Approval Probability
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ML Risk
LY2452473 · 3 trials · 2 indications
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. |
| LY2452473 | EXPERIMENTAL | 15 mg, containing 100 micro curies of 14C labeled LY2452473 taken once only |
| 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...
LY2452473 is an investigational small molecule being studied for erectile dysfunction. It has been evaluated in clinical trials enrolling men with erectile dysfunction, as well as in healthy volunteer studies to assess drug disposition and bioavailability. The drug is in Phase 2 development.
LY2452473 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker LLY. The company has sponsored clinical trials of the drug in the United States.
LY2452473 is in Phase 2 clinical development. It has completed two Phase 1 trials and one Phase 2 trial. The drug is investigational and has not been approved by regulatory authorities.
LY2452473 has been studied in three completed trials: NCT01160289, a Phase 2 study in erectile dysfunction with 410 participants; NCT01275157, a Phase 1 disposition study in healthy volunteers with 6 participants; and NCT01401543, a Phase 1 bioavailability study with 24 participants.
LY2452473 is associated with the name LY900010, which appears in the title of one of its clinical trials, NCT01160289. This trial is described as a study of LY900010 in erectile dysfunction, indicating the two names may refer to the same compound.