leuprolide acetate for depot suspension / Generic mfg. 
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  • ||||||||||  leuprolide acetate for depot suspension / Generic mfg.
    Enrollment open:  BASH-PC: Bariatric Arterial Embolization for Men Starting Hormones for Prostate Cancer (clinicaltrials.gov) -  Dec 3, 2020   
    P2,  N=20, Recruiting, 
    Active, not recruiting --> Completed | Trial completion date: Mar 2021 --> Sep 2020 | Trial primary completion date: Mar 2021 --> Jun 2020 Not yet recruiting --> Recruiting
  • ||||||||||  goserelin acetate / Generic mfg., leuprolide acetate for depot suspension / Generic mfg., bicalutamide / Generic mfg.
    Trial primary completion date:  CCRO025: Stereotactic Boost and Long-Term Androgen Deprivation for Adenocarcinoma of the Prostate (clinicaltrials.gov) -  Nov 13, 2020   
    P=N/A,  N=29, Recruiting, 
    Recruiting --> Active, not recruiting | Trial primary completion date: Aug 2021 --> May 2021 Trial primary completion date: Sep 2020 --> May 2021
  • ||||||||||  Lupron Depot (leuprorelin depot) / AbbVie, Takeda
    [VIRTUAL] Mood disorders during reproductive transitions: circuit and cellular substrates of risk () -  Nov 5, 2020 - Abstract #ISGEI2020ISGE-I_174;    
    Finally, preliminary network analysis of E2-exposed LCLs implicates DEGs involved in intracellular calcium regulation (NUCB1, GCC2, TRPM7; P<.01) in PMDD. These data demonstrate that the differential behavioral sensitivity in women with PMDD is paralleled by rCBF (in vivo) and cellular transcription (in vitro) responses to ovarian steroids.
  • ||||||||||  Xtandi (enzalutamide) / Pfizer, Astellas, Lupron Depot (leuprorelin depot) / AbbVie, Takeda
    [VIRTUAL] Macrophages regulate androgen receptor activation in prostate cancer () -  Oct 25, 2020 - Abstract #PCF2020PCF_27;    
    Our findings show that depleting macrophage using a neutralizing antibody against colony-stimulating factor (CSF)-1 in combination with ADT (Lupron) significantly extended survival of mice-bearing orthotoptic prostate tumors, compared with each agent alone...These findings were recapitulated in vitro, with the co-culture of macrophages and prostate cancer cells enhancing AR nuclear translocation, increasing cancer cell proliferation in androgen-deprived conditions, and reducing sensitivity to the AR antagonist, enzalutamide...In conclusion, macrophages regulate androgen levels in prostate tumors and contribute to resistance to ADT. Funding Acknowledgments: Prostate Cancer Foundation young investigator and Department of Defense award (CDMRP-PC181013) to Kosj Yamoah, MD, PhD.
  • ||||||||||  Erleada (apalutamide) / J&J
    Trial completion, Trial completion date, Trial primary completion date:  Apalutamide and Leuprolide in Intermediate and High-risk Prostate Cancer (clinicaltrials.gov) -  Oct 19, 2020   
    P2,  N=54, Completed, 
    Funding Acknowledgments: Prostate Cancer Foundation young investigator and Department of Defense award (CDMRP-PC181013) to Kosj Yamoah, MD, PhD. Recruiting --> Completed | Trial completion date: Dec 2020 --> May 2020 | Trial primary completion date: Dec 2020 --> May 2020
  • ||||||||||  Lupron Depot (leuprorelin depot) / AbbVie, Takeda, Eligard (leuprolide acetate) / TOLMAR, Astellas, Sanofi
    Preclinical, Journal:  Development of Level A in vitro-in vivo correlations for peptide loaded PLGA microspheres. (Pubmed Central) -  Oct 3, 2020   
    In conclusion, these results indicate the sensitivity of peptide release, and hence, the safety and efficacy of highly potent peptide microspheres, to minor manufacturing changes. Accordingly, development of IVIVCs for such complex drug products is highly desirable.
  • ||||||||||  leuprolide acetate for depot suspension / Generic mfg., bicalutamide / Generic mfg.
    Trial completion, Trial completion date, Trial primary completion date, Metastases:  Cytoreductive Prostatectomy in Treating Patients With Newly Diagnosed, Metastatic Prostate Cancer (clinicaltrials.gov) -  Oct 1, 2020   
    P1,  N=26, Completed, 
    Accordingly, development of IVIVCs for such complex drug products is highly desirable. Active, not recruiting --> Completed | Trial completion date: Aug 2021 --> Jan 2020 | Trial primary completion date: Aug 2021 --> Jan 2020
  • ||||||||||  Preclinical, Journal:  In vitro-in vivo correlation of parenteral PLGA microspheres: Effect of variable burst release. (Pubmed Central) -  Sep 27, 2020   
    Moreover, it was observed that IVIVCs developed using formulations with less variation in burst release had better predictability and vice-versa. Thus, the present research has provided a comprehensive understanding of the impact of the burst release phase on the development, complexity, and predictability of IVIVCs for complex parenteral microspheres containing a variety of therapeutic molecules.
  • ||||||||||  leuprolide acetate for depot suspension / Generic mfg.
    Trial completion date, Trial primary completion date:  Brown Adipose Tissue Activity in Pre- and Postmenopausal Women (clinicaltrials.gov) -  Sep 24, 2020   
    P=N/A,  N=72, Suspended, 
    Thus, the present research has provided a comprehensive understanding of the impact of the burst release phase on the development, complexity, and predictability of IVIVCs for complex parenteral microspheres containing a variety of therapeutic molecules. Trial completion date: Aug 2020 --> Aug 2021 | Trial primary completion date: Aug 2020 --> Aug 2021
  • ||||||||||  Livial (tibolone) / Organon
    Trial completion date, Trial primary completion date:  Psychological Impact of Amenorrhea in Women With Endometriosis (clinicaltrials.gov) -  Aug 12, 2020   
    P4,  N=50, Not yet recruiting, 
    Not yet recruiting --> Recruiting Trial completion date: Dec 2020 --> Mar 2021 | Trial primary completion date: Sep 2020 --> Jan 2021
  • ||||||||||  leuprolide acetate for depot suspension / Generic mfg.
    Enrollment open, Trial initiation date:  Skeletal Health and Bone Marrow Composition Among Youth (clinicaltrials.gov) -  Aug 7, 2020   
    P=N/A,  N=80, Recruiting, 
    Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting | Initiation date: Apr 2020 --> Aug 2020