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Hormonal · Dosing reference

Leuprolide dosage

Dosing as the FDA label states it, how long trials ran, and the arithmetic for working with vials.

FDA-approvedAHuman trial evidenceFDA label
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Regulatory status
FDA-approved
Human amounts
Prostate cancer (Lupron Depot): 7.5 mg every 4 weeks, 22.5 mg every 12 weeks, 30 mg every 16 weeks or 45 mg every 24 weeks. Endometriosis/fibroids (Lupron Depot 3.75 mg): 3.75 mg monthly. CPP: weight-based (Lupron Depot-PED)
Route studied
Intramuscular depot (Lupron Depot); subcutaneous (Eligard)
Frequency
Monthly to every 6 months depending on formulation
Half-life
Approximately 3 hours (elimination, two-compartment model)
Evidence grade
Grade A · Human trial evidence
Vial sizes on the market
Not recorded
Other forms seen
—

What Leuprolide is

Leuprolide (leuprorelin) is a synthetic GnRH agonist nonapeptide, FDA-approved in depot and injectable forms (Lupron Depot, Eligard, Camcevi, Fensolvi and generics) for advanced prostate cancer, endometriosis, fibroid-related anemia and central precocious puberty.

Leuprolide acetate is a GnRH agonist that acts as an inhibitor of gonadotropin secretion when given continuously 1. Biphasic effect Initial stimulation: administration produces an initial increase in LH and FSH and a transient rise in testosterone and dihydrotestosterone in men, or estrone and estradiol in premenopausal women 1. Suppression: continuous administration decreases LH and FSH; testosterone falls to… How it works →

Key evidence

  • Leuprolide Study Group, N Engl J Med · 1984 · Humans (199 men with stage D2 prostate cancer)
    Comparable testosterone suppression and objective response (86% versus 85%); 1-year survival 87% versus 78% (not significant); fewer gynecomastia, edema and thromboembolic events, more hot flashes 6. 6
  • Lupron Depot prescribing information, Section 14.1 · 2026 · Humans (56 men with stage D2 prostatic adenocarcinoma)
    Testosterone suppressed to castrate range within 30 days in 94% and within 66 days in all 54 evaluable patients; 'no progression' in 84% at week 24 1. 1
  • Shore et al., N Engl J Med (HERO) · 2020 · Humans (930 men with advanced prostate cancer)
    Sustained castration 88.8% with leuprolide versus 96.7% with relugolix; castrate testosterone on day 4 in 0% versus 56%; MACE 6.2% versus 2.9% 7. 7
All studies on the research page

Schedules by time period

Label regimens and laid out week by week. Each bar is what the label states or what investigators gave participants; none is a recommendation.

FDA label

Lupron Depot (FDA label): advanced prostate cancer 1

Men with advanced prostate cancer

7.5 mg (1-month)
IM · every 4 weeks
Week-by-week table
PeriodAmount
Weeks 0–onward7.5 mg (maintenance)
22.5 mg (3-month)
IM · every 12 weeks
Week-by-week table
PeriodAmount
Weeks 0–onward22.5 mg (maintenance)
30 mg (4-month)
IM · every 16 weeks
Week-by-week table
PeriodAmount
Weeks 0–onward30 mg (maintenance)
45 mg (6-month)
IM · every 24 weeks
Week-by-week table
PeriodAmount
Weeks 0–onward45 mg (maintenance)

Each depot strength is a separate formulation; they are alternatives, not escalation steps.

Dosing as stated on the FDA label

  • Advanced prostate cancer (Lupron Depot): one injection of 7.5 mg every 4 weeks, 22.5 mg every 12 weeks, 30 mg every 16 weeks, or 45 mg every 24 weeks, administered by a healthcare provider 1.
  • Advanced prostate cancer (Eligard, subcutaneous): 7.5 mg monthly, 22.5 mg every 3 months, 30 mg every 4 months or 45 mg every 6 months 4.
  • Endometriosis (Lupron Depot 3.75 mg): 3.75 mg IM monthly for 1 to 6 doses initially, with or without norethindrone acetate 5 mg daily; retreatment requires norethindrone add-back; total treatment should not exceed 12 months. Fibroids: one 3.75 mg injection monthly for up to 3 months 2.
  • Central precocious puberty (Lupron Depot-PED 1-month): starting dose by body weight (7.5 mg up to 25 kg, 11.25 mg above 25 to 37.5 kg, 15 mg above 37.5 kg) monthly, adjusted based on hormonal and clinical suppression 3.
  • Formulations have different release characteristics; labels state not to substitute or combine fractional doses. Preparation and administration instructions are in the labels and are not reproduced here 1,2.

How long did human studies run?

No human study durations are recorded for Leuprolide.

Cycle-length evidence for Leuprolide

Side effects reported in studies

  • Hot flashes/sweats
    57.1% (32/56) · Men with prostate cancer, Lupron Depot 7.5 mg, 24 weeks 1
  • General pain
    23.2% · Same study 1
  • GI disorders
    14.3% · Same study 1
  • Edema
    14.3% · Same study 1
  • Urinary disorder
    12.5% · Same study 1
  • Decreased libido, impotence, testicular atrophy
    5.4% each · Same study 1
Full adverse-event data

Supplies and handling

  • Lyophilized vial
    Sealed vial with the freeze-dried cake. Check the label, lot and the certificate of analysis before opening.
  • Sterile diluent
    The diluent named on the product documentation. Bacteriostatic water contains benzyl alcohol; sterile water does not.
  • Graduated syringes
    Sized to the volume being measured. U-100 insulin syringes are graduated in units where 100 units = 1 mL.
  • Alcohol prep pads
    For wiping vial stoppers before each puncture.
  • Nitrile gloves
    Clean gloves for aseptic handling.
  • Sharps container
    Puncture-resistant container for used needles.
Step-by-step reconstitution guideStorage and transport accessories

Storage

Lupron Depot prostate formulations are stored at controlled room temperature (20-25°C) per the label; other formulations differ, so follow the specific product label 1.

  • Lyophilized (unmixed) vials: typically stored cold and dry, away from light, as the documentation directs. Many are stable longer frozen.
  • Reconstituted vials: typically refrigerated (about 2–8 °C), protected from light and not frozen.
  • Bacteriostatic water contains benzyl alcohol, which inhibits bacterial growth in multi-use vials; sterile water has no preservative.

Handling mistakes and troubleshooting

Added the wrong volume of diluent
The concentration changes, not the amount of compound in the vial. Recalculate with the volume actually added and relabel the vial.
Shook the vial and it foamed
Let it settle in the refrigerator. Foam is a sign of agitation; some peptides aggregate when shaken. Note it on the label.
The solution is cloudy or has particles
Do not use it. Cloudiness can indicate incomplete dissolution, contamination or degradation. Record the lot and contact the supplier with the certificate of analysis.
The powder cake looks melted or shrunken before reconstitution
This can indicate the vial was exposed to heat or moisture. Record the lot and condition on arrival.
Liquid sprayed back when the needle was removed
Pressure built up in the vial. Withdraw a small volume of air while adding diluent to keep pressure neutral.

Regulatory status

Status
FDA-approved (Lupron Depot initial U.S. approval 1989; Lupron Depot-PED label lists 1985). As of 2026-10-24, Drugs@FDA lists Lupron Depot, Lupron Depot-PED, Eligard, Camcevi, Fensolvi and multiple generic leuprolide acetate products with prescription marketing status; some older products (Lupron injection, Viadur, Lupaneta Pack) are discontinued 1,3,5.
United States (FDA)
FDA-approved in multiple formulations; Drugs@FDA lists Lupron Depot (several NDAs), Lupron Depot-PED, Eligard, Camcevi, Fensolvi and generic leuprolide acetate products with prescription marketing status as of 2026-10-24 1,2,3,4,5.
Sport (WADA)
The WADA 2026 Prohibited List names leuprorelin among GnRH agonist analogues under S2.2.1 (testosterone-stimulating peptides in males); S2 is prohibited at all times 8.

Status varies by country and changes over time. How we describe regulatory status.

Leuprolide compared with related compounds

CompoundStatusEvidenceHuman amountsHalf-life
LeuprolideFDA-approvedAFDA labelApproximately 3 hours (elimination, two-
TriptorelinFDA-approvedAFDA labelTerminal half-life about 3 hours after I
GonadorelinApproved, no longer marketedBLabel not retrievableA review describes native GnRH as having
NAD+Not approved — research use onlyBNone established—
Kisspeptin-54Not approved — research use onlyBNone establishedAbout 28 minutes (intravenous, healthy m
Apelin-13Not approved — research use onlyBNone establishedNot located as a numeric value in the so

Frequently asked questions

What doses of Leuprolide have been studied in humans?
Leuprolide is FDA-approved, so the label states the dosing for the approved product. This page quotes it, with citations. It does not apply to research-grade material.
Is there an established Leuprolide cycle length?
No. We found no human studies that report treatment duration for Leuprolide.
How much bacteriostatic water should be added to a Leuprolide vial?
There is no compound-specific volume. The diluent volume only sets the concentration: concentration = mass in the vial ÷ volume added (for example, 10 mg in 2 mL gives 5 mg/mL). The calculator on this page shows the arithmetic for any combination.
How many units is a given amount on an insulin syringe?
On a U-100 syringe, 100 units = 1 mL. Units for an amount = amount ÷ (concentration per unit). The calculator converts any amount you enter at the concentration you choose; a unit is a volume mark, not an amount of compound.
What is the half-life of Leuprolide?
Approximately 3 hours (elimination, two-compartment model)
Is Leuprolide FDA-approved?
FDA-approved. FDA-approved (Lupron Depot initial U.S. approval 1989; Lupron Depot-PED label lists 1985). As of 2026-10-24, Drugs@FDA lists Lupron Depot, Lupron Depot-PED, Eligard, Camcevi, Fensolvi and multiple generic leuprolide acetate products with prescription marketing status; some older products (Lupron injection, Viadur, Lupaneta Pack) are discontinued 1,3,5.

References

  1. LUPRON DEPOT 7.5 mg, 22.5 mg, 30 mg, 45 mg (leuprolide acetate for depot suspension) prescribing information, advanced prostate cancer (effective 03/2026) FDA label (DailyMed). 2026
  2. LUPRON DEPOT 3.75 mg (leuprolide acetate for depot suspension) prescribing information, endometriosis and fibroids (effective 09/2025) FDA label (DailyMed). 2025
  3. LUPRON DEPOT-PED (leuprolide acetate for depot suspension) prescribing information, central precocious puberty (effective 11/2025) FDA label (DailyMed). 2025
  4. ELIGARD (leuprolide acetate) for injectable suspension prescribing information (effective 04/2026) FDA label (DailyMed). 2026
  5. Drugs@FDA (openFDA) application records for leuprolide U.S. FDA. 2026
  6. Leuprolide versus diethylstilbestrol for metastatic prostate cancer N Engl J Med. 1984
  7. Oral Relugolix for Androgen-Deprivation Therapy in Advanced Prostate Cancer (HERO) N Engl J Med. 2020
  8. World Anti-Doping Agency Prohibited List 2026 (online version) WADA. 2026
  9. PubChem compound record for leuprolide PubChem. 2026

Last reviewed October 24, 2026 by the Amiravo editorial team. Editorial policy · Report an error