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Cetrorelix 78+78

Phase 3

Benign Prostatic Hypertrophy | Small molecule | Urology |COSCIENS Biopharma Inc.|Last Updated: Jan 17, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment420

FDA Designations

No designations recorded

Clinical trial landscape

Cetrorelix 78+78 · 1 trial · 1 indication

Phase 3 1
NCT00663858Cetrorelix Pamoate in Patients With Symptomatic Benign Prostatic Hypertrophy (BPH)Benign Prostatic Hypertrophy
COMPLETED420 Analytics
PHASE3COMPLETED
Cetrorelix Pamoate in Patients With Symptomatic Benign Prostatic Hypertrophy (BPH)
Benign Prostatic HypertrophyUnlock trial analytics

Study Endpoints

Primary Endpoints

International Prostate Symptom Score (IPSS)
Baseline and 52 weeks

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)

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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cetrorelix 78+78EXPERIMENTAL -
Cetrorelix 78 + PlaceboEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Cetrorelix 78+78DRUGCetrorelix 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)
Cetrorelix 78 + PlaceboDRUGCetrorelix 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + Placebo on Week 26 and Week 28
PlaceboOTHERPlacebo on Week 0, Week 2, Week 26 and Week 28
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Eligibility Criteria

Age Range50 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites54

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 * C...

Countries:BelarusBulgariaCzechiaFranceGermanyItalyNetherlandsNorth MacedoniaRomaniaUnited Kingdom
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Frequently asked questions about Cetrorelix 78+78

What is Cetrorelix 78+78 used for?

Cetrorelix 78+78 is an investigational small molecule being developed for the treatment of benign prostatic hypertrophy (BPH), a condition also known as enlarged prostate. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.

Who makes Cetrorelix 78+78?

Cetrorelix 78+78 is being developed by COSCIENS Biopharma Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol CSCI. The company is conducting clinical trials to evaluate the drug's safety and efficacy for benign prostatic hypertrophy.

What phase is Cetrorelix 78+78 in?

Cetrorelix 78+78 is in Phase 3 clinical development for benign prostatic hypertrophy. It is an investigational drug, meaning it has not yet been approved by regulatory agencies and is still undergoing clinical trials to assess its safety and effectiveness.

What clinical trials is Cetrorelix 78+78 in?

Cetrorelix 78+78 has one completed Phase 3 clinical trial registered under NCT00663858, titled 'Cetrorelix Pamoate in Patients With Symptomatic Benign Prostatic Hypertrophy (BPH)'. This randomized, double-blind, placebo-controlled trial enrolled 420 male participants aged 50 years and older across multiple European countries.

Is Cetrorelix 78+78 the same as Cetrorelix pamoate?

Yes, Cetrorelix 78+78 is also known as Cetrorelix pamoate. The clinical trial NCT00663858 refers to the drug as 'Cetrorelix Pamoate', and it is being studied for the treatment of symptomatic benign prostatic hypertrophy.