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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-004865-17-BG

Enrollment

500

Registered

2008-08-19

Start date

2008-08-15

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostatic Hyperplasia (BPH) MedDRA version: 9.1 Level: LLT Classification code 10004446 Term: Benign prostatic hyperplasia

Interventions

Product Name: Cetrorelix 26 mg Product Code: D-20762 Pharmaceutical Form: Powder and solvent for suspension for injection INN or Proposed INN: Cetrorelix CAS Number: 120287-85-6 Current Sponsor code:

Eligibility

Sex/Gender

Male

Inclusion criteria

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

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 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

Design outcomes

Primary

Measure	Time frame
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	—

Countries

Bulgaria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026