Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00702585 | Study to Investigate the Optimal Dose of Org 36286 to Induce Monofollicular Ovulation in Women With WHO Group II Anovulatory Infertility (P07016) | PHASE2 | COMPLETED | 55 | — | — | Aug 1, 2001 | Oct 15, 2002 | Aug 15, 2024 | - | — |
| NCT00702806 | Investigate Dose of Org 36286 to Initiate Multiple Follicular Growth in a Controlled Ovarian Hyperstimulation Protocol for IVF or IVF/ICSI (P07015) | PHASE2 | COMPLETED | 99 | — | — | Jul 1, 2001 | Oct 15, 2002 | Aug 15, 2024 | - | — |
| NCT00647933 | An Open-label, Single Center Trial to Assess the Pharmacokinetics, Pharmacodynamics and Safety of Org 36286 (P07004) | PHASE1 | COMPLETED | 24 | — | — | Jun 1, 2000 | Dec 1, 2000 | Feb 3, 2022 | - | — |
| Arm | Type | Description |
|---|---|---|
| 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 | 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: * Wish to conceive; * Oligomenorrhea (cycle length \>=41 days) or amenorrhea (no menstrual cycle for \>6 months); * Body Mass Index (BMI) \>=18 and \<=32 kg/m\^2; * Serum FSH levels within normal limits (1-10 IU/L); * Normal serum prolactin and thyroid stimulating hormone (TSH) ...