leuprolide acetate for depot suspension / Generic mfg. 
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  • ||||||||||  Trial completion date, Trial primary completion date:  Aromatase Plus GnRH Analogue Versus GnRH Analog Alone in Adenomyosis (clinicaltrials.gov) -  Jul 23, 2022   
    P4,  N=300, Recruiting, 
    Trial completion date: Apr 2022 --> Sep 2022 | Trial primary completion date: Mar 2022 --> Aug 2022
  • ||||||||||  Firmagon (degarelix) / Astellas, Ferring, Orgovyx (relugolix) / Intas, Gedeon Richter, Takeda, ASKA Pharma, Sumitomo Pharma
    Journal:  Advances with androgen deprivation therapy for prostate cancer. (Pubmed Central) -  Jul 23, 2022   
    While the side-effect profile with ADT are generally equivalent, effects on cardiovascular morbidity may be improved with the use of oral relugolix though this is noted with caution since the cardiovascular side-effects were a result of secondary subgroup analyses. The choice of ADT hinges upon cost, availability, ease of administration, and preference amongst physicians and patients alike.
  • ||||||||||  leuprolide acetate for depot suspension / Generic mfg.
    Journal:  Multi-analyte screening of small peptides by alkaline pre-activated solid phase extraction coupled with liquid chromatography-high resolution mass spectrometry in doping controls. (Pubmed Central) -  Jul 23, 2022   
    The method was validated in accordance with WADA relevant criteria and validated with a main focus on qualitative parameters including selectivity, limits of detection (0.02-0.2 ng/mL), linearity (0.1-20 ng/mL for 46 analytes and 0.2-20 ng/mL for 9 analytes), accuracy and precision (RE% and RSD% < 20% at 1, 5 and 10 ng/mL), recovery (39.2%-100.1% except for the TB500(1-2) free acid: 9.2%), matrix effects (ion suppression effect: 0 to 49.4% and ion enhancement effect: 100% and 264.6%), carryover, reliability and sample extract stability. As a proof-of-principle, urine samples from two patients received a single injection of leuprorelin acetate microspheres (3.75 mg) 30 days before were analyzed and the results proved the applicability of the method.
  • ||||||||||  leuprolide acetate for depot suspension / Generic mfg.
    Journal:  Sleep fragmentation and estradiol suppression decrease fat oxidation in pre-menopausal women. (Pubmed Central) -  Jul 20, 2022   
    Sleep fragmentation and hypoestrogenism each independently alter fasting substrate oxidation in a manner that may contribute to body fat gain. These findings are important for understanding mechanisms underlying propensity to body fat gain in women across the menopause transition.
  • ||||||||||  Enrollment closed:  STAMP: Strength, Aging, and Memory in Prostate Cancer (clinicaltrials.gov) -  Jul 18, 2022   
    P=N/A,  N=60, Active, not recruiting, 
    Enzalutamide in combination with standard androgen deprivation therapy and radiation therapy was well-tolerated and effective warranting further study in a randomized controlled trial. Recruiting --> Active, not recruiting
  • ||||||||||  Improvement of final height in congenital adrenal hyperplasia patients treated with recombinant growth hormone () -  Jul 16, 2022 - Abstract #ENDO2022ENDO_3001;    
    Patients received hydrocortisone 12.6±6.6mg/m2/day in classical and 8.24±4.7mg/m2/day in NC-form); SW patients received fludrocortisone 36±9.6 mcg/m2/day...Patients received leuprorelin acetate 11.25 mg each 3 months during 3.9±1.1yrs or cyproterone acetate, 70±19 mg/m²/d during 4.7±2.5yrs... GH therapy associated with puberty blockers allowed the achievement of FH in the expected range of TH, without significant side effects.
  • ||||||||||  leuprolide acetate for depot suspension / Generic mfg.
    Effective Suppression of Gonadotropins and Gonadal Steroids Following Oral Administration of Leuprolide () -  Jul 16, 2022 - Abstract #ENDO2022ENDO_1451;    
    Adverse events are generally mild in intensity and distributed evenly across treatment groups. We thus demonstrate the ability to achieve therapeutic degrees of gonadal hormone suppression following oral administration of leuprolide, comparable to that following injectable leuprolide and some marketed doses of oral GnRH antagonists (historical data).
  • ||||||||||  Verzenio (abemaciclib) / Eli Lilly
    Enrollment closed, Trial completion date, Trial primary completion date:  CARABELA: Neoadjuvant Study Chemotherapy vs Letrozole + Abemaciclib in HR+/HER2- High/Intermediate Risk Breast Cancer Patients (clinicaltrials.gov) -  Jul 12, 2022   
    P2,  N=200, Active, not recruiting, 
    We thus demonstrate the ability to achieve therapeutic degrees of gonadal hormone suppression following oral administration of leuprolide, comparable to that following injectable leuprolide and some marketed doses of oral GnRH antagonists (historical data). Recruiting --> Active, not recruiting | Trial completion date: Jun 2033 --> Feb 2033 | Trial primary completion date: Jun 2023 --> Feb 2023
  • ||||||||||  letrozole / Generic mfg., leuprolide acetate for depot suspension / Generic mfg.
    Journal:  Fertility preservation in transgender men without discontinuation of testosterone. (Pubmed Central) -  Jul 8, 2022   
    This is the first published case report demonstrating the proof of concept of COS without cessation of high-dose testosterone therapy in two transgender men. Future studies with larger sample sizes should be performed to confirm these findings.
  • ||||||||||  Vesanoid (tretinoin) / Roche
    Enrollment closed, Enrollment change, Trial primary completion date:  A Pilot Study of 5-AZA and ATRA for Prostate Cancer With PSA-only Recurrence After Local Treatment (clinicaltrials.gov) -  Jun 30, 2022   
    P2,  N=14, Active, not recruiting, 
    Future studies with larger sample sizes should be performed to confirm these findings. Recruiting --> Active, not recruiting | N=20 --> 14 | Trial primary completion date: Feb 2022 --> May 2022
  • ||||||||||  leuprolide acetate for depot suspension / Generic mfg.
    Preclinical, Journal:  New long-acting injectable microspheres prepared by IVL-DrugFluidic™ system: 1-month and 3-month in vivo drug delivery of leuprolide. (Pubmed Central) -  Jun 22, 2022   
    Moreover, the testosterone level in plasma was suppressed to < 0.50 ng/mL after 28 days with a steady plasma drug concentration. The results suggested that newly developed leuprolide-loaded microspheres produced by the IVL-DrugFluidic™ system could provide extended drug release with advantages such as reduced initial burst release and testosterone level suppression, along with steady plasma drug concentration, over the existing products.
  • ||||||||||  leuprolide acetate for depot suspension / Generic mfg.
    Journal:  Nulligravida with Large Uterine Leiomyoma: A Case Report. (Pubmed Central) -  Jun 14, 2022   
    She received a gonadotropin-releasing hormone agonist (injection leuprolide) preoperatively for reduction of the size of uterine myoma. case reports; gonadotropin-releasing hormone; hysterectomy; leiomyoma.
  • ||||||||||  leuprolide acetate for depot suspension / Generic mfg.
    Journal:  Efficient aqueous remote loading of peptides in poly(lactic-co-glycolic acid). (Pubmed Central) -  Jun 10, 2022   
    Leuprolide encapsulated by this approach in low-molecular-weight PLGA 75/25 microspheres slowly and continuously released peptide for over 56 days in vitro and suppressed testosterone production in rats in an equivalent manner as the 1-month Lupron Depot®...In certain cases, in vitro and in vivo performance of remote-loaded PLGA microspheres exceeded that relative to marketed products. Remote absorption encapsulation further removes the need for a critical organic solvent removal step after encapsulation, allowing for simple and cost-effective sterilization of the drug-free microspheres before encapsulation of the peptide.
  • ||||||||||  Reimbursement, Journal:  Hospital-Administered Cancer Therapy Prices for Patients With Private Health Insurance. (Pubmed Central) -  Jun 9, 2022   
    Most NCI-designated cancer centers did not publicly disclose payer-specific prices for cancer therapies as required by federal regulation. The findings of this cross-sectional study suggest that, to reduce the financial burden of cancer treatment for patients, institution of public policies to discourage or prevent excessive hospital price markups on parenteral chemotherapeutics might be beneficial.
  • ||||||||||  Orgovyx (relugolix) / Intas, Gedeon Richter, Takeda, ASKA Pharma, Sumitomo Pharma, Pfizer
    Enrollment open:  REVELUTION: RElugolix VErsus LeUprolide Cardiac Trial (clinicaltrials.gov) -  Jun 8, 2022   
    P4,  N=90, Recruiting, 
    The findings of this cross-sectional study suggest that, to reduce the financial burden of cancer treatment for patients, institution of public policies to discourage or prevent excessive hospital price markups on parenteral chemotherapeutics might be beneficial. Not yet recruiting --> Recruiting