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Also known as MK-8962
SCH 900962/ Corifollitropin alfa/ Org 36286 · 1 trial · 1 indication
Vital pregnancy was defined as the presence of at least 1 fetus with heart activity at least 35 days (≥5 weeks) after embryo transfer in the controlled ovarian stimulation (COS) treatment cycle
| Arm | Type | Description |
|---|---|---|
| Single injection of 150 µg SCH 900962 (MK-8962) | EXPERIMENTAL | Participants received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recFSH from Stimulation Days 1-7 |
| Daily 300 IU recFSH | ACTIVE_COMPARATOR | Participants received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of recFSH from Stimulation Days 1-7 |
| Name | Type | Description |
|---|---|---|
| SCH 900962 / Corifollitropin alfa / Org 36286 | BIOLOGICAL | SCH 900962 will be provided as ready-for-use prefilled syringes containing 150 μg corifollitropin alfa per 0.5 mL. On day 2 or 3 of the menstrual cycle, a single dose of 150 μg corifollitropin alfa will be administered by subcutaneous injection in the abdominal wall in the morning. |
| RecFSH / follitropin beta | BIOLOGICAL | RecFSH will be provided as a ready-for-use solution in 900 IU cartridges for subcutaneous injection with the Follistim Pen. Starting on day 2 or 3 of the menstrual cycle (=Stimulation Day 1), administration of recFSH will be done in the morning by daily injections in the abdominal wall. A starting dose of 300 IU will be administered and fixed for at least 7 days. |
| Placebo for SCH 900962 | DRUG | Supplied as a pre-filled syringe containing an identical solution when compared to SCH 900962, however without the active ingredient corifollitropin alfa. On Day 2 or 3 of the menstrual cycle (=Stimulation Day 1), a single dose of placebo SCH 900962 is to be administered in the morning by subcutaneous injection in the abdominal wall. |
| Placebo for recFSH | DRUG | Supplied as identical ready-for-use solution, but without the active ingredient, in cartridges for subcutaneous injection with the Follistim Pen. Starting on day 2 or 3 of the menstrual cycle (=Stimulation Day 1), administration of placebo-recFSH will be done by daily injections in the abdominal wall in the morning for a period of 7 days. |
Inclusion Criteria: * Willing and able to provide written informed consent for trial P06029 as well as for the Frozen-Thawed Embryo Transfer (FTET) follow-up trial P06031, and for the pharmacogenetic analysis (if applicable). * Female and \>=35 to \<=42 years of age with indication for COS and IVF/...
SCH 900962 is being developed for infertility. It is studied in women undergoing controlled ovarian stimulation, where it is given as a single injection and compared with daily recombinant FSH injections. The program is led by Organon & Co. and has reached Phase 3 clinical development.
SCH 900962 is developed by Organon & Co., which trades on the New York Stock Exchange under the ticker OGN. The compound is also known as corifollitropin alfa and Org 36286, and it is being studied in the infertility therapeutic area.
SCH 900962 is in Phase 3 clinical development. It is an investigational agent and is not described as approved. One Phase 3 trial has been completed, and no trials are currently listed as active.
SCH 900962 has been evaluated in the Phase 3 trial NCT01144416, titled Efficacy and Safety Study of a Single Injection of SCH 900962 Versus Daily recFSH Injections in Women Undergoing Controlled Ovarian Stimulation (Study P06029). The trial is completed and enrolled 1,424 participants.
NCT01144416 was a randomized, double-blind, active-controlled Phase 3 trial in infertility. It enrolled 1,424 women aged 35 years and older and compared a single injection of SCH 900962 with daily recombinant FSH injections during controlled ovarian stimulation. The study is completed.
Yes. SCH 900962, corifollitropin alfa, and Org 36286 are alternative names for the same investigational drug, which Organon & Co. is developing for infertility. Searches for any of these names refer to the same Phase 3 asset.