AI illustration · not actual product photoDetails from the source.
This catalogue entry records Gonadorelin, 2 mg × 10 vials (SKU GND2), using the supplied source listing. The cited dossier describes: Human clinical research has examined pulsatile GnRH/gonadorelin to restore reproductive-axis activity in selected patients with hypothalamic amenorrhea or hypogonadotropic hypogonadism. Outcomes studied include LH/FSH release, ovulation, menstrual-cycle function, pregnancy, testosterone, and spermatogenesis. It also distinguishes available human evidence, limitations, safety concerns, and regulatory context. It does not verify this supplier-specific item’s identity, formulation, lot quality, or approval. This is not medical advice, a treatment recommendation, or authorization for human use.
- Catalogue code
- GND2
- Source specification
- 2mg*10vials
- Source document
- PriceList(1).pdf, page 1
- Photograph
- AI-generated illustration only — not an actual product photo or verified molecular depiction; owner-approved product photo still pending.
Product information is presented from supplied source materials. Inclusion on this website does not state that a product is an approved medicine or authorize human use. This is educational content, not medical advice.
Compound-level research and safety context.
Evidence below concerns the research family associated with this listing. For blends, findings about individual components do not establish evidence for the combination. This does not verify the supplier-specific vial or lot. Reviewed 2026-10-30.
What it is
Peptide hormone: gonadorelin is gonadotropin-releasing hormone (GnRH), a decapeptide. The source listing is exactly “Gonadorelin Acetate,” SKU GND2, specified as *10vials, price 30 per 10 vials; source price list does not state a currency. The name and catalogue details do not verify the exact vial contents or formulation.
Biological mechanism
Gonadorelin binds GnRH receptors on anterior-pituitary gonadotroph cells and stimulates secretion of luteinizing hormone (LH) and follicle-stimulating hormone (FSH). The physiological pulse pattern is important: intermittent pulses support gonadotropin release, whereas continuous exposure can produce an initial response followed by reduced pituitary responsiveness. LH and FSH in turn regulate gonadal hormone production and gamete development. [1] [2]
Research focus
Human clinical research has examined pulsatile GnRH/gonadorelin to restore reproductive-axis activity in selected patients with hypothalamic amenorrhea or hypogonadotropic hypogonadism. Outcomes studied include LH/FSH release, ovulation, menstrual-cycle function, pregnancy, testosterone, and spermatogenesis. Evidence is tied to particular formulations, delivery patterns, patient groups, and specialist monitoring; it does not identify or validate the GND2 vial. [2] [3]
Potential applications in the evidence
Investigated human applications include ovulation induction in selected patients with hypothalamic amenorrhea due to deficient or abnormal endogenous GnRH pulsatility, and pulsatile-GnRH research in male hypogonadotropic hypogonadism. FDA records document historical marketing approval for the specific branded formulation Lutrepulse for an orphan-designated indication; that status does not establish approval or an application for this catalog item. [2] [4]
Human evidence
In a 1990 multicentre clinical trial involving 109 women with primary or secondary hypothalamic amenorrhea, pulsatile Lutrepulse (gonadorelin acetate) was associated with ovulation in 91% and 96% of the respective patient groups. The report noted a 12% multiple-pregnancy rate and complications related to intravenous-line placement. An earlier clinical study of 18 women reported ovulation and pregnancies under supervised pulsatile regimens, with differing ovarian responses under different study regimens. These results support biological and clinical activity in selected patients using identified products and monitored protocols; they do not establish effectiveness, safety, route, schedule, or suitability of GND2. [3] A clinical review describes specialist use and research of pulsatile GnRH for anovulation and male hypogonadotropic hypogonadism but does not provide evidence for this supplier-specific vial. [2]
Known and potential effects
The Canadian Lutrepulse product monograph reports injection-site irritation, infusion-site inflammation, phlebitis or hematoma, hypersensitivity including rare anaphylaxis, headache and nausea, ovarian hyperstimulation, multiple follicle development, and multiple pregnancy. Human trial reports also described multiple pregnancies and intravenous-line complications. These reported effects come from particular clinical products and contexts and are not a verified adverse-effect profile for GND2. [3] [5]
Safety and contraindications
The 2010 Canadian Lutrepulse monograph lists hypersensitivity to gonadorelin or product components, ovarian cysts, and conditions that could be worsened by pregnancy or reproductive hormones among contraindications for that product; it also warns about ovarian hyperstimulation and multiple pregnancy. These formulation-specific warnings should not be treated as a complete label for GND2. The FDA-listed U.S. Factrel product is gonadorelin hydrochloride labeled for cattle only; veterinary indications and animal safety results do not establish human safety for this acetate listing. [5] [6] No human-use directions or dose are provided here.
U.S. FDA / regulatory status
FDA's Orphan Drug Designations and Approvals database records marketing approval of Lutrepulse (gonadorelin acetate) on October 10, 1989, associated with the orphan-designated indication of inducing ovulation in women with hypothalamic amenorrhea due to deficient or absent endogenous GnRH quantity or pulse pattern. This is evidence of a specific branded formulation's historical approval, not a transfer of approval to GND2, and the database record alone does not verify current marketing status. DailyMed's current FDA-listed Factrel label describes a different hydrochloride formulation approved as an animal drug for cattle only. The supplied catalogue does not identify a manufacturer, lot, formulation source, jurisdiction, or regulatory application. FDA approval, current marketed status, and legal/regulatory status of the exact GND2 vial cannot be verified. Do not label it FDA-approved, compounded, or research-only without reliable documentation. [4] [6]
Evidence limitations
Clinical studies were conducted with identified medicinal products and specific, generally pulsatile protocols under clinical monitoring. Populations, products, routes, regimens, study sizes, and endpoints differ; some trials are several decades old. Evidence about GnRH physiology or another gonadorelin product cannot authenticate or substantiate the contents, quality, sterility, approval, efficacy, or safety of the supplier-specific GND2 vial. Animal findings are not human evidence. No evidence reviewed verifies the exact vial's manufacturer, batch, composition, formulation source, quality controls, current approval, or intended regulatory category.
Supporting sources
- Physiology of GnRH and Gonadotrophin Secretion Endotext; NCBI Bookshelf, National Library of Medicine · Authoritative endocrine physiology review. Supports: What GnRH is, decapeptide identity, reproductive-axis physiology, and the importance of pulsatile versus continuous exposure; supports mechanism and evidence limitations.
- Pulsatile gonadotropin-releasing hormone: clinical applications of a physiologic paradigm F&S Reports / American Society for Reproductive Medicine · Peer-reviewed clinical review. Supports: Human clinical research focus and investigated applications of pulsatile GnRH in anovulation and male hypogonadotropic hypogonadism.
- Efficacy and safety of intravenous pulsatile gonadotropin-releasing hormone: Lutrepulse for injection PubMed, U.S. National Library of Medicine; American Journal of Obstetrics and Gynecology · Multicentre human clinical trial. Supports: Human ovulation outcomes, multiple-pregnancy rate, and infusion-line complications in a study of Lutrepulse in hypothalamic amenorrhea.
- FDA Search Orphan Drug Designations and Approvals: Gonadorelin acetate U.S. Food and Drug Administration · Official FDA orphan-drug database record. Supports: FDA record of Lutrepulse orphan designation and historical marketing approval date and indication; does not establish approval for GND2 or current marketing status.
- Lutrepulse Product Monograph, 2010 Ferring Inc., Canada · Canadian product monograph. Supports: Product-specific clinical indication, contraindications, warnings, and reported adverse effects for the Canadian Lutrepulse formulation; not a label for GND2.
- FACTREL Gonadorelin Hydrochloride Injection: FDA-approved cattle-only label DailyMed, U.S. National Library of Medicine; Zoetis Inc. label · Official drug-label database, prescription animal drug label. Supports: Distinguishes the FDA-approved cattle-only Factrel hydrochloride drug from the acetate catalog listing and supports the warning not to transfer animal indication or safety findings to people.