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Cetrorelix Pamoate in Patients With Symptomatic Benign Prostatic Hypertrophy (BPH)
Plain-language guide to NCT00663858: phase 3 randomized trial of Cetrorelix, 420 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00663858
- Phase
- phase 3
- Status
- completed
- Start
- 2008-03
- Completion (planned or actual)
- 2009-09
- Participants
- 420 (actual)
- Design
- randomized, quadruple-blind, treatment
- Conditions studied
- Benign Prostatic Hypertrophy
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
In this phase 3 trial, researchers set out to test Cetrorelix.
Benign Prostatic Hypertrophy (BPH) is a common and bothersome condition of aging men.
It had three arms (groups): Cetrorelix 78+78 (experimental), Cetrorelix 78 + Placebo (experimental) and Placebo (placebo comparator).
The registry classes the interventions as drug and other.
Who Took Part
420 actual participants took part.
It was open to men only aged from 50 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Benign Prostatic Hyperplasia, based on medical history.
The full record lists 2 inclusion and 6 exclusion criteria; among the exclusions: 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.
How the Study Was Run
The set-up was randomized, parallel-group and quadruple-blind.
Random assignment meant chance, not the researchers, decided who got Cetrorelix and who got the comparison, which limits bias.
The Cetrorelix group and the comparison group ran side by side rather than switching.
As a double-blind Cetrorelix study, the assignments were hidden from both participants and investigators until the end.
Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.
It started in 2008-03 with completion listed for 2009-09.
It ran at 54 sites in Czechia (9), Germany (9), Netherlands (9), Bulgaria (5), France (5) and Romania (5).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: International Prostate Symptom Score (IPSS) (time frame: Baseline and 52 weeks).
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Cetrorelix in 420 people.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Cetrorelix compound page, all human trials.
Our Notes on the Compound
Cetrorelix: An FDA-approved GnRH antagonist used in IVF to prevent a premature LH surge.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.