triptorelin / Generic mfg. - LARVOL DELTA

CARLHA-2: Combined Apalutamide, Radiotherapy, and LHRH Agonist in Prostate Cancer Patients After Prostatectomy (clinicaltrials.gov) - P3 | N=490 | Active, not recruiting | Sponsor: UNICANCER | Recruiting ➔ Active, not recruiting

Enrollment closed • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

VA STARPORT: Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate Cancer (clinicaltrials.gov) - P2/3 | N=464 | Recruiting | Sponsor: VA Office of Research and Development | Trial completion date: Dec 2025 ➔ Mar 2029 | Trial primary completion date: Jul 2025 ➔ Mar 2026

Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

AQbD-based development of a stability-indicating UHPLC-PDA-QDa method for triptorelin in parenteral formulations. (PubMed, Anal Methods) - "The method was subjected to forced degradation studies under hydrolytic (acidic and basic), oxidative, and thermal stress conditions to demonstrate its stability-indicating capability. These results support its overall suitability for routine quality control and regulatory applications in peptide drug analysis."

Journal

Retrospective Analysis on the Impact of Triptorelin on Final Height of Girls with Precocious and Early Puberty: A Single-Center, Long-Term Study. (PubMed, Children (Basel)) - "Triptorelin was effective in delaying the onset of menarche. Factors contributing to a better final height in treated girls were higher height at baseline, lower midparental height, and younger bone age."

Journal • Retrospective data • Endocrine Disorders • Pediatrics

The GnRH Agonist Triptorelin Causes Reversible, Focal, and Partial Testicular Atrophy in Rats, Maintaining Sperm Production. (PubMed, Int J Mol Sci) - "In conclusion, triptorelin treatment promotes a decline in testosterone levels accompanied by discrete atrophy of the seminiferous tubules, which is partially reversible and compatible with sperm production and fertility preservation. Triptorelin could be an appropriate treatment prior to estrogen therapy for patients seeking gender transition."

Journal • Preclinical

Tamoxifen and Exemestane Trial Bone Substudy - A substudy to Amendment 2 of the IBCSG 25-02 / BIG 3-02: Tamoxifen and Exemestane Trial (ACTRN12605000418673) hereby referred to as TEXT-2, which evaluates the effects of exemestane plus Gonadotropin-releasing hormone (GnRH) analogue as adjuvant therapy for premenopausal women with endocrine responsive breast cancer (ANZCTR) - P3 | N=200 | Terminated | Sponsor: Breast Cancer Trials | Active, not recruiting ➔ Terminated

Trial termination • Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • IGF1

Does Recombinant FSH (rFSH, i.g. Gonal F®) as Compared to Human Menopausal Gonadotrophin (hMG) Affect Telomere Length of Cumulus Cells During Antral Follicle Growth and Impact Blastocyst Status? (clinicaltrials.gov) - P=N/A | N=10 | Recruiting | Sponsor: ART Fertility Clinics LLC | Not yet recruiting ➔ Recruiting | Initiation date: Dec 2025 ➔ Jul 2025

Enrollment open • Trial initiation date

Cell-free DNA Analysis of Spent Embryo Culture Media as a Non-invasive Approach for Preimplantation Genetic Diagnosis (clinicaltrials.gov) - P=N/A | N=20 | Completed | Sponsor: Sohag University

New trial

Co-SOFT: Cognitive Function Substudy - A substudy to the SOFT trial (ACTRN12605000416695) which evaluates the cognitive function of premenopausal women with endocrine responsive breast cancer participating in SOFT. (clinicaltrials.gov) - P3 | N=357 | Terminated | Sponsor: Breast Cancer Trials | Active, not recruiting ➔ Terminated

Trial termination • Breast Cancer • Oncology • Solid Tumor

Embryo division timings and top-quality embryo rates in GnRH-Antagonist ICSI cycles: a comparison of hCG and dual trigger methods. (PubMed, J Assist Reprod Genet) - "Dual triggering in GnRH-antagonist ICSI cycles did not improve most morphokinetic parameters, top-quality embryo rates, or clinical outcomes over hCG alone, suggesting limited benefit in general populations."

Journal

Adverse event profile differences among long-acting gonadotropin-releasing hormone analogs: A real-world, pharmacovigilance study. (PubMed, PLoS One) - "Significant disparities exist between the adverse event profiles of long-acting GnRHa. The identification of high-risk factors and the enhancement of AEs monitoring are crucial during clinical application."

Adverse events • Journal • Real-world evidence • Breast Cancer • CNS Disorders • Endocrine Disorders • Endometriosis • Gastroenterology • Gastrointestinal Disorder • Genito-urinary Cancer • Gynecology • Mental Retardation • Oncology • Pediatrics • Prostate Cancer • Psychiatry • Solid Tumor • Uterine Leiomyoma • Women's Health

What a MES!: A Case of Abiraterone-induced Mineralocorticoid Excess Syndrome (ENDO 2025) - "However, its dual inhibition of 17α-hydroxylase and 17,20-lyase can lead to adverse effects from cortisol suppression.A 79-year-old male with prostate carcinoma and bone metastases on Triptorelin pamoate every six months and abiraterone 250 mg twice daily with prednisone 5 mg once daily for over a year has hypertension with more than three anti-hypertensive medications, including a diuretic, and also has diabetes with chronic kidney disease...Abiraterone was discontinued, and prednisone was switched to dexamethasone due to its lack of mineralocorticoid activity. As amiloride was unavailable, finerenone, a selective mineralocorticoid receptor antagonist, was initiated.Abiraterone inhibits CYP17A1, reducing cortisol production by blocking 17α-hydroxylase and suppressing androgen synthesis, key for prostate cancer progression...Finerenone, a novel, selective MRA, is as effective as spironolactone with fewer side effects and better cardiovascular outcomes, particularly in..."

Clinical • Cardiovascular • Chronic Kidney Disease • Diabetes • Endocrine Disorders • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Hypertension • Metabolic Disorders • Nephrology • Oncology • Prostate Cancer • Renal Disease • Solid Tumor • AR

Is the Triptorelin Stimulation Test Comparable to the Gonadorelin Test in Diagnosing Central Precocious Puberty in Boys? (ENDO 2025) - "The triptorelin stimulation test shows limitations as a reliable alternative to the traditional gonadorelin stimulation test in boys. Results from the triptorelin test should be interpreted with caution due to these differences."

Endocrine Disorders

Effectiveness of 6-Month Gnrha Formulations for Pubertal Suppression in Youth Assigned Male-At-Birth (ENDO 2025) - "In addition to monthly and three-monthly formulations, new long-acting GnRHa products, triptorelin and leuprolide acetate (Triptodur® and Fensolvi®) have been approved for use in central precocious puberty (CPP). The majority of TG/NB patients AMAB in our study achieved pubertal suppression (biochemical, clinical, or both) with Triptodur® or Fensolvi® based on strict criteria used for CPP. Of those with subjective data, all reported adequate suppression. This study provides novel clinical and biochemical data of TG/NB patients AMAB on long-acting GnRHa formulations, Triptodur® and Fensolvi®, which can guide clinicians in their care."

Endocrine Disorders

Pubertal Suppression for Youth Assigned Female At Birth: Experience With 6-Month Formulations (ENDO 2025) - "Within the last decade, new long-acting GnRHa formulations, triptorelin and leuprolide acetate (Triptodur® and Fensolvi®) were approved for use in central precocious puberty (CPP). Extrapolating suppression criteria from the CPP literature, the majority of TG/NB patients AFAB achieved or maintained pubertal suppression (biochemical and/or clinical) with Triptodur® or Fensolvi®. To our knowledge, our study is the first one to provide clinical and biochemical data of TG/NB patients AFAB on long-acting GnRHa formulations, Triptodur® and Fensolvi®, which can serve as a guide to clinicians."

Endocrine Disorders

TEXT-Bone: Study of Bone Mineral Density in Women With Breast Cancer Treated With Triptorelin and Tamoxifen or Exemestane on Protocol IBCSG 25-02 (clinicaltrials.gov) - P=N/A | N=119 | Completed | Sponsor: ETOP IBCSG Partners Foundation | Active, not recruiting ➔ Completed | Trial completion date: Dec 2025 ➔ Oct 2024

Trial completion • Trial completion date • Breast Cancer • Oncology • Rheumatology • Solid Tumor • IGF1

A Bioequivalence Study of Recombinant Human Follicle-Stimulating Hormone Injection Versus Recombinant Human Follitropin For Injection in Healthy Chinese Adult Women. (PubMed, Drugs R D) - "The novel prefilled rh-FSH injection (GenSci008) is bioequivalent to the reference formulation (Jinfollin®), offering a user-friendly and precise alternative for subcutaneous administration in the treatment of infertility."

Journal • Infertility • Sexual Disorders

Dong-A ST-Ipsen Korea, Joint Sales Agreement for ’Diphereline’, Precocious Puberty and Prostate Cancer Treatment [Google translation] (BioTimes) - "Dong-A ST...announced on the 30th that it has signed a joint sales agreement with Ipsen Korea...for the treatment of precocious puberty and prostate cancer, 'Diphereline (ingredient name Triptorelin)'....According to the agreement, the two companies will jointly conduct domestic promotion and marketing activities for Differelin starting July 1....The two companies will cooperate in sales targeting general hospitals, while Dong-A ST will be in charge of sales targeting hospitals and clinics. Based on their accumulated capabilities and expertise, the two companies plan to create synergy and actively expand Differelin’s domestic market."

Commercial • Prostate Cancer

IBCSG 24-02 / BIG 2-02: Suppression of Ovarian Function Trial (ANZCTR) - P2 | N=3000 | Completed | Sponsor: Breast Cancer Trials | Active, not recruiting ➔ Completed

Trial completion • Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor

DiWB-1: A Luteinizing Hormone Releasing Hormone (LHRH)-Targeted Peptide-Drug Conjugate (PDC) With Enhanced Tumor Selectivity and PI3K Inhibition Efficacy. (PubMed, Arch Pharm (Weinheim)) - "IV-6 was then conjugated to the PI3K inhibitor buparlisib, forming the target PDC, DiWB-1. Pharmacokinetic studies further indicated that DiWB-1 had favorable metabolic stability, with a half-life of 5.6 h, slightly exceeding that of triptorelin (4.2 h). These findings suggest that DiWB-1 holds promise as a selective, potent, and long-acting anticancer PDC, warranting further investigation."

Journal • Diabetes • Oncology

Comparing IVF/ICSI Cycle Outcomes of Post Ovulation Ovarian Stimulation Protocol With Elonva Without GnRH Antagonist to Follicular Phase Day 2 Stimulation Fixed Day 5 Antagonist Protocol (clinicaltrials.gov) - P=N/A | N=252 | Not yet recruiting | Sponsor: ART Fertility Clinics LLC | Initiation date: Apr 2025 ➔ Jul 2025

Trial initiation date

In vitro assessment of polyethylene glycol-coated iron oxide nanoparticles integrating luteinizing hormone releasing-hormone targeted magnetic hyperthermia and doxorubicin for lung and breast cancer cells. (PubMed, Biointerphases) - "In this study, a targeted magnetic drug delivery system was developed, comprising doxorubicin (DOX), a [D-Trp6] luteinizing hormone-releasing hormone (LHRH) (Triptorelin) ligand, and a polyethylene glycol (PEG)-coated magnetite core, aiming to enhance cancer therapy efficacy. Similarly, in MCF-7 cells, the combined treatment at 8 μg/ml DOX led to a 91% reduction in viability, surpassing the effects of chemotherapy (57%) and thermotherapy (45%) individually. Additionally, the targeted DOX-loaded nanoparticles significantly elevated interferon-gamma production, indicating an enhanced immune response and increased cancer cell apoptosis."

Journal • Preclinical • Breast Cancer • Oncology • Solid Tumor • IFNG

Application of Triptorelin Acetate Microspheres for Injection in the long protocol of GnRH-a: A randomized controlled clinical trial (ChiCTR) - P4 | N=400 | Not yet recruiting | Sponsor: The first people's Hospital of Yunnan Province; The first people's Hospital of Yunnan Province

New P4 trial • Infertility • Sexual Disorders

Triptorelin and Radiation Therapy in Treating Patients Who Have Undergone Surgery for Intermediate-Risk Stage III or Stage IV Prostate Cancer (clinicaltrials.gov) - P3 | N=424 | Completed | Sponsor: UNICANCER | Active, not recruiting ➔ Completed

Trial completion • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

Results of the prospective randomized controlled trial VOG-01: Neoadjuvant endocrine therapy ribociclib + fulvestrant + GnRH-a versus chemotherapy 4 AC + 4 T for early HR+/HER2-negative breast cancer in premenopausal patients. (ASCO 2025) - P2/3 | " Premenopausal women with HR+/HER2-negative stage II-III were randomly assigned to Fulvestrant (500 mg on the 1st, 15th, 28th days of the first cycle, then once every 28 days), Triptorelin (3.75 mg every 28 days) and Ribociclib (600 mg daily, 3 weeks/4) during 16-24 weeks (NET), or Doxorubicin 60 mg/m2 + Cyclophosphamide 600 mg/m2 x4 21-day courses followed by Docetaxel 75 mg/m2 x4 21-day courses (NCT). For the first time randomised trial comparing NET and NCT was conducted in premenopausal women with HR+/HER2- early breast cancer. NET was not inferior to standard NCT in terms of objective response rate, complete or pronounced pathological response rate and breast-conserving surgery. At the same time it was associated with a lower severity of adverse events and increased quality of life."

Clinical • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2