Cetrorelix Pamoate in Patients With Symptomatic Benign Prostatic Hypertrophy (BPH)

NCTNCT00663858Other idAEZS-102-036

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 420 participants (actual)
Sponsor: AEterna Zentaris · Industry
Design: Randomized · Quadruple masking
Countries: 10 countries
Belarus, Bulgaria, Czechia, France, Germany, Italy, Netherlands, North Macedonia, Romania, United Kingdom
Start: Mar 2008
Primary completion: Sept 2009
Completion: Jan 2010
First posted: 22 Apr 2008 (estimated)
Last update posted: 17 Jan 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

2008200920102011

Ph 3
Cetrorelix Pamoate in Patients With Symptomatic Benign Prostatic Hypertrophy (BPH)
NCT00663858
Mar 2008 to Jan 2010

Registry summary

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

Benign Prostatic Hypertrophy (BPH) is a common and bothersome condition of aging men. It is characterized by an enlargement of the prostate occurring in human male over the age of 50 which increases in prevalence with age, and among those aged 50 to 80, about 40% report moderate or severe urinary symptoms of prostatism. The aim of treatment is to improve patients' quality of life which primarily depends on the severity of the symptoms of BPH. Current treatments of BPH have a benefit / risk ratio which leaves room for improvement. For this study, study medication (Cetrorelix pamoate or placebo) is administered by injection in the buttocks (Intramuscular). All patients completing the double-blind portion (Week 0 to 52) are eligible to receive the active drug during the open-label part of the study (Week 52 to 90).

Interventions

Cetrorelix 78+78Drug
Cetrorelix 78 + PlaceboDrug
PlaceboOther

Arms3

Experimental
Cetrorelix 78+78
Experimental
Cetrorelix 78 + Placebo
Placebo comparator
Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

International Prostate Symptom Score (IPSS)
Time frame · Baseline and 52 weeks
Registry description
IPSS score of BPH symptoms based on a patient questionnaire assessing 7 items (incomplete voiding, frequency, intermittency, urgency, weak stream, hesitancy, nocturia) on a scale from 0 (best) to 5 (worst); total overall score range: 0 points (best) to 35 points (worst)

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 52 weeks

International Prostate Symptom Score (IPSS)

Group	Value (Units on a scale)	Spread
Cetrorelix 78+78	-6.2	5.68
CET 78+Placebo	-5.1	5.18
Placebo	-5.7	6.04

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+7878 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)	–	8 / 212	10 / 212
CET 78+Placebo78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + Placebo on Week 26 and Week 28.	–	7 / 106	5 / 106
PlaceboPlacebo on Week 0, 2, 26 and 28.	–	5 / 102	6 / 102

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 Exclusion Criteria: * Urgent need for prostate surgery or prior surgical treatment of the prostate or bladder * Major organ dysfunction * Eczema (atopic dermatitis) treated during the last 6 months * 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 randomization or with α blockers or saw palmetto within the last 6 weeks prior to randomization * 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

PepBank is a research reference. Talk to a doctor before you use any peptide.