Cetrorelix pamoate (AEZS-102) in patients with symptomatic BPH: a double-blind placebo-controlled efficacy study

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 400

Inclusion Criteria

1. Benign Prostatic Hyperplasia, based on medical history
2. Voiding symptoms: IPSS = 13
3. 50 years or older (at time of randomization)
4. Complete Week 52 visit to be eligible to the open-label phase
5. Uroflow (max) 5 - 15 mL/sec.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Safety concerns:
1. Urgent need for prostate surgery
2. Serum PSA = 10 ng/ml (if PSA > 4 and < 10 ng/ml, patient is eligible if prostate cancer has been excluded);
3. History of allergic reactivity to peptide hormones
4. Eczema (atopic dermatitis) treated during the last 6 months;
5. Major organ dysfunction, e.g. insulin-dependent diabetes, recent myocardial infarction (within 6 months of enrolment), history of unstable angina or newly diagnosed angina pectoris, current congestive heart failure, current serious arrhythmia, use of concomitant Class 1A or Class III antiarrhythmic medications, personal or family history of long QT syndrome, clinically relevant ECG abnormalities (including QT/QTc interval > 450 ms) or clinically relevant chronic or acute infections;
6. BMD at baseline: T-score (hip) < -2 SD, based upon young normal males.

Lack of suitability for the trial:
7. Prior surgical treatment of the prostate or bladder;
8. Current or recent treatment with sexual hormone drugs or 5 a reductase inhibitors or botulinum toxin type a (Botox) within the last 6 months prior to randomization at Week 0 or with a blockers or saw palmetto within the last 6 weeks prior to randomization at Week 0
9. Newly started treatment with tricyclic antidepressants, cholestyramine, disopyramide, ketoconazole, and anticholinergics drugs.
10. Urologic disorders including neurogenic bladder dysfunction due to diabetes mellitus or documented neurologic disorder, urethral stricture disease or history of pelvic radiation therapy
11. History of acute obstructive, infectious, or neurological disorders of the genitourinary tract within the last 3 months;
12. Residual urine volume of > 350 mL;
13. Neurological, psychiatric disease, drug or alcohol abuse which could interfere with the patient’s proper compliance.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To develop a safe and tolerable intermittent dosage regimen of cetrorelix pamoate that provides prolonged improvement in BPH-related signs and symptoms;Secondary Objective: Determination of change in bone mass density in a subgroub of patients;Primary end point(s): Absolute change in IPSS between baseline (Week -1) and Week 52

Secondary Outcome Measures

Name	Time	Method

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