{"slug":"hmg","seoKey":"hmg","inn":"menotropins","displayName":"Menotropin (hMG)","codes":["HP-hMG","hMG","G03GA02"],"synonyms":["hMG","human menopausal gonadotropin","human menopausal gonadotrophin","menotropin","menotrophin","Menotrophin BP","humanes Menopausengonadotropin","hochgereinigtes Menotropin","highly purified human menopausal gonadotropin"],"legalClass":"rx","identifiers":{"unii":"5Y9QQM372Q","drugbankId":"DB00032"},"approvals":[{"market":"US","status":"approved_rx","date":"2004-10-29","note":"Approved and prescription-only, held as a biologics licence since the former application was deemed to be one on 2020-03-23. The single indication is the development of multiple follicles and pregnancy in ovulatory women as part of an assisted reproductive technology cycle; the labelling carries no male indication. Since the same date the substance no longer qualifies for the compounding exemptions for pharmacies and outsourcing facilities, and the regulator names it expressly among the affected bulk substances. Three further menotropin applications are discontinued.","source":"https://www.fda.gov/drugs/human-drug-compounding/notice-compounders-changes-affect-compounding-march-23-2020"},{"market":"EU","status":"approved_rx","date":"2011-06-17","note":"Authorised and prescription-only, but through national procedures only: no centrally authorised product and therefore no European assessment report exists. The date is the Irish authorisation used here as the documented example, classified in the stricter of the two European prescription categories, where a prescription may not be dispensed a second time. CAVEAT: the central-authorisation negative is indirect. The agency's search page answered with HTTP 401 on 2026-09-15; the finding rests on every European licence found carrying a national number. The mutual-recognition procedure number and the reference member state remain unverified.","source":"https://www.hpra.ie/find-a-medicine/for-human-use/authorised-medicines/details/23818"},{"market":"DE","status":"approved_rx","date":"2023-01-19","note":"Authorised and prescription-only. The date is the grant of authorisation for the pen strengths of the nationally licensed product. The prescription-only annex lists gonadotrophin of human and horse serum without any exemption, and lists chorionic gonadotrophin separately, so the substance is caught twice over: through the collective entry and through its hCG content. The German product information restricts use to female infertility and names no male indication, unlike the British one.","source":"https://www.gesetze-im-internet.de/amvv/anlage_1.html"},{"market":"UK","status":"approved_rx","note":"Authorised as a prescription only medicine under licence PL 03194/0074. No date is given because the register exposes no first-authorisation date; the product information carries a revision of 2026-06-03. The indication is broader than in the United States and Germany: besides female infertility it covers hypogonadotropic hypogonadism in men in combination with chorionic gonadotrophin. A full-text search of the compendium on 2026-09-15 found only the four strengths of a single brand and no other menotrophin-containing product.","source":"https://www.medicines.org.uk/emc/product/1294/smpc"},{"market":"AU","status":"scheduled","note":"Prescription only: the Poisons Standard names menotrophin in Schedule 4 without any exemption, carries an index cross-reference from human menopausal gonadotrophin, and additionally lists gonadotrophic hormones as a class except where separately specified. There is NO Appendix D entry, so no restriction on who may prescribe applies, unlike growth hormone releasing peptides. CAVEAT: the register of therapeutic goods timed out after 60 seconds on 2026-09-15, so no individual register numbers exist, and no date is given because the scheduling is far older than the instrument carrying it. The full text was searched on 2026-09-15 with working control queries.","source":"https://www.tga.gov.au/resources/artg"},{"market":"CA","status":"approved_rx","date":"2006-09-19","note":"Authorised and marketed, classified as prescription and, as a biologic drug, additionally under Schedule D. The date is first marketing of the currently marketed product; a second, older menotropin product has been cancelled post market since 2019-04-23 with an expiry date of 2020-04-30.","source":"https://health-products.canada.ca/api/drug/"},{"market":"CH","status":"approved_rx","note":"Authorised and prescription-only in dispensing category A, meaning a single dispensing against a prescription that may not be repeated. The indication covers stimulation of follicular maturation in hypo- or normogonadotropic amenorrhoea, oligomenorrhoea, anovulatory cycles and luteal insufficiency after failure of clomifene, plus multifollicular stimulation in assisted reproduction. CAVEAT: no date is given because no authorisation date could be established. The dispensing category is documented directly from the product information as read on 2026-09-15, but the five-digit authorisation number could not be confirmed from a primary source of the regulator itself; the published number is an article number in barcode form.","source":"https://compendium.ch/product/1169352-menopur-multidos-trockensub-600-ie-c-sol/mpub"}],"devStage":"approved","strongestEvidence":"meta_analysis","wada":{"status":"prohibited","section":"S2.2.1","listYear":2026,"source":"https://www.wada-ama.org/en/prohibited-list"},"trials":[{"nct":"NCT00884221","name":"MEGASET: highly purified hMG versus recombinant FSH in a GnRH antagonist cycle with compulsory single-blastocyst transfer","n":749,"status":"COMPLETED"},{"nct":"NCT02554279","name":"MEGASET-HR: highly purified menotropin versus recombinant FSH in predicted high responders","phase":"Phase 4","n":620,"status":"COMPLETED"},{"nct":"NCT04163458","name":"Liquid versus powder formulation in assisted reproduction","phase":"Phase 3","n":405,"status":"COMPLETED"},{"nct":"NCT00802360","name":"Head-to-head comparison against a recombinant FSH product","phase":"Phase 4","n":173,"status":"COMPLETED"},{"nct":"NCT01703728","name":"Ovarian hyperstimulation syndrome in a cohort of women aged 18 to 36 under HP-hMG","n":455,"status":"COMPLETED"},{"nct":"NCT01202123","name":"Post-marketing surveillance","n":2501,"status":"COMPLETED"},{"nct":"NCT04876300","name":"MEDAM: retrospective data programme","n":11488,"status":"COMPLETED"},{"nct":"NCT07216742","name":"Cumulative live birth with frozen transfers included","phase":"Phase 3","n":659,"status":"RECRUITING"},{"nct":"NCT07340827","name":"Recombinant follitropin alfa plus lutropin alfa versus hMG in Japan","phase":"Phase 3","n":266,"status":"RECRUITING"},{"nct":"NCT01604044","name":"HP-hMG versus recombinant FSH plus recombinant LH","phase":"Phase 1","n":579,"status":"COMPLETED"},{"nct":"NCT03687606","name":"Long-term hCG or hCG plus hMG in men with isolated hypogonadotropic hypogonadism","phase":"Phase 4","n":210,"status":"UNKNOWN"},{"nct":"NCT02458768","name":"Comparison against another highly purified urinary menotropin product","phase":"Phase 4","n":112,"status":"COMPLETED"},{"nct":"NCT01417195","name":"Mixed stimulation protocol","phase":"Phase 4","n":122,"status":"COMPLETED"},{"nct":"NCT00669786","name":"hMG versus recombinant FSH in gonadotrophin-releasing hormone antagonist cycles","phase":"Phase 3","status":"COMPLETED"},{"nct":"NCT02544191","name":"GnRH agonist combined with hCG and hMG in non-obstructive azoospermia","phase":"Phase 2","n":30,"status":"UNKNOWN"}],"sameAs":[],"lastVerified":"2026-09-15","version":"1.0","published":true,"locale":"en","title":"Menotropin (hMG): what the trials show, status and safety","summary":"Menotropin, usually shortened to hMG, is a fertility medicine extracted from the urine of women after the menopause. It carries the activity of two hormones at once, and the second activity comes mostly from added pregnancy hormone hCG. It is prescription-only in all seven markets on this page, and an American biological product since 2020. Pooled trials give it a modest edge over laboratory-made FSH for live birth, at moderate confidence, from a body of evidence in which many of the individual studies were paid for by manufacturers.","updated":"2026-09-15","url":"https://mypep.app/peptides/hmg"}