Menotropins (hMG): Mixture Identity, Activity Units, Human Evidence, and FDA Product Boundary

Menotropins are an activity-standardized mixture

Menotropins, also called human menopausal gonadotropin or hMG, are not one small molecule with one simple molecular mass. FDA’s substance registry classifies menotropins as a mixture and identifies follitropin and luteinizing hormone as required components.[3]

The current MENOPUR label describes its menotropins as extracted from the urine of postmenopausal women and further purified. It lists 75 International Units of follicle-stimulating hormone activity and 75 International Units of luteinizing hormone activity for the named presentation, and it states that hCG is detected in the product.[1]

This page summarizes mixture identity, activity measurement, human evidence, and current U.S. regulatory records. It does not provide medical advice or instructions for using any substance.

Identity and composition at a glance

The presence of a UNII identifies a substance record. It does not approve a product, verify a lot, or establish that an unlabeled powder matches MENOPUR.

Why “75 IU” and “75 mg” describe different things

The current MENOPUR label assigns two activities: 75 IU of FSH activity and 75 IU of LH activity.[1] These values are established using biological assays and standardized against WHO international standards. They are not masses of purified FSH and LH.

The same finished-product label separately lists 21 mg of lactose monohydrate. That excipient mass illustrates why the weight of the material in a container is not the same as the amount of each gonadotropin activity. A “75 mg” label could refer to total powder, an excipient-rich formulation, protein mass, a supplier specification, or a unit transcription error; the number alone cannot resolve which.

For a menotropins research material, a useful specification would have to separate:

• FSH biological activity and its assay/reference;
• LH biological activity and its assay/reference;
• the presence and contribution of hCG;
• total protein, component mass, and total powder mass;
• biological source and purification basis;
• excipients and lot-linked composition.

Evidence label: Official product and identity records. F, unresolved for any catalog material described only as “HMG 75 mg.”

What did the comparative MENOPUR study find?

The current label summarizes a randomized, open-label, multicenter study in an assisted-reproduction setting. It reports 373 participants randomized to MENOPUR and identifies continuing pregnancy as the primary efficacy parameter. MENOPUR was noninferior to comparator recombinant human FSH on that endpoint.[1]

Noninferiority is not superiority. The label also states that clinical pregnancy was a secondary parameter and that the study was not powered to demonstrate a difference in that outcome.[1] These limits prevent a claim that the study proved broadly better reproductive outcomes.

Evidence tier: B, Human evidence for the named MENOPUR product, studied population, protocol, comparator, and continuing-pregnancy endpoint. F, unsupported for superiority or transfer to an unverified hMG material.

Negative, null, and unmeasured findings

The official record leaves important questions unanswered:

• The pivotal comparison supported noninferiority, not superiority.[1]
• Clinical pregnancy was secondary, and the study was not powered to establish a difference in that outcome.[1]
• Human tissue or organ distribution of the FSH and LH components was not studied for MENOPUR.[1]
• Metabolism of the FSH and LH components was not studied for MENOPUR in humans.[1]
• Long-term animal studies evaluating carcinogenic potential were not performed.[1]

“Not studied” is different from “shown safe” or “shown ineffective.” These gaps should remain explicit and should not be converted into fertility, hormone-optimization, performance, or wellness claims.

Current U.S. FDA status

MENOPUR is listed in FDA’s Purple Book as a licensed prescription biological product with the proper name menotropins, a 75 IU strength presentation, and BLA 021663.[2] Its approval and current label are tied to the named finished product, manufacturing record, presentation, and defined assisted-reproduction scope.[1][2]

That status does not attach to:

• the abbreviations hMG or HMG;
• every urinary gonadotropin mixture;
• an uncharacterized research vial;
• a product labeled by mass rather than component activities;
• a material claiming similarity to MENOPUR without a recognized regulatory determination.

FDA’s GSRS entry identifies the menotropins substance mixture but states that UNII availability does not imply approval.[3]

Status checked: August 27, 2026.

Important evidence limitations

• Menotropins are a mixture, not one defined peptide with a single mass.
• FSH and LH activities need separate values and traceable assay references.
• hCG may contribute to the labeled preparation and should not be hidden by the generic term hMG.
• Total powder mass, protein mass, component mass, and biological activity are different fields.
• Evidence for MENOPUR does not identify, validate, or establish performance of another material.
• The cited comparative study does not support a superiority claim.
• This page does not assess the identity, purity, sterility, stability, or suitability of a catalog lot.

Frequently asked questions

What does hMG mean?

hMG commonly means human menopausal gonadotropin, another name for menotropins. FDA classifies menotropins as a mixture with follitropin and luteinizing-hormone components.[3]

Is menotropins a single peptide?

No. It is a biologically sourced mixture characterized by multiple gonadotropin components and activities. Treating it as one peptide obscures composition and assay requirements.

Does MENOPUR contain “75 mg” of menotropins?

The current MENOPUR presentation cited here is labeled with 75 IU FSH activity and 75 IU LH activity, not 75 mg of active menotropins.[1][2] Its label separately lists excipient mass, including 21 mg lactose monohydrate.

Are FSH activity and LH activity the same measurement?

No. They are separate biological activities with their own assay and reference requirements. Both should be reported for a menotropins material.

Did the MENOPUR trial show it was superior to recombinant FSH?

No. The current label describes a noninferiority result for continuing pregnancy. It also says the clinical-pregnancy secondary endpoint was not powered to demonstrate a difference.[1]

Does MENOPUR approval make all hMG products FDA-approved?

No. FDA approval applies to the named finished product under BLA 021663, not the abbreviation hMG or another seller’s material.

Does this page provide instructions for menotropins use?

No. It intentionally excludes dosing, administration, reconstitution, treatment, monitoring, and self-use guidance.

Related research-library reading

• Human Chorionic Gonadotropin (hCG): Identity, Activity Units, Evidence, and FDA Product Boundaries
• How We Review Evidence
• Quality Testing: What Identity, Assay, and Purity Results Can and Cannot Show
• Certificates and Lot-Specific Records

Do not place product cards or commercial calls to action inside this evidence discussion.

Sources

1. DailyMed: current MENOPUR label, urinary source, mixture composition, FSH and LH activity, assays, hCG detection, human study, and unmeasured findings.
2. FDA Purple Book: MENOPUR, BLA 021663, licensed finished product, proper name, presentation, and application.
3. FDA GSRS: menotropins, UNII 5Y9QQM372Q, mixture identity, required components, synonyms, and approval disclaimer.
4. FDA clinical review: application 21-663, primary regulatory review of composition and clinical evidence.
5. FDA: Approved Drugs, Questions and Answers, product-specific meaning of FDA approval.