Review · United States
Gonadorelin
Reviewed on
Approval and product status
Former human products were FDA-approved; current human drug records list Factrel and Lutrepulse as discontinued
FDA once approved human products named Factrel and Lutrepulse. Current human drug records list both as discontinued. FDA also lists current cattle products, including a separate Factrel product. Animal approval does not apply to people. A compounded or online product needs its own review.
What was measured in people?
- Health results · Moderate
- Human studies measured ovulation and sperm development in people with defined hormone disorders. They do not establish broad fertility or testosterone benefits.
- Body changes · Moderate
- Human studies show that gonadorelin can trigger reproductive hormone signals in selected disorders and controlled settings.
A change in a hormone or body signal does not by itself prove a health benefit.
Important limits
This tool is not an independent medical review. It does not recommend treatment.
FDA records and a 2026 warning letter show that each product has its own status. Approval for an animal or a former human product does not approve an online or compounded product for people. This guide gives no dosing, sourcing, injection, fertility, or testosterone-treatment instructions.
Still unknown: These studies did not test gonadorelin during testosterone therapy. They do not show that taking it from time to time protects fertility. They do not show a general testosterone benefit for men without the studied disorders. A compounded or online product is not proven to match former human products or study material. Current FDA-approved animal gonadorelin products are not approved for people.
This record cannot check a package, seller, batch, or personal treatment. It does not provide sport clearance.
Approval fact checks
“Gonadorelin has never been FDA-approved for people.”
Misleading. FDA approved Factrel and Lutrepulse for human uses. Current Drugs@FDA records list both products as discontinued. That history does not mean that a current gonadorelin product is approved.
Applies to: Former U.S. human products and current U.S. human drug records as reviewed August 30, 2026.
“Current animal gonadorelin products are FDA-approved for people.”
Misleading. FDA lists current gonadorelin products for cattle. Their animal approvals do not approve them for people. One cattle product also uses the Factrel name, but it is not the former human Factrel product.
Applies to: Current FDA-approved animal products for cattle, not human products.
Products in this review
These are selected records, not every product or form.
No product label record is included here. That is not a separate approval decision. Read the status and sources above.
What the research shows
FDA approved Factrel and Lutrepulse for people. Current records list both as discontinued. Lutrepulse was approved for women with hypothalamic amenorrhea, which can stop periods when the brain sends too little GnRH. Studies used a pump to copy the body's normal signal pattern. One study of 109 women found ovulation in more than 9 in 10. A study of 28 men was not randomized. It found earlier sperm development with the pump, but the overall rate was not clearly different.
Read all Gonadorelin fact checksSources used in this review
A source may support some statements, not all of them. Use the links above or this review to see what each source supports.
Show 13 sources
- Gonadorelin substance identity record (UNII 9O7312W37G)
U.S. Food and Drug Administration Global Substance Registration System · Reference · 2026
Source accessed
- FACTREL (gonadorelin) Drugs@FDA record, NDA 018123
U.S. Food and Drug Administration · Regulatory · 1982
Source accessed
- LUTREPULSE KIT (gonadorelin) Drugs@FDA record, NDA 019687
U.S. Food and Drug Administration · Regulatory · 1989
Source accessed
- Lutrepulse orphan-drug approval record
U.S. Food and Drug Administration · Regulatory · 1989
Source accessed
- Cattle estrous-cycle resource and FDA-approved animal drugs
U.S. Food and Drug Administration · Regulatory · 2026
Source accessed
- FACTREL cattle product label and gonadorelin identity
DailyMed · U.S. National Library of Medicine · Drug label · 2026
Source accessed
- Wholesale Peptide warning letter
U.S. Food and Drug Administration · Regulatory · 2026
Source accessed
- Human drug compounding: FDA questions and answers
U.S. Food and Drug Administration · Regulatory · 2026
Source accessed
- Gonadorelin study in hypogonadotropic hypogonadism
ClinicalTrials.gov · Trial registry · 2026
Source accessed
- Gonadorelin treatment in hypothalamic amenorrhea
PubMed · Human clinical study · 1986
Source accessed
- Lutrepulse study in women with hypothalamic amenorrhea
PubMed · Human clinical study · 1990
Source accessed
- Nonrandomized gonadorelin study in congenital hypogonadotropic hypogonadism
PubMed · Human clinical study · 2019
Source accessed
- 2026 Prohibited List
World Anti-Doping Agency · Anti-doping · 2026
Source accessed