9.5 | 0.0047 sig |
| SECONDARY Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 4 Percentage of "Yes" Responses |
11.7; 14.6; 44.1; 18.3 | <0.001 sig |
| SECONDARY Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 5 Percentage of "Yes" Responses |
10.3; 12.9; 43.2; 18.5 | <0.001 sig |
| SECONDARY Global Assessment Question (GAQ) Question 1 at 12 Week Endpoint |
49; 7; 41; 8; 29; 19 | <0.0001 sig |
| SECONDARY Global Assessment Question (GAQ) Question 2 at 12 Week Endpoint |
40; 5; 49; 11; 28; 17 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- You are male and aged at least 18 years.
- Have a history of erectile dysfunction (ED)(defined as the consistent inability to achieve and/or maintain an erection sufficient to permit satisfactory sexual intercourse) of at least 3 months duration.
- Agree not to use any other treatment for ED, including herbal and over-the-counter (OTC) medications, during the study
- You agree to make at least four sexual intercourse attempts with the female sexual study partner during the 4-week run-in period without medication
- Your entry laboratory test results and medical tests meet study requirements
- You agree to use the study drug only as instructed by your study doctor and staff and to return any unused study drug and containers at the end of the study or as otherwise instructed by the study doctor.
- If currently using cholesterol lowering medications (for example: statins) or medications to lower blood pressure (example: angiotensin-converting enzyme (ACE) inhibitors or calcium channel blocker medications), you need to be on a stable dose and you and your study doctor do not expect any dose change during the study.
Exclusion Criteria
- You have received previous or current treatment with tadalafil or any other PDE5 inhibitor.
- Currently receives treatment with doxazosin, nitrates, cancer chemotherapy, or anti-androgens (except finasteride e.g. Propecia™ or Proscar®, or dutasteride e.g. Avodart®).
- You have had significant heart disease as determined by your doctor in charge of this study or a member of the doctor's staff.
- Have a history of significant central nervous system injuries (including stroke or spinal cord injury) within the last 6 months.
- Have a history of loss of vision in one eye because of nonarteritic anterior ischemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure.
Data sourced from ClinicalTrials.gov (NCT00836693). 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.