Trial · Interventional

TerminatedPhase 3Results postedRegistry data

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

NCTNCT00449150Other idZ033

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: Trial did not meet primary efficacy endpoint for double blind phase.

Results were posted for this trial.

Overview

Status: Terminated
Phase: Phase 3
Enrollment: 667 participants (actual)
Sponsor: AEterna Zentaris · Industry
Design: Randomized · Double masking
Countries: 4 countries
United States, Bulgaria, Canada, Germany
Start: Mar 2007
Primary completion: Jun 2009
Completion: Dec 2009
First posted: 19 Mar 2007 (estimated)
Last update posted: 3 Aug 2018
Conditions: Benign Prostatic Hypertrophy

Timeline

1 trial · 1 stopped early · 1 with posted results

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

2007200820092010

Ph 3
Cetrorelix (CET) Pamoate Regimens in Patients With Symptomatic Benign Prostatic Hypertrophy (BPH)
NCT00449150
Mar 2007 to Dec 2009
Terminated
Terminated

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 mg + 78 mgDrug
Cetrorelix 78 mg + 52 mgDrug
PlaceboDrug

Arms3

Experimental
Treatment Group A: CET 78 mg + 78 mg
Treatment course 1: Cetrorelix 78 mg + 78 mg * Week 0: 52 mg CET (2 injections) * Week 2: 26 mg CET (1 injection) Treatment course 2: * Week 26: 52 mg CET (2 injections) * Week 28: 26 mg CET(1 injection) 4 days with treatment, Day 1 of each indicated week, 6 injections in total per patient.
Experimental
Treatment Group B: CET 78 mg + 52 mg
Treatment course 1: Cetrorelix 78 mg + 52 mg * Week 0: 52 mg CET (2 injections) * Week 2: 26 mg CET (1 injection) Treatment course 2: * Week 26: 52 mg CET (2 injections) * Week 28: Placebo (1 injection) 4 days with treatment, Day 1 of each indicated week, 6 injections in total per patient.
Placebo comparator
Treatment Group C: Placebo
Treatment course 1: * Week 0: placebo (2 injections) * Week 2: placebo (1 injection) Treatment course 2: * Week 26: placebo (2 injections) * Week 28: placebo (1 injection) 4 days with treatment, Day 1 of each indicated week, 6 injections in total per patient.

Primary outcomes1

Outcomes the sponsor listed as primary.

International Prostate Symptoms Score (IPSS)
Time frame · Baseline and 52 weeks
Registry description
The International Prostate Symptoms Score (IPSS) score of benign prostata hyperplasia (BPH) symptoms is calculated 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 range: 0 points (best) to 35 points (worst)

Secondary outcomes(1)

Time Course of Quality of Life
Time frame · Quality of life assessment in the following weeks: 4,12,26,30,38,46,52
Registry description
The time course of quality of life: assessed by the following disease specific quality of life:"If you were to spend the rest of your life with the urinary conditions just the way it is now, how would you feel about that?" The rating scale is comprising a range of values from 0 to 6, with = delighted, 1 = pleased, 2 = mostly satisfied, 3 = mixed, 4 = mostly dissatisfied, 5 = unhappy, 6 = terrible.

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 Symptoms Score (IPSS)

Group	Value (Units on a scale)	Spread
Cetrorelix 78+78	-4.0	6.61
Cetrorelix 78+52	-3.7	5.90
Placebo	-3.8	6.22

Secondary and other outcome results(1)

Secondary outcomeMean· Quality of life assessment in the following weeks: 4,12,26,30,38,46,52

Time Course of Quality of Life

Group	Value (score on a scale)	Spread
Treatment Group A: Cetrorelix (CET) 78 mg + 78 mg	-0.33	1.16
Treatment Group B: CET 78 mg + 52 mg	-0.42	1.09
Treatment Group C: Placebo	-0.35	1.00

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+78 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)	–	11 / 219	177 / 219
Cetrorelix 78+5278+52 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 52 mg combining Week 26 (52 mg) and Week 28 (0 mg)	–	16 / 230	179 / 230
PlaceboPlacebo on Week 0, 2 26 and 28	–	21 / 218	169 / 218

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

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