Benign Prostatic Hyperplasia
Conditions
Brief summary
The purpose of this study is: * To assess safety of Afalaza drug within 12 months in patients with symptoms of benign prostatic hyperplasia (BPH) and risk of progression. * To assess efficacy of Afalaza drug within 12 months in patients with symptoms of benign prostatic hyperplasia and risk of progression.
Interventions
DRUGAfalaza
Safety and Efficacy
DRUGPlacebo
Safety and Efficacy
Sponsors
Materia Medica Holding
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
45 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Male patients 45 to 60 y.o. inclusive with a documented diagnosis of Benign prostatic hyperplasia. 2. Lower urinary tract symptoms (LUTS) having been experienced for 3 months and longer. 3. Total IPSS score (International Prostate Symptome Score) of 8 to 15. 4. Prostate volume of more than 30 cm3. 5. Maximal urinary flow rate of 10-15 mL/sec. 6. Micturition volume of 125-350 mL. 7. Residual volume of less than 100 mL. 8. Serum prostate-specific antigen (PSA) level of less than 4 ng/mL. 9. Use of and compliance with contraceptive methods during the trial and for 30 days upon completion of participation in the trial. 10. Presence of the patient's information sheet (informed consent form) for participation in the clinical trial.
Exclusion criteria
1. Invasive therapies for BPH including a transurethral prostatic resection, thermotherapy, microwave therapy, transurethral needle ablation, stenting, etc. 2. Malignant oncological disease of the urogenital system as well as malignancies of any other localization during last 5 years. 3. Acute urinary retention (AUR) within 3 months before inclusion in the trial. 4. Neurogenic dysfunctions and bladder ears. 5. Urinary stone disease. 6. Urethral stricture, bladder neck sclerosis. 7. History of operative aids for pelvic organs. 8. Urogenital infections in the phase of active inflammation. 9. Systematic administration of agents exhibiting effects on bladder function and urine production. 10. Exacerbation or decompensation of chronic diseases affecting the possibility of patients to participate in the clinical trial, including severe concurrent cardiovascular conditions and disorders of the nervous system, renal and hepatic insufficiency. 11. History of administration of testosterone 5-alpha-reductase inhibitors (finasteride, dutasteride). 12. History of polyvalent allergy. 13. Allergy/intolerance to any component of drug agents used in the therapy. 14. Malabsorption syndrome, including congenital or acquired lactase or other disaccharidase deficiency. 15. Administration of drugs specified as Prohibited concomitant therapy, within 3 months before enrollment. 16. Exacerbation or decompensation of chronic diseases affecting the possibility of patients to participate in the clinical trial. 17. Drug and alcohol consumption (over 2 alc. units daily), mental diseases. Legal incapacity or limited legal capacity. 18. Legal incapacitation or limited legal capacity. 19. Patients, who, in the investigator's opinion, will fail to observe the requirements during the trial or adhere to the studied drug administration procedure. 20. Participation in other clinical trials within 3 months before enrolment in this trial. 21. Presence of other factors, complicating the patient's participation in the trial (e.g., planned lengthy business and other trips). 22. A patient is a part of the center's research staff, taking a direct part in the trial, or an immediate family member of the investigator. Immediate family members are defined as spouses, parents, children or siblings, regardless of whether full blood or adopted. 23. The patient is employed with Scientific Production Firm Materia Medica Holding LLC, i.e. is the company's employee, part-time employee under contract, or appointed official in charge of the trial, or their immediate family.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total IPSS Scores (International Prostate Symptome Score) After 1, 3, 6 and 12 Months Compared to Baseline. | Baseline, 1, 3, 6 and 12 months | The International Prostate Symptom Score (IPSS) is based on the answers to 7 questions concerning urinary symptoms plus one question concerning quality of life (QoL). Each of the seven symptoms includes the assignment of scores from 0 to 5. The total score can therefore range from 0 to 35 points (asymptomatic to very symptomatic). The patient's quality of life (QoL) was evaluated separately in this clinical study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Maximum Urinary Flow Rate After 1, 3, 6 and 12 Months Compared to Baseline | Baseline and 1, 3, 6 and 12 months | — |
| Change in Average Urinary Flow Rate After 1, 3, 6 and 12 Months Compared to Baseline | Baseline and 1, 3, 6 and 12 months | — |
| Percent Change in Mean Values of Prostate Gland Volume at 3, 6 and 12 Months Compared to Baseline | Baseline and 3, 6 and 12 months | Change in the volume of the prostate gland as a percentage of the baseline according to transrectal ultrasound |
| Change in Mean Values of Micturition Volume at 3, 6 and 12 Months Compared to Baseline | Baseline and 3, 6 and 12 months | — |
| Change in Dynamics of Irritative Symptoms Evaluated by IPSS (International Prostate Symptome Score) After 1, 3, 6 and 12 Months Compared to Baseline | Baseline and 1, 3, 6, 12 months | The International Prostate Symptom Score (IPSS) is based on the answers to 7 questions concerning urinary symptoms plus one question concerning quality of life (QoL). Each of the seven symptoms includes the assignment of scores from 0 to 5. The total score can therefore range from 0 to 35 points (asymptomatic to very symptomatic). The patient's quality of life (QoL) was evaluated separately in this clinical study. The sum of IPSS questions 2, 4, and 7 related to irritative symptoms. The total score of irritative symptoms can therefore range from 0 to 15 points (asymptomatic to very symptomatic). |
| Change in Quality of Life (QoL Index of IPSS) at 3, 6 and 12 Months Compared to Baseline | Baseline and 3, 6 and 12 months | Quality of life (QoL) Due to Urinary Symptoms is an eight point of the IPSS scale referred to the patient's quality of life. The answers to this question range from delighted to terrible or 0 to 5. |
| Change in Total Value of Risk Factors for Progression (Total Score of IPSS, Prostate Volume, PSA Level, Maximum Urinary Flow Rate, Residual Urine Volume) Compared to Baseline | Baseline and 3, 6 and 12 months | To assess the risk of BPH progression, the following were used: 1) moderate to severe BPH symptoms (ie, IPSS total score\> 7); 2) an increase in the volume of the prostate gland (\> 30 cm\^2); 3) increased PSA level in the blood (≥ 1.4 ng / ml); 4) a decrease in Qmax (\<12 ml / s) and 5) a large volume of residual urine (\> 200 ml). The total value of risk factors for progression is assessed as the sum of the risk factors that the patient had at the time of inclusion in the study (presence of risk factors = 1 point, absence = 0 points). After 3, 6 and 12 months of treatment, the dynamics of risk factors for progression was assessed: an increase in the severity of the risk factor meant +1, no change = 0, a decrease in the severity of the risk factor of -1. |
| Number of Episodes of Acute Urinary Retention, Surgical Intervention During the Observation Period | 12 months | — |
| Change in the Mean Values of Residual Urine Volume at 3, 6 and 12 Months Compared to Baseline | Baseline and 3, 6 and 12 months | according to transabdominal ultrasound |
Countries
Russia, Ukraine
Participant flow
Pre-assignment details
Selection procedures were carried out after participant enrollment to determine whether the patient could participate in the study in accordance with the inclusion criteria. Of the 260 patients enrolled, 11 did not meet inclusion criteria after screening procedures, they were not randomized.
Participants by arm
| Arm | Count |
|---|---|
| Afalaza Afalaza (2 tablets twice a day): Safety and Efficiency | 119 |
| Placebo Placebo (2 tablets twice a day): Safety and Efficiency | 117 |
| Total | 236 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Do not meet inclusion criteria | 6 | 7 |
Baseline characteristics
| Characteristic | Afalaza | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 54.3 years STANDARD_DEVIATION 4.2 | 54.4 years STANDARD_DEVIATION 4.4 | 54.4 years STANDARD_DEVIATION 4.3 |
| Region of Enrollment Russia | 118 participants | 114 participants | 232 participants |
| Region of Enrollment Ukraine | 1 participants | 3 participants | 4 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 119 Participants | 117 Participants | 236 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 25 / 125 | 29 / 124 |
| serious Total, serious adverse events | 0 / 125 | 1 / 124 |
Outcome results
Primary
Change in Total IPSS Scores (International Prostate Symptome Score) After 1, 3, 6 and 12 Months Compared to Baseline.
The International Prostate Symptom Score (IPSS) is based on the answers to 7 questions concerning urinary symptoms plus one question concerning quality of life (QoL). Each of the seven symptoms includes the assignment of scores from 0 to 5. The total score can therefore range from 0 to 35 points (asymptomatic to very symptomatic). The patient's quality of life (QoL) was evaluated separately in this clinical study.
Time frame: Baseline, 1, 3, 6 and 12 months
Population: ITT set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Afalaza | Change in Total IPSS Scores (International Prostate Symptome Score) After 1, 3, 6 and 12 Months Compared to Baseline. | Month 1 | -1.3 Scores on a scale | Standard Deviation 1.7 |
| Afalaza | Change in Total IPSS Scores (International Prostate Symptome Score) After 1, 3, 6 and 12 Months Compared to Baseline. | Month 6 | -3.0 Scores on a scale | Standard Deviation 2.5 |
| Afalaza | Change in Total IPSS Scores (International Prostate Symptome Score) After 1, 3, 6 and 12 Months Compared to Baseline. | Month 3 | -2.3 Scores on a scale | Standard Deviation 2.1 |
| Afalaza | Change in Total IPSS Scores (International Prostate Symptome Score) After 1, 3, 6 and 12 Months Compared to Baseline. | Month 12 | -3.7 Scores on a scale | Standard Deviation 3 |
| Placebo | Change in Total IPSS Scores (International Prostate Symptome Score) After 1, 3, 6 and 12 Months Compared to Baseline. | Month 12 | -2.9 Scores on a scale | Standard Deviation 2.4 |
| Placebo | Change in Total IPSS Scores (International Prostate Symptome Score) After 1, 3, 6 and 12 Months Compared to Baseline. | Month 1 | -0.6 Scores on a scale | Standard Deviation 1.3 |
| Placebo | Change in Total IPSS Scores (International Prostate Symptome Score) After 1, 3, 6 and 12 Months Compared to Baseline. | Month 3 | -1.5 Scores on a scale | Standard Deviation 1.9 |
| Placebo | Change in Total IPSS Scores (International Prostate Symptome Score) After 1, 3, 6 and 12 Months Compared to Baseline. | Month 6 | -1.9 Scores on a scale | Standard Deviation 2.5 |
p-value: 0.0005Mixed Models Analysis
Secondary
Change in Average Urinary Flow Rate After 1, 3, 6 and 12 Months Compared to Baseline
Time frame: Baseline and 1, 3, 6 and 12 months
Population: ITT set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Afalaza | Change in Average Urinary Flow Rate After 1, 3, 6 and 12 Months Compared to Baseline | Month 1 | 0.9 ml/s | Standard Deviation 2 |
| Afalaza | Change in Average Urinary Flow Rate After 1, 3, 6 and 12 Months Compared to Baseline | Month 3 | 1.3 ml/s | Standard Deviation 2.1 |
| Afalaza | Change in Average Urinary Flow Rate After 1, 3, 6 and 12 Months Compared to Baseline | Month 6 | 1.4 ml/s | Standard Deviation 2 |
| Afalaza | Change in Average Urinary Flow Rate After 1, 3, 6 and 12 Months Compared to Baseline | Month 12 | 1.4 ml/s | Standard Deviation 2.2 |
| Placebo | Change in Average Urinary Flow Rate After 1, 3, 6 and 12 Months Compared to Baseline | Month 12 | 0.6 ml/s | Standard Deviation 2.5 |
| Placebo | Change in Average Urinary Flow Rate After 1, 3, 6 and 12 Months Compared to Baseline | Month 1 | 0.2 ml/s | Standard Deviation 1.9 |
| Placebo | Change in Average Urinary Flow Rate After 1, 3, 6 and 12 Months Compared to Baseline | Month 6 | 0.5 ml/s | Standard Deviation 2.2 |
| Placebo | Change in Average Urinary Flow Rate After 1, 3, 6 and 12 Months Compared to Baseline | Month 3 | 0.7 ml/s | Standard Deviation 2.5 |
p-value: 0.0011Mixed Models Analysis
Secondary
Change in Dynamics of Irritative Symptoms Evaluated by IPSS (International Prostate Symptome Score) After 1, 3, 6 and 12 Months Compared to Baseline
The International Prostate Symptom Score (IPSS) is based on the answers to 7 questions concerning urinary symptoms plus one question concerning quality of life (QoL). Each of the seven symptoms includes the assignment of scores from 0 to 5. The total score can therefore range from 0 to 35 points (asymptomatic to very symptomatic). The patient's quality of life (QoL) was evaluated separately in this clinical study. The sum of IPSS questions 2, 4, and 7 related to irritative symptoms. The total score of irritative symptoms can therefore range from 0 to 15 points (asymptomatic to very symptomatic).
Time frame: Baseline and 1, 3, 6, 12 months
Population: ITT set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Afalaza | Change in Dynamics of Irritative Symptoms Evaluated by IPSS (International Prostate Symptome Score) After 1, 3, 6 and 12 Months Compared to Baseline | Month 1 | -0.5 Scores on a scale | Standard Deviation 0.9 |
| Afalaza | Change in Dynamics of Irritative Symptoms Evaluated by IPSS (International Prostate Symptome Score) After 1, 3, 6 and 12 Months Compared to Baseline | Month 3 | -0.9 Scores on a scale | Standard Deviation 1.2 |
| Afalaza | Change in Dynamics of Irritative Symptoms Evaluated by IPSS (International Prostate Symptome Score) After 1, 3, 6 and 12 Months Compared to Baseline | Month 6 | -1.3 Scores on a scale | Standard Deviation 1.5 |
| Afalaza | Change in Dynamics of Irritative Symptoms Evaluated by IPSS (International Prostate Symptome Score) After 1, 3, 6 and 12 Months Compared to Baseline | Month 12 | -1.5 Scores on a scale | Standard Deviation 1.6 |
| Placebo | Change in Dynamics of Irritative Symptoms Evaluated by IPSS (International Prostate Symptome Score) After 1, 3, 6 and 12 Months Compared to Baseline | Month 12 | -1.3 Scores on a scale | Standard Deviation 1.5 |
| Placebo | Change in Dynamics of Irritative Symptoms Evaluated by IPSS (International Prostate Symptome Score) After 1, 3, 6 and 12 Months Compared to Baseline | Month 1 | -0.3 Scores on a scale | Standard Deviation 1.1 |
| Placebo | Change in Dynamics of Irritative Symptoms Evaluated by IPSS (International Prostate Symptome Score) After 1, 3, 6 and 12 Months Compared to Baseline | Month 6 | -0.8 Scores on a scale | Standard Deviation 1.4 |
| Placebo | Change in Dynamics of Irritative Symptoms Evaluated by IPSS (International Prostate Symptome Score) After 1, 3, 6 and 12 Months Compared to Baseline | Month 3 | -0.6 Scores on a scale | Standard Deviation 1.2 |
p-value: 0.035Mixed Models Analysis
Secondary
Change in Maximum Urinary Flow Rate After 1, 3, 6 and 12 Months Compared to Baseline
Time frame: Baseline and 1, 3, 6 and 12 months
Population: ITT set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Afalaza | Change in Maximum Urinary Flow Rate After 1, 3, 6 and 12 Months Compared to Baseline | Month 1 | 1.3 ml/s | Standard Deviation 3.2 |
| Afalaza | Change in Maximum Urinary Flow Rate After 1, 3, 6 and 12 Months Compared to Baseline | Month 3 | 1.5 ml/s | Standard Deviation 3.2 |
| Afalaza | Change in Maximum Urinary Flow Rate After 1, 3, 6 and 12 Months Compared to Baseline | Month 6 | 1.7 ml/s | Standard Deviation 3.2 |
| Afalaza | Change in Maximum Urinary Flow Rate After 1, 3, 6 and 12 Months Compared to Baseline | Month 12 | 2.5 ml/s | Standard Deviation 4.3 |
| Placebo | Change in Maximum Urinary Flow Rate After 1, 3, 6 and 12 Months Compared to Baseline | Month 12 | 1.4 ml/s | Standard Deviation 3.3 |
| Placebo | Change in Maximum Urinary Flow Rate After 1, 3, 6 and 12 Months Compared to Baseline | Month 1 | 0.2 ml/s | Standard Deviation 2.6 |
| Placebo | Change in Maximum Urinary Flow Rate After 1, 3, 6 and 12 Months Compared to Baseline | Month 6 | 0.5 ml/s | Standard Deviation 2.7 |
| Placebo | Change in Maximum Urinary Flow Rate After 1, 3, 6 and 12 Months Compared to Baseline | Month 3 | 0.7 ml/s | Standard Deviation 3.3 |
p-value: 0.0008Mixed Models Analysis
Secondary
Change in Mean Values of Micturition Volume at 3, 6 and 12 Months Compared to Baseline
Time frame: Baseline and 3, 6 and 12 months
Population: ITT set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Afalaza | Change in Mean Values of Micturition Volume at 3, 6 and 12 Months Compared to Baseline | Month 3 | 14.6 ml | Standard Deviation 105 |
| Afalaza | Change in Mean Values of Micturition Volume at 3, 6 and 12 Months Compared to Baseline | Month 6 | 27.5 ml | Standard Deviation 96.6 |
| Afalaza | Change in Mean Values of Micturition Volume at 3, 6 and 12 Months Compared to Baseline | Month 12 | 17.9 ml | Standard Deviation 106 |
| Placebo | Change in Mean Values of Micturition Volume at 3, 6 and 12 Months Compared to Baseline | Month 3 | 1.4 ml | Standard Deviation 76.8 |
| Placebo | Change in Mean Values of Micturition Volume at 3, 6 and 12 Months Compared to Baseline | Month 6 | 5.0 ml | Standard Deviation 88.4 |
| Placebo | Change in Mean Values of Micturition Volume at 3, 6 and 12 Months Compared to Baseline | Month 12 | 0.4 ml | Standard Deviation 71.2 |
p-value: 0.0437Mixed Models Analysis
Secondary
Change in Quality of Life (QoL Index of IPSS) at 3, 6 and 12 Months Compared to Baseline
Quality of life (QoL) Due to Urinary Symptoms is an eight point of the IPSS scale referred to the patient's quality of life. The answers to this question range from delighted to terrible or 0 to 5.
Time frame: Baseline and 3, 6 and 12 months
Population: ITT set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Afalaza | Change in Quality of Life (QoL Index of IPSS) at 3, 6 and 12 Months Compared to Baseline | Month 3 | -0.4 Scores on a scale | Standard Deviation 0.8 |
| Afalaza | Change in Quality of Life (QoL Index of IPSS) at 3, 6 and 12 Months Compared to Baseline | Month 6 | -0.7 Scores on a scale | Standard Deviation 0.8 |
| Afalaza | Change in Quality of Life (QoL Index of IPSS) at 3, 6 and 12 Months Compared to Baseline | Month 12 | -1.0 Scores on a scale | Standard Deviation 1 |
| Placebo | Change in Quality of Life (QoL Index of IPSS) at 3, 6 and 12 Months Compared to Baseline | Month 12 | -0.6 Scores on a scale | Standard Deviation 1.2 |
| Placebo | Change in Quality of Life (QoL Index of IPSS) at 3, 6 and 12 Months Compared to Baseline | Month 3 | -0.4 Scores on a scale | Standard Deviation 0.7 |
| Placebo | Change in Quality of Life (QoL Index of IPSS) at 3, 6 and 12 Months Compared to Baseline | Month 6 | -0.5 Scores on a scale | Standard Deviation 1 |
p-value: 0.0621Mixed Models Analysis
Secondary
Change in the Mean Values of Residual Urine Volume at 3, 6 and 12 Months Compared to Baseline
according to transabdominal ultrasound
Time frame: Baseline and 3, 6 and 12 months
Population: ITT set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Afalaza | Change in the Mean Values of Residual Urine Volume at 3, 6 and 12 Months Compared to Baseline | Month 12 | -8.0 ml | Standard Deviation 30.1 |
| Afalaza | Change in the Mean Values of Residual Urine Volume at 3, 6 and 12 Months Compared to Baseline | Month 3 | -6.5 ml | Standard Deviation 26.5 |
| Afalaza | Change in the Mean Values of Residual Urine Volume at 3, 6 and 12 Months Compared to Baseline | Month 6 | -8.8 ml | Standard Deviation 28.1 |
| Placebo | Change in the Mean Values of Residual Urine Volume at 3, 6 and 12 Months Compared to Baseline | Month 12 | -3.5 ml | Standard Deviation 26.9 |
| Placebo | Change in the Mean Values of Residual Urine Volume at 3, 6 and 12 Months Compared to Baseline | Month 3 | -0.9 ml | Standard Deviation 21.6 |
| Placebo | Change in the Mean Values of Residual Urine Volume at 3, 6 and 12 Months Compared to Baseline | Month 6 | -4.3 ml | Standard Deviation 20.9 |
p-value: 0.0862Mixed Models Analysis
Secondary
Change in Total Value of Risk Factors for Progression (Total Score of IPSS, Prostate Volume, PSA Level, Maximum Urinary Flow Rate, Residual Urine Volume) Compared to Baseline
To assess the risk of BPH progression, the following were used: 1) moderate to severe BPH symptoms (ie, IPSS total score\> 7); 2) an increase in the volume of the prostate gland (\> 30 cm\^2); 3) increased PSA level in the blood (≥ 1.4 ng / ml); 4) a decrease in Qmax (\<12 ml / s) and 5) a large volume of residual urine (\> 200 ml). The total value of risk factors for progression is assessed as the sum of the risk factors that the patient had at the time of inclusion in the study (presence of risk factors = 1 point, absence = 0 points). After 3, 6 and 12 months of treatment, the dynamics of risk factors for progression was assessed: an increase in the severity of the risk factor meant +1, no change = 0, a decrease in the severity of the risk factor of -1.
Time frame: Baseline and 3, 6 and 12 months
Population: ITT set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Afalaza | Change in Total Value of Risk Factors for Progression (Total Score of IPSS, Prostate Volume, PSA Level, Maximum Urinary Flow Rate, Residual Urine Volume) Compared to Baseline | Month 3 | -0.9 Scores | Standard Deviation 0.9 |
| Afalaza | Change in Total Value of Risk Factors for Progression (Total Score of IPSS, Prostate Volume, PSA Level, Maximum Urinary Flow Rate, Residual Urine Volume) Compared to Baseline | Month 6 | -0.7 Scores | Standard Deviation 1 |
| Afalaza | Change in Total Value of Risk Factors for Progression (Total Score of IPSS, Prostate Volume, PSA Level, Maximum Urinary Flow Rate, Residual Urine Volume) Compared to Baseline | Month 12 | -1.0 Scores | Standard Deviation 1 |
| Placebo | Change in Total Value of Risk Factors for Progression (Total Score of IPSS, Prostate Volume, PSA Level, Maximum Urinary Flow Rate, Residual Urine Volume) Compared to Baseline | Month 3 | -0.7 Scores | Standard Deviation 0.8 |
| Placebo | Change in Total Value of Risk Factors for Progression (Total Score of IPSS, Prostate Volume, PSA Level, Maximum Urinary Flow Rate, Residual Urine Volume) Compared to Baseline | Month 6 | -0.4 Scores | Standard Deviation 0.8 |
| Placebo | Change in Total Value of Risk Factors for Progression (Total Score of IPSS, Prostate Volume, PSA Level, Maximum Urinary Flow Rate, Residual Urine Volume) Compared to Baseline | Month 12 | -0.6 Scores | Standard Deviation 1 |
p-value: 0.0142Mixed Models Analysis
Secondary
Number of Episodes of Acute Urinary Retention, Surgical Intervention During the Observation Period
Time frame: 12 months
Population: ITT set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Afalaza | Number of Episodes of Acute Urinary Retention, Surgical Intervention During the Observation Period | 0 episodes |
| Placebo | Number of Episodes of Acute Urinary Retention, Surgical Intervention During the Observation Period | 0 episodes |
Secondary
Percent Change in Mean Values of Prostate Gland Volume at 3, 6 and 12 Months Compared to Baseline
Change in the volume of the prostate gland as a percentage of the baseline according to transrectal ultrasound
Time frame: Baseline and 3, 6 and 12 months
Population: ITT set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Afalaza | Percent Change in Mean Values of Prostate Gland Volume at 3, 6 and 12 Months Compared to Baseline | Month 3 | -6.6 percentage of prostate gland volume | Standard Deviation 13.1 |
| Afalaza | Percent Change in Mean Values of Prostate Gland Volume at 3, 6 and 12 Months Compared to Baseline | Month 6 | -10.0 percentage of prostate gland volume | Standard Deviation 13.4 |
| Afalaza | Percent Change in Mean Values of Prostate Gland Volume at 3, 6 and 12 Months Compared to Baseline | Month 12 | -11.8 percentage of prostate gland volume | Standard Deviation 16 |
| Placebo | Percent Change in Mean Values of Prostate Gland Volume at 3, 6 and 12 Months Compared to Baseline | Month 3 | -2.9 percentage of prostate gland volume | Standard Deviation 12.5 |
| Placebo | Percent Change in Mean Values of Prostate Gland Volume at 3, 6 and 12 Months Compared to Baseline | Month 6 | -4.9 percentage of prostate gland volume | Standard Deviation 14.1 |
| Placebo | Percent Change in Mean Values of Prostate Gland Volume at 3, 6 and 12 Months Compared to Baseline | Month 12 | -6.5 percentage of prostate gland volume | Standard Deviation 14.7 |
p-value: 0.0054Mixed Models Analysis