Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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, also known as corifollitropin alfa or Org 36286, is used for infertility. It is being studied in women undergoing controlled ovarian stimulation as part of infertility treatment.
SCH 900962 is a monoclonal antibody, but its specific molecular target has not been disclosed. It is being investigated for its role in controlled ovarian stimulation for infertility treatment.
SCH 900962 is being developed by Organon & Co., a company traded under the ticker OGN on the stock market.
SCH 900962 is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities.
SCH 900962 has one completed Phase 3 trial, NCT01144416, which studied a single injection of SCH 900962 versus daily recFSH injections in 1,424 women undergoing controlled ovarian stimulation.
Yes, SCH 900962 is also known as corifollitropin alfa and Org 36286. These names refer to the same investigational drug being developed for infertility.