Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Gonalef® (Follitropin alfa), follitropin alfa, recombinant human follicle-stimulating hormone, r-hFSH, SJ-0021
Gonalef · 2 trials · 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 | - |
| r-hLH (825 International Units [IU]) | EXPERIMENTAL | - |
| r-hLH (2750 IU) | EXPERIMENTAL | - |
| r-hLH (5500 IU) | EXPERIMENTAL | - |
| r-hLH (11000 IU) | EXPERIMENTAL | - |
| r-hLH (22000 IU) | EXPERIMENTAL | - |
| u-hCG (5000 IU) | 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. |
| r-hFSH | DRUG | Daily r-hFSH treatment will be administered subcutaneously at a starting dose according to the site's standard practice from Day 3-5 of menstrual cycle up to follicular development or 28 days. Dose can be altered according to ovarian response (reduced to 75 IU/day; increased to 225 IU/day). |
| r-hLH | DRUG | Ovulation triggering will be performed using a single injection of r-hLH injection subcutaneously at a dose of 825 or 2750 or 5500 or 11,000 or 22,000 IU as soon as follicles satisfy the criteria for follicular development, that is at least 1 follicle with diameter \>= 18 mm, not more than 5 follicles with diameter \>= 15 mm and with E2 levels less than 9000 picomoles per liter (pmol/L). |
| u-hCG | DRUG | Ovulation triggering will be performed using a single injection of 5000 IU of u-hCG as soon as follicles satisfy the criteria for follicular development, that is at least 1 follicle with diameter \>= 18 mm, not more than 5 follicles with diameter \>= 15 mm and with E2 levels less than 9000 picomoles per liter (pmol/L). |
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 infertility treatment developed by Merck KGaA. It is also known as Gonalef (Follitropin alfa). It was studied for ovulation induction in infertile women, specifically in a Phase 3 trial conducted in Japan. The trial compared Gonalef with purified pituitary gonadotropin for ovulation induction.
Gonalef is used for ovulation induction in infertile women. Its Phase 3 trial enrolled Japanese infertile women aged 20 years and older for ovulation induction. The condition studied was infertility, with ovulation induction as the specific treatment goal. Gonalef is not indicated for male infertility based on the available trial data.
Gonalef is developed by Merck KGaA, which trades under the ticker MKGAF. Merck KGaA sponsored the Phase 3 clinical trial evaluating Gonalef for ovulation induction in Japanese infertile women. The company is the developer and manufacturer associated with the Gonalef brand.
Gonalef has completed a Phase 3 clinical trial. The trial, NCT01185782, was an active-controlled study comparing Gonalef with purified pituitary gonadotropin for ovulation induction. It enrolled 300 participants and is listed as completed. Gonalef remains an investigational product in clinical development based on the available information.
Gonalef has been studied in one completed Phase 3 trial, NCT01185782. The trial was titled SJ-0021 (Gonalef) Versus Purified Pituitary Gonadotropin (Fertinorm-P) for Ovulation Induction in Japanese Infertile Women. It was randomized, active-controlled, enrolled 300 female participants aged 20 years and older, and was conducted in Japan.
Gonalef is also known as Gonalef (Follitropin alfa). Follitropin alfa is the active ingredient name associated with the Gonalef brand. Readers searching for either Gonalef or Follitropin alfa are referring to the same Merck KGaA infertility product studied for ovulation induction in Japanese infertile women.