Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Recombinant human luteinizing hormone · 1 trial · 1 indication
The three indices were defined as; Index 1: diameter of at least one follicle is greater than 17 mm; Index 2: serum oestradiol (E2) level in blood serum above 109 picogram/ milliliter (pg/mL) on human chorionic gonadotropin (hCG) injection day; Index 3: participant refuses to take hCG injection for the concern of ovarian hyperstimulation syndrome (OHSS) or participant is pregnant. A subset of these participants met Index 3.
Participant refused to take hCG injection for the concern of OHSS or the participant was pregnant.
| Name | Type | Description |
|---|---|---|
| Recombinant human luteinizing hormone (r-hLH) | DRUG | One r-hLH (75 International Units \[IU\]) injection s.c. once daily. |
| Recombinant human follicle-stimulating hormone (r-hFSH) | DRUG | One r-hFSH (150 IU) injection s.c. once daily. |
| Human chorionic gonadotropin (hCG) | DRUG | After adequate follicular response, ovulation induction was triggered by an injection of 10,000 IU hCG. |
Inclusion Criteria: * Be premenopausal, between 18 and 39 years of age * Have a clinical history of hypogonadotropic hypogonadism, and laboratory test result comply with diagnosis of hypogonadotropic hypogonadism during screening procedure * Have discontinued gonadotropins, gonadotropin-releasing h...
Recombinant human luteinizing hormone is used for the treatment of hypogonadism, specifically hypogonadotropic hypogonadism in women. It is being developed as a therapeutic option for this endocrine condition, with clinical studies conducted in Chinese women.
Recombinant human luteinizing hormone is being developed by Merck KGaA, a pharmaceutical company traded under the ticker MKGAF. The company is conducting clinical research on this drug for the treatment of hypogonadism.
Recombinant human luteinizing hormone is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial for this drug has been completed.
Recombinant human luteinizing hormone has one completed Phase 3 clinical trial, identified as NCT01084265. This study evaluated the drug in 31 Chinese women with hypogonadotropic hypogonadism. The trial was uncontrolled and not randomized or double-blinded.
Yes, recombinant human luteinizing hormone is also known as Luveris. The clinical trial NCT01084265 used the brand name Luveris in its title, confirming that these names refer to the same drug product.