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Gonalef · 1 trial · 2 indications
Participants were considered to have ovulated if serum progesterone (P4) level was greater than or equal to 5 nanogram (ng)/mL on Day 6±1 or 9±1 during the post-treatment assessment period, or if the participant became clinically pregnant.
| Arm | Type | Description |
|---|---|---|
| SJ-0021 group | EXPERIMENTAL | - |
| Purified pituitary gonadotropin group | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Gonalef® (Follitropin alfa) | DRUG | Subcutaneous administration of follitropin alfa at a dose of 75 IU/day was started on dosing Day 1 and the same daily dose was maintained for the first 7 days of the treatment period. Dose increment by 37.5 IU was permitted on dosing Day 8, Day 15 and Day 22 if the dosage increase criterion was met. |
| Purified pituitary gonadotropin (Fertinorm-P®) | DRUG | Subcutaneous administration of purified pituitary gonadotropin at a dose of 75 IU/day was started on dosing Day 1 and the same daily dose was maintained for the first 7 days of the treatment period. Dose increment by 37.5 IU was permitted on dosing Day 8, Day 15 and Day 22 if the dosage increase criterion was met. |
Inclusion Criteria: * Women aged 20 to 39 years (inclusive) who hope to bear children * Subjects who failed to achieve ovulation or pregnancy despite 2 cycles or more of anti-estrogen therapies (clomiphene citrate, cyclofenil, etc.) * Subjects who exhibited withdrawal bleeding in a progesterone tes...
Gonalef is an investigational small molecule being developed for infertility. It is studied for ovulation induction in infertile women, specifically in a Phase 3 clinical trial. The drug is not approved and remains in clinical development.
Gonalef is being developed by Merck KGaA, a company traded under the ticker MKGAF. The drug is currently in Phase 3 clinical development for infertility.
Gonalef is in Phase 3 clinical development. It is an investigational drug and has not been approved. One Phase 3 trial has been completed, involving 300 participants.
Gonalef has one completed Phase 3 trial, NCT01185782, which compared Gonalef to purified pituitary gonadotropin (Fertinorm-P) for ovulation induction in Japanese infertile women. The trial enrolled 300 female participants aged 20 years and older.
Yes, Gonalef is also known as SJ-0021. The Phase 3 clinical trial NCT01185782 refers to the drug as SJ-0021 (Gonalef) in its title.