Benign Prostatic Hypertrophy
Conditions
Brief summary
Benign Prostatic Hypertrophy (BPH) is a common and bothersome condition of aging men. It is characterized by an enlargement of the prostate occurring in human male over the age of 50 which increases in prevalence with age, and among those aged 50 to 80, about 40% report moderate or severe urinary symptoms of prostatism. The aim of treatment is to improve patients' quality of life which primarily depends on the severity of the symptoms of BPH. Current treatments of BPH have a benefit / risk ratio which leaves room for improvement. For this study, study medication (Cetrorelix pamoate or placebo) is administered by injection in the buttocks (Intramuscular). All patients completing the double-blind portion (Week 0 to 52) are eligible to receive the active drug during the open-label part of the study (Week 52 to 90).
Interventions
DRUGCetrorelix 78+78
Cetrorelix 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)
DRUGCetrorelix 78 + Placebo
Cetrorelix 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + Placebo on Week 26 and Week 28
OTHERPlacebo
Placebo on Week 0, Week 2, Week 26 and Week 28
Sponsors
AEterna Zentaris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Benign Prostatic Hyperplasia, based on medical history * Voiding symptoms
Exclusion criteria
* Urgent need for prostate surgery or prior surgical treatment of the prostate or bladder * Major organ dysfunction * Eczema (atopic dermatitis) treated during the last 6 months * Current or recent treatment with sexual hormone drugs or 5 α reductase inhibitors or botulinum toxin type a (Botox) within the last 6 months prior randomization or with α blockers or saw palmetto within the last 6 weeks prior to randomization * Urologic disorders including neurogenic bladder dysfunction due to diabetes mellitus or documented neurologic disorder, urethral stricture disease or history of pelvic radiation therapy * History of acute obstructive, infectious, or neurological disorders of the genitourinary tract within the last 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| International Prostate Symptom Score (IPSS) | Baseline and 52 weeks | IPSS score of BPH symptoms based on a patient questionnaire assessing 7 items (incomplete voiding, frequency, intermittency, urgency, weak stream, hesitancy, nocturia) on a scale from 0 (best) to 5 (worst); total overall score range: 0 points (best) to 35 points (worst) |
Countries
Belarus, Bulgaria, Czechia, France, Germany, Italy, Netherlands, North Macedonia, Romania, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cetrorelix 78+78 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg) | 212 |
| CET 78+Placebo 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + Placebo on Week 26 and Week 28. | 106 |
| Placebo Placebo on Week 0, 2, 26 and 28. | 102 |
| Total | 420 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 9 | 1 | 6 |
| Overall Study | Lack of Efficacy | 5 | 1 | 3 |
| Overall Study | Other | 8 | 2 | 4 |
| Overall Study | Protocol Violation | 5 | 3 | 4 |
| Overall Study | Withdrawal by Subject | 7 | 3 | 3 |
Baseline characteristics
| Characteristic | Total | Placebo | Cetrorelix 78+78 | CET 78+Placebo |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 237 Participants | 65 Participants | 111 Participants | 61 Participants |
| Age, Categorical Between 18 and 65 years | 183 Participants | 37 Participants | 101 Participants | 45 Participants |
| Age Continuous | 66.83 years STANDARD_DEVIATION 7.71 | 67.72 years STANDARD_DEVIATION 7.17 | 66.58 years STANDARD_DEVIATION 8.16 | 66.50 years STANDARD_DEVIATION 7.29 |
| Region of Enrollment Belarus | 73 participants | 18 participants | 37 participants | 18 participants |
| Region of Enrollment Bulgaria | 81 participants | 20 participants | 41 participants | 20 participants |
| Region of Enrollment Czech Republic | 67 participants | 19 participants | 33 participants | 15 participants |
| Region of Enrollment France | 1 participants | 0 participants | 0 participants | 1 participants |
| Region of Enrollment Germany | 28 participants | 6 participants | 15 participants | 7 participants |
| Region of Enrollment Italy | 3 participants | 0 participants | 2 participants | 1 participants |
| Region of Enrollment Macedonia, The Former Yugoslav Republic of | 12 participants | 3 participants | 6 participants | 3 participants |
| Region of Enrollment Netherlands | 46 participants | 10 participants | 23 participants | 13 participants |
| Region of Enrollment Romania | 108 participants | 26 participants | 54 participants | 28 participants |
| Region of Enrollment United Kingdom | 1 participants | 0 participants | 1 participants | 0 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 420 Participants | 102 Participants | 212 Participants | 106 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 10 / 212 | 5 / 106 | 6 / 102 |
| serious Total, serious adverse events | 8 / 212 | 7 / 106 | 5 / 102 |
Outcome results
Primary
International Prostate Symptom Score (IPSS)
IPSS score of BPH symptoms based on a patient questionnaire assessing 7 items (incomplete voiding, frequency, intermittency, urgency, weak stream, hesitancy, nocturia) on a scale from 0 (best) to 5 (worst); total overall score range: 0 points (best) to 35 points (worst)
Time frame: Baseline and 52 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cetrorelix 78+78 | International Prostate Symptom Score (IPSS) | -6.2 Units on a scale | Standard Deviation 5.68 |
| CET 78+Placebo | International Prostate Symptom Score (IPSS) | -5.1 Units on a scale | Standard Deviation 5.18 |
| Placebo | International Prostate Symptom Score (IPSS) | -5.7 Units on a scale | Standard Deviation 6.04 |
p-value: 0.37195% CI: [-1.894, 0.709]ANOVA
p-value: 0.325395% CI: [-709, 2.132]ANCOVA
p-value: 0.033395% CI: [-2.542, -0.106]ANCOVA