FDA Approved Sexual & Reproductive Health

Menotropin

also known as: Menopur, Repronex, Humegon, hMG, human menopausal gonadotropin, highly purified hMG

Ferring's Menopur (and earlier Repronex, Humegon) — a urinary-derived FSH/LH combination used for ovulation induction and IVF controlled ovarian stimulation, particularly when LH supplementation is clinically desired.

Human menopausal gonadotropin (hMG) — a highly purified urinary preparation providing FSH and LH activity in approximately a 1:1 ratio per IU, with most of the "LH bioactivity" actually supplied by small amounts of co-purified hCG. Used when LH supplementation is clinically desired alongside FSH, such as in hypogonadotropic hypogonadism, older IVF patients, or protocols where LH drive is suppressed (pituitary downregulation with GnRH agonists). Menopur (Ferring) is the currently dominant US product.

Mechanism of action

Combined FSHR agonism (supporting follicular recruitment and growth) and LH receptor agonism (supporting theca-cell androgen production, follicular maturation, and steroidogenesis in the late follicular phase). Clinically useful in patients with suppressed endogenous LH or in IVF protocols where LH supplementation is considered beneficial.

Primary uses

  • Controlled ovarian stimulation in IVF/ICSI (particularly in GnRH-agonist-downregulated cycles)
  • Ovulation induction in hypogonadotropic hypogonadism

Typical dosing

75–450 IU/day (combined FSH activity) daily (subcutaneous or intramuscular)

IVF: 150–300 IU/day SC starting dose, adjusted by response. Hypogonadotropic hypogonadism: 75 IU/day, titrated. Dosing is expressed as IU of FSH activity; the LH activity is proportionate in the menotropin preparation.

Regulatory status

FDA-approved as Menopur (menotropins for injection, Ferring Pharmaceuticals, approved 2005) for development of multiple follicles and pregnancy in ovulatory women as part of an assisted reproductive technology cycle, and for ovulation induction in women with hypogonadotropic hypogonadism. Earlier FDA-approved products in this class included Repronex (Ferring, discontinued) and Humegon (Organon, discontinued). Menopur is typically provided in vials of 75 IU FSH + 75 IU LH activity.

References

  1. [fda-pi] Menopur (menotropins for injection) Prescribing Information. Ferring Pharmaceuticals.
  2. [pubmed] Al-Inany HG, et al. "Recombinant versus urinary gonadotrophins for triggering ovulation in assisted conception." Cochrane Database Syst Rev, 2011;(2):CD003719.

Related peptides

Follitropin alfa

EMD Serono's Gonal-f — the first recombinant human FSH approved by the FDA (1997). Used for ovulation induction, IVF controlled ovarian stimulation, and male hypogonadotropic hypogonadism fertility induction.

Follitropin beta

Organon/Merck's Follistim AQ (Puregon internationally) — a recombinant human FSH produced independently of follitropin alfa but clinically equivalent; FDA-approved 1997 for ovulation induction and IVF controlled ovarian stimulation.

Urofollitropin

Ferring's Bravelle (and earlier Fertinex) — highly purified urinary-derived FSH used for ovulation induction and IVF controlled ovarian stimulation. FDA-approved 2002; branded Bravelle was withdrawn from the US market in 2015 due to manufacturing/potency concerns but the molecule class remains available via urinary-derived menotropin combination products.

Lutropin alfa

EMD Serono's Luveris — the only recombinant human LH ever FDA-approved (2004, accelerated approval). Discontinued from the US market in 2012; approval formally withdrawn in 2016 after EMD Serono notified the FDA it could not complete the required postmarketing pregnancy-outcome trial.

HCG

An FDA-approved fertility and hypogonadism medication commonly discussed in peptide and TRT communities for post-cycle recovery and testicular preservation during testosterone therapy.
Disclaimer

This entry is for educational purposes only and does not constitute medical advice. Dosing information reflects published regulatory or research data and is not a recommendation. Many compounds described here are not approved for human use in the United States. Consult a licensed medical professional before considering any peptide therapy.