Cetrorelix Pamoate IM Regimens in Patients With Symptomatic Benign Prostatic Hyperplasia (BPH)

Short name AEZS-102-Z041

NCTNCT00670306Other idAEZS-102-Z041

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 528 participants (actual)
Sponsor: AEterna Zentaris · Industry
Design: Allocation not applicable · Open label (no masking)
Countries: 2 countries
United States, Canada
Start: Mar 2008
Primary completion: Aug 2009
Completion: Aug 2009
First posted: 1 May 2008 (estimated)
Last update posted: 5 Apr 2011 (estimated)
Conditions: Benign Prostatic Hypertrophy

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

200820092010

Ph 3
AEZS-102-Z041
NCT00670306
Mar 2008 to Aug 2009

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Cetrorelix PamoateDrug

Arms1

Experimental
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.

Primary outcomes1

Outcomes the sponsor listed as primary.

IPSS Change From Baseline
Time frame · Baseline and Week 26
Registry description
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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline and Week 26

IPSS Change From Baseline

Group	Value (Units on a scale)	Spread
Cetrorelix 78 mg	-5.6	7.1

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Cetrorelix 78 mgDrug: Cetrorelix 52 mg week 0, and 26 mg week 2, intra muscular-2 doses in 2 weeks and follow up to week 26.	–	12 / 528	49 / 528

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Male
Age: from 50 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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