Benign Prostatic Hypertrophy
Conditions
Keywords
Cetrorelix, BPH
Brief summary
Benign Prostatic Hyperplasia (BPH) is the most common hyperplastic disease occuring in human males over the age of 50 which increases in prevalence with age and 40% of males reported moderate or severe urinary symptoms of prostatism by the age of 50 to 80. The purpose of this study is to collect safety and efficacy data for this dosage regimen of cetrorelix pamoate. For this study, study medication (Cetrorelix pamoate) is administered by injection in the buttocks (Intramuscular).
Interventions
DRUGCetrorelix Pamoate
Cetrorelix Pamoate IM, 52 mg week 0, 26 mg week 2,
Sponsors
AEterna Zentaris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Benign Prostatic Hyperplasia, based on medical history * Voiding symptoms * Uroflow (max) 5-15mL/sec
Exclusion criteria
* Urgent need for prostate surgery * History of allergic reaction to peptide * Major organ dysfunction * Prior surgical treatment of the prostate or bladder * 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 to trial medication at Week 0 or with α blockers or saw palmetto within the last 6 weeks prior to trial medication at Week 0 * 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 |
|---|---|---|
| IPSS Change From Baseline | Baseline and Week 26 | International Prostate Symptom Score (IPSS) Patient Questionnaire assessing 7 items (incomplete voiding, frequency, intermittency, urgency, weak stream, hesitancy, nocturia) on a scale from 0 (best) to 5 (worst); total range: 0 - 35 points; absolute change from baseline to Week 26 |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cetrorelix 78 mg Drug: Cetrorelix 52 mg week 0, and 26 mg week 2, intra muscular-2 doses in 2 weeks and follow up to week 26. | 528 |
| Total | 528 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 8 |
| Overall Study | incl/excl criterias did not meet | 19 |
| Overall Study | Lack of Efficacy | 10 |
| Overall Study | Lost to Follow-up | 8 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 9 |
Baseline characteristics
| Characteristic | Cetrorelix 78 mg |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 227 Participants |
| Age, Categorical Between 18 and 65 years | 301 Participants |
| Age Continuous | 64.9 years STANDARD_DEVIATION 8.2 |
| Region of Enrollment Canada | 114 participants |
| Region of Enrollment United States | 414 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 528 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 49 / 528 |
| serious Total, serious adverse events | 12 / 528 |
Outcome results
Primary
IPSS Change From Baseline
International Prostate Symptom Score (IPSS) Patient Questionnaire assessing 7 items (incomplete voiding, frequency, intermittency, urgency, weak stream, hesitancy, nocturia) on a scale from 0 (best) to 5 (worst); total range: 0 - 35 points; absolute change from baseline to Week 26
Time frame: Baseline and Week 26
Population: Intention to treat (ITT) analysis with Last Observation Carried Forward (LOCF) imputation technique
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cetrorelix 78 mg | IPSS Change From Baseline | -5.6 Units on a scale | Standard Deviation 7.1 |
p-value: <0.001t-test, 2 sided