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NCT00449150 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by AEterna Zentaris.

Terminated
Registry status
Phase 3
Development phase
667
Enrollment target

NCT00449150: Clinical Trial Phase 3 study, sponsored by AEterna Zentaris.

NCT00449150 is a Phase 3 study that was terminated before completion, run by AEterna Zentaris. The registered enrollment target is 667 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (14% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00449150, a Phase 3 study, was terminated before completion, sponsored by AEterna Zentaris.

TERMINATED
Registry status
Phase 3
Development phase
667 participants
Enrollment target

Study Summary

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).

Primary Outcome

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)

Interventions

  • DRUG Placebo
  • DRUG Cetrorelix 78 mg + 78 mg
  • DRUG Cetrorelix 78 mg + 52 mg

Trial Details

FieldValue
Enrollment Target 667 participants
Start Date 2007-03
Est. Completion 2009-12
Phase Phase 3
AEterna Zentaris

21 total trials

Why NCT00449150 stopped before completion

NCT00449150 is an interventional study that assigns participants to a tested intervention. The registered 667 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (14% lower).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT00449150 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00449150 about?

NCT00449150 is a clinical study titled "Cetrorelix (CET) Pamoate Regimens in Patients With Symptomatic Benign Prostatic Hypertrophy (BPH)". 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 sy...

What is the current status of trial NCT00449150?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 667 participants. The study started on 2007-03. Estimated completion is 2009-12.

What interventions are being tested in trial NCT00449150?

The interventions under investigation include: Placebo (DRUG), Cetrorelix 78 mg + 78 mg (DRUG), Cetrorelix 78 mg + 52 mg (DRUG).

Who is sponsoring clinical trial NCT00449150?

This trial is sponsored by AEterna Zentaris, which has 21 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00449150's enrollment target sits among peer trials

667 551st of 2000 higher than 1,450 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00449150, the US trial registry maintained by the National Library of Medicine. NCT00449150 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.