Phase 4
Completed N=770
A Study in Patients With Erectile Dysfunction
Source: ClinicalTrials.gov NCT01122264 ↗Enrolled (actual)
770
Serious AEs
1.8%
Results posted
Oct 2012
Primary outcomePrimary: Time to Discontinuation of Randomized Treatment — NA; 130; 67 days — p=<0.001
Summary
The purpose of this study is to investigate if treatment in erectile dysfunction with a long-acting drug (Tadalafil) taken once a day or taken as needed results in a longer treatment adherence and better long term outcomes (over 24 weeks), compared with a short-acting drug (Sildenafil Citrate) taken as needed.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Discontinuation of Randomized Treatment |
NA; 130; 67 | <0.001 sig |
| SECONDARY Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Erectile Function (EF) Domain |
7.92; 8.60; 8.86; 8.98; 9.08; 9.70 | — |
| SECONDARY Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Orgasmic Function Domain |
1.64; 1.75; 1.92; 1.77; 2.08; 2.26 | — |
| SECONDARY Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Sexual Desire Domain |
0.77; 0.75; 0.69; 0.96; 0.90; 0.87 | — |
| SECONDARY Change From Baseline to 4, 8, 16 and 24 Weeks of the Sexual Encounter Profile (SEP) |
14.50; 18.49; 18.41; 16.62; 19.88; 20.41 | — |
| SECONDARY Global Assessment Questions (GAQ) |
218; 219; 203; 20; 23; 34 | — |
| SECONDARY Number of Treatment Switches |
1.2; 1.2; 1.3 | — |
| SECONDARY Patterns of Erectile Dysfunction Treatment Change |
3; 409; 95; 84; 97; 35 | — |
| SECONDARY Reasons for Discontinuation of Randomized Erectile Dysfunction Treatment |
5; 9; 10; 1; 1; 1 | — |
| SECONDARY Number of Days From the 8-Week Study Visit to the Time the Participant Discontinues From All Phosphodiesterase Type 5 (PDE5) Inhibitor Treatments |
NA; NA; 187 | — |
| SECONDARY Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Intercourse Satisfaction Domain |
3.21; 3.22; 3.53; 3.69; 3.15; 3.95 | — |
| SECONDARY Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Overall Satisfaction Domain |
2.46; 2.58; 2.72; 2.80; 2.85; 2.98 | — |
| SECONDARY Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire at 4, 8, 16, and 24 Weeks |
72.36; 75.20; 71.98; 75.28; 76.64; 72.74 | — |
| SECONDARY Change From Baseline to 24 Week Endpoint of the Sexual Self-Confidence, Spontaneity, and Time Concerns Domains (23-items) of the Psychological and Interpersonal Relationships Scale (PAIRS) |
0.93; 0.90; 0.73; 0.13; 0.11; 0.02 | — |
| SECONDARY Change From Baseline to 4, 8, 16, and 24 Weeks of the Sexual Relationship Domain of the Self-Esteem and Relationship (SEAR) Questionnaire |
27.65; 29.26; 29.50; 31.42; 31.07; 31.15 | — |
| SECONDARY Change From Baseline to 4, 8, 16, and 24 Weeks of the Confidence Domain of the Self-Esteem and Relationship (SEAR) Questionnaire |
23.43; 23.04; 25.03; 26.97; 26.10; 27.14 | — |
| SECONDARY Change From Baseline to 4, 8, 16, and 24 Weeks of the Self Esteem Domain of the Self-Esteem and Relationship (SEAR) Questionnaire |
25.18; 24.10; 26.59; 29.14; 27.80; 28.92 | — |
| SECONDARY Change From Baseline to 4, 8, 16, and 24 Weeks of the Overall Relationship Domain of the Self-Esteem and Relationship (SEAR) Questionnaire |
19.92; 21.10; 22.00; 22.75; 22.96; 23.74 | — |
Eligibility Criteria
Inclusion Criteria
- History of Erectile Dysfunction (ED) of at least 3 months duration.
- Anticipate having the same adult female sexual partner during the study.
- Agree not to use any other treatment for ED and to participate in recording responses to questionnaires and other instruments used in this study.
Exclusion Criteria
- Previous or current treatment with tadalafil or any other phosphodiesterase type 5 (PDE5) inhibitor.
- ED caused by other primary sexual disorders, history of radical prostatectomy or other pelvic surgery with subsequent failure to achieve any erection, or history of penile implant or clinically significant penile deformity.
- ED caused by untreated or inadequately treated endocrine disease.
- Current treatment with doxazosin, nitrates, cancer chemotherapy, or anti-androgens.
- Severe renal or hepatic impairment, history of malignant hypertension.
- Presence or history of specific heart conditions.
Data sourced from ClinicalTrials.gov (NCT01122264). 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.