HMG (Human Menopausal Gonadotropin)

Efficacy and safety were established in one randomised, open-label, multicentre phase 3 trial in ovulatory women undergoing ovarian stimulation for in vitro fertilisation and embryo transfer after pituitary suppression, with 373 randomised to the menotropins arm. The primary efficacy parameter measured was continuing pregnancy, defined as ultrasound visualisation of a gestational sac with fetal heartbeat at ten weeks or more after transfer, reported at 87 of 373. Safety measures recorded ovarian hyperstimulation syndrome in 7.2 per cent of the 373 and multiple pregnancy by ultrasound in 35.3 per cent of pregnancies. Two open-label randomised pharmacokinetic studies in 57 and 33 healthy premenopausal women took follicle-stimulating hormone area under the curve and peak concentration as primary endpoints and measured an elimination half-life of 11 to 13 hours.

What is not established

The label records that human tissue or organ distribution of the two hormones has not been studied for this product, that their metabolism has not been studied in humans, that no drug interaction studies have been conducted, and that safety and efficacy in renal and hepatic insufficiency have not been studied. Long-term animal studies of carcinogenic potential have not been performed.

What distinguishes HMG (Human Menopausal Gonadotropin)

It is not a single molecule. The approved specification is expressed as two separate biological activities rather than a quantity of one substance: 75 international units of follicle-stimulating hormone activity plus 75 international units of luteinising hormone activity per vial, with chorionic gonadotropin additionally detected in the preparation, which the label states. Potency is fixed by two in-vivo rodent bioassays, an ovarian weight gain assay in female rats and a seminal vesicle weight gain assay in male rats, standardised against a World Health Organization reference standard. The source material is post-menopausal urine, not the urine of pregnant people and not a cell culture.

Sources

1. US FDA. MENOPUR (menotropins for injection, USP), approved label, October 2004
2. US FDA. MENOPUR approved label, 2014 revision
3. US FDA. List of approved NDAs for biological products deemed to be BLAs on 23 March 2020
4. European Medicines Agency. Menotropin, nationally authorised, procedure DK/H/0606/01-06/DC
5. World Anti-Doping Agency. 2026 Prohibited List, section S2.2.1

This page describes a compound as a material and summarises published research about it. It is for general and procurement information only. It is not medical advice, not a treatment recommendation, and not guidance on use. Supplied for laboratory and research use, not for human consumption.