PeptideTrace
Research CompoundNative GnRH PeptideSexual Health & Hormonal

Gonadorelin (Factrel, Lutrepulse)

B

Evidence Grade B — Strong clinical evidence. 294 published studies, 117 human. 468 registered clinical trials.

468 trials294 studiesUSEUCA

Medically reviewed by a licensed medical professional

Overview

Gonadorelin is the natural form of GnRH — the brain hormone that controls reproductive function. Unlike the modified synthetic versions (leuprolide, goserelin, etc.) that suppress hormones, gonadorelin delivered in pulses can actually restore normal hormone production. Previously available as approved products (Factrel and Lutrepulse), all formulations have been voluntarily discontinued, and it is now available only from compounding pharmacies.

Also Known As

Gonadorelin is also known by these brand and alternate names:

Research Activity

294studies
Human 117
Animal 126
In-vitro 17
Reviews 28

294 published studies: 117 human, 126 animal, 17 in-vitro, 28 reviews

Regulatory Status

US
Not approved by FDA(FDA)
EU
Not authorised by EMA(EMA)
CA
Cancelled in Canada(Health Canada)

Legal Status

USNot applicable (not approved)
EUNot applicable (not authorised)
CAPrescription drug

Summary

Gonadorelin was previously marketed as Factrel (for diagnostic testing of pituitary function) and Lutrepulse (pulsatile GnRH pump for treating infertility caused by hypothalamic dysfunction). Both have been voluntarily discontinued due to low commercial demand and the complexity of pulsatile administration.

Research suggests that pulsatile gonadorelin remains one of the most physiologically appropriate treatments for certain types of infertility where the underlying problem is insufficient GnRH production in the brain. However, the practical challenges of wearing a pump that delivers pulses every 90 minutes, combined with the availability of simpler alternatives, have made it commercially unviable. It continues to be used in research settings studying reproductive endocrinology and GnRH receptor function.

Mechanism of Action

Gonadorelin is the body's own signalling hormone that tells the pituitary gland to release the hormones (LH and FSH) that drive testosterone and oestrogen production. When given in pulses that mimic the brain's natural 90-minute rhythm, it can actually restore normal hormone function — the opposite of what synthetic GnRH agonists do. When given continuously, however, it causes the same shutdown effect as synthetic agonists, though it is far less potent and shorter-acting because the body breaks it down within minutes.

Research Summary

Research suggests pulsatile gonadorelin remains one of the most physiologically appropriate treatments for infertility caused by insufficient GnRH production — it restores the brain's natural signalling rather than overriding it. However, the practical challenges of wearing a pump that delivers pulses every 90 minutes, combined with simpler alternatives, made it commercially unviable. Compounding pharmacies have filled the gap, particularly for off-label use during testosterone therapy to maintain natural hormone production. No controlled clinical trials exist for these compounding pharmacy use cases. The distinction between pulsatile (stimulatory) and continuous (suppressive) administration is a key pharmacological concept for this compound.

Clinical Trials

PeptideTrace tracks 468 registered clinical trials for Gonadorelin sourced from ClinicalTrials.gov.

NCT00669786Phase IIICompleted

Human Menopausal Gonadotropin (HMG) vs Recombinant Follicle Stimulating Hormone (rFSH) in Gonadotropin Releasing Hormone (GnRH) Antagonist Cycles

Instituto Valenciano de Infertilidad, IVI VALENCIA
NCT02065323Phase IIWithdrawn

A Study of Dovitinib With Androgen Deprivation Therapy (ADT) in Patients With Metastatic Prostate Cancer Receiving Primary ADT

Oscar Goodman, Jr.Endpoint: Time to onset of castration resistant prostate cancer (CRPC)
NCT00888082Phase IIIWithdrawn

Protection of Ovarian Function With Goserelin Acetate in Premenopausal Early Breast Cancer Patients With Chemotherapy

AstraZenecaEndpoint: The ovarian function will be considered as regained, if E2 measurements return to premenopausal levels (equal to or above 20 pg/ml), FSH measurements return to premenopausal levels (less than or equal to 40 IU/L)Completion: 2012-04-01
NCT01240928Phase IWithdrawn

MK-2206+Endocrine Therapy in Patients With Hormone Receptor-Positive Breast Cancer

Vanderbilt-Ingram Cancer CenterEndpoint: Tolerability of MK-2206 given in combination with exemestane +/- goserelin, as measured by maximum tolerated dose (MTD).
NCT00767286Phase IIICompleted

Goserelin, Flutamine, and Radiation Therapy in Treating Patients With Locally Advanced Prostate Cancer

Radiation Therapy Oncology GroupCompletion: 2003-11-01
View all 468 trials on ClinicalTrials.gov →

Regulatory Timeline

1994
Regulatory

Health Canada Market Authorisation

Scientific Detail

Overview (Scientific)

Gonadorelin is the native GnRH decapeptide (pyroGlu-His-Trp-Ser-Tyr-Gly-Leu-Arg-Pro-Gly-NH₂). It is the endogenous hypothalamic releasing hormone that regulates the HPG axis. All FDA-approved formulations have been discontinued, making it a research compound in the PeptideTrace classification system.

Mechanism of Action (Scientific)

Gonadorelin binds the GnRH receptor on anterior pituitary gonadotrophs. When administered in a pulsatile pattern mimicking physiological hypothalamic secretion (~90-minute intervals), it stimulates normal LH and FSH release and can restore ovulatory cycles. When administered continuously, it paradoxically suppresses gonadotropin release (the same principle exploited by GnRH agonists). As a single bolus, it produces an acute LH/FSH surge useful for diagnostic testing.

Summary (Scientific)

Gonadorelin was formerly marketed as Factrel (diagnostic testing of pituitary gonadotroph function) and Lutrepulse (pulsatile GnRH pump for hypothalamic amenorrhea/infertility). All human NDAs were voluntarily discontinued due to low commercial demand, complexity of pulsatile administration, and availability of simpler alternatives (gonadotropins for fertility, GnRH agonists/antagonists for suppression). Gonadorelin is widely available through US compounding pharmacies, where it is prescribed off-label in men's health protocols as an alternative to hCG for maintaining testicular function during testosterone replacement therapy.

The information on this page is provided for educational and research reference purposes only. This is not medical advice. Always consult a qualified healthcare professional before making any health-related decisions.

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Related Compounds

Carbetocin

Research Compound
Oxytocin Analogue (Long-Acting)

Carbetocin has not been approved by the FDA. It is registered in over 80 countries for prevention of uterine atony and excessive bleeding after caesarean delivery. A heat-stable formulation was added to the WHO Essential Medicines List in 2019. The CHAMPION trial (WHO, 2018; over 29,000 women) compared a heat-stable carbetocin formulation to oxytocin for preventing postpartum haemorrhage after vaginal delivery, and found it to be non-inferior. The heat-stable formulation addresses a significant limitation of oxytocin, which degrades in warm climates without refrigeration — a major concern in low-resource settings where postpartum haemorrhage causes the most deaths. Its regulatory status varies by jurisdiction.

Kisspeptin-54

Research Compound
Full-Length Kisspeptin (Investigational)

Kisspeptin-54 has no marketing authorisation. Phase II trials conducted primarily at Imperial College London have investigated its use as an IVF oocyte maturation trigger. One trial (60 patients) reported 95% oocyte maturation with zero cases of ovarian hyperstimulation syndrome. Kisspeptin-54 has a more advanced clinical evidence base than kisspeptin-10, with multiple Phase II studies in reproductive medicine. Its potential advantage over conventional IVF triggers relates to a lower risk of the serious complication of ovarian hyperstimulation. Clinical development is ongoing in academic settings. No Phase III trials have been completed.

Goserelin

Approved
GnRH Agonist

Goserelin is marketed as Zoladex by AstraZeneca, available as 3.6 mg monthly and 10.8 mg three-monthly subcutaneous implants. First approved in 1989, it is used in advanced prostate cancer, premenopausal breast cancer, endometriosis, and for thinning the uterine lining before surgical procedures. Goserelin achieves castrate-level testosterone suppression (below 50 ng/dL) within two to four weeks. Its unique implant delivery system means there is no liquid injection, reconstitution, or refrigeration required — a practical advantage in some clinical settings. Like all GnRH agonists, it causes an initial hormone flare before suppression takes effect. Goserelin holds an important niche in breast cancer treatment, where it is used to suppress ovarian function in premenopausal women with hormone-receptor-positive disease, often in combination with aromatase inhibitors.

Related Research

This content is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional before making decisions about your health.