Phase 3
N=528
Cetrorelix Pamoate IM Regimens in Patients With Symptomatic Benign Prostatic Hyperplasia (BPH)
Benign Prostatic Hypertrophy
Bottom Line
View on ClinicalTrials.gov: NCT00670306 ↗Enrolled (actual)
528
Serious AEs
2.3%
Results posted
Jan 2011
Primary outcome: Primary: IPSS Change From Baseline — -5.6 Units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Cetrorelix Pamoate (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- Male
- Sponsor
- AEterna Zentaris
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY IPSS Change From Baseline |
-5.6 | <0.001 sig |
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00670306). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.