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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 in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). It is a small molecule being developed by Organon & Co. for this endocrine indication.
Ganirelix is a gonadotropin-releasing hormone (GnRH) antagonist. It works by blocking GnRH receptors in the pituitary gland, thereby preventing premature ovulation during controlled ovarian stimulation for assisted reproductive technologies.
Ganirelix is being developed by Organon & Co., a company listed on the New York Stock Exchange under the ticker symbol OGN.
Ganirelix is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two clinical trials have been completed, including one Phase 3 study.
Ganirelix has completed two clinical trials: NCT00725491, a Phase 3 study in Chinese women undergoing controlled ovarian stimulation for IVF or ICSI, and NCT00988260, a Phase 2 Japanese bridging trial. Both trials were completed.
Yes, Ganirelix is also known as Orgalutran. The Phase 3 clinical trial NCT00725491 assessed the efficacy and safety of Ganirelix (Orgalutran) treatment in women undergoing controlled ovarian stimulation.