- |||||||||| Mifeprex (mifepristone) / Danco Laboratories
Enrollment closed, Trial completion date, Trial primary completion date: MIFD: Mifepristone Induction for Fetal Demise (clinicaltrials.gov) - Aug 29, 2019
P4, N=74, Active, not recruiting,
Recruiting --> Active, not recruiting | Trial completion date: Jan 2019 --> Jan 2020 | Trial primary completion date: Sep 2018 --> Oct 2019
- |||||||||| Mifeprex (mifepristone) / Danco Laboratories
Trial termination: Blocking Mifepristone Action With Progesterone (clinicaltrials.gov) - Aug 28, 2019
P1/2, N=12, Terminated,
Recruiting --> Active, not recruiting | Trial completion date: Jan 2019 --> Jan 2020 | Trial primary completion date: Sep 2018 --> Oct 2019 Suspended --> Terminated; Safety
- |||||||||| glycopyrrolate/indacaterol/mometasone (QVM149) / Novartis, Trelegy Ellipta (fluticasone furoate/umeclidinium bromide/vilanterol) / GSK, Innoviva, Seebri (glycopyrronium bromide) / Novartis, Vectura, Sosei
Mechanisms leading to the bronchorelaxant synergy of ICS/LABA/LAMA combination (6C) - Aug 26, 2019 - Abstract #ERS2019ERS_4111;
Methods Human isolated airways undergoing ex vivo asthma and COPD models were treated overnight with the intracellular glucocorticoid receptors antagonist RU486 (1 μM) to assess the role of the genomic mechanisms activated by BDP...Conclusion The synergy elicited by triple ICS/LABA/LAMA combination was related with the genomic effect of intracellular glucocorticoid receptors and the activation of Gsα subunit G-protein of β2-adrenoceptor, at least in human models of asthma and COPD. Funding This study was supported by Chiesi Farmaceutici, Italy.
- |||||||||| NN1213 / Novo Nordisk, Mifeprex (mifepristone) / Danco Laboratories
Trial completion date, Trial suspension, Trial primary completion date: Non-surgical Alternatives to Treatment of Failed Medical Abortion (clinicaltrials.gov) - Aug 22, 2019
P4, N=326, Suspended,
We propose that hiPSC technology offers an ideal system to get more insight into the synthesising and regulatory pathways in steroidogenesis in human neurons and to differentiate between the mechanism by which adrenal GC and neuronal GC impact on neurodevelopment. Trial completion date: Dec 2018 --> Dec 2020 | Active, not recruiting --> Suspended | Trial primary completion date: Dec 2018 --> Dec 2020
- |||||||||| Mifeprex (mifepristone) / Danco Laboratories
Clinical, Journal: Clinical comparison of mifepristone and gestrinone for laparoscopic endometriosis. (Pubmed Central) - Aug 21, 2019
Mifepristone and gestrinone can be used for endometriosis postoperative adjuvant treatment, is safe and effective, but using mifepristone has the lower rate of adverse reaction. In conclusion, mifepristone is a current research focus, its mechanism of action in the process of exploration, has broad prospects in the treatment of endometriosis, its long-term application security is paid more and more attention.
- |||||||||| Mifeprex (mifepristone) / Danco Laboratories
Clinical, Journal: MIFEPRISTONE TREATMENT FOR MILD AUTONOMOUS CORTISOL SECRETION DUE TO ADRENAL ADENOMAS: A PILOT STUDY. (Pubmed Central) - Aug 21, 2019
Conclusion This pilot study demonstrates that mifepristone treatment of ACS is associated with a significant decrease in fasting glucose and insulin resistance as measured by HOMA-IR scores. Mifepristone treatment of ACS may be considered as a medical option for patients with ACS due to adrenal adenomas with concomitant abnormal glucose parameters in whom surgical removal is not being considered.
- |||||||||| Mifeprex (mifepristone) / Danco Laboratories
Journal: The Stress Hormone Cortisol Enhances Interferon-υ-Mediated Proinflammatory Responses of Human Immune Cells. (Pubmed Central) - Aug 17, 2019
The results support an emerging physiological model with an adaptive role for cortisol, wherein acute release of cortisol suppresses early proinflammatory responses but also primes immune cells for an augmented response to a subsequent immune challenge. These findings have broad clinical implications and provide an experimental framework to examine individual differences, mechanisms, and translational implications of cortisol-enhanced immune responses in humans.
- |||||||||| Mifeprex (mifepristone) / Danco Laboratories
Journal: Using a Call Center to Reduce Harm From Self-Administration of Reproductive Health Medicines in Bangladesh: Interrupted Time-Series. (Pubmed Central) - Aug 17, 2019
...In settings where abortion is restricted, women are increasingly able to self-manage abortions by purchasing abortion medications such as misoprostol and mifepristone (RU-486) from pharmacies or other drug sellers...The high call volume suggests that this call center intervention addressed an unmet demand for information about MR medications from both MR users and health care providers. Call center interventions may improve the quality of information available by providing information directly to MR users and drug sellers, and thus reducing the potential harm from self-management of MR medications.
- |||||||||| Mifeprex (mifepristone) / Danco Laboratories
Enrollment change, Trial completion date, Trial suspension, Trial primary completion date: Blocking Mifepristone Action With Progesterone (clinicaltrials.gov) - Aug 8, 2019
P1/2, N=12, Suspended,
Call center interventions may improve the quality of information available by providing information directly to MR users and drug sellers, and thus reducing the potential harm from self-management of MR medications. N=40 --> 12 | Trial completion date: Feb 2020 --> Aug 2019 | Recruiting --> Suspended | Trial primary completion date: Jan 2020 --> Jul 2019
- |||||||||| Mifeprex (mifepristone) / Danco Laboratories
Enrollment change, Trial completion date, Trial primary completion date: Mifepristone for the Prevention of Relapses of Alcohol Drinking (clinicaltrials.gov) - Aug 7, 2019
P1/2, N=30, Recruiting,
Selectively targeting the FP receptor in combination with existing tocolytics may be an effective strategy for preventing or delaying preterm delivery. N=20 --> 30 | Trial completion date: Dec 2019 --> Dec 2020 | Trial primary completion date: Dec 2019 --> Dec 2020
- |||||||||| Mifeprex (mifepristone) / Danco Laboratories
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: A Study on the Mifepristone Tablets in the Treatment of Symptomatic Uterine Fibroids With Safety and Efficacy (clinicaltrials.gov) - Aug 7, 2019
P4, N=434, Terminated,
N=20 --> 30 | Trial completion date: Dec 2019 --> Dec 2020 | Trial primary completion date: Dec 2019 --> Dec 2020 N=2200 --> 434 | Trial completion date: Jun 2018 --> Jul 2019 | Recruiting --> Terminated | Trial primary completion date: Jan 2018 --> Jan 2019; It is difficult to recruit enough participants
- |||||||||| Mifeprex (mifepristone) / Danco Laboratories
Trial completion date, Trial primary completion date: Study of Clinic-based Versus Self-use of Medical Abortion Pills (clinicaltrials.gov) - Aug 7, 2019
P=N/A, N=4000, Recruiting,
N=2200 --> 434 | Trial completion date: Jun 2018 --> Jul 2019 | Recruiting --> Terminated | Trial primary completion date: Jan 2018 --> Jan 2019; It is difficult to recruit enough participants Trial completion date: Jan 2020 --> Jan 2021 | Trial primary completion date: Mar 2019 --> Jul 2020
- |||||||||| Mifeprex (mifepristone) / Danco Laboratories
Trial initiation date: Mail Order Mifepristone Study (clinicaltrials.gov) - Aug 6, 2019
P4, N=425, Not yet recruiting,
This study reports that antiprogestin mifepristone inhibits migration and invasion of highly metastatic cancer cell lines, and that double fluorescence cytochemical labeling increases the value of well-known approaches to study cell movement. Initiation date: May 2019 --> Sep 2019
- |||||||||| Esmya (ulipristal acetate) / ASKA, HRA Pharma, Allergan, Gedeon Richter, Mifeprex (mifepristone) / Danco Laboratories
Journal: Selective progesterone receptor modulators: current applications and perspectives. (Pubmed Central) - Aug 3, 2019
In conclusion, use of SPRMs has allowed significant progress in emergency contraception and treatment of myoma-related symptoms. Numerous future perspectives in women's health care are currently under evaluation.
- |||||||||| Mifeprex (mifepristone) / Danco Laboratories
Journal: Simultaneous Compared With Interval Medical Abortion Regimens Where Home Use Is Restricted. (Pubmed Central) - Aug 1, 2019
Simultaneous administration of mifepristone and misoprostol is 97% as effective as a 24- to 48-hour interval at all gestational ages 63 days or less with no increase in the risk of clinically significant adverse events. Pragmatic use of simultaneous dosing is reasonable given the small difference in effectiveness.
- |||||||||| Mifeprex (mifepristone) / Danco Laboratories
Journal: Advances in the management of early pregnancy loss. (Pubmed Central) - Aug 1, 2019
Pragmatic use of simultaneous dosing is reasonable given the small difference in effectiveness. Miscarriage is a common experience among reproductive-aged women and advances in medical management and modern-day aspiration techniques make the use of the sharp curette obsolete.
- |||||||||| Mifeprex (mifepristone) / Danco Laboratories
Journal: Abortion through telemedicine. (Pubmed Central) - Aug 1, 2019
Currently, there are limitations to the reach of telemedicine because of specific restrictions on mifepristone in the United States as well as laws that specifically prohibit telemedicine for abortion. If these barriers are removed, telemedicine can potentially increase abortion access.
- |||||||||| Mifeprex (mifepristone) / Danco Laboratories
PK/PD data, Journal: Sex-related pharmacokinetic differences and mechanisms of metapristone (RU486 metabolite). (Pubmed Central) - Jul 28, 2019
The highest tissue concentration of metapristone was found in the liver. The study demonstrates, for the first time, the sex-related pharmacokinetics of metapristone, and reveals that activities of liver microsomal CYP1A2 and CYP3A4 as well as the renal clearance are primarily responsible for the sex-related pharmacokinetics.
- |||||||||| Mifeprex (mifepristone) / Danco Laboratories
Clinical, Journal: A case of 20-week abortion in a rare communicating rudimentary horn of a misinterpreted unicornuate uterus, incorrectly diagnosed as bicornuate: A serious hazard! (Pubmed Central) - Jul 26, 2019
...We present a rare case of a 20-week spontaneous abortion in a 24 years old patient affected by a misunderstood unicornuate uterus with communicating rudimentary horn, previously diagnosed as bicornuate, and for this reason subjected to induction of abortive labor, using mifepristone and gemeprost...3D-ultrasonography, and above all MRI, should be performed in all those cases of suspected uterine anomalies, especially in presence of pregnancy or abortion, with the aim of avoiding wrong treatments, which leads to a high risk of uterine rupture. In this case, given the uncertainty of imaging exams performed in such an advanced second trimester of pregnancy, only the surgical approach was able to discover the real communication.
- |||||||||| Mifeprex (mifepristone) / Danco Laboratories
Journal: The use of mifepristone for medical abortion. (Pubmed Central) - Jul 26, 2019
This statement was first developed by Women's Health Committee in November 2007 and reviewed in March 2019. The development and review of this statement was funded by RANZCOG.
- |||||||||| Mifeprex (mifepristone) / Danco Laboratories
Clinical, Journal: Activation of local bone RAS by maternal excessive glucocorticoid participated in the fetal programing of adult osteopenia induced by prenatal caffeine exposure. (Pubmed Central) - Jul 19, 2019
Corticosterone (1250 nM) suppressed osteogenic differentiation of BMSCs and gene expression of BGLAP, ALP and BSP, which was attenuated by enalapril, while it stimulated ACE mRNA expression and induced hypomethylation of ACE promoter, which was attenuated by mifepristone. It indicated that PCE caused bone growth retardation and adult osteopenia in offspring, which might be triggered by the activation of local RAS induced by excessive maternal glucocorticoid, while the hypomethylation of ACE gene might be the key point of the sustained activation of the local RAS.
- |||||||||| Mirena (levonorgestrel-releasing intrauterine system) / Bayer, Visanne (dienogest) / Mochida, Bayer, Mifeprex (mifepristone) / Danco Laboratories
Journal: Progress on medical treatment in the management of adenomyosis (Pubmed Central) - Jul 18, 2019
Drug selection should be based on patient's age, symptoms, uterine size, fertility requirements and economical conditions. At present, there is no specific drug for adenomyosis, and symptoms are easy to recur after drug withdrawal, so the long-term drug use needs further study.
- |||||||||| NN1213 / Novo Nordisk, Mifeprex (mifepristone) / Danco Laboratories
Trial completion date, Trial suspension, Trial primary completion date: Medication Enhanced Rapid Therapy (clinicaltrials.gov) - Jul 18, 2019
P1, N=90, Suspended,
At present, there is no specific drug for adenomyosis, and symptoms are easy to recur after drug withdrawal, so the long-term drug use needs further study. Trial completion date: Aug 2018 --> Aug 2022 | Active, not recruiting --> Suspended | Trial primary completion date: Aug 2018 --> Aug 2022
- |||||||||| NN1213 / Novo Nordisk, Mifeprex (mifepristone) / Danco Laboratories
Trial completion, HEOR: Comparative Effectiveness of Pregnancy Failure Management Regimens (clinicaltrials.gov) - Jul 18, 2019
P3, N=300, Completed,
Trial completion date: Aug 2018 --> Aug 2022 | Active, not recruiting --> Suspended | Trial primary completion date: Aug 2018 --> Aug 2022 Active, not recruiting --> Completed
- |||||||||| Mifeprex (mifepristone) / Danco Laboratories
Preclinical, Journal: Rapid Intracellular Zn Dysregulation via Membrane Corticosteroid Receptor Activation Affects In Vivo CA1 LTP. (Pubmed Central) - Jul 13, 2019
Mifepristone, a GC receptor antagonist, which canceled corticosterone-induced attenuation of LTP, also blocked corticosterone-induced increase in intracellular Zn, but not extracellular Zn...Membrane MC and GC receptors induce intracellular Zn dysregulation via differential mechanisms. In contrast, glucocorticoid-induced intracellular Ca dysregulation is not crucial for affecting LTP.
- |||||||||| dexamethasone / generics
Preclinical, Journal: Inhibition of mucin secretion via glucocorticoid-induced regulation of calcium-related proteins in mouse lung. (Pubmed Central) - Jul 4, 2019
...To confirm the effect of steroid hormones, immature mice were injected with estrogen (E2) or progesterone (P4), and mature mice were injected with dexamethasone (DEX)...There were no significant differences in calcium-related gene expression in E2- and P4-treated mice, but TRPV4, NCX1, and PMCA1 were increased in DEX-treated mice and were recovered by RU486 treatment...Control of calcium-related gene expression may affect the control of mucus secretion in the lung. Such a control mechanism can form the basis of studies into diseases such as inflammation due to mucus secretion abnormalities, coughing, and respiratory disorders and distress.
- |||||||||| Mifeprex (mifepristone) / Danco Laboratories
Journal: Simplified Medical Abortion Screening: A Demonstration Project. (Pubmed Central) - Jun 26, 2019
Screening for medical abortion without exam or ultrasound shows promise as a means for increasing access to this service. More research is needed to develop screening criteria that are more inclusive and simpler for clinical use.
- |||||||||| Mifeprex (mifepristone) / Danco Laboratories
Journal: Self-Assessment of Medical Abortion Outcome using Symptoms and Home Pregnancy Testing. (Pubmed Central) - Jun 26, 2019
Perceived feasibility of the self-assessment approach was high. Implications Statement The common practice of scheduling a clinical contact after every medical abortion may not be necessary to ensure safety; enabling patients to determine for themselves whether or not a contact is needed can be a reasonable approach.
- |||||||||| Mifeprex (mifepristone) / Danco Laboratories
Preclinical, Journal: The mechanical response of the mouse cervix to tensile cyclic loading in term and preterm pregnancy. (Pubmed Central) - Jun 24, 2019
...Assessments were made in nonpregnant, pregnant (gestation days 6, 12, 15 and 18) and mouse models of infection mediated PTB treated with lipopolysaccharide on gestation d15 (LPS treated) and hormone withdrawal mediated PTB on gestation d15 (RU486 treated)...The developed methodology links mechanical parameters to specific microstructural components. This work identifies a distinct biomechanical signature associated with inflammation mediated PTB that differs from PTB induced by hormone withdrawal and from normal term remodeling.
- |||||||||| Mifeprex (mifepristone) / Danco Laboratories
Journal: A novel therapeutic approach for treatment of catamenial epilepsy. (Pubmed Central) - Jun 20, 2019
The progesterone-induced plasticity of AMPA receptors was blocked by RU-486 treatment and progesterone also failed to increase AMPA receptor expression in progesterone receptor knockout mice. These studies demonstrate that progesterone receptor activation regulates AMPA receptor expression and may play a role in catamenial seizure exacerbation.
- |||||||||| Mifeprex (mifepristone) / Danco Laboratories
Preclinical, Journal: The Flavonoid Apigenin Is a Progesterone Receptor Modulator with In Vivo Activity in the Uterus. (Pubmed Central) - Jun 15, 2019
...In contrast, apigenin and progesterone both stimulated proliferation of T47D cells, an effect blocked by RU486...In vivo, apigenin blocked the genistein-stimulated increase in uterine epithelial cell height; stimulated endometrial expression of Hand2, a transcription factor stimulated by PR, and significantly reduced genistein-induced proliferation. In summary, apigenin is a phytoprogestin, with mixed agonist activity that demonstrates activity in vivo by hindering estrogen receptor-mediated uterine proliferation.
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