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

Protocol with Progestin-primed Ovarian Stimulation (PPOS) from the Beginning of Stimulation Versus Protocol with GnRH Antagonists for Ovarian Stimulation in Patients Undergoing DUOSTIM with Embryo Accumulation for PGT-A.

Phase 4

Not yet recruiting

Conditions: Stimulation in the Ovary
Embryo
Oocyte
Oocyte Retrieval
Fertilization in Vitro
Blastocyst
PGT-A

Interventions: Drug: Medroxyprogesterone Acetate 10 MG
Drug: Ganirelix

First Posted Date: 2024-10-11

Last Posted Date: 2024-10-14

Lead Sponsor: Ginefiv

Target Recruit Count: 144

Registration Number: NCT06637189

To Investigate Efficacy and Safety of a Single Injection of GenSci094 for Ovarian Stimulation Using Daily Recombinant FSH as Reference

Phase 3

Completed

Conditions: Infertility

Interventions: Drug: GenSci094
Drug: Placebo GenSci094
Biological: RecFSH / Follitropin alfa (Days 8 to hCG)
Drug: Placebo RecFSH / follitropin alfa
Biological: hCG
Drug: Ganirelix
Drug: Progesterone

First Posted Date: 2023-10-19

Last Posted Date: 2024-12-03

Lead Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

Target Recruit Count: 176

Registration Number: NCT06091436

Locations: 🇨🇳
The Sixth Affiliated Hospital, Sun Yat-sen University Guangdong Gastrointestinal Hospital, Guangzhou, Guangdong, China

Sub-therapeutic GnRH- Antagonist Treatment to Rectify LH Pulsatility in Lean Women With PCOS.

Early Phase 1

Not yet recruiting

Conditions: Polycystic Ovary Syndrome

Interventions: Drug: Ganirelix

First Posted Date: 2023-03-02

Last Posted Date: 2023-03-02

Lead Sponsor: University Hospital, Lille

Target Recruit Count: 20

Registration Number: NCT05751252

Hormonal Mechanisms of Sleep Restriction - Axis Study in Older Men and Postmenopausal Women

Early Phase 1

Active, not recruiting

Conditions: Sleep Restriction

Interventions: Drug: Gonadorelin (also known as Lutrepulse)
Drug: Ketoconazole Pill (also known as nizoral)
Drug: Ganirelix
Drug: Dexamethasone injection
Drug: Dexamethasone Pill
Drug: Hydrocortisone Injection (also known as solu-cortef)
Drug: Placebo oral tablet
Drug: Cosyntropin Injectable Product
Drug: Saline Solution
Drug: Corticorelin (also known as Acthrel)
Drug: Recombinant Human Luteinizing Hormone (also known as luveris)
Drug: Saline solution for injection

First Posted Date: 2019-07-30

Last Posted Date: 2023-11-07

Lead Sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Target Recruit Count: 5

Registration Number: NCT04037605

Locations: 🇺🇸
Los Angeles Biomedical Research Institute, Torrance, California, United States

Effectiveness of Estradiol Valerate Pretreatment in Antagonist Protocol for Poor Ovarian Response Patient

Not Applicable

Completed

Conditions: Infertility

Interventions: Drug: Follitropin Beta;MSD
Drug: Ganirelix
Drug: hCG
Drug: estradiol valerate

First Posted Date: 2017-10-03

Last Posted Date: 2022-01-11

Lead Sponsor: Reproductive & Genetic Hospital of CITIC-Xiangya

Target Recruit Count: 552

Registration Number: NCT03300518

Locations: 🇨🇳
Reproductive & Genetic Hospital of Citic-Xiangya, Changsha, Hunan, China

Hormonal Mechanisms of Sleep Restriction - Axis Study

Phase 1

Active, not recruiting

Conditions: Sleep Restriction

Interventions: Drug: Gonadorelin
Drug: Ganirelix
Drug: Ketoconazole Pill
Drug: Dexamethasone Injection
Drug: Corticorelin
Drug: Hydrocortisone Injection
Drug: Dexamethasone
Drug: Placebo oral capsule
Drug: Cosyntropin Injectable Product
Drug: Saline Solution
Drug: Recombinant Human Luteinizing Hormone
Drug: Saline Solution for Injection

First Posted Date: 2017-05-08

Last Posted Date: 2024-04-23

Lead Sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Target Recruit Count: 80

Registration Number: NCT03142893

Locations: 🇺🇸
Los Angeles Biomedical Research Institute, Torrance, California, United States

Effectiveness and Safety Study of Fixed Versus Flexible of Gonadotropin-releasing Hormone Antagonist Protocol

Not Applicable

Conditions: Infertility

Interventions: Drug: Follitropin Beta
Drug: Ganirelix
Drug: rhCG
Drug: triptorelin

First Posted Date: 2015-12-21

Last Posted Date: 2015-12-21

Lead Sponsor: Chong Qing Reproducive and Genetic Institute

Target Recruit Count: 200

Registration Number: NCT02635607

Efficacy of Recombinant FSH/GnRH Antagonist Protocol With and Without LH Adjunct for Egg Bank Donation

Phase 4

Completed

Conditions: Egg Donation

Interventions: Drug: Follistim
Drug: Ganirelix
Drug: Menotropins
Drug: Leuprolide
Procedure: Transvaginal ultrasound guided needle aspiration of oocytes

First Posted Date: 2014-02-24

Last Posted Date: 2018-03-23

Lead Sponsor: Michigan Reproductive Medicine

Target Recruit Count: 38

Registration Number: NCT02069808

Locations: 🇺🇸
Michigan Reproductive Medicine, Bloomfield Hills, Michigan, United States

Corifollitropin Alfa Followed by Menotropin for Poor Ovarian Responders Trial

Phase 3

Completed

Conditions: Poor Ovarian Response
Infertility

Interventions: Drug: recombinant FSH
Drug: Corifollitropin alfa
Drug: Ganirelix
Drug: hp HMG

First Posted Date: 2013-03-22

Last Posted Date: 2016-06-23

Lead Sponsor: Universitair Ziekenhuis Brussel

Target Recruit Count: 150

Registration Number: NCT01816321

Locations: 🇧🇪
Universitair Ziekenhuis Brussel, Brussels, Belgium
🇻🇳
University of Medicine and Pharmacy of Ho Chi Minh City, Ho Chi Minh City, Vietnam

Evolutive Potential of Embryos Obtained From Oocytes After Luteal Phase Ovarian Stimulation

Not Applicable

Completed

Conditions: INFERTILITY
Vitrification
Oocyte Donation
Ovulation Induction
Fertility Preservation

Interventions: Drug: gonadotropins plus GnRH antagonists
Drug: ganirelix

First Posted Date: 2012-07-20

Last Posted Date: 2014-10-27

Lead Sponsor: Institut Universitari Dexeus

Target Recruit Count: 15

Registration Number: NCT01645241

Locations: 🇪🇸
Departamento de Obstetricia Ginecologia y Reproducción. Institut Universitari Dexeus, Barcelona, Spain

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