- |||||||||| Livial (tibolone) / Organon, NN1213 / Novo Nordisk
Trial completion date, Trial primary completion date: Psychological Impact of Amenorrhea in Women With Endometriosis (clinicaltrials.gov) - Feb 4, 2021 P4, N=50, Not yet recruiting, Trial completion date: Mar 2021 --> Jun 2022 | Trial primary completion date: Jan 2021 --> Dec 2021
- |||||||||| leuprolide acetate for depot suspension / Generic mfg.
Biomarker, Trial completion date, Trial primary completion date: Menopausal Sleep Fragmentation and Body Fat Gain (clinicaltrials.gov) - Jan 26, 2021 P4, N=58, Recruiting, Trial completion date: Dec 2020 --> Dec 2021 Trial completion date: Mar 2021 --> Mar 2022 | Trial primary completion date: Dec 2020 --> Dec 2021
- |||||||||| Orgovyx (relugolix) / Intas, Gedeon Richter, Takeda, ASKA Pharma, Sumitomo Pharma, Pfizer
Trial completion, Trial completion date, Trial primary completion date: Clinical Study to Evaluate Efficacy and Safety of TAK-385 40 mg Compared With Leuprorelin in Patients With Endometriosis (clinicaltrials.gov) - Dec 11, 2020 P3, N=335, Completed, Under this set of conditions, a single Lupron dose was inadequate for suppressing intraspecific aggression in a group of three males with a pre-established history of aggression. Active, not recruiting --> Completed | Trial completion date: Mar 2021 --> Sep 2020 | Trial primary completion date: Mar 2021 --> Jun 2020
- |||||||||| 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.
- |||||||||| NN1213 / Novo Nordisk
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.
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