Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01160289 | A Study of LY900010 in Erectile Dysfunction | PHASE2 | COMPLETED | 410 | — | — | Oct 1, 2010 | Nov 1, 2011 | Apr 9, 2019 | 36 | United States |
| NCT01401543 | A Bioavailability Study of LY2452473 and Tadalafil | PHASE1 | COMPLETED | 24 | — | — | Jul 1, 2011 | Sep 1, 2011 | Jun 14, 2019 | 1 | United States |
The IIEF EF domain score was the sum of Questions (Q) 1 to Q5 and Q15 of the IIEF self-reported questionnaire. Q1 to Q5 were rated 0 (low/no EF) to 5 (high EF) and Q15 was rated 1 (no/low confidence) to 5 (high confidence). IIEF EF domain scores ranged from 1 to 30. Higher scores denoted better EF.
| Arm | Type | Description |
|---|---|---|
| 1 milligram (mg) LY2452473 + 5 mg tadalafil | EXPERIMENTAL | - |
| 5 mg LY2452473 + 5 mg tadalafil | EXPERIMENTAL | - |
| 5 mg LY2452473 + placebo | EXPERIMENTAL | - |
| 10 mg tadalafil + placebo | ACTIVE_COMPARATOR | - |
| 5 mg tadalafil + placebo | ACTIVE_COMPARATOR | - |
| LY900010 (particle size #1) | EXPERIMENTAL | Single combination tablet containing 5 mg tadalafil and 5 mg LY2452473 with a smaller particle size (d90 = 10 microns), administered orally, once only. There will be a washout period of at least 7 days between doses of study drug. d90 is a measurement of the distribution of particle widths such that 90% of the particles have a diameter less than the specified value. |
| LY900010 (particle size #2) | EXPERIMENTAL | Single combination tablet containing 5 mg tadalafil and 5 mg LY2452473 with an intermediate particle size (d90 = 25 microns), administered orally, once only. There will be a washout period of at least 7 days between doses of study drug. d90 is a measurement of the distribution of particle widths such that 90% of the particles have a diameter less than the specified value. |
| LY900010 (particle size #3) | EXPERIMENTAL | Single combination tablet containing 5 mg tadalafil and 5 mg LY2452473 with a larger particle size (d90 = 40 microns), administered orally, once only. There will be a washout period of at least 7 days between doses of study drug. d90 is a measurement of the distribution of particle widths such that 90% of the particles have a diameter less than the specified value. |
| Name | Type | Description |
|---|---|---|
| LY2452473 | DRUG | Administered orally, once daily for 12 weeks |
| tadalafil | DRUG | Administered orally, once daily for 12 weeks |
| placebo (tadalafil) | DRUG | Administered orally, once daily for 12 weeks |
| placebo (LY2452473) | DRUG | Administered orally, once daily for 12 weeks |
| LY900010 | DRUG | Administered orally |
Inclusion Criteria include: * Ambulatory men * History of erectile dysfunction of at least 3 months duration * History of incomplete response to any phosphodiesterase type 5 inhibitor (PDE5i) at the maximum tolerated dose within the label * Anticipate having the same female sexual partner throughou...