Human chorionic gonadotropin

A glycoprotein hormone purified from the urine of pregnant women. Licensed in the United States for prepubertal cryptorchidism, selected cases of hypogonadotropic hypogonadism in males, and induction of ovulation in anovulatory infertile women pretreated with menotropins. Originally approved as a drug in 1974, it was administratively deemed a biologic under the BPCI Act in March 2020, so no generic ANDA versions exist and compounded hCG is no longer lawfully produced. The label states explicitly that it has not been shown effective as adjunctive therapy for obesity.

hCG binds the LH/hCG receptor and reproduces the actions of luteinising hormone. In males it stimulates Leydig cell production of testosterone within the testis; in females it triggers final follicular maturation, ovulation and luteinisation after adequate follicular development has been achieved.

Yes. Human chorionic gonadotropin is approved by the U.S. FDA and has official prescribing information. Evidence level: approved labeling. Official prescribing information exists, based on clinical trials in people.

Reported half-life: Not stated in any US label for urinary-derived hCG. Human data for the urinary product given intramuscularly show a biphasic decline with an initial-phase half-life of roughly 5.6 to 11 hours and a terminal-phase half-life of about 23 hours. For comparison, the recombinant product choriogonadotropin alfa (Ovidrel), which is a different molecule given subcutaneously, has a labeled mean terminal half-life of about 29 hours after subcutaneous and 26.5 hours after intravenous administration. The recombinant subcutaneous figures should not be applied to the urinary intramuscular product.

Intramuscular injection.

Reported in the sources: Contraindicated in precocious puberty, in prostatic carcinoma or other androgen-dependent neoplasm, and in patients with a prior allergic reaction to hCG. hCG may cause fetal harm and should not be used in pregnancy; Ovarian hyperstimulation syndrome with sudden ovarian enlargement, ascites with or without pain and/or pleural effusion, and rupture of ovarian cysts with resulting hemoperitoneum, when used with menotropins; Arterial thromboembolism, and multiple births with the associated maternal and fetal risks; Anaphylaxis has been reported with urinary-derived hCG products; localised and systemic hypersensitivity reactions including angioedema and dyspnea have occurred; Induction of precocious puberty in pediatric patients treated for cryptorchidism, in which case treatment is to be discontinued. Not indicated in children under 4 years of age; Headache, irritability, restlessness, depression, fatigue, edema, gynecomastia and injection site pain; androgen-induced fluid retention warrants caution in cardiac or renal disease, epilepsy, migraine and asthma; The supplied diluent contains benzyl alcohol and is not for use in newborns; benzyl alcohol has been associated with fatal gasping syndrome in neonates. hCG is measured by pregnancy tests and can interfere with interpretation of pregnancy test results. Caution is advised in nursing mothers; NOT effective for obesity or weight loss. The US labels state, in bold capitals within Indications and Usage, that hCG has not been demonstrated to be effective adjunctive therapy in the treatment of obesity, that there is no substantial evidence it increases weight loss beyond that from caloric restriction, that it causes a more attractive or normal distribution of fat, or that it decreases hunger or discomfort from calorie-restricted diets. FDA has separately acted against compounded and over-the-counter hCG marketed for weight loss; Off-label use alongside or after testosterone therapy to preserve testicular function or fertility is common in practice but is NOT a US labeled indication and is not an established benefit. The strongest controlled human evidence is a randomized study in 29 men with normal reproductive physiology given testosterone enanthate plus placebo or low-dose hCG for 3 weeks (Coviello et al., J Clin Endocrinol Metab 2005), whose endpoint was intratesticular testosterone measured by testicular aspiration — a short-term surrogate marker. It did not measure sperm concentration, fertility, testicular volume or any clinical outcome, and it did not study men on long-term testosterone therapy. Claims about preserving testicular volume or fertility rest on uncontrolled series. No labeled dosing exists for this use.