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Org 36286 · 4 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | 150 µg Org 36286 (corifollitropin alfa) |
| Arm 2 | EXPERIMENTAL | 100 µg Org 36286 (corifollitropin alfa) |
| Org 36286 7.5 µg | EXPERIMENTAL | Org 36286 7.5 µg administered as a single subcutaneous injection on the day of the onset of a spontaneous or progestagen induced withdrawal bleeding or one to two days later. |
| Org 36286 15 µg | EXPERIMENTAL | Org 36286 15 µg administered as a single subcutaneous injection on the day of the onset of a spontaneous or progestagen induced withdrawal bleeding or one to two days later. |
| Org 36286 30 µg | EXPERIMENTAL | Org 36286 30 µg administered as a single subcutaneous injection on the day of the onset of a spontaneous or progestagen induced withdrawal bleeding or one to two days later. |
| Org 36286 60 µg | EXPERIMENTAL | Org 36286 60 µg administered as a single subcutaneous injection on the day of the onset of a spontaneous or progestagen induced withdrawal bleeding or one to two days later. |
| Placebo | PLACEBO_COMPARATOR | Placebo to Org 36286 administered as a single subcutaneous injection on the day of the onset of a spontaneous or progestagen induced withdrawal bleeding or one to two days later. |
| Org 36286 120 μg + Puregon® 150 IU | EXPERIMENTAL | On Cycle Day 2 or Day 3, a single intra-abdominal injection of Org 36286 120 μg was administered to participants. On stimulation Day 8, a daily subcutaneous dose of Puregon® 150 IU was administered up to and including the time of Pregnyl® administration as a single dose of 10,000 IU subcutaneously. The maximum treatment duration of Puregon® 150 IU was 19 days. Orgalutran® 0.25 mg was administered subcutaneously once daily up to and including the day of Pregnyl®, when the leading follicle reached a size of \>= 14 mm. |
| Org 36286 180 μg + Puregon® 150 IU | EXPERIMENTAL | Cycle Day 2 or Day 3, a single intra-abdominal injection of Org 36286 180 μg was administered to participants. On stimulation Day 8, a daily subcutaneous dose of Puregon® 150 IU was administered up to and including the time of Pregnyl® administration as a single dose of 10,000 IU subcutaneously. The maximum treatment duration of Puregon® 150 IU was 19 days. Orgalutran® 0.25 mg was administered subcutaneously once daily up to and including the day of Pregnyl®, when the leading follicle reached a size of \>= 14 mm. |
| Org 36286 240 μg + Puregon® 150 IU | EXPERIMENTAL | Cycle Day 2 or Day 3, a single intra-abdominal injection of Org 36286 240 μg was administered to participants. On stimulation Day 8, a daily subcutaneous dose of Puregon® 150 IU was administered up to and including the time of Pregnyl® administration as a single dose of 10,000 IU subcutaneously. The maximum treatment duration of Puregon® 150 IU was 19 days. Orgalutran® 0.25 mg was administered subcutaneously once daily up to and including the day of Pregnyl®, when the leading follicle reached a size of \>= 14 mm. |
| Puregon® 150 IU | ACTIVE_COMPARATOR | On stimulation Day 8, a daily subcutaneous dose of Puregon® 150 IU was administered up to and including the time of Pregnyl® administration as a single dose of 10,000 IU subcutaneously. The maximum treatment duration of Puregon® 150 IU was 19 days. Orgalutran® 0.25 mg was administered subcutaneously once daily up to and including the day of Pregnyl®, when the leading follicle reached a size of \>= 14 mm. |
| Org 36286 15 μg + Lyndiol® | EXPERIMENTAL | After a pill-free period of 7 days, participants took 1 oral tablet of Lyndiol® (50 μg ethinylestradiol + 2.5 mg lynestrenol) daily for a total period of at least 6 weeks to suppress endogenous gonadotropin secretion. After 3 weeks of Lyndiol® intake, participants received a single subcutaneous dose of Org 36286 15 μg. |
| Org 36286 30 μg + Lyndiol® | EXPERIMENTAL | After a pill-free period of 7 days, participants took 1 oral tablet of Lyndiol® (50 μg ethinylestradiol + 2.5 mg lynestrenol) daily for a total period of at least 6 weeks to suppress endogenous gonadotropin secretion. After 3 weeks of Lyndiol® intake, participants received a single subcutaneous dose of Org 36286 30 μg. |
| Org 36286 60 μg + Lyndiol® | EXPERIMENTAL | After a pill-free period of 7 days, participants took 1 oral tablet of Lyndiol® (50 μg ethinylestradiol + 2.5 mg lynestrenol) daily for a total period of at least 6 weeks to suppress endogenous gonadotropin secretion. After 3 weeks of Lyndiol® intake, participants received a single subcutaneous dose of Org 36286 60 μg. |
| Org 36286 120 μg + Lyndiol® | EXPERIMENTAL | After a pill-free period of 7 days, participants took 1 oral tablet of Lyndiol® (50 μg ethinylestradiol + 2.5 mg lynestrenol) daily for a total period of at least 6 weeks to suppress endogenous gonadotropin secretion. After 3 weeks of Lyndiol® intake, participants received a single subcutaneous dose of Org 36286 120 μg. |
| Name | Type | Description |
|---|---|---|
| Org 36286 (corifollitropin alfa) | DRUG | A single dose of Org 36286 will be administered after down-regulation has been confirmed (E2 below 50 ng/L and P below 1.48 μg/L). The first group comprising subjects weighing \>= 50 kg will receive a dose of 150 μg Org 36286 (150 μg dose group). The second group comprising subjects weighing \<= 60 kg will receive a dose of 100 μg Org 36286 (100 μg dose group). |
| Org 36286 | DRUG | Org 36286 single-dose subcutaneous injection |
| Placebo | DRUG | Placebo to Org 36286 as a single-dose subcutaneous injection |
| Puregon® | DRUG | Subcutaneous Puregon® 150 IU |
| Orgalutran® | DRUG | Subcutaneous Orgalutran® 0.25 mg |
| Pregnyl® | DRUG | Subcutaneous Pregnyl® 10,000 IU |
| Lyndiol® | DRUG | Lyndiol® (50 μg ethinylestradiol + 2.5 mg lynestrenol) tablets orally once a day for 6 weeks. |
Inclusion Criteria: * Females of couples with an indication for controlled ovarian stimulation (COS) and IVF or ICSI that have had at least one previous COS cycle with proven normal ovarian response; * \>=18 and \<= 39 years of age at the time of signing informed consent; * a. First group: Body wei...
Org 36286 is an investigational small molecule being developed for infertility and in vitro fertilization (IVF). It is studied for its ability to induce multiple follicular growth during controlled ovarian stimulation for IVF or ICSI, and to induce monofollicular ovulation in women with WHO Group II anovulatory infertility.
Org 36286 is being developed by Organon & Co. (NYSE: OGN). The company is conducting clinical trials to evaluate the drug's safety and efficacy in infertility and IVF treatments.
Org 36286 is in Phase 2 clinical development. It has completed three trials, including one Phase 1 study and two Phase 2 studies, all of which are finished. The drug remains investigational and has not been approved by regulatory authorities.
Org 36286 has completed three clinical trials: NCT00647933, a Phase 1 pharmacokinetic and safety study in healthy women; NCT00702351, a Phase 2 trial for IVF or ICSI; and NCT00702585, a Phase 2 trial for anovulatory infertility. A fourth trial, NCT00702806, also Phase 2, studied multiple follicular growth for IVF.
Org 36286 is also known as corifollitropin alfa. One of its Phase 2 trials, NCT00702351, explicitly tested single-dose corifollitropin alfa's ability to induce multiple follicular growth during the first week of controlled ovarian stimulation for IVF or ICSI.