Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
dutasteride once daily for 4 years · 1 trial · 1 indication
A participant was considered to have AUR when he was unable to urinate and required bladder catheterization. BPH is also known as an enlarged prostate. When symptoms of BPH become bothersome, surgery may be required. When events of AUR and BPH-related surgery were participant-reported or identified, they were recorded in the participants' clinic record.
A participant was considered to have AUR when he was unable to urinate and required bladder catheterization. BPH is also known as an enlarged prostate. When symptoms of BPH become bothersome, surgery may be required. When events of AUR and BPH-related surgery were participant reported or identified, they were recorded in the participants' clinic record.
| Arm | Type | Description |
|---|---|---|
| dutasteride | ACTIVE_COMPARATOR | dutasteride 0.5mg once daily |
| Combo | EXPERIMENTAL | Combination of dutasteride (0.5mg) and tamsulosin (0.4mg), once daily |
| tamsulosin | ACTIVE_COMPARATOR | tamsulosin 0.4mg once daily |
| Name | Type | Description |
|---|---|---|
| dutasteride 0.5mg once daily for 4 years | DRUG | combination or single agent |
| tamsulosin 0.4mg once daily for 4 years | DRUG | combination agent or single agent |
Inclusion criteria: * A subject will be considered eligible for inclusion in this study only if all of the following criteria apply: * males, aged ≥50 years * clinical diagnosis of BPH by medical history and physical examination, including a digital rectal examination (DRE) * International Prostate...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Boston Scientific Corporation | BSX | 2 | - | Undisclosed |
| PROCEPT BioRobotics Corp. | PRCT | 2 | N/A | Undisclosed |
| EDAP TMS SA Sponsored ADR | EDAP | 1 | N/A | Undisclosed |
| Profound Medical Corp | PROF | 1 | - | Undisclosed |
Dutasteride once daily for 4 years is used for the treatment of Prostatic Hyperplasia, also known as benign prostatic hyperplasia (BPH). It is a small molecule being developed by GSK plc for this condition. The drug is administered once daily over a four-year treatment period.
Dutasteride targets the enzyme 5-alpha-reductase, which converts testosterone to dihydrotestosterone (DHT) in the prostate. By inhibiting this enzyme, dutasteride reduces DHT levels, which helps to shrink the prostate and relieve symptoms of Prostatic Hyperplasia.
Dutasteride once daily for 4 years is developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug for the treatment of Prostatic Hyperplasia.
Dutasteride once daily for 4 years is in Phase 3 clinical development for Prostatic Hyperplasia. It is an investigational drug and has not yet been approved by regulatory authorities. One Phase 3 trial has been completed, with no active trials currently ongoing.
Dutasteride once daily for 4 years has been studied in one completed Phase 3 clinical trial, identified as NCT00090103. This trial, titled 'Benign Prostatic Hyperplasia Trial With Dutasteride And Tamsulosin Combination Treatment,' enrolled 4,844 male participants aged 50 years and older across multiple countries.
Dutasteride once daily for 4 years refers to a specific dosing regimen of dutasteride, a medication used to treat Prostatic Hyperplasia. The drug is being evaluated for its efficacy and safety when taken once daily over a four-year period, as studied in clinical trials.