Triptorelin

Dosing from the Literature

Published for hormones: depot doses of 3.75–22.5 mg, monthly to every 6 months, for prostate cancer. Not published: a trial of the single 'restart' shot.

What It Is

Triptorelin is a synthetic gonadotropin-releasing hormone (GnRH) agonist — technically a GnRH super-agonist because its receptor-binding affinity and metabolic stability are substantially greater than endogenous GnRH. It is a decapeptide (a chain of 10 amino acids) with the sequence pGlu-His-Trp-Ser-Tyr-D-Trp-Leu-Arg-Pro-Gly-NH₂. The key change is D-tryptophan in place of glycine at position 6; in GnRH agonists, a D-amino acid there is the main source of their resistance to enzymatic breakdown (Lahlou et al., 2000). In laboratory tests, triptorelin was 100-fold more active than native GnRH at releasing LH from rat pituitary cells and 20-fold more active at displacing GnRH from pituitary receptors (Trelstar label). The free peptide was first described in the 1970s alongside the other GnRH agonist peptides (leuprolide, goserelin, buserelin, nafarelin) and has been in clinical use since the 1980s.

Triptorelin is marketed in the United States as Trelstar^® (triptorelin pamoate) as a long-acting intramuscular depot (3.75 mg monthly, 11.25 mg every 3 months, 22.5 mg every 6 months), approved by the FDA in 2000 for the palliative treatment of advanced prostate cancer. In Europe and much of the rest of the world it is marketed as Decapeptyl^® with broader approved indications including endometriosis, uterine fibroids, central precocious puberty, controlled ovarian stimulation / IVF trigger, and estrogen-sensitive breast cancer adjuvant therapy in premenopausal women.

The defining clinical property of triptorelin — and of every GnRH super-agonist — is the biphasic effect on the hypothalamic-pituitary-gonadal axis. A single dose or the beginning of continuous exposure produces an initial surge ("flare") of LH and FSH release from the anterior pituitary, raising testosterone in men or estrogen in women; in men on Trelstar, mean testosterone rose in the first week and was back to baseline or below by the end of the second (Trelstar label). Continuous exposure (from depot formulation or repeated short-acting dosing) then downregulates and internalizes pituitary GnRH receptors, shutting down LH/FSH release and collapsing gonadal steroid production to castrate levels by approximately week 3–4. This "chemical castration" is the therapeutic mechanism in hormone-responsive cancers.

The short-acting formulation is used in very different contexts: as a single 0.2 mg trigger for final oocyte maturation in IVF, in place of the traditional hCG trigger (Kolibianakis et al., 2005), and — off-label, in recreational / community contexts — as a single-dose "HPG-axis restart" attempt after anabolic androgenic steroid use. The restart idea is to capture the first-dose surge without the shutdown that continued exposure brings. No trial has tested it; a 2010 case report describes a man given one 100 µg dose (Pirola et al., 2010).

Mechanism of Action

Triptorelin is a synthetic agonist of the pituitary GnRH receptor (Trelstar label). Given continuously, GnRH agonists suppress LH and FSH instead of stimulating them for good, through gradual downregulation of the pituitary receptors (Engel & Schally, 2007; PMID 17237842); the paradox is still incompletely understood (Lahlou et al., 2000; PMID 10969915).

• GnRH receptor super-agonism — In laboratory tests, triptorelin was 100-fold more active than native GnRH at releasing LH from rat pituitary cells and 20-fold more active at displacing GnRH from pituitary receptors (Trelstar label). GnRH agonists also stay in the blood 3 to 10 times longer than natural GnRH; one reason is their resistance to enzymatic breakdown, which comes mainly from a D-amino acid in place of glycine at position 6 (D-Trp⁶ in triptorelin) (Lahlou et al., 2000; PMID 10969915).
• Initial flare (days 1–14) — The first dose briefly raises LH, FSH, testosterone and estradiol; in the prostate cancer trials, mean testosterone rose above baseline in the first week and was back to baseline or below by the end of the second (Trelstar label). In advanced prostate cancer the surge can briefly worsen the disease, bringing bone pain, nerve symptoms, blood in the urine or urinary obstruction; spinal cord compression has occurred (Trelstar label); the UK label advises considering an anti-androgen in the first weeks (UK label, Decapeptyl SR, 2026).
• Pituitary desensitization (weeks 2–4) — Continued exposure downregulates the pituitary GnRH receptors (Engel & Schally, 2007; PMID 17237842). Usually 2 to 4 weeks in, LH and FSH secretion falls, and in most men testosterone reaches castrate levels (<50 ng/dL) within four weeks (Trelstar label); in premenopausal women the UK label describes the result as a medically induced menopause (UK label, Decapeptyl SR, 2026). The shutdown is not total: in children on depots, the pituitary still releases the free alpha subunit in response to GnRH (Lahlou et al., 2000; PMID 10969915).
• Castrate-level suppression (weeks 4 onward) — With continued injections, testosterone stayed at castrate levels from day 57 onward in 93–96% of men in the label's trials, a level the label likens to surgical castration (Trelstar label). In a randomized trial of 284 men, monthly triptorelin kept testosterone at castrate levels as well as monthly leuprolide: mean maintenance from day 29 to day 253 was 98.8% against 97.3% (Heyns et al., BJU Int 2003; PMID 12887472).
• Reversibility — The label describes the effects as usually reversible once treatment stops (Trelstar label). After the 6-month pediatric depot, pituitary and gonadal function is expected to recover within 6 to 12 months (Triptodur label); in women, ovulation returns about 2 months after the last monthly injection (UK label, Decapeptyl SR, 2026).
• "Agonist trigger" in IVF — A single dose of short-acting triptorelin at the end of ovarian stimulation is used in place of hCG to set off the body's own LH surge for final oocyte maturation: in a randomized trial of 106 IVF patients on a GnRH-antagonist protocol, 0.2 mg triptorelin matched hCG on oocytes retrieved, their maturity, fertilization and embryos, but ongoing pregnancy was much less likely (odds ratio 0.11) and the trial was stopped early (Kolibianakis et al., Hum Reprod 2005; PMID 15979994); a buserelin trigger trial the same year found the same, most probably from a luteal-phase deficiency (Humaidan et al., Hum Reprod 2005; PMID 15760966). In 100 oocyte donors, who have no embryo transfer of their own, 0.2 mg triptorelin gave as many mature oocytes as recombinant hCG with fewer cases of ovarian hyperstimulation syndrome (Melo et al., Reprod Biomed Online 2009; PMID 19909588).
• "Restart" off-label rationale — The off-label idea is that one small dose of short-acting triptorelin, in a man whose axis is suppressed after anabolic steroids, gives the first-dose LH and FSH surge without the shutdown that continued exposure brings. No trial has tested it; a 2010 case report describes a man whose testosterone was in the normal range within a month of a single 100 µg dose (Pirola et al., 2010). Men's-health clinic protocols describe it alone or followed by a SERM (tamoxifen, clomiphene or enclomiphene); no study has tested the combination.
• Acts through the pituitary — Triptorelin's effect on sex hormones runs through the pituitary: falling LH and FSH secretion brings a marked reduction in testicular steroid production (Trelstar label). GnRH receptors are also present on several human tumors, including breast, prostate and ovarian cancers (Engel & Schally, 2007; PMID 17237842).

What the Research Shows

• Advanced prostate cancer — Multiple Phase 3 trials established triptorelin depot non-inferiority or equivalence to surgical orchiectomy and to other GnRH agonists (leuprolide, goserelin) for testosterone suppression and PSA response. Heyns et al. (BJU Int 2003; PMID 12887472) head-to-head vs leuprolide — comparable efficacy and castrate-suppression rates.
• Intermittent vs continuous ADT (TAP-22, SEUG trials) — Comparative research has examined intermittent vs continuous triptorelin depot in advanced prostate cancer. Intermittent regimens may preserve quality of life and reduce some adverse effects without clear survival disadvantage in non-metastatic / biochemical-only settings.
• Central precocious puberty — Carel et al., Eur J Endocrinol 2006 (PMID 16382000) — a 12-month open-label multicentre trial in 64 children with central precocious puberty found that the triptorelin 11.25 mg three-month depot suppressed gonadotropic activation.
• Endometriosis — Approved in EU; reduces estrogen-dependent lesion activity and pelvic pain. The UK labels give it for up to 6 months, with no further course because of concerns about bone loss, and note that estrogen-progestogen add-back therapy reduces bone loss and vasomotor symptoms (UK label, Decapeptyl SR, 2026).
• IVF / controlled ovarian stimulation — Two roles: downregulation protocols (long depot to suppress endogenous LH surge during stimulation) and agonist trigger (single SubQ dose for final oocyte maturation). In a randomised trial of 122 patients on an antagonist protocol, a buserelin trigger gave more mature oocytes than hCG but fewer pregnancies, most probably from a luteal-phase deficiency (Humaidan et al., 2005); in 100 oocyte donors, who have no embryo transfer of their own, a 0.2 mg triptorelin trigger caused less OHSS than recombinant hCG (Melo et al., 2009).
• Breast cancer adjuvant (premenopausal, estrogen-receptor-positive) — SOFT/TEXT trials established ovarian function suppression with triptorelin (or other GnRH agonists) plus aromatase inhibitor or tamoxifen as adjuvant therapy in premenopausal ER+ breast cancer (Francis et al., NEJM 2015 and updates).
• Gender-affirming care (off-label pediatric) — Triptorelin depot is used as a puberty blocker in adolescents with gender dysphoria in jurisdictions where pediatric gender care is practiced. Evidence base is primarily observational cohort data.
• HPG-axis restart (off-label, community / some clinicians) — Single-dose use after anabolic steroids is described in harm-reduction and men's-health clinic settings; no trial has tested it. A 2010 case report describes a 34-year-old man with long-lasting hypogonadism after anabolic-steroid use whose testosterone was in the normal range within a month of one 100 µg dose (Pirola et al., 2010).

Human Data

Triptorelin has one of the deepest human trial records of any peptide on the site, almost entirely in indications other than the community "restart" off-label use.

• Phase 3 registration in advanced prostate cancer — Multiple head-to-head studies vs leuprolide, goserelin, and surgical orchiectomy; comparable efficacy on testosterone suppression (>95% to <50 ng/dL) and PSA response.
• Real-world registries / European prostate cancer data — Decades of post-marketing data in Europe (Decapeptyl^®) establishing long-term safety and efficacy.
• Pediatric central precocious puberty — Multi-year cohorts documenting safe suppression of puberty and improved adult height in early-treated patients (Carel 2004 and follow-on studies).
• IVF agonist-trigger meta-analyses — Cochrane and other meta-analyses supporting agonist-trigger use to reduce OHSS in antagonist-cycle IVF, with attention to luteal-phase support protocols.
• SOFT/TEXT breast cancer — Established ovarian-function-suppression paradigm for premenopausal ER+ breast cancer adjuvant therapy.
• Post-AAS restart: a case report — At a university endocrinology unit in Italy, a 34-year-old man with long-lasting hypogonadism after anabolic-steroid use was given a single 100 µg "triptorelin test" dose; within a month his testosterone was in the normal range and he reported normal energy and libido (Pirola et al., 2010).
• No large RCT for restart use — The off-label "restart" protocol has never been the subject of a Phase 2/3 RCT.

Reconstitution & Storage

• Depot injection — The Trelstar label describes one injection into the gluteal muscle with the kit's 1½-inch needle, alternating sites from one injection to the next (Trelstar label); Triptodur goes into either buttock or thigh (Triptodur label).
• Timing — Depots are given on a fixed schedule, every 4, 12 or 24 weeks (Trelstar label); the IVF trigger and the "restart" dose are single doses (Kolibianakis et al., 2005; Pirola et al., 2010).
• Inspection — The labels describe the mixed depot as a milky, homogeneous suspension, checked by eye for particles and discoloration before it is injected (Trelstar and Triptodur labels).

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Side Effects & Risks

• Testosterone flare (men, initial) — In the Trelstar trials, mean testosterone rose above baseline in the first week and was back to baseline or below by the end of the second. In prostate cancer the surge can bring bone pain, nerve symptoms, blood in the urine or urinary obstruction; spinal cord compression with leg weakness or paralysis has occurred (Trelstar label). The UK label advises considering an anti-androgen in the first weeks (UK label, Decapeptyl SR, 2026).
• Hypogonadism symptoms (chronic therapy) — In the Trelstar trials, 59% to 73% of men reported hot flashes; skeletal pain, erectile dysfunction or impotence, testicular atrophy, decreased libido, fatigue, breast pain and gynecomastia were less common. The label attributes most adverse reactions to the drug's effect on testosterone (Trelstar label).
• Bone density loss — Long-term androgen deprivation, by surgery or GnRH agonists, is linked to bone loss, osteoporosis and a higher risk of fracture; in women, bone density falls by about 1% a month over a 6-month course. In men, preliminary data suggest a bisphosphonate given with a GnRH agonist may reduce the loss (UK label, Decapeptyl SR, 2026).
• Metabolic syndrome / cardiovascular — GnRH agonists, triptorelin included, may cause high blood sugar, diabetes and high blood lipids; fatty liver disease, including cirrhosis, has been reported after approval. A higher risk of heart attack, sudden cardiac death and stroke has been reported in men on GnRH agonists; the label calls the risk low. It asks prescribers to check lipids and blood sugar or HbA1c periodically and to watch for signs of heart disease (Trelstar label).
• Mood disturbance — Depression, and suicidal thoughts and attempts, have been reported after approval (Trelstar label). In the SOFT and TEXT breast cancer trials, about half the women on triptorelin with tamoxifen or exemestane reported depression, under 5% of it severe (UK label, Decapeptyl SR, 2026). In children the label lists emotional lability: crying, irritability, impatience, anger and aggression (Triptodur label).
• Injection-site reactions — About 4% of men in the Trelstar trials reported injection-site pain (Trelstar label); in the pediatric trial, 45% of children had pain and 14% redness within 2 hours of the injection (Triptodur label).
• QT prolongation — Androgen deprivation with triptorelin may prolong the QT interval. The label asks prescribers to weigh this in patients with congenital long QT syndrome, heart failure, frequent electrolyte abnormalities or QT-prolonging drugs, and to consider periodic ECG and electrolyte checks (Trelstar label).
• Pituitary apoplexy (rare) — Rare cases have been reported after GnRH agonists, most in people then found to have a pituitary adenoma and most within 2 weeks of the first dose, some within the first hour (Trelstar label).
• Pregnancy / lactation — Pregnancy is a contraindication on the Triptodur label, and pregnancy and breastfeeding are on the UK labels (Triptodur label; UK label, Decapeptyl SR, 2026); the Trelstar label warns of fetal harm. In pregnant rats, triptorelin caused pregnancy loss; no birth defects were seen in surviving rat or mouse fetuses (Trelstar label).
• Pediatric precocious puberty use — The 3-month depot was well tolerated over 12 months in 64 children, with one case of severe injection pain and withdrawal bleeding in five girls (Carel et al., 2006). Puberty develops after treatment stops (UK label, Decapeptyl SR, 2026). The pediatric label warns of pseudotumor cerebri (raised pressure around the brain), convulsions and psychiatric events (Triptodur label).
• Other label warnings — Anaphylaxis, angioedema and other hypersensitivity reactions; convulsions; and severe skin reactions, including Stevens-Johnson syndrome/toxic epidermal necrolysis, DRESS and AGEP (Trelstar label).
• Drug interactions — No interaction studies have been done, and liver enzymes are unlikely to break triptorelin down. The labels advise against drugs that raise prolactin, which lowers the number of pituitary GnRH receptors, and ask prescribers to weigh QT risk with drugs that prolong the QT interval (Trelstar label).

Bloodwork & Monitoring

• Total testosterone — The Trelstar label calls for serum testosterone to be monitored after injection; its trials defined castration as 50 ng/dL or less (Trelstar label). No trial, label or guideline sets monitoring for the off-label restart use; the 2010 case report tracked testosterone, LH and FSH (Pirola et al., 2010).
• LH and FSH — The Trelstar trials measured LH 2 hours after a repeat injection to show the pituitary had stopped responding: 98.4% of men had LH of 1.0 IU/L or less (Trelstar label).
• PSA (prostate cancer) — Measured as a secondary endpoint in the triptorelin–leuprolide trial (Heyns et al., 2003).
• Bone density — In breast cancer treatment, the UK label calls for bone density to be assessed before triptorelin is started, especially in women with several risk factors for osteoporosis (UK label, Decapeptyl SR, 2026).
• Lipids, blood glucose, HbA1c, blood pressure — The Trelstar label calls for periodic checks of serum lipids and blood glucose or HbA1c (Trelstar label); the UK label adds blood pressure, at intervals of no more than 3 months in patients at high risk (UK label, Decapeptyl SR, 2026).
• Blood count and chemistry — The UK label notes that androgen deprivation can raise the risk of anemia and asks for it to be monitored (UK label, Decapeptyl SR, 2026); in the Trelstar trials, hemoglobin fell and glucose and liver enzymes rose in some men (Trelstar label).
• ECG and electrolytes — Because androgen deprivation may prolong the QT interval, the Trelstar label suggests considering periodic ECG and electrolyte checks (Trelstar label).
• Estradiol and FSH (women) — In breast cancer, the UK label calls for low FSH and estradiol to confirm ovarian suppression before an aromatase inhibitor is started, and every 3 months during the combination (UK label, Decapeptyl SR, 2026).
• Pediatric puberty monitoring — The Triptodur label checks response with LH after a GnRH or GnRH-agonist stimulation test, basal LH or sex-steroid levels from 1 to 2 months after the start and with each dose, height every 3 to 6 months, and bone age periodically (Triptodur label).

What to Expect — Timeline

For depot treatment, the labels describe the timeline below. The off-label single-dose "restart" use has no trial behind it; a 2010 case report describes it (Pirola et al., 2010).

• Prostate cancer — day 1–7 (flare) — LH, FSH and testosterone rise briefly; after a single injection, testosterone peaked on days 2 to 4 (Trelstar label). The UK label advises considering an anti-androgen in this initial phase (UK label, Decapeptyl SR, 2026).
• Prostate cancer — week 2–4 — LH and FSH secretion falls, usually 2 to 4 weeks after the start, and in most men testosterone reaches castrate levels (<50 ng/dL) within four weeks (Trelstar label).
• Prostate cancer — week 4+ — With continued injections, testosterone stayed at castrate levels from day 57 onward in 93–96% of men in the label's trials (Trelstar label).
• Pediatric precocious puberty — first year — In the Triptodur trial of 44 children, 95% had prepubertal LH responses at month 1; at month 12, sexual maturation had stabilized in 89% and bone age had not advanced relative to age in 95% (Triptodur label).
• Off-label HPG restart — No trial has measured the timing. In a 2010 case report, testosterone was in the normal range within a month of a single 100 µg dose (Pirola et al., 2010).
• Post-depot recovery — The labels describe the effects as usually reversible once treatment stops (Trelstar label); after the 6-month pediatric depot, pituitary and gonadal function is expected to recover within 6 to 12 months (Triptodur label).

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References

1. Heyns CF, Simonin MP, Grosgurin P, Schall R, Porchet HC; South African Triptorelin Study Group. Comparative efficacy of triptorelin pamoate and leuprolide acetate in men with advanced prostate cancer. BJU Int. 2003;92(3):226-231. PMID: 12887472.
2. Carel JC, Lahlou N, Roger M, Chaussain JL. Precocious puberty and statural growth. Hum Reprod Update. 2004;10(2):135-147. PMID: 15073143.
3. Carel JC, Blumberg J, Seymour C, Adamsbaum C, Lahlou N; Triptorelin 3-month CPP Study Group. Three-month sustained-release triptorelin (11.25 mg) in the treatment of central precocious puberty. Eur J Endocrinol. 2006;154(1):119-124. PMID: 16382000.
4. Humaidan P, Bredkjaer HE, Bungum L, Bungum M, Grøndahl ML, Westergaard L, Andersen CY. GnRH agonist (buserelin) or hCG for ovulation induction in GnRH antagonist IVF/ICSI cycles: a prospective randomized study. Hum Reprod. 2005;20(5):1213-1220. PMID: 15760966.
5. Francis PA, Regan MM, Fleming GF, Láng I, Ciruelos E, Bellet M, et al.; SOFT Investigators. Adjuvant ovarian suppression in premenopausal breast cancer. N Engl J Med. 2015;372(5):436-446. PMID: 25495490.
6. Klotz L, Boccon-Gibod L, Shore ND, Andreou C, Persson BE, Cantor P, Jensen JK, Olesen TK, Schröder FH. The efficacy and safety of degarelix: a 12-month, comparative, randomized, open-label, parallel-group phase III study in patients with prostate cancer. BJU Int. 2008;102(11):1531-1538. PMID: 19035858.
7. Engel JB, Schally AV. Drug Insight: clinical use of agonists and antagonists of luteinizing-hormone-releasing hormone. Nat Clin Pract Endocrinol Metab. 2007;3(2):157-167. PMID: 17237842.
8. Jungwirth A, Diemer T, Dohle GR, et al. European Association of Urology Guidelines on Male Infertility. Eur Urol. 2012;62(2):324-332. PMID: 22591628.
9. Crawford ED, Tombal B, Miller K, Boccon-Gibod L, Schröder F, Shore N, Moul JW, Jensen JK, Olesen TK, Persson BE. A phase III extension trial with a 1-arm crossover from leuprolide to degarelix: comparison of gonadotropin-releasing hormone agonist and antagonist effect on prostate cancer. J Urol. 2011;186(3):889-897. PMID: 21788033.
10. Lahlou N, Carel JC, Chaussain JL, Roger M. Pharmacokinetics and pharmacodynamics of GnRH agonists: clinical implications in pediatrics. J Pediatr Endocrinol Metab. 2000;13 Suppl 1:723-737. PMID: 10969915.
11. U.S. Food and Drug Administration. Trelstar (triptorelin pamoate for injectable suspension) Prescribing Information. Verity Pharmaceuticals. FDA.gov.
12. European Medicines Agency / EU summary of product characteristics. Decapeptyl (triptorelin). Ipsen Pharma.
13. World Anti-Doping Agency. The 2026 Prohibited List. Section S2.2.1: Testosterone-stimulating peptides in males (gonadorelin and its agonist analogues, e.g. triptorelin). wada-ama.org.
14. Shore ND, Crawford ED. Intermittent androgen deprivation therapy: redefining the standard of care? Rev Urol. 2010;12(1):1-11. PMID: 20428288.
15. FDA. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the FD&C Act (503A categories list), versions updated April 15, April 22 and May 14, 2026. fda.gov/media/94155/download. Read October 3, 2026. (Notice that 12 peptides would leave Category 2 because their nominations were withdrawn; their removal; GHK-Cu, except injectable, back in Category 1.)
16. Kolibianakis EM, Schultze-Mosgau A, Schroer A, van Steirteghem A, Devroey P, Diedrich K, Griesinger G. A lower ongoing pregnancy rate can be expected when GnRH agonist is used for triggering final oocyte maturation instead of HCG in patients undergoing IVF with GnRH antagonists. Hum Reprod. 2005;20(10):2887-2892. PMID: 15979994.
17. Melo M, Busso CE, Bellver J, Alama P, Garrido N, Meseguer M, Pellicer A, Remohí J. GnRH agonist versus recombinant HCG in an oocyte donation programme: a randomized, prospective, controlled, assessor-blind study. Reprod Biomed Online. 2009;19(4):486-492. PMID: 19909588.
18. Pirola I, Cappelli C, Delbarba A, Scalvini T, Agosti B, Assanelli D, Bonetti A, Castellano M. Anabolic steroids purchased on the Internet as a cause of prolonged hypogonadotropic hypogonadism. Fertil Steril. 2010;94(6):2331.e1-2331.e3. PMID: 20416868.
19. Azurity Pharmaceuticals. Triptodur (triptorelin) for extended-release injectable suspension, for intramuscular use: prescribing information. DailyMed set ID f41380e7-b830-432d-a5f5-a872932f107e (version effective September 14, 2025). dailymed.nlm.nih.gov. Read October 3, 2026.
20. Ipsen Ltd. Decapeptyl SR 3 mg, 11.25 mg and 22.5 mg powder and solvent for suspension for injection: summaries of product characteristics (UK), revised June 1, 2026. medicines.org.uk/emc/product/963, /780 and /5906. Read October 3, 2026.
21. Ferring Pharmaceuticals Ltd. Gonapeptyl Depot 3.75 mg powder and solvent for suspension for injection: summary of product characteristics (UK), revised December 2, 2024. medicines.org.uk/emc/product/2229. Read October 3, 2026.

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