Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Follitropin alfa/lutropin alfa · 1 trial · 1 indication
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 | - |
| 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. |
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/lutropin alfa is used for infertility. It is being studied in Japanese participants with LH and FSH deficiency undergoing assisted reproductive technology (ART). The drug is currently in Phase 3 clinical development and is investigational, meaning it has not yet been approved by regulatory authorities.
Follitropin alfa/lutropin alfa is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company is conducting a Phase 3 clinical trial to evaluate the drug's efficacy and safety in patients with infertility.
Follitropin alfa/lutropin alfa is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. The ongoing Phase 3 trial is actively recruiting participants to assess the drug's safety and efficacy.
Follitropin alfa/lutropin alfa is being studied in one Phase 3 clinical trial with the identifier NCT07340827. The trial, titled HINATA, compares follitropin alfa/lutropin alfa versus hMG in Japanese participants with LH and FSH deficiency undergoing ART. It is actively recruiting and has an enrollment of 266 participants.
Yes, Follitropin alfa/lutropin alfa is also known as MBJ-0011. This alternative name may be used in clinical or research contexts. The drug is being developed by Merck & Company, Inc. for the treatment of infertility.