Cetrorelix pamoate (AEZS-102) in patients with symptomatic BPH: an open-labeled safety and efficacy assessment study

• Conditions: Benign Prostatic Hyperplasia (BPH); MedDRA version: 9.1Level: LLTClassification code 10004446Term: Benign prostatic hyperplasia

• Registration Number: EUCTR2007-004865-17-BG
• Lead Sponsor: Aeterna Zentaris GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08-19
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 500

Inclusion Criteria

1. Benign Prostatic Hyperplasia, based on medical history;
2. Voiding symptoms: IPSS = 13;
3. 50 years or older (at time of screening);
4. 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; a patient with serum PSA > 4 ng/ml (but < 10 ng/ml) is only eligible if prostate cancer has been excluded to the satisfaction of the investigator (e.g. by prostate biopsy).;
3. History of allergic reactivity to peptide;
4. Clinical significant increase of bleeding time
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, uncontrolled hypertension, 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), cancer (considered as not cured) except basal cell or squamous cell carcinoma of the skin or clinically relevant chronic or acute infections;

Lack of suitability for the trial:
6. Prior surgical treatment of the prostate or bladder;
7. Current or recent treatment with sexual hormone drugs or 5a reductase inhibitors or botulinum toxin type a (Botox) within the last 6 months prior to trial medication at Week 0 or with a blockers or saw palmetto within the last 6 weeks prior to trial medication at Week 0;
8. Newly started treatment with tricyclic antidepressants, cholestyramine, disopyramide, ketoconazole, and anticholinergics drugs.;
9. Urologic disorders including neurogenic bladder dysfunction due to diabetes mellitus or documented neurologic disorder, urethral stricture disease or history of pelvic radiation therapy;
10. History of acute obstructive, infectious, or neurological disorders of the genitourinary tract within the last 3 months;
11. Residual urine volume of > 350 mL;
12.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 collect safety and efficacy data for this dosage regimen of cetrorelix pamoate ;Secondary Objective: ;Primary end point(s): Incidence of treatment-emergent AEs