Gonadorelin news and clinical trials

Assisting Nature registered a trial for 180 participants to test a physiology-oriented mild ovarian stimulation protocol. The trial investigates whether a late-start protocol with corifollitropin alfa can simplify IVF while maintaining clinical outcomes.

A randomized trial evaluating the GnRH agonist leuprorelin in women with polycystic liver disease was terminated early after finding the treatment did not reduce liver volume and was associated with severe menopausal side effects and adverse events.

Sponsor Praful Ravi terminated a phase 1/2 study of darolutamide and abemaciclib in 9 prostate cancer patients after drug provider Lilly withdrew funding and support for the trial.

The study of darolutamide and abemaciclib for prostate cancer was terminated because the funding company, Lilly, withdrew support based on new data regarding abemaciclib in advanced prostate cancer.

Al-Azhar University registered a randomized controlled trial of 100 participants to compare the reproductive outcomes of a dual trigger versus a conventional hCG trigger for oocyte maturation in normal responders.

Virginia Commonwealth University registered a phase 4 study of 50 participants to examine whether nervous system or kidney dysfunction contributes to hypertension in men receiving androgen deprivation therapy for prostate cancer.

The University of Colorado, Denver posted results for study NCT05700903, which examined autonomic and renal contributions to hypertension in 10 men undergoing androgen deprivation therapy for prostate cancer. The study has been completed and terminated.

The University of Colorado, Denver terminated study NCT05700903 after completing the research on autonomic and renal contributions to hypertension in 10 men receiving androgen deprivation therapy for prostate cancer.

Stephanie B. Seminara posted results for a phase 2 study of 18 participants investigating the use of exogenous kisspeptin 112-121 in treating hypogonadotropic hypogonadism. The study is completed.

Astellas Pharma Global Development, Inc. registered a phase 1 study with 56 participants to determine how standard prostate cancer hormone therapies like enzalutamide, apalutamide, or bicalutamide affect the way the body processes fezolinetant.

Researchers registered a trial with 360 participants to test whether a superovulation protocol substituting standard gonadotropins with human chorionic gonadotropin (hCG) is as effective for IVF outcomes as standard protocols, with the goal of reducing treatment costs.

Ahmed Saad registered a phase 1/2 pilot trial comparing drospirenone-primed ovarian stimulation against a flexible GnRH antagonist protocol in 100 participants with poor ovarian reserve undergoing a freeze-all in vitro fertilization strategy.

Antev Ltd. registered a Phase 2 trial of Teverelix DP involving 126 men with acute urinary retention and benign prostatic hyperplasia. The study evaluates the GnRH antagonist's effects on total prostate volume and urinary function over a 28-week period.

Centro A.M.B.R.A. registered a trial comparing oral linzagolix to injectable GnRH antagonists for controlled ovarian stimulation in 120 patients undergoing IVF or ICSI.

Cairo University registered a trial investigating the effect of 4mg oral estradiol valerate pretreatment on follicular synchronization and IVF outcomes in 61 women with polycystic ovary syndrome undergoing ICSI.

A systematic review and meta-analysis of five cohort studies involving 162 women with systemic lupus erythematosus concluded that co-treatment with GnRH agonists during cyclophosphamide therapy markedly reduces the risk of primary ovarian insufficiency.

Debiopharm International SA completed a phase 2 dose-finding study of 55 participants to determine the pharmacokinetics and pharmacodynamics of Debio 4228, an extended-release gonadotropin-releasing hormone antagonist for advanced prostate cancer.

Li-jun Ding registered a Phase 4 trial of 120 participants to evaluate whether ultra-long Triptorelin pretreatment before hormone replacement therapy improves clinical pregnancy outcomes in patients with deep infiltrating endometriosis.

New meta-analysis in Ultrasound in obstetrics & gynecology : the official journal of the…: Progestogen-primed ovarian stimulation vs GnRH antagonists and/or agonists for women undergoing assisted reproduction: systematic review and meta-analysis.

Assisting Nature completed a 180-participant trial investigating a physiology-oriented mild ovarian stimulation protocol. The study used corifollitropin alfa, a GnRH antagonist, and progesterone to assess ovarian response and the feasibility of a late-start stimulation strategy.

An interim analysis of a randomized controlled trial comparing two fertility-sparing treatments for endometrial carcinoma and atypical hyperplasia found that a regimen of GnRH agonist plus letrozole resulted in a significantly higher 24-week complete response rate than oral progestins.

Cairo University completed a trial involving 61 infertile women with polycystic ovary syndrome to evaluate if 4mg daily oral estradiol valerate during the luteal phase affects follicular synchronization and IVF outcomes.

Assiut University registered a Phase 1/2 trial of 122 participants to evaluate the impact of a single dose of GnRH agonist as luteal phase support on pregnancy outcomes in frozen ICSI cycles.

Yale University completed a Phase 3 clinical trial of 103 women with endometriosis to test if pretreatment with 200 MG of the oral GnRH antagonist Elagolix improves live birth rates during IVF compared to no pretreatment.

New meta-analysis in Breast cancer research and treatment: Three-monthly gonadotropin-releasing hormone agonist for ovarian function suppression in premenopausal breast cancer: a systematic review and meta-analysis.

Guoxia Yang registered an observational study of 150 women with persistent chronic endometritis to investigate if GnRH agonist pretreatment plus estrogen-progesterone improves clinical pregnancy and live birth rates during frozen embryo transfer.

Heli Alexandroni registered an observational study of 150 participants to examine the mechanism of action of GnRH agonist luteal support in women undergoing IVF treatment.

Fudan University registered a phase 2 trial of 100 participants to compare the effect of switching from a 3-month to a 1-month GnRHa formulation versus continuing the 3-month dose on estrogen control in young breast cancer patients.

The University of Illinois at Chicago registered a phase 1/2 trial to test if adding Bupropion to aromatase inhibitor therapy improves sexual functioning in 100 women with early-stage breast cancer and hypoactive sexual desire disorder.

A network meta-analysis of 20 randomized controlled trials with 2,400 patients found that leuprorelin ranked highest for improving clinical pregnancy and live birth rates, while cetrorelix was ranked as the most effective for reducing the risk of ovarian hyperstimulation syndrome.

A systematic review of 52 research articles using rodent models found that postnatally androgenized PCOS-like rats and mice show reduced kisspeptinergic, monoaminergic, and GABAergic neurotransmission, suggesting shared neurobiological mechanisms for reproductive and mood regulation.

Bedaya Hospital registered a phase 2 trial with 190 participants to compare the efficacy of three successive doses of a GnRH agonist against a single dose for triggering ovulation in hyper-responders.

New randomized trial in Journal of assisted reproduction and genetics: An injection-lite approach to ovarian stimulation in poor responder patients using corifollitropin alfa and nasal GnRH agonist.

Memorial Sloan Kettering Cancer Center posted results for a phase 2 study investigating whether adding atezolizumab and SBRT to standard hormone-sensitive prostate cancer therapy improves outcomes for 28 participants.

A systematic review and meta-analysis of five phase 3 trials involving 2060 participants found that oral GnRH antagonists elagolix, linzagolix, and relugolix significantly reduced endometriosis-associated dysmenorrhea and non-menstrual pelvic pain compared to placebo.

IRCCS Azienda Ospedaliero-Universitaria di Bologna registered an observational study with 200 participants to compare the use of GnRH analogue or dual trigger for ovulation induction in oncology patients undergoing fertility preservation.

Beni-Suef University completed a phase 2/3 trial with 200 participants that compared the effectiveness and safety of a Progesterone Primed Ovarian Stimulation protocol using dydrogesterone against a GnRH antagonist protocol in patients with expected high ovarian response.

Amy DiVasta terminated this interventional study of 78 participants investigating the effects of GnRH agonist use on bone development in transgender youth because the study funding was terminated.

Ferring Pharmaceuticals terminated this phase 1 trial of 310 participants investigating FE999302 and follitropin delta due to a company portfolio assessment, not because of safety concerns.

A randomized controlled trial of 318 women compared a modified letrozole protocol to a GnRH antagonist protocol for IVF. The modified letrozole protocol significantly improved clinical pregnancy rates among patients with diminished ovarian reserve.

A phase III randomized controlled trial evaluated the pharmacokinetics of a 3-month leuprolide acetate depot in 48 pediatric patients with central precocious puberty and determined that the results support the use of a fixed dose.

A randomized controlled trial of 156 women with adenomyosis compared low-dose letrozole to GnRH agonist treatment. Both groups showed similar clinical pregnancy and live birth rates, suggesting low-dose letrozole may be a viable alternative to GnRH agonist therapy.

Researchers developed a population pharmacokinetic/pharmacodynamic model for merigolix to optimize endometriosis treatment dosing. Simulations indicated that daily doses of 120 and 160 mg achieved partial estrogen suppression, while 240 and 320 mg doses achieved full suppression.

A meta-analysis of 5 studies with 520 patients indicated that combining dienogest with GnRH agonists improves symptom scores and reduces uterine volume in adenomyosis patients compared to monotherapy. Researchers also found adenomyosis is associated with increased obstetric risks.

A systematic review and meta-analysis of six studies found that dienogest and GnRH agonists have comparable efficacy in postoperative pain management and lesion recurrence for endometriosis, though dienogest increased the risk of vaginal bleeding while GnRH agonists increased hot flushes.

A meta-analysis comparing degarelix and GnRH agonists for prostate cancer found that degarelix caused more injection site reactions but fewer cardiovascular and urinary adverse events. Degarelix also achieved faster testosterone suppression, though overall adverse event rates were higher.

A meta-analysis of 6 studies with 352 patients found that a double trigger protocol improved reproductive outcomes compared to hCG-only triggering. The double trigger increased oocyte retrieval in poor responders and improved embryo quality and pregnancy rates in normo-responders.