Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Test: Follitropin alfa · 3 trials · 3 indications
Mean number of oocytes retrieved will be calculated. Oocyte retrieval was a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body.
| Arm | Type | Description |
|---|---|---|
| Arm 1: Follitropin alfa/lutropin alfa | EXPERIMENTAL | Participants will receive fixed combination product of recombinant Follitropin alfa (rechFSH)/lutropin alfa (rechLH) in a 2:1 ratio. |
| Arm 2: Human Menopausal Gonadotropin (hMG) | ACTIVE_COMPARATOR | - |
| Group 1: Japanese Female Participants | EXPERIMENTAL | - |
| Group 2: Caucasian Female Participants | EXPERIMENTAL | - |
| Sequence 1 | EXPERIMENTAL | Participants will receive Test follitropin alfa in Period 1 followed by Reference follitropin alfa in Period 2. |
| Sequence 2 | EXPERIMENTAL | Participants will receive reference follitropin alfa in Period 1 followed by test follitropin alfa in Period 2. |
| Name | Type | Description |
|---|---|---|
| Follitropin alfa/lutropin alfa (MBJ-0011) | COMBINATION_PRODUCT | Follitropin alfa and lutropin alfa will be administered subcutaneously once daily with a starting dose of 150 International Unit (IU) of follitropin alfa, 75 IU of lutropin alfa, in ovarian stimulation up to 18 days. |
| hMG | DRUG | Participants will receive 150 IU as solvent, subcutaneously, for solution for injection, daily (up to 18 days) during ovarian stimulation. |
| Cetrorelix acetate | DRUG | Participants will receive 250 micrograms (mcg) of Cetrorelix acetate as Powder for reconstitution to a solution for injection with diluent in ampule, daily from Day 5 or 6 of stimulation up to the day of r-hCG. |
| Coriogonadotropin alfa | DRUG | Participants will receive 250 mcg of r-hCG, as solution for injection, subcutaneously, during final follicular maturation. |
| Progesterone gel | DRUG | Participants will self-administer progesterone gel 8 percent, with an applicator, at a dose of 90 milligram (mg), intravaginally, daily from oocyte retrieval during Luteal phase support. |
| Desogestrel and ethinylestradiol fixed dose combination | DRUG | Participants will self-administer one tablet of desogestrel and ethinylestradiol fixed dose combination once daily to ensure downregulation. |
| Follitropin alfa/lutropin alfa | COMBINATION_PRODUCT | Participants will receive a combination product of follitropin alfa and lutropin alfa subcutaneously (SC) on Day 1 after confirmation of down regulation. |
| Test: Follitropin alfa | COMBINATION_PRODUCT | It is a solution for injection in prefilled pen. Participants will receive follitropin alfa on Day 1 in Study Period 1 or Study Period 2. A washout period of at least 23 days will be maintained between period 1 and 2. |
| Reference: Follitropin alfa | DRUG | It is a powder and diluent for solution for injection in multidose vial. Participants will receive follitropin alfa on Day 1 in Study Period 1 or Study Period 2. A washout period of 23 days will be maintained between period 1 and 2. |
| Zoladex | DRUG | It is a auxiliary medicinal product. Participants will receive Zoladex injection on Day -11 in down regulation period, and on Day 17 prior to the start of Period 2. |
Inclusion Criteria: * Participants who are premenopausal wishing to conceive * Participants with maximum 1 previous stimulation for assisted reproductive technology (ART) without pregnancy * Japanese Participants * Participants are women with Luteinizing hormone (LH) and Follicle stimulating hormon...
Follitropin alfa is used in fertility treatment and assisted reproductive technology, and it is also studied in hypogonadism and infertility. In the HINATA study it is being evaluated in Japanese participants with LH and FSH deficiency undergoing assisted reproductive technology. It is given as part of controlled ovarian stimulation protocols.
Follitropin alfa is being developed by Merck KGaA, which trades under the ticker MKGAF. The company is running clinical studies of the follitropin alfa/lutropin alfa combination, including the Phase 3 HINATA trial in Japan and earlier Phase 1 studies in the United Kingdom and the United States.
Follitropin alfa is investigational and remains in clinical development. The follitropin alfa/lutropin alfa combination is in a Phase 3 trial, NCT07340827, which is currently recruiting in Japan. Two Phase 1 studies, NCT07269327 and NCT07097259, have been completed.
Follitropin alfa has been studied in three trials. NCT07340827 is a recruiting Phase 3 study of follitropin alfa/lutropin alfa versus hMG in Japanese participants with LH and FSH deficiency undergoing ART. NCT07269327 and NCT07097259 are completed Phase 1 studies in healthy premenopausal women and healthy downregulated men.
Across the three listed trials, total enrollment is 266 participants. The Phase 3 HINATA study, NCT07340827, accounts for 266 participants and is recruiting in Japan. The completed Phase 1 studies enrolled 24 participants in the United Kingdom and 55 participants in the United States.