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Cetrorelix Pamoate

Phase 3

Benign Prostatic Hypertrophy | Small molecule | Urology |COSCIENS Biopharma Inc.|Last Updated: Apr 5, 2011

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment528

FDA Designations

No designations recorded

Clinical trial landscape

Cetrorelix Pamoate · 1 trial · 1 indication

Phase 3 1
NCT00670306Cetrorelix Pamoate IM Regimens in Patients With Symptomatic Benign Prostatic Hyperplasia (BPH)Benign Prostatic Hypertrophy
COMPLETED528 Analytics
PHASE3COMPLETED
Cetrorelix Pamoate IM Regimens in Patients With Symptomatic Benign Prostatic Hyperplasia (BPH)
Benign Prostatic HypertrophyUnlock trial analytics

Study Endpoints

Primary Endpoints

IPSS Change From Baseline
Baseline and Week 26

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

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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cetrorelix 78 mgEXPERIMENTALDrug: Cetrorelix 52 mg week 0, and 26 mg week 2, intra muscular-2 doses in 2 weeks and follow up to week 26.

Interventions

NameTypeDescription
Cetrorelix PamoateDRUGCetrorelix Pamoate IM, 52 mg week 0, 26 mg week 2,
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Eligibility Criteria

Age Range50 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites69

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 bladd...

Countries:United StatesCanada
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Frequently asked questions about Cetrorelix Pamoate

What is Cetrorelix Pamoate used for in Benign Prostatic Hypertrophy?

Cetrorelix Pamoate is an investigational small molecule being studied for the treatment of symptomatic Benign Prostatic Hypertrophy (BPH), also known as benign prostatic hyperplasia. It is administered via intramuscular injection and is intended to address symptoms associated with an enlarged prostate.

What does Cetrorelix Pamoate target?

Cetrorelix Pamoate is a gonadotropin-releasing hormone (GnRH) antagonist. It works by blocking GnRH receptors, which reduces the production of sex hormones like testosterone. This hormonal suppression is thought to help reduce prostate size and alleviate symptoms of Benign Prostatic Hypertrophy.

Who makes Cetrorelix Pamoate?

Cetrorelix Pamoate is being developed by COSCIENS Biopharma Inc., a biopharmaceutical company traded under the ticker symbol CSCI. The company is conducting clinical research to evaluate the drug's safety and efficacy for treating Benign Prostatic Hypertrophy.

What phase is Cetrorelix Pamoate in?

Cetrorelix Pamoate is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the results will inform potential regulatory submissions for the treatment of Benign Prostatic Hypertrophy.

What clinical trials is Cetrorelix Pamoate in?

Cetrorelix Pamoate has been studied in one completed Phase 3 clinical trial with the identifier NCT00670306. This trial, titled 'Cetrorelix Pamoate IM Regimens in Patients With Symptomatic Benign Prostatic Hyperplasia (BPH),' enrolled 528 male participants aged 50 years and older in the United States and Canada.