Norethisterone 350microgram tablets

BackgroundEndometrial hyperplasia (EH) is a hyperplastic endometrial lesion with irregular gland size, increased glands, and increased glandular interstitial ratio. During follow-up, some EH progressed further to endometrial cancer. It is crucial to provide timely treatment for EH and improve the overall prognosis of EH patients.MethodsWe searched the PubMed, ClinicalTrials.gov., and Embase databases for studies published from their inception to March 31, 2023. The methodological quality of each study was evaluated in accordance with the Cochrane Collaboration's tool for assessing the risk of bias. The RevMan5.3 software provided by the Cochrane Collaboration was used for direct meta-analysis statistical analysis; and the relative risk and 95% confidence interval along with the mean difference and 95% confidence interval, were used as evaluation indexes.ResultsWe included 21 randomized controlled trials involving a total of 2276 women with EH, 6 studies were of high quality, and 15 were of moderate quality. The blinding of subjects and intervention providers was identified as the main source of potential bias. Six interventions were addressed in the network meta-analysis: medroxyprogesterone acetate (MPA), plus metformin, norethisterone (NET), levonorgestrel-releasing intrauterine system (LNG-IUD), megestrol acetate, and other drugs. In the direct meta-analysis, we found the probability of endometrial complete regression (CR) in the LNG-IUD group to be significantly higher than those in the NET. In the network meta-analysis, we found the probability of CR in the NET group to be significantly lower than those in the MPA and plus metformin groups, the probability of CR in the LNG-IUD group to be significantly higher than those in the NET, the probability of CR in the other drugs group to be significantly higher than those in the LNG-IUD. The NET group had the lowest incidences of endometrial complete regression, plus metformin could have a better outcome.ConclusionAccording to the 21 randomized controlled trials included in this study, MPA is the most effective for EH endometrial outcome when applied as a single agent, while the combination of metformin can achieve a more significant effect.

Abstract licence: CC BY-NC

Abnormal uterine bleeding due to ovulatory dysfunction (AUB-O) is a frequent gynecological problem affecting women of reproductive and perimenopausal age. While norethisterone, a synthetic progestogen, has been widely used for medical management, ormeloxifene, a selective estrogen receptor modulator, has recently emerged as a promising alternative. The objective of this study is to compare the efficacy and safety of ormeloxifene versus norethisterone in the treatment of AUB-O. A systematic review and meta-analysis were conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and registered with PROSPERO (CRD42024514294). A comprehensive search of PubMed, Google Scholar, Web of Science, and the Cochrane Library was performed up to 2025. Eligible studies included randomized controlled trials and prospective comparative studies evaluating ormeloxifene against norethisterone in women with AUB-O. Outcomes assessed were hemoglobin improvement, reduction in endometrial thickness, and change in Pictorial Blood Assessment Chart (PBAC) score. Data were extracted independently by two authors and analyzed using RevMan 5.4 (The Cochrane Collaboration, Oxford, UK) with a random-effects model. Five studies comprising 661 women were included (331 received ormeloxifene; 330 received norethisterone). Ormeloxifene significantly improved hemoglobin levels compared with norethisterone (standardized mean difference (SMD) = 0.81 g/dL, 95% CI 0.14-1.47; p < 0.00001; I² = 93%). It was also superior in reducing endometrial thickness (SMD = -0.74 mm, 95% CI -1.48 to -0.01; p < 0.00001; I² = 91%) and lowering PBAC scores (SMD = -1.06, 95% CI -1.25 to -0.87; p < 0.00001; I² = 0%). This meta-analysis suggests that ormeloxifene is more effective than norethisterone in improving clinical outcomes of AUB-O, with better control of menstrual blood loss, hemoglobin levels, and endometrial thickness. Larger, high-quality multicenter trials with longer follow-up are warranted to confirm long-term safety and efficacy.

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BackgroundRelugolix, an oral GnRH receptor antagonist, is effective in treating uterine myomas and endometriosis. However, concerns persist regarding the venous thromboembolism (VTE) risk associated with its combination with oral estradiol (E2) and norethisterone acetate (NETA).ObjectiveThis expert opinion evaluates the thrombotic risk of relugolix combined therapy (relugolix-CT) based on pharmacological data, clinical trials, and regulatory assessments.MethodsA review of pivotal trials (LIBERTY 1, LIBERTY 2, SPIRIT 1, SPIRIT 2), regulatory reports (European Medicines Agency, Food and Drug Administration), and real-world safety data was conducted, focusing on hemostatic effects and VTE risk.ResultsRelugolix monotherapy reduces estrogen levels, leading to minor decreases in coagulation factors. While E2 and NETA mitigate hypoestrogenic effects, concerns about their prothrombotic potential remain. However, clinical trials and postmarketing surveillance have not shown a significant increase in VTE risk. A meta-analysis suggests that E2-based regimens have a lower thrombotic risk than ethinylestradiol-based therapies.ConclusionThe VTE risk of relugolix-CT appears lower than that of traditional combined oral contraceptives. Nonetheless, patient selection is essential, particularly for those with thrombotic risk factors. Continued real-world surveillance is crucial to refining its safety profile in clinical practice.

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