Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as tadalafil once a day [T(OaD)]
tadalafil once a day · 1 trial · 1 indication
The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Sexual Self-Confidence score is the average of responses on 6 PAIRS item scores. Sexual Self-Confidence scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater sexual self-confidence.
| Arm | Type | Description |
|---|---|---|
| T(OaD)/S(PRN)/T(PRN) | EXPERIMENTAL | Tadalafil 5 mg once a day \[T(OaD)\] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed \[S(PRN)\] for 8 weeks, 1 week washout, tadalafil 20 mg as needed \[T(PRN)\] for 8 weeks |
| T(OaD)/T(PRN)/S(PRN) | EXPERIMENTAL | Tadalafil 5 mg once a day \[T(OaD)\] for 8 weeks, 1 week washout, tadalafil 20 mg as needed \[T(PRN)\] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed \[S(PRN)\] for 8 weeks |
| S(PRN)/T(OaD)/T(PRN) | EXPERIMENTAL | Sildenafil citrate 100 mg as needed \[S(PRN)\] for 8 weeks, 1 week washout, tadalafil 5 mg once a day \[T(OaD)\] for 8 weeks, 1 week washout, tadalafil 20 mg as needed \[T(PRN)\] for 8 weeks |
| S(PRN)/T(PRN)/T(OaD) | EXPERIMENTAL | Sildenafil citrate 100 mg as needed \[S(PRN)\] for 8 weeks, 1 week washout, tadalafil 20 mg as needed \[T(PRN)\] for 8 weeks, 1 week washout, tadalafil 5 mg once a day \[T(OaD)\] for 8 weeks |
| T(PRN)/T(OaD)/S(PRN) | EXPERIMENTAL | Tadalafil 20 mg as needed \[T(PRN)\] for 8 weeks, 1 week washout, tadalafil 5 mg once a day \[T(OaD)\] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed \[S(PRN)\] for 8 weeks |
| T(PRN)/S(PRN)/T(OaD) | EXPERIMENTAL | Tadalafil 20 mg as needed \[T(PRN)\] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed \[S(PRN)\] for 8 weeks, 1 week washout, tadalafil 5 mg once a day \[T(OaD)\] for 8 weeks |
| Name | Type | Description |
|---|---|---|
| tadalafil once a day [T(OaD)] | DRUG | 5 mg tablet taken once a day (OaD) by mouth for 8 weeks |
| sildenafil citrate as needed [S(PRN)] | DRUG | 100 mg tablet taken as needed (PRN) by mouth for 8 weeks |
| tadalafil as needed [T(PRN)] | DRUG | 20 mg tablet taken as needed (PRN) by mouth for 8 weeks |
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 tadalafi...