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Cetrorelix

Phase 3

Polycystic Ovarian Syndrome | Small molecule | Other |Merck & Company, Inc.|Last Updated: Feb 13, 2014

Target and mechanism

Molecular targetGNRHR
Target classAntagonist
ModalitySmall molecule

Also known as Cetrorelix acetate

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment136

FDA Designations

No designations recorded

Clinical trial landscape

Cetrorelix · 1 trial · 1 indication

Phase 3 1
NCT01185704Analysis of Two Therapeutic With Cetrotide® in Polycystic Ovarian (PCO) Women in Assisted Reproductive Technology (ART)Polycystic Ovarian Syndrome
COMPLETED136 Analytics
PHASE3COMPLETED
Analysis of Two Therapeutic With Cetrotide® in Polycystic Ovarian (PCO) Women in Assisted Reproductive Technology (ART)
Polycystic Ovarian SyndromeUnlock trial analytics

Study Endpoints

Primary Endpoints

Estradiol (E2) Levels on r-hCG Day
r-hCG day (end of stimulation cycle [approximately 15 days])

Secondary Endpoints

Serum Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Levels
Day 1
Serum Estradiol (E2) Levels
Day 1
Serum Progesterone (P4) Levels
Day 1
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Day 1 protocolEXPERIMENTAL -
Day 7 protocolEXPERIMENTAL -

Interventions

NameTypeDescription
Cetrorelix acetateDRUGCetrotide® 0.25 mg will be administered subcutaneously once daily from Day 1 (Day 0 of stimulation period \[S0\]) until r-hCG day (at least 2 follicles \>=17 mm)
Recombinant Human Choriogonadotropin (r-hCG)DRUGThe r-hCG will be administered subcutaneously as a single dose of 250 microgram (mcg) on r-hCG day
Recombinant human follicle stimulating hormone (r-hFSH)DRUGRecombinant human follicle stimulating hormone (r-hFSH) will be administered subcutaneously at a dose between 75 and 187.5 international unit (IU) once daily from Day 2 (Day 1 of stimulation period \[S1\]) until r-hCG day
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Eligibility Criteria

Age Range18 Years to 35 Years
SexFEMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Female subjects with PCO or Polycystic ovary syndrome (PCOS) according to the revised 2003 Rotterdam Consensus * Female subjects suitable for IVF/ICSI, undergoing first or second attempt * 18-35 years old, Body Mass Index (BMI) less than or equal to 32, non-smoking at least fr...

Countries:France
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Frequently asked questions about Cetrorelix

What is Cetrorelix used for in Polycystic Ovarian Syndrome?

Cetrorelix is used for Polycystic Ovarian Syndrome, specifically in women undergoing assisted reproductive technology. It is a small molecule being developed by Merck & Company, Inc. (MRK) and is currently in Phase 3 clinical development.

What does Cetrorelix target?

Cetrorelix targets the gonadotropin-releasing hormone receptor, acting as an antagonist to suppress premature luteinizing hormone surges during controlled ovarian stimulation. This mechanism helps manage Polycystic Ovarian Syndrome in assisted reproductive technology.

Who makes Cetrorelix?

Cetrorelix is developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker MRK. The drug is also known as Cetrorelix acetate.

What phase is Cetrorelix in?

Cetrorelix is in Phase 3 clinical development. It is an investigational drug, not yet approved by regulatory authorities, and is being studied for Polycystic Ovarian Syndrome.

What clinical trials is Cetrorelix in?

Cetrorelix has one completed Phase 3 trial, NCT01185704, which analyzed two therapeutic approaches with Cetrotide in Polycystic Ovarian women in assisted reproductive technology. The trial enrolled 136 female participants aged 18 years and older in France.

Is Cetrorelix the same as Cetrorelix acetate?

Yes, Cetrorelix is also known as Cetrorelix acetate. Both names refer to the same drug, which is being developed by Merck & Company, Inc. for Polycystic Ovarian Syndrome.