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Triptorelin research

What published studies found for Triptorelin: 8 papers, 8 in humans, with sample sizes and key results, plus 167 registered clinical trials.

A
Strong human evidence
Why: Approved drug; large RCTs and meta-analyses (thousands of patients) consistently show hormone suppression for cancers, endometriosis and early puberty.

Triptorelin is an approved long-acting GnRH agonist with extensive human RCT and meta-analysis evidence for suppressing sex hormones in prostate cancer, breast cancer, endometriosis and precocious puberty. Its sustained effect is to shut down, not stimulate, the reproductive axis; no study in the candidates tests the off-label single-dose use to 'restart' testosterone after anabolic steroids.

✓ 5 positive✗ 1 negative~ 1 mixed? 1 inconclusive

Adverse effects largely reflect intended sex-hormone suppression; there is no published human safety data in the candidates on single-dose use in men after anabolic steroid cycles.

US compounding: FDA-approved drug. FDA-approved (Trelstar, Triptodur). Status for every peptide.

Browse and filter these papersTriptorelin prices and vendors

Reported side effects

Registered clinical trials

167 trials of Triptorelin on ClinicalTrials.gov: 28 active, 77 completed, 33 with posted results. Registered trials include ones that haven't published yet.

TrialStatusPhasePeopleSponsor
Evaluation of Clinical Outcomes of Chemotherapy or Androgen-receptor Targeting Agent (Alone or Combined) or Radiotherapy on Primary Tumor in Addition to Androgen Deprivation Therapy in HOrmone-Sensitive Metastatic Prostate Cancer PatientsNCT06473259 · started 2016-12-16Recruiting–3,000Santa Chiara Hospital
Two Studies for Patients With High Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a High Gene Risk Score, The PREDICT-RT TrialNCT04513717 · started 2021-01-21Active, not recruitingPhase 32,753NRG Oncology
Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a Higher Gene Risk Score, The Guidance TrialNCT05050084 · started 2021-12-06Active, not recruitingPhase 32,050NRG Oncology
Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate CancerNCT03678025 · started 2018-09-24RecruitingPhase 31,273SWOG Cancer Research Network
Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET ImagingNCT04423211 · started 2020-10-08RecruitingPhase 3804ECOG-ACRIN Cancer Research Group
GnRH Agonist for Dual Trigger in IVF and for Luteal Phase Support in FETNCT04064840 · started 2019-09-01RecruitingPhase 3784The University of Hong Kong
Luteal Phase Support With GnRH Agonist After GnRH Agonist Triggering in IVF/ICSI CyclesNCT06150703 · started 2024-06-27RecruitingPhase 3652Assistance Publique - Hôpitaux de Paris
Short Versus Long-term Androgen Deprivation Therapy With Salvage Radiotherapy in Prostate Cancer. URONCOR 0624NCT05781217 · started 2023-03-14RecruitingPhase 3534Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic
Stereotactic Body Radiation Therapy Plus Immediate or Delayed Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy or Salvage Radiation Therapy for the Treatment of Prostate Cancer, DIVINE TrialNCT06378866 · started 2024-06-03RecruitingPhase 2532Mayo Clinic
Use of GnRHa During Chemotherapy for Fertility ProtectionNCT05328258 · started 2023-03-31RecruitingPhase 3500Kenny Rodriguez-Wallberg
Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular TracersNCT06282588 · started 2023-12-13RecruitingPhase 2, Phase 3493Cancer Research Antwerp
Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate CancerNCT04787744 · started 2021-07-01RecruitingPhase 2, Phase 3464VA Office of Research and Development

All 167 Triptorelin trials, with countries and recruiting status

Meta-analyses & systematic reviews

✓ Positivemeta-analysisLancet Oncol · 2022

Aromatase inhibitors versus tamoxifen in premenopausal women with oestrogen receptor-positive early-stage breast cancer treated with ovarian suppression: a patient-level meta-analysis of 7030 women from four randomised trials.

n = 7,030 humansPatient-level meta-analysis of four randomised trialsMedian follow-up 8.0 years

Patient-level meta-analysis of 7,030 premenopausal women receiving ovarian suppression (goserelin or triptorelin): an aromatase inhibitor reduced breast cancer recurrence vs tamoxifen (RR 0.79), without a difference in mortality; more fractures with aromatase inhibitors.

Key resultRecurrence lower with aromatase inhibitor (RR 0.79, 95% CI 0.69-0.90, p=0.0005); breast cancer mortality RR 1.01 (95% CI 0.82-1.24; p=0.94); fractures 6.4% vs 5.1% (p=0.017)
Studied
Premenopausal women with ER-positive early breast cancer receiving ovarian suppression (goserelin or triptorelin) or ablation
Compared with
Tamoxifen
Main outcome
Breast cancer recurrence, breast cancer mortality, all-cause mortality
Sample
7030 women from four randomised trials
Authors' conclusion
Using an aromatase inhibitor rather than tamoxifen in premenopausal women receiving ovarian suppression reduces recurrence risk; longer follow-up is needed for any effect on mortality.
Limitations
Compares aromatase inhibitor vs tamoxifen, not triptorelin; ovarian suppression agent included goserelin.
PubMed 35123662DOIFree full text
Figure 1: Aromatase inhibitors versus tamoxifen in premenopausal women(A) Any recurrence, (B) distant recurrence, (C) breast cancer mortality, and (D)
Figure 1. From PMC8885431, CC BY (terms); resized.
✓ Positivemeta-analysisHorm Res Paediatr · 2017

Meta-Analysis of Paediatric Patients with Central Precocious Puberty Treated with Intramuscular Triptorelin 11.25 mg 3-Month Prolonged-Release Formulation
.

n = 153 humansMeta-analysis of clinical studies of triptorelin 11.25 mg 3-month formulation3 and 6 months

Meta-analysis of 153 children with central precocious puberty: the 3-month triptorelin formulation suppressed the LH response in 87.6% at 3 months and 92.8% at 6 months.

Key resultSuppressed peak LH in 87.6% (95% CI 81.3-92.4) at 3 months and 92.8% (95% CI 87.5-96.4) at 6 months
Studied
Children with central precocious puberty
Main outcome
Proportion with suppressed peak LH response to GnRH test
Sample
153 children (13 boys, 140 girls) in a meta-analysis of all available studies
Authors' conclusion
The triptorelin 11.25 mg 3-month formulation is efficacious in suppressing LH peak and other gonadal hormones and slowing the progression of CPP in children.
Limitations
Mostly girls; single-arm pooled data without a control group.
PubMed 28334719DOI

Human studies

✓ Positivehuman RCTN Engl J Med · 2014

Adjuvant exemestane with ovarian suppression in premenopausal breast cancer.

n = 4,690 humansTwo phase 3 randomized trials, combined analysis; ovarian suppression by triptorelin, oophorectomy or ovarian irradiation5 years of therapy; median follow-up 68 months

SOFT/TEXT trials in 4,690 premenopausal women with hormone-receptor-positive breast cancer (ovarian suppression mostly with triptorelin): exemestane plus suppression improved 5-year disease-free survival vs tamoxifen plus suppression (91.1% vs 87.3%); grade 3-4 adverse events ~30% in both arms.

Key result5-year disease-free survival 91.1% vs 87.3% (HR 0.72; 95% CI 0.60 to 0.85; P<0.001); overall survival not different (HR 1.14; P=0.37)
Studied
Premenopausal women with hormone-receptor-positive early breast cancer
Compared with
Tamoxifen plus ovarian suppression
Main outcome
Disease-free survival at 5 years
Sample
4690 premenopausal women pooled from the SOFT and TEXT trials
Authors' conclusion
In premenopausal women, exemestane plus ovarian suppression significantly reduced recurrence compared with tamoxifen plus ovarian suppression.
Limitations
Ovarian suppression was triptorelin in some patients only; the comparison is of the aromatase inhibitor, not of triptorelin itself.
PubMed 24881463DOIFree full text
✓ Positivehuman RCTAdv Ther · 2022

Assessment of Two Formulations of Triptorelin in Chinese Patients with Endometriosis: A Phase 3, Randomized Controlled Trial.

n = 300 humansPhase 3 randomized, open-label, active-controlled, multicenter noninferiority trial6 months of treatment; primary outcome at 12 weeks

300 women with endometriosis: 3-month triptorelin was noninferior to the 1-month formulation, with over 98% reaching castration-level estradiol at 12 weeks and similar pelvic-pain reduction.

Key resultOver 98% of patients in both groups were chemically castrated at week 12
Studied
Chinese women aged 18-45 with endometriosis needing GnRH agonist treatment for 6 months
Compared with
Triptorelin acetate PR 1-month (3.75 mg every 4 weeks)
Main outcome
Proportion with estradiol suppressed to castration level at 12 weeks
Sample
300 Chinese women, 150 per arm
Authors' conclusion
Triptorelin pamoate PR 3-month was noninferior to the 1-month formulation, equally efficacious for pelvic pain, with no new safety concerns and fewer injections.
Limitations
Open-label design.
PubMed 35947347DOIFree full text
✓ Positivehuman RCTJ Natl Cancer Inst · 2022

Long-Term Outcomes With Pharmacological Ovarian Suppression During Chemotherapy in Premenopausal Early Breast Cancer Patients.

n = 281 humansMulticenter randomized open-label phase III superiority trial (PROMISE-GIM6), long-term post hoc analysisMedian follow-up 12.4 years

PROMISE-GIM6 trial in 281 premenopausal breast cancer patients: adding triptorelin during chemotherapy (to protect ovarian function) did not worsen 12-year disease-free or overall survival.

Key result12-year DFS 65.7% vs 69.2% (HR = 1.16, 95% CI = 0.76 to 1.77); 12-year OS 81.2% vs 81.3% (HR = 1.17, 95% CI = 0.67 to 2.03)
Studied
Premenopausal women with early breast cancer (80.4% hormone receptor-positive) receiving (neo)adjuvant chemotherapy
Compared with
Chemotherapy alone
Main outcome
12-year disease-free and overall survival (post hoc)
Sample
281 randomly assigned patients
Authors' conclusion
Final analysis provides reassuring results on the safety of GnRHa during chemotherapy for ovarian function preservation, including in hormone receptor-positive disease.
Limitations
Survival endpoints were post hoc; open-label.
PubMed 34850043DOIFree full text
✗ Negativehuman RCTArch Dis Child · 1999

Randomised trial of LHRH analogue treatment on final height in girls with onset of puberty aged 7.5-8.5 years.

Forty-six girls (written as words), 20 in treatment group and 18 analysed in controlsRandomised trial: triptorelin vs no treatmentFollowed to final height

46 girls with puberty onset at 7.5-8.5 years randomized to triptorelin or no treatment: final adult height was the same (158.1 vs 158.6 cm).

Key resultFinal height 158.1 (6.2) cm with triptorelin vs 158.6 (6.0) cm without treatment, not significantly different
Studied
Girls with onset of puberty aged 7.5-8.5 years
Compared with
No treatment
Main outcome
Final adult height
Authors' conclusion
LHRH analogue has no apparent effect on final height in girls with onset of puberty between 7.5 and 8.5 years.
Limitations
Small trial with no placebo (untreated control).
PubMed 10490438DOIFree full text
~ Mixedhuman RCTBJU Int · 2019

Metabolic consequences of gonadotropin-releasing hormone agonists vs orchiectomy: a randomized clinical study.

Fifty-eight men randomised 1:1 (written as words)Randomized clinical study: subcapsular orchiectomy vs triptorelin 22.5 mg depot every 24 weeks48 weeks

58 men with advanced prostate cancer randomized to triptorelin depot or orchiectomy: androgen deprivation by either route increased fat mass, cholesterol and insulin resistance and reduced lean mass within 12-24 weeks; orchiectomy caused more fat gain.

Key resultNo difference in fasting glucose change (0.2 mmol/L, 95% CI -0.1, 0.4; P = 0.32); orchiectomy had greater total fat mass gain (+2.06 kg, 95% CI 0.55, 3.56) at 48 weeks
Studied
Hormone-naive men with advanced prostate cancer
Compared with
Orchiectomy
Main outcome
Change in fasting plasma glucose; body composition, lipids, insulin resistance
Authors' conclusion
Androgen deprivation therapy worsens body composition, insulin resistance and cholesterol within 12-24 weeks; orchiectomy causes greater fat accumulation than GnRH agonists.
Limitations
Comparison is triptorelin vs orchiectomy; no untreated control group.
PubMed 30388320DOI
? Inconclusivehuman trialJ Pediatr · 1995

Use of the gonadotropin-releasing hormone agonist triptorelin in the diagnosis of delayed puberty in boys.

Number of boys not stated in the abstractDiagnostic test: single subcutaneous triptorelin 0.1 mg/m2 at 4 AMBlood sampled at baseline and 4 hours after injection

In teenage boys, a single triptorelin injection raised gonadotropins and testosterone more in constitutional delayed puberty than in gonadotropin deficiency, supporting its use as a diagnostic test.

Studied
Teenage boys with delayed puberty or gonadotropin deficiency
Compared with
Boys with gonadotropin deficiency vs delayed puberty
Main outcome
Rise in serum gonadotropins and testosterone
Authors' conclusion
The increase in blood gonadotropin and testosterone levels was significantly greater in boys with delayed puberty than in those with gonadotropin deficiency.
Limitations
Abstract gives no sample size or numerical data.
PubMed 7752001DOI

Verdicts are judged on each paper's own main outcome; grades run from A (strong human evidence) to D (little or none). Details are read from the abstracts, and figures are reproduced only from openly licensed full texts. Not medical advice.