To observe and investigate the in vitro effect of ulipristal acetate (UPA) on human sperm parameters and function. The 20 patients with normal semen parameters and average age of (32.5±8.5) years old,...
Since late 2017, the use of ulipristal acetate 5 mg (UPA; Proprietary name: Esmya) has been under review in the European Union, due to an emerging hepatic risk. In February 2018 and in July 2018, the ...
Two quasi-experimental ITS analyses to examine the use of UPA before and after the RMM release were performed: (a) an ecological study using aggregated data from a drug consumption database; and (b) a...
Regulatory interventions were associated with an immediate and significant decrease level of DID (the number of DDD dispensed per 100 000 inhabitants and day) and incidence. The DID was 70% less than ...
Despite RMM had an immediate strong impact on UPA use, the last segment upward trend in the long-term might have been affected by the lack of comparable therapeutic alternatives. Further studies shoul...
Ulipristal acetate is a selective progesterone receptor modulator that acts on progesterone receptors in uterine muscle and endometrium. It is effective in reducing the size of uterine leiomyomas (fib...
The European Medicines Agency has suspended the use of ulipristal acetate (UPA) in the treatment of uterine fibroids and is reassessing its association with a risk of liver injury....
Our objectives were to characterize the post-marketing reporting of drug-induced liver injury (DILI) with UPA and investigate the underlying pharmacological basis....
We queried the worldwide FDA Adverse Event Reporting System and performed a disproportionality analysis, selecting only hepatic designated medical events (DMEs) where UPA was reported as suspect. The ...
A significantly higher proportion of liver disorders was reported for UPA than for mifepristone (2.9 vs. 0.8%; p < 0.00001) and leuprolide (2.9 vs. 1.6%; p = 0.015). As regards hepatic DMEs, statistic...
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-...
Is the failure of the selective progesterone receptor modulator ulipristal acetate (UPA) as emergency contraception (EC; 30 mg, single) or inadvertent exposure for myoma treatment (5 mg/d) in pregnanc...
We did not find an increased risk for birth defects, SABs or ETOPs after UPA exposure during implantation and early embryogenesis....
Pregnancy outcome data after exposure to UPA are very limited. In cases of EC failure or unplanned pregnancy during myoma treatment, women need well-grounded risk assessment to minimize anxiety and pr...
Observational study of prospectively ascertained pregnancies from the German Embryotox institute with UPA exposure (EC, n = 95; myoma, n = 7). Four retrospectively reported pregnancy outcomes were eva...
A total of 226 requests on ulipristal were directed to the German Embryotox institute during the study period 2010-2018. Outcomes of pregnancies exposed-(i) precycle, (ii) preconceptional or (iii) fir...
Failed EC with UPA resulted in 95 prospectively ascertained pregnancies, of which 56 had completed follow-up: 37 live births, 7 SABs and 12 ETOPs. There was no major birth defect. Just 34% of women ha...
Our limited sample size does not allow concluding safety of UPA use in pregnancy....
We provide a preliminary basis for reassuring women who wish to carry their pregnancy to term after EC or myoma treatment with UPA. However, because of the report of a BWS after UPA exposure, a possib...
This work was performed with financial support from the German Federal Institute for Drugs and Medical Devices (BfArM). All authors declare that they have no conflicts of interest....
Registered with the German Clinical Trial Register (DRKS00015155)....
Uterine Fibroids (UFs), or leiomyomas, represent the most frequent pelvic tumor in reproductive-aged women. Although of benign origin, UFs decrease fertility and cause significant reproductive dysfunc...
Disseminated peritoneal leiomyomatosis is a rare condition manifesting as hormone-sensitive soft tissue nodules lining the peritoneal cavity. Given the extensiveness of this disease, surgical manageme...
A 23-year-old woman presenting with abdominal pain was found to have innumerable abdominopelvic nodules on imaging. Biopsy of these lesions was consistent with disseminated peritoneal leiomyomatosis. ...
The use of ulipristal acetate may be an effective, novel therapeutic option for the management of disseminated peritoneal leiomyomatosis....
To investigate effects of ulipristal acetate on health-related quality of life (QOL) and symptom severity in women with symptomatic uterine leiomyomas and abnormal uterine bleeding....
Women were randomized to ulipristal (5 mg, 10 mg) or placebo in two phase 3, multicenter, double-blind, placebo-controlled trials (VENUS I and II). Health-related QOL and symptom severity were assesse...
In pooled analyses, the intent-to-treat population included 589 patients (placebo, n=169; ulipristal 5 mg, n=215; ulipristal 10 mg, n=205). Significantly greater improvements from baseline in all Uter...
Ulipristal was associated with significant improvements in health-related QOL and symptom severity compared with placebo for women with symptomatic uterine leiomyomas....
ClinicalTrials.gov, NCT02147197 and NCT02147158....
Allergan plc, Dublin, Ireland....
The aim of this guideline is to provide clinicians with an update to the 2015 Clinical Practice Guideline on the Management of Uterine Fibroids. As new information and evidence has become available si...
Implementation of this guideline update should optimize the decision-making process of women and their health care providers in proceeding with further investigation or therapy for uterine leiomyomas,...
Published literature was retrieved through searches of PubMed, CINAHL, and Cochrane Systematic Reviews in February 2015 to April 2018, using appropriate controlled vocabulary (uterine fibroids, myoma,...
The majority of fibroids are asymptomatic and require no intervention or further investigations. For symptomatic fibroids such as those causing menstrual abnormalities (e.g., heavy, irregular, and pro...
The quality of evidence in this document was rated using the criteria described in the Report of the Canadian Task Force on Preventive Health Care....
The main pharmacovigilance updates in 2020 are reviewed. Remdesivir in COVID-19: relatively safe but turns out to be less effective than expected. Hydroxychloroquine in COVID-19 : lack of efficacy and...
