A randomized controlled pilot study of ulipristal acetate for abnormal bleeding among women using the 52‐mg levonorgestrel intrauterine system

Fava, Mariana; Peloggia, Alessandra; Baccaro, Luiz Francisco; Castro, Simone Martins de; Carvalho, Nelsilene Mota; Bahamondes, Luís

doi:10.1002/ijgo.13068

Cited by 9 publications

(3 citation statements)

References 28 publications

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“…In a randomised, double-blind, placebo-controlled pilot study, Fava et al investigated the effect of 5 days of 5 mg UPA on the LNG-IUD bleeding pattern in 15 women. After 90 days of follow-up, a trend towards fewer days until bleeding cessation and more bleeding-free days in the intervention group was observed, although without reaching statistical significance ( Fava et al, 2020 ; Henkel and Goldthwaite, 2020 ).…”

Section: Resultsmentioning

confidence: 90%

The use of a short course of Ulipristal Acetate for acute abnormal uterine bleeding in women without uterine fibroids

Lambrecht¹,

Bosch²

2023

Facts Views Vis ObGyn

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Background: Ulipristal Acetate (UPA) is a synthetic selective progesterone receptor modulator. It is used as emergency contraception and to reduce pain and blood loss in women of reproductive age with uterine fibroids. The first mechanism of action is myometrial apoptosis, the second is on the hypo-thalamic-pituitary-ovarian axis and the third action, is an anti-proliferative effect on the endometrium. Mainly based on the latter two, UPA is increasingly used off-label in women with abnormal uterine bleeding (AUB) without fibroids. Objectives: The aim of this paper is to find evidence for a short course of UPA to treat acute AUB without fibroids, performing a systematic review as well as scrutinising literature data on the pharmacokinetics and on short term bleeding control in women with fibroids. Materials and methods: A systematic electronic literature review was performed in February 2022. Inclusion criteria were UPA administered to women without myomas in a setting of acute uterine bleeding. Further criteria included papers describing early bleeding control using UPA, deemed independent of the presence of fibroids, with specific attention to the median time to amenorrhoea. Main outcome measures: The main outcome measured was the bleeding control within 10 days. Results: One case report was identified. The data on symptomatic women with fibroids using 5 mg or 10 mg daily revealed bleeding control was reported within 10 days in 81% and 89% respectively, with amenorrhoea in 57% and in 78% respectively. Conclusion: A short-term administration may prove effective in abnormal uterine bleeding irrespective of the presence of uterine fibroids. However, more randomised controlled trials are needed and should be performed before implementation in general clinical practice. What is new? A short course of Ulipristal acetate as promising treatment for acute uterine bleeding without fibroids.

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Section: Resultsmentioning

confidence: 90%

The use of a short course of Ulipristal Acetate for acute abnormal uterine bleeding in women without uterine fibroids

Lambrecht¹,

Bosch²

2023

Facts Views Vis ObGyn

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“…There is enough information that there is no effective treatment, although tranexamic and mefenamic acid were tested [24,25]. In addition, recently ulipristal acetate (UPA) at the dose of 5mg/5 days was compared to placebo, showing a trend of superiority over placebo in the bleeding control [26]; however, the drug is not available in Brazil. Although one-third of the panelists reported the use of COC or progestin-only pills to bleeding control, it is not supported by the evidence because it is well described that the endometrium in users of Mirena® is refractory to estrogens [27,28].…”

Section: Discussionmentioning

confidence: 99%

Practical Recommendations on the Management of Issues Related to the Levonorgestrel 52mg Intrauterine System: A Delphi Panel

Ushikusa

2021

OAJBS

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Objective: To gather the routine practice of Brazilian physicians with large experience on the Levonorgestrel 52mg intrauterine system (LNG IUS) use in order to generate practical recommendations on how to manage common aspects related to it. Material and Methods:Twenty gynecologists with large experience with LNG IUS answered 39 questions grouped into five main topics: exams before the procedure, technical aspects of the device placement, practical recommendations, irregular bleeding, and pregnancy. A second round of questions was carried when responses were very divergent.Results: Eighteen panelists responded to the questions. Recommendations that had more than 90% of agreement were i) the gynecological exam is the most important assessment before the insertion of LNG IUS; ii) in case of expulsion, a new device could be inserted; iii) there is no minimum age after menarche to use LNG IUS as a contraceptive, and iv) the device can be maintained after menopause. All the panelists responded that the duration of the insertion procedure was less than 10 minutes. Some topics did not reach more than 50% of agreement. Conclusion:Most aspects related to LNG IUS usage reached an agreement in terms of clinical practices among physicians with different backgrounds, and also tend to correlate to the available guidelines. However, despite the availability of LNG IUS in Brazil for many years, there is still some disagreement regarding routine practices. There is a need for continuous education of physicians and the standardization of certain procedures to expand the use of this contraceptive method.

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“…Their potential use as estrogen-free contraception remains unclear. As they can maintain mid-follicular levels of estradiol, they are a theoretical alternative to progestin-only contraception and may be helpful in reducing unscheduled bleeding in women with IUDs [43 ▪ ]. They may promote cervical ripening.…”

Section: Therapeutic Potential Of These Agentsmentioning

confidence: 99%

Selective progesterone receptor modulators and reproductive health

Nieman¹

2022

Current Opinion in Endocrinology, Diabetes &Amp; Obesity

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Purpose of reviewThis review is intended to provide perspective on the history of selective progesterone receptor modulators (SPRMs) and progesterone antagonists, their current availability, therapeutic promise and safety concerns. Recent findingsDespite keen interest in synthesis of these compounds, only a handful have had clinical test results allowing for commercialization. Mifepristone is well tolerated and effective for single dose first trimester at-home pregnancy termination and is available in much of the world. Ulipristal acetate, at single doses, is well tolerated and effective for emergency contraception, with less availability. Chronic use of these agents has been associated with abnormal liver enzymes, and rarely, with hepatic failure; causality is not understood. SummarySPRMs and progesterone antagonists have great therapeutic promise for use in other reproductive disorders, including breast cancer, endometriosis, adenomyosis, estrogen-free contraception and cervical ripening but require additional study. Alternative formulations, whether local (topical breast or intrauterine) or extended-release may reduce the incidence of liver function abnormalities and should be explored.

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A randomized controlled pilot study of ulipristal acetate for abnormal bleeding among women using the 52‐mg levonorgestrel intrauterine system

Cited by 9 publications

References 28 publications

The use of a short course of Ulipristal Acetate for acute abnormal uterine bleeding in women without uterine fibroids

The use of a short course of Ulipristal Acetate for acute abnormal uterine bleeding in women without uterine fibroids

Practical Recommendations on the Management of Issues Related to the Levonorgestrel 52mg Intrauterine System: A Delphi Panel

Selective progesterone receptor modulators and reproductive health

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