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ALFUZOSIN · 9 trials · 11 indications
The International Index of Erectile Function (IIEF) is used for the evaluation of male sexual function and diagnostic evaluation of Erectile Dysfunction (ED) severity. There are 5 domains of the IIEF: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. The Erectile Function (EF) domain of the IIEF is used to assess specific key components of ED including ability to achieve penetration and ability to maintain erection sufficient for satisfactory sexual performance. A score of 0-5 is awarded to each question of the IIEF. The EF domain pertains to questions 1, 2, 3, 4, 5, and 15. Scores are totaled and ranges are assigned to results. In the EF domain, a score of 0-30 is possible. The EF scores can be interpreted as follows: 0-6 severe dysfunction, 7-12 moderate dysfunction, 13-18 mild to moderate dysfunction, 19-24 mild dysfunction, and 25-30 no dysfunction.
Hydronephrosis was investigated by ultrasound and graded using SFU classification at each time point. 'Complete response' was assessed when bilateral hydronephrosis at baseline and grade decrease from baseline ≥ 1 for both kidneys, or, unilateral hydronephrosis at baseline and grade decrease from baseline ≥ 1 for the affected kidney without worsening of the other kidney. 'Partial response' was assessed when bilateral hydronephrosis at baseline and grade decrease from baseline ≥ 1 for one kidney without worsening of the other kidney.
Detrusor Leak Point Pressure (LPP) was measured by cystometry. For each measure, 2 or 3 cystometries were carried out depending on the difference between the 2 first LPP values (if the difference ≥ 20 cm H2O, a 3rd cystometry was done). The lowest value was retained. Investigators reading was then consolidated by the review of all cystometry data by 2 external "Expert Reviewers", who were blinded for the study treatment. The analysis was performed on consolidated investigators data (i.e. endorsed by the Investigator taking into account reviewers opinion).
| Arm | Type | Description |
|---|---|---|
| Placebo, Then Alfuzosin | PLACEBO_COMPARATOR | Participants first received 1 Placebo tablet once daily for 12 weeks. Participants then received a 10 mg tablet of Alfuzosin daily for 12 weeks. |
| Alfuzosin, Then Placebo | EXPERIMENTAL | Participants first received a 10 mg tablet of Alfuzosin once daily for 12 weeks. Participants then received 1 Placebo tablet once daily for 12 weeks. |
| Alfuzosin solution - 2-7 years | EXPERIMENTAL | Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children 2-7 years of age. |
| Alfuzosin solution - 8-16 years | EXPERIMENTAL | Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children and adolescents 8-16 years of age who were not able to swallow tablets or preferred to take the solution or had a body weight \< 30 kg. |
| Alfuzosin tablet - 8-16 years | EXPERIMENTAL | Alfuzosin tablet, daily dose divided in 2 doses given at breakfast and dinner to children and adolescents 8-16 years of age who were able to swallow tablets and had a body weight ≥ 30 kg. |
| Placebo | PLACEBO_COMPARATOR | Matching placebo 0.1 mg/kg/day or 0.2 mg/kg/day |
| Alfuzosin 0.1 mg/kg/day | EXPERIMENTAL | - |
| Alfuzosin 0.2 mg/kg/day | EXPERIMENTAL | - |
| 1 | ACTIVE_COMPARATOR | Alfuzosin 10mg |
| 2 | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Alfuzosin-matched One tablet once daily |
| Alfuzosin | DRUG | 10 mg once daily |
| alfuzosin (SL770499) | DRUG | - |
Inclusion Criteria: * Male, 30-69 years of age * Has mild to moderate Erectile Dysfunction with a score \< 25 on EF domain in IIEF * AUA score of less than or equal to 14 * Negative urinalysis with no evidence of a Urinary Tract Infection Exclusion Criteria: * Blood pressure \< 90/50 or \> 170/11...
| 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 |
ALFUZOSIN is used for urologic conditions including acute urinary retention, hydronephrosis, neurogenic urinary bladder, prostatic hyperplasia, urinary retention, and benign prostatic hyperplasia. It is being studied in clinical trials for these indications, primarily in male patients with lower urinary tract symptoms.
ALFUZOSIN is a small molecule developed by Sanofi. It is an alpha-blocker that works by relaxing smooth muscle in the prostate and bladder neck to improve urine flow. The drug targets alpha-1 adrenergic receptors, which are involved in controlling muscle tone in these areas.
ALFUZOSIN is developed by Sanofi, a global pharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is conducting clinical trials to evaluate the drug's efficacy and safety for various urological conditions.
ALFUZOSIN is in Phase 3 clinical development. It has completed two Phase 3 trials and two Phase 2 trials, with a total enrollment of 1,977 participants. The drug is investigational and has not been approved by regulatory authorities.
ALFUZOSIN has completed four clinical trials. NCT00336921 studied acute urinary retention in China. NCT00540891 evaluated benign prostatic hyperplasia in the United States. NCT00549939 and NCT00576823 assessed neurogenic urinary bladder and hydronephrosis in children and adolescents across multiple countries.
ALFUZOSIN is the generic name for the drug, and it is also known as alfuzosin hydrochloride. The drug is being developed by Sanofi for urological conditions such as benign prostatic hyperplasia and urinary retention.