leuprolide acetate for depot suspension / Generic mfg. 
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  • ||||||||||  leuprorelin depot / Generic mfg.
    Journal:  Physical-chemical characterization of octreotide encapsulated in commercial glucose-star PLGA microspheres. (Pubmed Central) -  Sep 16, 2021   
    Sandostatin LAR (SLAR) is an injectable long-acting release (LAR) microsphere formulation for octreotide based on a biodegradeable glucose star copolymer of d,l-lactic and glycolic acids (PLGA-glu), which is primarily used for the treatment of patients with acromegaly...Leuprolide is considered as a cationic peptide competitor for octreotide-PLGA interactions and its presence in the release medium resulted in more continuous octreotide release from SLAR, which was linearly correlated with the mass loss from the polymer (i.e., an indication of erosion-controlled release)...This salt is expected to catalyze octreotide acylation and extend peptide release beyond that is driven by erosion-control. The characterization studies of physicochemical properties of SLAR described here could be useful for development and regulatory evaluation of generic octreotide microspheres as well as new polymer formulations in which the polymer strongly interacts with encapsulated peptides.
  • ||||||||||  Esmya (ulipristal acetate) / ASKA Pharma, HRA Pharma, Gedeon Richter, AbbVie
    Journal:  Liver Injury with Ulipristal Acetate: Exploring the Underlying Pharmacological Basis. (Pubmed Central) -  Sep 11, 2021   
    Different drug properties previously linked to the occurrence of DILI may partially explain the reporting pattern observed with UPA. Our "bedside-to-bench" approach may support regulators in the risk-benefit assessment of UPA.
  • ||||||||||  leuprolide acetate for depot suspension / Generic mfg.
    Trial completion:  CRONOS II: Evaluation of Diet and Exercise in Prostate Cancer Patients (clinicaltrials.gov) -  Sep 10, 2021   
    P=N/A,  N=1331, Completed, 
    Our "bedside-to-bench" approach may support regulators in the risk-benefit assessment of UPA. Active, not recruiting --> Completed
  • ||||||||||  leuprorelin depot / Generic mfg., bicalutamide / Generic mfg.
    An Unusual Case of Rectal Bleeding (Shoreline Exhibit Hall) -  Sep 8, 2021 - Abstract #ACG2021ACG_2291;    
    B: MRI of pelvis with an enlarged prostate measuring 6.7cm x 6.2cm x 8.9cm. The gland abuts the anterior rectal wall with loss of the anterior serosal surface.
  • ||||||||||  leuprorelin depot / Generic mfg., bicalutamide / Generic mfg.
    A Case of Metastatic Prostate Cancer Masquerading as Radiation Proctitis on Colonoscopy (Shoreline Exhibit Hall) -  Sep 8, 2021 - Abstract #ACG2021ACG_924;    
    He was previously treated with radiation therapy 20 years ago followed by brachytherapy and Bicalutamide, and was on biannual Leuprolide at the time of exam...Patient was subsequently started on Enzalutamide which led to a decline in PSA...Center: Medium power view of hematoxylin and eosin stained section showing neoplastic cells expanding the lamina propria. Right: The neoplastic cells are positive for pancytokeratin (AE1/AE3), NKX3.1 and PSAP, confirming metastatic carcinoma consistent with prostate primary.
  • ||||||||||  leuprorelin depot / Generic mfg., bicalutamide / Generic mfg.
    Clinical, Journal:  Failure to achieve castrate level of serum testosterone during luteinizing hormone-releasing hormone agonist therapy in a patient with prostate cancer. (Pubmed Central) -  Sep 2, 2021   
    Due to liver dysfunction, antiandrogens, both bicalutamide and flutamide, were stopped...Leuprorelin acetate was replaced by goserelin acetate...Androgen deprivation therapy is the standard treatment for patients with advanced prostate cancer and luteinizing hormone-releasing hormone aims to suppress serum testosterone to castrate range. We recommend assessing the serum testosterone levels during luteinizing hormone-releasing hormone agonist therapy for monitoring treatment efficacy and verifying progression when the PSA level increases.
  • ||||||||||  leuprorelin depot / Generic mfg.
    [VIRTUAL] Diagnostic Dilemma in a Patient with Central Precocious Puberty: Ovarian Steroid Cell Tumor () -  Aug 27, 2021 - Abstract #ESPE2021ESPE_1015;    
    GnRH therapy (leuprolide acetate therapy 3,75 mg/28 days) was initiated due to centrally rapidly progressing puberty and early menarche...Estrogensecreting ovarian masses may not be detected by USG when they are still small in size. Radiological imaging may be repeated, especially in rapidly progressing puberty cases showing clinical and hormonal progression despite treatment.
  • ||||||||||  leuprorelin depot / Generic mfg.
    [VIRTUAL] Sterile Abscess Formation with Two Different GnRH Analogues: Three Case Reports () -  Aug 27, 2021 - Abstract #ESPE2021ESPE_960;    
    Enantone appeared to have been effective in the treatment of CPP. Although SA is a rare side effect, it is very important as it causes patients to be left untreated.In our cases, the active substance of the drug accumulates in the localization of SA and cannot be absorbed, so it cannot enter the systemic circulation.Therefore, puberty cannot be suppressed.Also, often leaving a scar is annoying for patients and their families.We suggest that if a dose increase is required, SA may develop.For this, we recommend the injection site check.If SA develops, we recommend discontinuing the treatment and not insisting on treatment.
  • ||||||||||  leuprorelin depot / Generic mfg.
    [VIRTUAL] Gonadotropin Flare with Different Depot GnRH Agonists: Comparative Analysis. () -  Aug 27, 2021 - Abstract #ESPE2021ESPE_957;    
    Leuprolide 45 mg, long-acting, biannual administration did not induce a significant higher gonadotropin flare as compared to the monthly Triptorelin 3.75 mg. This result suggests that there should be no concerns regarding flare when using Leuprolide 45 mg to initiate treatment of CPP in girls.
  • ||||||||||  leuprorelin depot / Generic mfg.
    [VIRTUAL] Query By Telarquia: Has there been an increase due to the SARS-COV19 pandemic? () -  Aug 27, 2021 - Abstract #ESPE2021ESPE_569;    
    first consultation, difference between chronological age and bone age, sex hormone values (FSH,LH and estradiol) in the first analysis, if a functional test was performed to study the gonadal axis (Procrin) and result of the same, abdominal ultrasound, if they had received stopping treatment, if they had had contact with disruptors, if they had gained at least 3kg in weight in the last 6 months and the final diagnosis given.Comparing both years, in 2020 there were 28% more first consultations by early thelarchies than, in 2019 (p: 0.0001 average comparison)...But we can also observe that in 2020 there are more children who consult with a higher BMI and with an increase in weight gain in the last 6 months. This increase in weight could suggest a trigger effect due to an increase in fat mass and a greater number of advanced puberty.
  • ||||||||||  NN1213 / Novo Nordisk
    Enrollment open, Trial completion date, Trial primary completion date:  Brown Adipose Tissue Activity in Pre- and Postmenopausal Women (clinicaltrials.gov) -  Aug 24, 2021   
    P=N/A,  N=72, Recruiting, 
    This increase in weight could suggest a trigger effect due to an increase in fat mass and a greater number of advanced puberty. Suspended --> Recruiting | Trial completion date: Aug 2021 --> Aug 2022 | Trial primary completion date: Aug 2021 --> Aug 2022
  • ||||||||||  Orgovyx (relugolix) / Gedeon Richter, Takeda, ASKA Pharma, Sumitomo Dainippon
    Clinical, Review, Journal:  Relugolix: a novel androgen deprivation therapy for management of patients with advanced prostate cancer. (Pubmed Central) -  Aug 20, 2021   
    Taken together, the data indicate that relugolix may mitigate some of the cardiovascular concerns surrounding ADT and has the potential to become a new standard of care for men with prostate cancer. In summary, relugolix represents a novel and recently available prostate cancer management strategy, incorporating the mechanistic advantages of GnRH antagonists and the potential benefits of oral administration.
  • ||||||||||  Firmagon (degarelix) / Astellas, Ferring, NN1213 / Novo Nordisk
    Trial suspension, Monotherapy:  High-Dose Brachytherapy in Treating Patients With Prostate Cancer (clinicaltrials.gov) -  Aug 18, 2021   
    P1/2,  N=163, Suspended, 
    In summary, relugolix represents a novel and recently available prostate cancer management strategy, incorporating the mechanistic advantages of GnRH antagonists and the potential benefits of oral administration. Recruiting --> Suspended
  • ||||||||||  Firmagon (degarelix) / Astellas, Ferring
    Trial completion date, Trial primary completion date:  Androgen Deprivation Therapy on Bone Mineral Density Change in Prostate Cancer Patients (clinicaltrials.gov) -  Aug 18, 2021   
    P4,  N=164, Recruiting, 
    Recruiting --> Suspended Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Apr 2021 --> Apr 2022
  • ||||||||||  leuprorelin depot / Generic mfg.
    Clinical, Retrospective data, Journal:  Evaluation of Dual Trigger with Combination of Gonadotropin-Releasing Hormone Agonist and Human Chorionic Gonadotropin in İmproving Oocyte-Follicle Ratio in Normo-Responder Patients. (Pubmed Central) -  Aug 17, 2021   
    When at least ≥3 follicles reached ≥17 mm diameter, 116 patients received dual trigger with GnRH agonist plus hCG (1mg Leuprolide acetate plus 10.000 IU uhCG) and 178 patients received uhCG (10.000 IU u hCG) for final oocyte maturation...Dual triggering in normal responders with a GnRH-agonist and a standard dosage of hCG is superior to hCG only protocol in terms of oocyte/follicle ratio but does not improve metaphase II oocyte, implantation and clinical pregnancy rates in GnRH-antagonist cycles. Dual triggering method may be beneficial in patients with immature oocytes and emty follicle syndrome.
  • ||||||||||  leuprorelin depot / Generic mfg.
    Journal:  Hydrogen-Bonded Films for Zero-Order Release of Leuprolide. (Pubmed Central) -  Aug 12, 2021   
    Initially, an increase in the level of serum testosterone is induced by the released drug, followed by testosterone suppression to a constant level below the castrate level, which could be maintained as long as a constant serum drug level is maintained. Since the new drug carriers avoid an initial burst release of the drug and maintain a constant serum drug level and hence a constant serum testosterone level below the castrate level, these carriers are highly promising for androgen deprivation therapy.
  • ||||||||||  leuprorelin depot / Generic mfg.
    Journal:  Non-Adaptive MR-Guided Radiotherapy for Prostate SBRT: Less Time, Equal Results. (Pubmed Central) -  Aug 8, 2021   
    By avoiding the extra time required for plan adaptation, MRgRT without daily adaptation allows for successful prostate SBRT with manageable toxicity. We continue to reserve our limited adaptive treatment slots for preoperative pancreatic and ultra-central lung SBRT patients, which require time-intensive respiratory gating and adaptive planning.
  • ||||||||||  leuprorelin depot / Generic mfg.
    Journal:  'Flexible-acceptor' General Solubility Equation for 'beyond Rule of 5' Drugs. (Pubmed Central) -  Aug 4, 2021   
    The mp coefficient ( 0.007) remains practically constant, near the traditional value (-0.01) for most molecules, which suggests that the small-to-large molecule continuum is mainly solvation responsive, apparently with only minor changes in the crystal lattice contributions. For a test set of 32 large molecules (e.g., cyclosporine A, gramicidin A, leuprolide, nafarelin, oxytocin, vancomycin - mostly natural-product derived therapeutics used in infectious/viral diseases, in immunosuppression, and in oncology) the modified equation predicted the intrinsic solubility with a root-mean-square-error of 1.10 log unit, compared to 3.0 by the traditional GSE, and 1.07 by RFR.