Prescription / GLP-1

Gonadorelin Dosage: The FDA Approval-Era Study Doses

Gonadorelin dosage: the 100 mcg diagnostic test dose and the pulsatile-pump doses from its approval-era trials - not the self-injected TRT protocol sold today.

Written bySebastian Hunter, Founder and EditorI'm a 42-year-old senior advisor and distance runner who came to peptides as a sceptic. I'm not a doctor: I read the research, run my own experiment and keep honest notes. Read full bio

Published September 27, 2026

The short version

Gonadorelin has no current FDA-approved dose, because it has no current FDA-approved product. Its approval-era evidence used two very different patterns: a single 100-microgram IV bolus for diagnostic testing, and repeated pulsatile pump dosing for treatment. A separate pediatric study used 5 micrograms every 90 minutes by subcutaneous pump in infants, a dose for infants and not a template for adults. None of this is the low-dose, self-injected, TRT-adjacent protocol gonadorelin is mostly sold for today, which has no published human trial behind it.

The diagnostic GnRH stimulation test used 100 mcg gonadorelin acetate as a single IV bolus in adult men.
The Lutrepulse approval trial used pulsatile intravenous dosing in women with hypothalamic amenorrhea; the abstract doesn't give a per-pulse microgram figure.
A pediatric study used 5 mcg every 90 minutes by subcutaneous pump in infants with congenital hypogonadotropic hypogonadism. It is not an adult dose.
I found no published human trial of the low-dose, self-injected, TRT-adjacent protocol vendors and clinics describe.

Gonadorelin dosage chart

Units on a U-100 insulin syringe across the common Gonadorelin range, by vial size - common practice, not a dose established in trials.

2 mg vialwith 1.5 mL water

Dose	Units	Volume	Doses per vial
50 mcg	4 units	0.04 mL	40
60 mcg	4.5 units	0.045 mL	33
70 mcg	5.5 units	0.055 mL	28
80 mcg	6 units	0.06 mL	25
90 mcg	7 units	0.07 mL	22
100 mcg	7.5 units	0.075 mL	20

Full 2 mg vial page: other water volumes, mixing, storage →

5 mg vialwith 5 mL water

Dose	Units	Volume	Doses per vial
50 mcg	5 units	0.05 mL	100
60 mcg	6 units	0.06 mL	83
70 mcg	7 units	0.07 mL	71
80 mcg	8 units	0.08 mL	62
90 mcg	9 units	0.09 mL	55
100 mcg	10 units	0.1 mL	50

Full 5 mg vial page: other water volumes, mixing, storage →

U-100 insulin syringe (100 units = 1 mL), to the nearest half unit. Arithmetic only. Other numbers: peptide calculator.

Gonadorelin has no current approved dose, because it has no current approved product. This page reports what the studies behind its two historical FDA approvals used, plus what a pediatric study and a diagnostic-test study report. It is not a recommendation, and it is not the self-injected protocol vendors describe. For what gonadorelin is and why both approvals were discontinued, see the main gonadorelin guide.

US legal status - FDA-approved · prescription only

Both FDA-approved gonadorelin products (Factrel, Lutrepulse) are discontinued. No current label or approved dose exists.

Study 1: the diagnostic GnRH stimulation test (single IV bolus, adults)

A 2021 study at a German andrology centre ran a GnRH stimulation test on 67 men (mean age 24.6 years) being evaluated for secondary hypogonadism. Each man got a single 100-microgram intravenous bolus of gonadorelin acetate Sansone 2021 - Sansone A, Schubert M, Tüttelmann F et al. Pituitary response to GnRH stimulation tests in different FSHB-211 G/T genotypes. Hum Reprod. 2021;36(5):1376-1382., in the references below. Blood was drawn before the injection and at 30 and 45 minutes after, to measure the LH and FSH response.

This is a single diagnostic dose, given and monitored by clinical staff. It tests whether the pituitary can respond to GnRH. It is not a treatment dose and not a schedule for repeated use.

Study 2: the Lutrepulse approval trial (pulsatile IV, women)

The multicenter trial behind Lutrepulse’s 1989 FDA approval gave pulsatile intravenous gonadorelin acetate to 109 women with primary or secondary hypothalamic amenorrhea Santoro 1990 - Santoro N. Efficacy and safety of intravenous pulsatile gonadotropin-releasing hormone: Lutrepulse for injection. Am J Obstet Gynecol. 1990;163(5 Pt 2):1759-64., in the references below. The published abstract reports:

Ovulation in 91% of the primary-amenorrhea group and 96% of the secondary-amenorrhea group.
A 12% rate of multiple pregnancy.
One case of ovarian hyperstimulation, in a patient also taking clomiphene citrate.

It does not state a per-pulse microgram dose or pulse interval, so I am not inventing one. Lutrepulse was delivered by a dedicated portable infusion pump designed for that pulsatile pattern, not a manual injection schedule.

Study 3: pulsatile subcutaneous pump in adult men (congenital hypogonadotropic hypogonadism)

Chinese cohort studies have treated adult men with congenital hypogonadotropic hypogonadism (CHH) using a pulsatile gonadorelin pump (PGP), delivered subcutaneously, as one treatment arm alongside cyclical gonadotropin therapy.

A nonrandomised study of 28 azoospermic CHH men found the pump group reached spermatogenesis sooner (median 6 months) than the cyclical-gonadotropin group (median 14 months) Zhang 2019 - Zhang L, Cai K, Wang Y et al. The Pulsatile Gonadorelin Pump Induces Earlier Spermatogenesis Than Cyclical Gonadotropin Therapy in Congenital Hypogonadotropic Hypogonadism Men. Am J Mens Health. 2019;13(1):1557988318818280., in the references below.
A three-year follow-up of 73 CHH men who self-selected their treatment reported that 70.2% of those on cyclical gonadotropins or the pulsatile pump reached spermatogenesis within three years Zhang 2021 - Zhang L, Gao Y, Du Q et al. Genetic Profiles and Three-year Follow-up Study of Chinese Males With Congenital Hypogonadotropic Hypogonadism. J Sex Med. 2021;18(9):1500-1510., in the references below.

Neither abstract states the microgram-per-pulse dose, so I report the route, population and outcome without inventing a number.

Study 4: pulsatile subcutaneous pump in infants (pediatric - not an adult dose)

A 2025 study treated seven male infants with congenital hypogonadotropic hypogonadism using 5 micrograms every 90 minutes, by subcutaneous pump, for 3 to 5 months Wang 2025 - Wang X, Zhang ZX, Chen J et al. Efficacy and safety of pulsatile GnRH pump therapy in male infants with congenital hypogonadotropic hypogonadism. Endocr Connect. 2025;14(5)., in the references below. Penile length, testicular volume, inhibin B and anti-Müllerian hormone all increased, with no adverse reactions reported. This is a pediatric dose in infants. This page does not scale it or present it as an adult dose.

What vendors and clinics describe instead

Gonadorelin is mostly sold today as low, self-injected, subcutaneous doses given several times a week alongside testosterone therapy. The aim is to keep the pituitary-testicular signal alive, not to diagnose or treat amenorrhea. That use does not appear in any published human study I located. It is not the diagnostic bolus, the Lutrepulse pump protocol or the pediatric infant dose above.

See the main guide for why gonadorelin and hCG are often discussed together for that purpose, and how they differ mechanically.

How to reconstitute Gonadorelin

None of the studies above used a reconstituted vial the way a compounded or research-peptide product is typically sold. They used prepared clinical infusions or a fixed test dose. If you are working through concentration and volume math for a specific product, the dosage calculator does that arithmetic. It does not choose a dose.

What is not established

No approved dose exists today, for any population or setting, because no gonadorelin product currently holds FDA approval.
No published human study of the self-injected, TRT-adjacent protocol exists that I could locate. The numbers circulating for that use are not attributed to a trial or paper this page can verify.
No specific per-pulse microgram dose is reported in the abstracts of the adult pulsatile-pump studies cited above, only the route, population and outcome.
The pediatric infant dose is not an adult dose, and this page does not convert it into one.

Who should not use it

No FDA-reviewed contraindication list exists, because no product currently holds FDA review. The historical trials show who was excluded from monitored studies. They are not a safety clearance for anyone self-directing outside one.

The diagnostic-test study excluded anyone not already being evaluated for secondary hypogonadism.
The Lutrepulse trial was in women with a specific, diagnosed cause of amenorrhea. Trial staff screened and monitored them for line-placement complications, multiple pregnancy and ovarian hyperstimulation.

These people should not self-direct use outside a clinician’s care:

Anyone with a known hypersensitivity reaction to gonadorelin or GnRH-class peptides (see below).
Anyone pregnant or trying to avoid multiple pregnancy without monitoring.
Anyone with an androgen- or gonadotropin-sensitive condition.

Gonadorelin side effects and risks

Beyond the general risks of an unapproved, unverified vial, two specific findings are documented:

Hypersensitivity. A published case report describes a patient who developed an IgE-mediated hypersensitivity reaction after long-term treatment with pump-delivered gonadorelin hydrochloride (Factrel) Foster 1989 - Foster WG, Jarrell JF, Dolovich J et al. Immunoglobulin-mediated hypersensitivity in response to long-term treatment with gonadorelin hydrochloride (Factrel) in a female patient. Am J Obstet Gynecol. 1989;160(4):979-83., in the references below. It was a wheal-and-flare skin response at injection sites, confirmed by skin-prick testing and radioimmunoassay. Treatment was discontinued once the reaction was identified.
Receptor desensitisation. Continuous or excessively frequent dosing desensitises the pituitary GnRH receptor and can suppress, rather than stimulate, LH and FSH release. That is the opposite of the intended effect on the hypothalamic-pituitary-gonadal axis. It is a mechanistic risk of dosing pattern, not a rare side effect.

There is no long-term outpatient safety data for the low-dose, self-injected use gonadorelin is sold for today. A vial bought outside the discontinued, formally approved supply chain carries no verified content, purity or actual concentration.

Gonadorelin dosage calculator

Preset to a 5 mg vial and 50 mcg, the low end of the common protocol. Enter your own vial size, water and dose to get the syringe units to draw.

Your vial

Peptide in vial (mg)

Printed on the vial. There is no standard size - enter what yours says.

Bacteriostatic water added (mL)

This changes how much you draw - never how many doses the vial holds.

Desired dose (mcg)

Syringe scale

100 units per mL. 1 unit = 0.01 mL. This is what almost every insulin syringe sold is, in every barrel size.

Barrel size

Capacity only. A 1 mL U-100 syringe holds 100 units - the scale decides that, not the barrel.

Draw this much

2units

= 0.02 mL on a 1 mL U-100 syringe

Concentration: 2,500 mcg/mL
Exact volume: 0.02 mL
Dose you actually get: 50 mcg
Doses per vial(unaffected by water volume): 100

Where to get Gonadorelin legally

No FDA-approved human gonadorelin is on the market: Factrel and Lutrepulse are both discontinued, and the current gonadorelin labels are veterinary drugs for cattle.

With a prescription, compounded gonadorelin costs $209 every 2 months at Regen Doctors (as of 3 October 2026).

Every legal route for gonadorelin, with dated prices →

How telehealth prescribing works, what it costs and what to check: telehealth peptide prescribing.

Common questions

What dose of gonadorelin did human studies use?

Two different patterns, for two different purposes. The diagnostic GnRH stimulation test used a single 100-microgram intravenous bolus of gonadorelin acetate in adult men. The approval trial for hypothalamic amenorrhea used pulsatile intravenous gonadorelin acetate delivered by infusion pump in women. Its published abstract reports the outcome (ovulation in 91-96% of 109 women) but not a per-pulse microgram dose. A separate pediatric study used 5 micrograms every 90 minutes by subcutaneous pump in infants.

Is there an FDA-approved gonadorelin dose today?

No. Both FDA-approved gonadorelin products (Factrel and Lutrepulse) are discontinued, and no approved product or label exists today. The doses on this page come from the published studies behind those historical approvals and from the diagnostic test literature, not from a current label.

References (7 sources)

Bibliographic detail is fetched from PubMed, not written by me - so a citation here cannot drift from the paper it names. Study design comes from PubMed's own tags rather than my judgement.