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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...
Top 1 of 6 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Medicus Pharma Ltd | MDCX | 1 | PHASE2 | Teverelix DP |
Dutasteride once daily for 4 years is a treatment regimen for benign prostatic hyperplasia, also called prostatic hyperplasia, an enlargement of the prostate gland in men. The four-year duration refers to the long-term dosing period studied in a Phase 3 clinical trial in men aged 50 years and older with this condition.
Dutasteride targets the enzymes SRD5A1, SRD5A2, and SRD5A3, which are 5-alpha reductase isoenzymes. It acts as an inhibitor of these targets. By inhibiting all three isoenzymes, the drug blocks conversion of testosterone to dihydrotestosterone, the androgen that drives prostate growth in benign prostatic hyperplasia.
GSK plc, which trades under the ticker GSK, is the developer of dutasteride once daily for 4 years. The company sponsored the Phase 3 clinical program evaluating this four-year dosing regimen in men with prostatic hyperplasia.
Dutasteride once daily for 4 years has been studied in Phase 3 clinical development. It is an investigational long-term dosing regimen rather than a separately approved product, and the Phase 3 trial supporting this four-year regimen has been completed.
The regimen was evaluated in the Phase 3 trial NCT00090103, titled Benign Prostatic Hyperplasia Trial With Dutasteride And Tamsulosin Combination Treatment. That completed trial enrolled 4,844 men aged 50 years and older across 37 countries. It was randomized, double-blind, and active-controlled, and it did not select patients by biomarker.