Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tamsulosin · 4 trials · 4 indications
IPSS Total Score is the sum of Questions 1 through 7 of the IPSS questionnaire. Each question was scored from 0 (none/no symptoms) to 5 (frequent symptoms) for an IPSS Total Score ranging from 0 to 35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis mixed model for repeated measures (MMRM).The model includes effects for treatment, country/region, prior alpha-blocker therapy, baseline Erectile dysfunction (ED) severity (mild/moderate/severe),visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment.The centered baseline-by-treatment and treatment-by-country interactions was removed if p \>= 0.10.
The IPSS Total Score was obtained by combining the scores of the responses to Component Questions 1-7. Each question was scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represented greater severity of symptoms. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.
The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least Squares Mean values were controlled for prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan) and baseline value.
The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks. |
| 5 mg Tadalafil | EXPERIMENTAL | Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period. Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period |
| 0.2 mg Tamsulosin | OTHER | Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period. Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period |
| Tadalafil 5 milligram (mg) | EXPERIMENTAL | Tadalafil 5 mg tablet po QD and placebo capsule po QD for 12 weeks |
| Tamsulosin 0.4 mg | ACTIVE_COMPARATOR | Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks |
| 2.5 mg Tadalafil | EXPERIMENTAL | - |
| 5.0 mg Tadalafil | EXPERIMENTAL | - |
| Tadalafil | EXPERIMENTAL | - |
| Tamsulosin | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| 5 mg Tadalafil | DRUG | Administered orally |
| Placebo | DRUG | Administered orally |
| 0.2 mg Tamsulosin | DRUG | Administered orally |
| Tadalafil 5 mg | DRUG | Tadalafil 5 mg po QD for 12 weeks |
| Placebo tablet | DRUG | Placebo tablet po QD for 12 weeks |
| Tamsulosin | DRUG | Tamsulosin 0.4 mg po QD for 12 weeks |
| Placebo capsule | DRUG | Placebo capsule po QD for 12 weeks |
| Tadalafil | DRUG | by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks |
Main Inclusion Criteria: * Present with a history of ED and signs and symptoms of BPH. * Are sexually active with an adult female partner, and expect to remain sexually active with the same adult female partner for the duration of the study. Main Exclusion Criteria: * Current treatment with nitra...
Tamsulosin is used for benign prostatic hyperplasia (BPH), also called benign prostate hyperplasia, a condition in which the prostate gland is enlarged. It is being studied in men with signs and symptoms of BPH, and in one trial it was evaluated in men with both BPH and erectile dysfunction.
Tamsulosin is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The company is conducting clinical trials to evaluate the drug for the treatment of benign prostatic hyperplasia.
Tamsulosin is in Phase 3 clinical development. It is an investigational small molecule being studied for benign prostatic hyperplasia. The drug is not yet approved, and it remains in clinical trials to assess its safety and efficacy in men with this condition.
Tamsulosin has been studied in several clinical trials, including NCT00540124, a Phase 2 pilot study in South Korea, and NCT00861757, a Phase 3 study in Japan and Taiwan. Other trials include NCT00970632 and NCT01937871, both Phase 3 studies in multiple countries.
No, Tamsulosin is not the same as Tadalafil. Tamsulosin is an alpha-blocker used for benign prostatic hyperplasia, while Tadalafil is a PDE5 inhibitor. However, the clinical trials listed for Tamsulosin actually evaluate Tadalafil, indicating a potential mix-up in the data.