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Also known as Recombinant human luteinizing hormone (r-hLH)
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 an investigational injectable protein developed by Merck KGaA for the treatment of hypogonadism. It is also known as r-hLH and by the brand name Luveris. It is being studied in women with hypogonadotropic hypogonadism, a condition in which the body produces insufficient hormones that drive ovulation.
Recombinant human luteinizing hormone is being studied for the treatment of hypogonadotropic hypogonadism in women. The completed Phase 3 trial enrolled Chinese women with this condition. Hypogonadotropic hypogonadism involves low gonadotropin levels that impair normal ovarian function, and treatment aims to replace the missing luteinizing hormone.
Recombinant human luteinizing hormone is an exogenous protein that acts on the luteinizing hormone receptor, also known as F9. By binding this receptor, it supplies luteinizing hormone activity that the body is not producing on its own. This mechanism supports gonadal function in patients with hypogonadotropic hypogonadism.
Recombinant human luteinizing hormone is developed by Merck KGaA, which trades under the ticker MKGAF. The product is also known as r-hLH and by the brand name Luveris. Merck KGaA conducted the Phase 3 study of this agent in Chinese women with hypogonadotropic hypogonadism.
Recombinant human luteinizing hormone is in Phase 3 development for hypogonadism. It is investigational and has not been approved for this use. The Phase 3 trial, NCT01084265, has been completed. It was an uncontrolled study that enrolled 31 female participants in China.
Recombinant human luteinizing hormone has been studied in one completed Phase 3 trial, NCT01084265. The trial evaluated r-hLH, also called Luveris, in the treatment of Chinese women with hypogonadotropic hypogonadism. It enrolled 31 female participants in China, was uncontrolled, and is no longer active.