Ganirelix

Generic Name: Ganirelix

Brand Names: Fyremadel, Orgalutran, Ganirelix Gedeon Richter

Drug Type: Small Molecule

Chemical Formula: C_₈₀H_₁₁₃ClN_₁₈O_₁₃

CAS Number: 124904-93-4

Unique Ingredient Identifier: IX503L9WN0

Background: Ganirelix is a synthetic decapeptide and a competitive gonadotropin-releasing hormone (GnRH) antagonist. Derived from endogenous GnRH, ganirelix has amino acid substitutions. Ganirelix is indicated for controlled ovarian hyperstimulation in assisted reproduction techniques. The first case of pregnancy achieved after the use of ganirelix in an assisted reproduction program was reported in 1998. Ganirelix was first approved by the FDA on July 29, 1999.

Indication: Ganirelix is indicated for the inhibition of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation for assisted reproduction techniques (ART).

Associated Conditions: -

Associated Therapies: Controlled ovarian hyperstimulation therapy

Clinical Trials

An Efficacy and Safety Study of Corifollitropin Alfa (MK-8962) in Contrast to Recombinant FSH for Use in Controlled Ovarian Stimulation of Indian Women (P07056, Also Known as MK-8962-029)

Phase 3

Withdrawn

Conditions: Infertility

Interventions: Drug: MK-8962
Drug: recFSH
Drug: Ganirelix
Drug: human Chorionic Gonadotropin (hCG)
Drug: Progesterone

First Posted Date: 2012-05-16

Last Posted Date: 2022-02-03

Lead Sponsor: Organon and Co

Registration Number: NCT01599494

A Novel Approach to Endometrial Preparation in Recipients of Donor Eggs

Not Applicable

Conditions: Implantation, Embryo

Interventions: Drug: Leuprolide
Drug: Ganirelix

First Posted Date: 2011-08-29

Last Posted Date: 2011-08-29

Lead Sponsor: Kelly, Maureen, M.D.

Target Recruit Count: 20

Registration Number: NCT01424618

Locations: 🇺🇸
Society Hill Reproductive Medicine, Philadelphia, Pennsylvania, United States

Japanese Bridging Trial of Org 37462 (Study P05969)(COMPLETED)

Phase 2

Completed

Conditions: Controlled Ovarian Stimulation

Interventions: Drug: Ganirelix

First Posted Date: 2009-10-02

Last Posted Date: 2024-08-15

Lead Sponsor: Organon and Co

Target Recruit Count: 266

Registration Number: NCT00988260

Agonist Gonadotropin-Releasing Hormone (GnRH) Versus Antagonist GnRH

Phase 3

Conditions: Infertility

Interventions: Drug: ganirelix
Drug: suprefact

First Posted Date: 2009-01-15

Last Posted Date: 2009-01-15

Lead Sponsor: Yazd Research & Clinical Center for Infertility

Target Recruit Count: 2

Registration Number: NCT00823602

Locations: 🇮🇷
Yazd Research and Clinical Center For Infertility, Yazd, Iran, Islamic Republic of

MENOPUR® Versus FOLLISTIM®

Phase 4

Completed

Conditions: Infertility

Interventions: Drug: Menotropin
Drug: Progestrone vaginal insert
Drug: Progesterone in oil
Drug: follitropin beta
Drug: Ganirelix

First Posted Date: 2008-12-04

Last Posted Date: 2011-11-02

Lead Sponsor: Ferring Pharmaceuticals

Target Recruit Count: 173

Registration Number: NCT00802360

Locations: 🇺🇸
A Woman's Center for Reproductive Medicine, Baton Rouge, Louisiana, United States
🇺🇸
Huntington Reproductive Center, Pasadena, California, United States
🇺🇸
Women's Medical Research Group, LLC, Clearwater, Florida, United States

and more 4 locations

Premature Luteinization Prevention by GnRH Antagonist in Patients Undergoing IUI

Completed

Conditions: Infertility

Interventions: Drug: Ganirelix

First Posted Date: 2008-10-28

Last Posted Date: 2015-05-06

Lead Sponsor: IVI Madrid

Target Recruit Count: 662

Registration Number: NCT00780858

Locations: 🇪🇸
IVI-Madrid, Madrid, Spain

A Study to Assess the Efficacy and Safety of Ganirelix (Orgalutran®) Treatment in Chinese Women Undergoing Controlled Ovarian Stimulation for in Vitro Fertilization (IVF) or Intra Cytoplasmatic Sperm Injection (ICSI) (Study 38651)(P05703)

Phase 3

Completed

Conditions: Controlled Ovarian Stimulation

Interventions: Drug: ganirelix
Drug: triptorelin

First Posted Date: 2008-07-30

Last Posted Date: 2022-02-03

Lead Sponsor: Organon and Co

Target Recruit Count: 259

Registration Number: NCT00725491

Monitor the Incidence of Congenital Malformations in Infants of Women Who Have Been Treated With Ganirelix (Orgalutran®)(Study 38644)(P05966)(COMPLETED)

Completed

Conditions: Pregnancy
Neonates

Interventions: Drug: GnRH agonist
Drug: ganirelix

First Posted Date: 2008-07-30

Last Posted Date: 2022-02-03

Lead Sponsor: Organon and Co

Target Recruit Count: 2066

Registration Number: NCT00724789

Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05787 (P05712)

Completed

Conditions: Pregnancy
Neonates

Interventions: Drug: Corifollitropin Alfa 150 μg
Biological: 200 IU RecFSH/Follitropin beta (Days 1 to 7)
Drug: Placebo for RecFSH/Follitropin beta
Drug: Placebo for Corifollitropin Alfa
Biological: 200 IU RecFSH/Follitropin beta (Days 8 to hCG)
Drug: Ganirelix
Biological: hCG
Biological: Progesterone

First Posted Date: 2008-06-20

Last Posted Date: 2022-02-03

Lead Sponsor: Organon and Co

Target Recruit Count: 541

Registration Number: NCT00703014

Follow-up Study of Frozen-thawed Embryo Transfer (FTET) Cycles After Cryopreservation of Embryos in Clinical Trial P05787 (P05716)

Completed

Conditions: In Vitro Fertilization

Interventions: Drug: 150 µg Corifollitropin Alfa
Biological: 200 IU RecFSH/Follitropin beta (Days 1 to 7)
Drug: Placebo for RecFSH/Follitropin beta
Drug: Placebo for Corifollitropin Alfa
Biological: 200 IU RecFSH/Follitropin beta (Days 8 to hCG)
Drug: Ganirelix
Biological: hCG
Biological: Progesterone

First Posted Date: 2008-06-20

Last Posted Date: 2022-02-03

Lead Sponsor: Organon and Co

Target Recruit Count: 344

Registration Number: NCT00702273

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