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Label indication Ganirelix Acetate Injection is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation. FDA label
Also known as Orgalutran®, Org 37462, SCH 900761, Ganirest
Ganirelix · 2 trials · 1 indication
The hCG criterion is met the first day that 3 follicles \>= 17 mm are observed.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | ganirelix |
| 2 | ACTIVE_COMPARATOR | triptorelin |
| Ganirelix 0.125 mg | EXPERIMENTAL | - |
| Ganirelix 0.25 mg | EXPERIMENTAL | - |
| Ganirelix 0.5 mg | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| ganirelix | DRUG | On day 6 of recFSH treatment, Org 37462 treatment will start by daily SC administration (0.25 mg) up to and including the day of hCG administration. |
| triptorelin | DRUG | a daily dose of 0.05 mg SC is to be injected. Triptorelin treatment will start in the luteal phase at day 21-24 of the menstrual cycle. Treatment with recFSH will start 14 days later if treatment with triptorelin has resulted in downregulation, i.e. serum E2 \<= 50 pg/ml (\<= 200pmol/l). In case the hypogonadotropic state is not reached after 14 days of pretreatment, the dose of triptorelin will be increased to 0.1 mg. If downregulation is not reached within 28 days of pre-treatment with triptorelin, the subject will be discontinued from further hormonal treatment. The daily dose of triptorelin is sustained up to and including the day of hCG. |
Inclusion Criteria: * females of infertile couples for whom COS and IVF or ICSI is indicated * body mass index between 18 and 29 kg/m2 * willing and able to give written informed consent. Exclusion Criteria: * More than three previous COS cycles for assisted reproduction since last established on...
Ganirelix is used for controlled ovarian stimulation in women undergoing fertility treatment, including in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). It is studied in women aged 18 and older and is given as part of a controlled ovarian stimulation regimen to support egg maturation before retrieval.
Ganirelix targets the gonadotropin-releasing hormone receptor, or GNRHR, acting as an antagonist. By blocking this receptor, it suppresses premature luteinizing hormone surges during controlled ovarian stimulation, which helps prevent early ovulation while ovarian follicles are being stimulated for IVF or ICSI procedures.
Ganirelix is developed by Organon & Co., which trades under the ticker OGN. The company is associated with the clinical development program for the drug in controlled ovarian stimulation, including the Phase 3 study conducted in Chinese women undergoing fertility treatment.
Ganirelix has been evaluated in Phase 3 clinical development for controlled ovarian stimulation. Two completed trials are recorded, one Phase 2 Japanese bridging study and one Phase 3 study in Chinese women, with no active trials currently listed. It is an investigational agent in this development context.
Ganirelix has been studied in two completed trials. NCT00725491 was a Phase 3 study of Ganirelix (Orgalutran) in Chinese women undergoing controlled ovarian stimulation for IVF or ICSI, enrolling 259 participants. NCT00988260 was a Phase 2 Japanese bridging trial of Org 37462 enrolling 266 participants.
Ganirelix is also known as Orgalutran, the brand name used in the Phase 3 study NCT00725491. The trial title refers to Ganirelix (Orgalutran) treatment in Chinese women undergoing controlled ovarian stimulation for in vitro fertilization or intracytoplasmic sperm injection, confirming they are the same drug.