- |||||||||| Mifeprex (mifepristone) / Danco Laboratories
[VIRTUAL] The Development of Hypogonadotropic Hypogonadism After Starting Low Dose Mifepristone for Cushing’s Syndrome () - Mar 27, 2021 - Abstract #ENDO2021ENDO_3132;
He had several abnormal 1 mg overnight dexamethasone suppression tests (ACTH 3 & <1 pg/ml and cortisol 10 ug/dL & 11.1 ug/dL)...He was started on mifepristone 300 mg/day and spironolactone 12.5 mg/day given eGFR 47 mL/min/1.73sq m. His mifepristone dose was dropped to 300 mg every other day after he had several episodes of orthostatic hypotension, nausea, and hot flashes...For oral presentations, the abstracts are embargoed until the session begins. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO 2021.
- |||||||||| Mifeprex (mifepristone) / Danco Laboratories
[VIRTUAL] TRP53 LOSS IN KRT15+ INTESTINAL STEM CELLS SEVERELY AFFECTS SECRETORY CELL FATE AND SELF-RENEWAL () - Mar 25, 2021 - Abstract #CDDW2021CDDW_242;
Aims: Identify if Krt15+ cells may act as the cell-of-origin in colitis-associated colorectal cancer To induce Trp53 loss specifically in Krt15+ cells, we generated Krt15-CrePR1;Trp53fl/fl (Krt15△Trp53) mice, induced Cre recombination by injecting RU486 (PR agonist) and euthanized the mice at different time points following recombination... Trp53 loss specifically in Krt15+ cells impaired cell fate decision, induced secretory cell hyperplasia, affected self-renewal ability, and initiated adenoma formation supporting the possible role of Krt15+ cells in gut inflammation and cancer.
- |||||||||| Mifeprex (mifepristone) / Danco Laboratories
[VIRTUAL] KRT15+ TUMOR CELLS AS PUTATIVE CANCER STEM CELLS IN ESOPHAGEAL CANCER. () - Mar 25, 2021 - Abstract #CDDW2021CDDW_6;
Krt15+ tumoroids display higher CSC content and hyperplastic capacity suggesting their potential role in esophageal cancer. With this project, we aim to highlight the role of Krt15+ cells in treatment resistance and put forward new targets to overcome this deadly issue in ESCC patients.
- |||||||||| Mifeprex (mifepristone) / Danco Laboratories
Trial completion date, Trial primary completion date: Assessing Medical Menstrual Regulation in the United States (clinicaltrials.gov) - Mar 23, 2021
P2, N=284, Recruiting,
With this project, we aim to highlight the role of Krt15+ cells in treatment resistance and put forward new targets to overcome this deadly issue in ESCC patients. Trial completion date: Dec 2020 --> Dec 2021 | Trial primary completion date: Dec 2020 --> Dec 2021
- |||||||||| Mifeprex (mifepristone) / Danco Laboratories
[VIRTUAL] LR26: Mifepristone – How and Why to Become a Certified Provider () - Mar 19, 2021 - Abstract #ACOG2021ACOG_125;
This session demystifies the process for becoming a certified mifepristone provider, overcoming external barriers, and dispensing mifepristone. Objectives: Understand the FDA Risk Evaluation and Mitigation Strategy (REMS) for mifepristone. Apply a step-by-step approach to becoming a certified mifepristone provider and identify next steps specific to each attendee’s practice. Anticipate and overcome systemic barriers to mifepristone provision that arise at the institutional, regulatory, and community levels specific to each attendee’s practice.
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Journal: Cortisol Directly Stimulates Spermatogonial Differentiation, Meiosis, and Spermiogenesis in Zebrafish (Danio rerio) Testicular Explants. (Pubmed Central) - Mar 19, 2021
Moreover, we demonstrated that concomitant treatment with RU 486, a potent glucocorticoid receptor (Gr) antagonist, did not affect the cortisol effects on spermatogonial differentiation but blocked the induced effects on meiosis and spermiogenesis...Finally, we also showed that grα mRNA is expressed in Sertoli and Leydig cells, but also in several types of germ cells, including spermatogonia and spermatocytes. Altogether, this evidence indicates that cortisol exerts paracrine roles in the zebrafish testicular function and spermatogenesis, highlighting its effects on spermatogonial differentiation, meiosis, and spermiogenesis.
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Journal: Control of brown adipose tissue adaptation to nutrient stress by the activin receptor ALK7. (Pubmed Central) - Mar 17, 2021
Treatment of mutant mice with the glucocorticoid receptor antagonist RU486 restored KLF15 and POX expression levels in mutant BAT, suggesting that loss of BAT ALK7 results in excessive activation of glucocorticoid signaling upon fasting. These results reveal a novel signaling pathway downstream of ALK7 which regulates the adaptation of BAT to nutrient availability by limiting nutrient stress-induced overactivation of catabolic responses in brown adipocytes.
- |||||||||| abiraterone acetate / Generic mfg., danazol oral / Generic mfg.
Review, Journal: Drug-induced endocrine blood pressure elevation. (Pubmed Central) - Mar 16, 2021
Drugs with known adverse effects but where benefits outweigh their risks, drug candidates or market withdrawals are reviewed. Finally, potential therapeutic strategies are discussed.
- |||||||||| Mifeprex (mifepristone) / Danco Laboratories
[VIRTUAL] SerpinA6 and itspotential role in prostate cancer progression. () - Mar 13, 2021 - Abstract #AACR2021AACR_4327;
Next, in PC-3 cells we observed Dexamethasone (15µM) treatment increased SerpinA6, conversely Mifepristone (15µM) deceased SerpinA6 expression after 24 hours of treatment...We suggest that decreasing levels of SerpinA6 and FOXO3a expressions in the prostate cancer patients may have potential role in disease progression. Moreover we need to have an effective agent, which could prevent the decreasing levels of SerpinA6 and FOXO3a in prostate to inhibit the progression of prostate cancer.
- |||||||||| Mifeprex (mifepristone) / Danco Laboratories
Preclinical, Journal: GR/Sp3/HDAC1/UGDH signaling participated in the maternal dexamethasone-induced dysplasia of the rat fetal growth plate. (Pubmed Central) - Mar 12, 2021
However, antagonizing GR with RU486 and silencing Hdac1 or Sp3 with specific siRNAs could all stimulate the H3K9 acetylation and gene expression of Ugdh previously inhibited by dexamethasone...Collectively, our study revealed that maternal dexamethasone induced the direct binding of GR to the Ugdh promoter of the chondrocyte in the rat fetal growth plate, which recruited HDAC1 and Sp3, induced deacetylation of the H3K9, and subsequently inhibited Ugdh gene expression. Such changes further led to attenuated proteoglycan synthesis in the developing chondrocyte and therefore disrupted the development of growth plate and fetal long bone.
- |||||||||| Mifeprex (mifepristone) / Danco Laboratories
Review, Journal: Mifepristone Repurposing in Treatment of High-Grade Gliomas. (Pubmed Central) - Mar 9, 2021
The mechanisms by which mifepristone enhances glioma treatment are not yet known. The current review aims to discuss the potential role of mifepristone as an adjuvant drug for the treatment of high-grade gliomas.
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Clinical, Review, Journal: Women's voices and medical abortions: A review of the literature. (Pubmed Central) - Mar 6, 2021
Our review suggests that medical abortions are used by women either in countries where the health system is fully supportive or where the health system is completely disengaged, usually due to restricted abortion laws. In those countries where abortions are legal but often difficult to access due to health system barriers, women tend to prefer surgical abortions.
- |||||||||| Mifeprex (mifepristone) / Danco Laboratories
Retrospective data, Journal: Systematic evaluation and sequential Meta-analysis of modified Xuefu Zhuyu Decoction combined with Western medicine in treatment of leiomyoma (Pubmed Central) - Mar 2, 2021
Meta-analysis was performed for the reported indicators, including total efficiency, serum hormone level [progesterone(P), luteinizing hormone(LH), estradiol(E_2), follicle stimulating hormone(FSH)], uterine size, fibroids size and adverse reactions by using Stata 14.0 software...Trial sequential analysis(TSA) was performed by using TSA 0.9 software, and showed a reliable therapeutic effect of the experimental group. In short, our study indicated that modified Xuefu Zhuyu Decoction combined with Western medicine had a better therapeutic effect on leiomyoma than Western medicine alone, but more high-quality studies are needed to verify this conclusion in the future.
- |||||||||| methotrexate / Generic mfg.
Journal: Ectopic Cervical Pregnancy: Treatment Route. (Pubmed Central) - Feb 27, 2021
One case with βhCG levels <5000 mUi/mL was treated using MTX combined to Mifepristone and Misoprostol...Hysteroscopy, alone or in combination with MTX, may provide a greater effect on the descent of βhCG, leading to a reduction of the hospitalization stay, decreasing costs and period for attempt pregnancy. Further prospective studies on larger samples are needed to define therapeutic protocols for CP management.
- |||||||||| Mifeprex (mifepristone) / Danco Laboratories
Retrospective data, Review, Journal: Medical abortion at 13 or more weeks gestation provided through telemedicine: A retrospective review of services. (Pubmed Central) - Feb 23, 2021
Women received mifepristone and misoprostol or misoprostol alone for abortion...Limited data suggest that medical abortion through telemedicine services may be a safe option through 15 weeks gestation in settings where there is ready access to the formal health system. More research with adequate sample sizes and high rates of follow-up is needed to inform on the safety of telemedicine for pregnancies 13 weeks and greater.
- |||||||||| dexamethasone / Generic mfg.
Journal: Independent roles of beta-adrenergic and glucocorticoid receptors in systemic and pulmonary effects of ozone. (Pubmed Central) - Feb 20, 2021
In summary, 1) activating βAR, even with GR inhibition, exacerbated and inhibiting βAR, even with GR activation, attenuated ozone-induced pulmonary effects; and 2) activating GR exacerbated ozone systemic effects, but with βAR inhibition, this exacerbation was less remarkable. These data suggest the independent roles of βAR in pulmonary and dependent roles of βAR and GR in systemic effects of ozone.
- |||||||||| Mifeprex (mifepristone) / Danco Laboratories
Journal: Prenatal ethanol exposure-induced hypothalamic an imbalance of glutamatergic/GABAergic projections and low functional expression in male offspring rats. (Pubmed Central) - Feb 20, 2021
Hypothalamic cells from male GD20~postnatal day (PD) 7 rats were treated with different doses of corticosterone and the glucocorticoid receptor (GR) antagonist mifepristone for 5 days...The imbalance change was maintained until after birth, resulting in the inhibition of parvocellular neurons and low functional expression of the hypothalamus in PEE offspring rats. Our study indicated that low functional expression of the hypothalamus in male PEE offspring rats was associated with developmental programming of an imbalance of glutamatergic/GABAergic projections to the PVN.
- |||||||||| Mifeprex (mifepristone) / Danco Laboratories
Enrollment change, Trial termination: MIFD: Mifepristone Induction for Fetal Demise (clinicaltrials.gov) - Feb 18, 2021
P4, N=9, Terminated,
Projected completion was 2018 however, enrollment and recruitment were difficult. The study was terminated due to inability to enroll.
- |||||||||| Mifeprex (mifepristone) / Danco Laboratories
Trial completion date, Trial primary completion date, IO biomarker: BRCA1/2 and Effect of Mifepristone on the Breast (clinicaltrials.gov) - Feb 17, 2021
P2, N=45, Recruiting,
The study was terminated due to inability to enroll. Trial completion date: Apr 2021 --> Apr 2022 | Trial primary completion date: Dec 2020 --> Dec 2021
- |||||||||| Mifeprex (mifepristone) / Danco Laboratories
Trial completion date, Trial primary completion date: Study of Clinic-based Versus Self-use of Medical Abortion Pills (clinicaltrials.gov) - Feb 15, 2021
P=N/A, N=4000, Recruiting,
This provides a novel therapeutic target in clinical treatment of depression. Trial completion date: Jan 2021 --> Jun 2021 | Trial primary completion date: Jul 2020 --> Jun 2021
- |||||||||| Mifeprex (mifepristone) / Danco Laboratories
Clinical, Journal: Local administration of IL-12 with an HC vector results in local and metastatic tumor control in pediatric osteosarcoma. (Pubmed Central) - Feb 13, 2021
This vector harbored a mifepristone-inducible system for controlled expression of IL-12 (High-Capacity adenoviral vector enconding the EF1α promoter [HCA-EFZP]-IL-12)...Immunohistochemical analyses showed profound remodeling of the osteosarcoma microenvironment with decreases in angiogenesis and macrophage and myeloid cell numbers. In summary, our data underscore the potential therapeutic value of IL-12 in the context of a drug-inducible system that allows controlled expression of this cytokine, which can trigger a potent antitumor immune response in primary and metastatic pediatric osteosarcoma.
- |||||||||| Metopirone (metyrapone) / HRA Pharma, Mifeprex (mifepristone) / Danco Laboratories
Journal: Allergen challenge-induced changes in bone-marrow responses to leukotriene D, nonsteroidal anti-inflammatory drugs and cytokines. (Pubmed Central) - Feb 12, 2021
Hence, allergen challenge has two separate effects on bone-marrow: (a) it enhances eosinopoiesis in vivo and upregulates ex vivo responses to IL-5; (b) it promotes a faster, but self-limiting, response to LTD and CysLT1R-dependent stimuli. Allergen challenge modifies eosinopoiesis through systemic (glucocorticoid- and CysLT1R-dependent) mechanisms, increasing responses to IL-5 but restricting responses to subsequent CysLT1R stimulation.
- |||||||||| Mifeprex (mifepristone) / Danco Laboratories
Journal: Mifepristone polymorph with enhanced solubility, dissolution and oral bioavailability. (Pubmed Central) - Feb 10, 2021
In addition, Mifepristone in form D exhibited a 1.43-fold higher peak plasma concentration (C) and 1.46-fold higher area under the curve (AUC) in rats. The work in this paper is a complement to the present understanding of drug polymorphism on the in vitro and in vivo behavior, and establishes the ground work for future development of Mifepristone in form D as a promising drug for the market.
- |||||||||| Mifeprex (mifepristone) / Danco Laboratories
Journal: Ensuring Safe Access to Mifepristone During the Pandemic and Beyond. (Pubmed Central) - Feb 10, 2021
The work in this paper is a complement to the present understanding of drug polymorphism on the in vitro and in vivo behavior, and establishes the ground work for future development of Mifepristone in form D as a promising drug for the market. No abstract available
- |||||||||| dexamethasone / Generic mfg.
[VIRTUAL] Recurrent Cushing Syndrome Secondary to Metastatic Adrenocortical Carcinoma in a Patient With Previously Resected Adenoma (On-Demand) - Feb 2, 2021 - Abstract #ENDO2021ENDO_2189;
She was treated with doxorubicin, cisplatin and etoposide chemotherapy every 4 weeks...The transition from severe CS to AI due to mitotane was challenging to monitor biochemically due to mifepristone use...For oral presentations, the abstracts are embargoed until the session begins. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO 2021.
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