Rationale and design of ASTEROID 2, a randomized, placebo- and active comparator-controlled study to assess the efficacy and safety of vilaprisan in patients with uterine fibroids

Seitz, Christian; Bumbulienė, Žana; Costa, Anı́bal; Heikinheimo, Oskari; Heweker, Andrea; Hudeček, Robert; Jacquemyn, Yves; Melis, Gian Benedetto; Parashar, Pooja; Rechberger, Tomasz; Sánchez, Amaury Flores; Aken, Bart van; Zatik, János; Gemzell‐Danielsson, Kristina

doi:10.1016/j.cct.2017.02.002

Cited by 27 publications

(20 citation statements)

References 27 publications

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“…Others have advocated a percentage reduction in score; values of 20-50% have been reported [36,58,59,63,[99][100][101][102][103][104][105]. If the treatment goal is amenorrhea (PBAC score < 2), the endpoint is clearly defined [54,[106][107][108][109]. The aim of several reports is just to detect a significant difference in MBL reduction between different treatments for HMB.…”

Section: Recognition Of Limitationsmentioning

confidence: 99%

Pictorial methods to assess heavy menstrual bleeding in research and clinical practice: a systematic literature review

Magnay¹,

O’Brien

Gerlinger

et al. 2020

BMC Women's Health

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Background: Pictorial blood loss assessment charts (PBACs) represent the most widely used method to assess menstrual blood loss (MBL) in clinical trials. The aims of this review were to: (1) determine the diagnostic accuracy of PBACs that have been validated against the reference alkaline hematin technique; (2) categorize the pitfalls of using obsolete and nonvalidated charts; (3) provide guidelines for development of a new PBAC or use of an existing chart to measure MBL in clinical trials; and (4) consider the feasibility of using pictorial charts in primary care. Methods: A literature review was conducted using Embase and MEDLINE databases. The review identified reports of women with self-perceived or actual heavy menstrual bleeding (HMB), bleeding disorders, abnormal uterine bleeding, leiomyomata (uterine fibroids) or endometriosis, and women undergoing treatment for HMB, as well as those with normal menstrual periods. Data were reviewed from studies that focused on the development and validation of PBACs and from those that used derivative noncertified charts to assess HMB. Results: Nine studies reported validation of PBAC scoring systems against the alkaline hematin technique. Across these studies, the sensitivity was 58-97%, the specificity was 7.5-95.5%, the positive and negative likelihood ratios were 1.1-13.8 and 0.14-0.56, respectively, and the diagnostic odds ratio was 2.6-52.4. The cut-off score above which the diagnosis of HMB was made ranged from 50 to 185. Several modifications of these PBACs were used in other studies; however, objective confirmation of their validity was not reported. Overall, there was widespread inconsistency of chart design, scoring systems, diagnostic cut-off limits and post-treatment outcome measures. Conclusions: PBACs are best suited to the controlled and specific environment of clinical studies, where clinical outcome parameters are defined. The current lack of standardization precludes widespread use of the PBAC in primary care. Review registration number: PROSPERO international prospective register of systematic reviews: CRD42016030083.

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Section: Recognition Of Limitationsmentioning

confidence: 99%

Pictorial methods to assess heavy menstrual bleeding in research and clinical practice: a systematic literature review

Magnay¹,

O’Brien

Gerlinger

et al. 2020

BMC Women's Health

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“…12 Vilaprisan is a novel SPRM currently in the late stages of clinical development. 13 The history of the development of SPRMs cannot be separated from the simultaneous evolution of a classification system for the unique endometrial changes accompanying SPRM treatment. The concerns initially arose when early studies reported high rates of endometrial hyperplasia following treatment with mifepristone.…”

Section: The Pastmentioning

confidence: 99%

“…Two novel SPRMs (oral vilaprisan and orally or vaginally administered telapristone acetate) are currently in development for management of UF. 13 Additional new agents or therapeutic strategies may also emerge based on new insights into the effects of PR and their tissuespecific effects.…”

Section: Treatment Options For Symptomatic Uterine Fibroidsmentioning

confidence: 99%

The past, present, and future of selective progesterone receptor modulators in the management of uterine fibroids

Singh

Belland

Leyland

et al. 2018

American Journal of Obstetrics and Gynecology

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Uterine fibroids are common in women of reproductive age and can have a significant impact on quality of life and fertility. Although a number of international obstetrics/gynecology societies have issued evidence-based clinical practice guidelines for the management of symptomatic uterine fibroids, many of these guidelines do not yet reflect the most recent clinical evidence and approved indication for one of the key medical management options: the selective progesterone receptor modulator class. This article aims to share the clinical experience gained with selective progesterone receptor modulators in Europe and Canada by reviewing the historical development of selective progesterone receptor modulators, current best practices for selective progesterone receptor modulator use based on available data, and potential future uses for selective progesterone receptor modulators in uterine fibroids and other gynecologic conditions.

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“…ASTEROID II is a phase 2 randomised, placebo-controlled study assessing the efficacy and safety of vilaprisan in patients with uterine fibroids and comparing its effects to UPA. 37 …”

Section: Selective Progesterone Receptor Modulators and Upamentioning

confidence: 99%

Is ulipristal acetate the new drug of choice for the medical management of uterine fibroids? Res ipsa loquitur?

Odejinmi

Oliver

Mallick

2017

Womens Health (Lond Engl)

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Ulipristal acetate (Esmya © ) has been hailed the new wonder drug with regard to the medical management of uterine fibroids, and many postulate that it will remove the need for surgical treatment in the future. While the results from the PEARL studies are certainly promising and its amenorrhoeic rates and reduction in fibroid size are unquestionable, there is still a paucity of data with regard to its long-term effects, the effects on its usage prior to surgery and its variable efficacy in different ethnic populations. To facilitate our knowledge further, independent studies with clear outcome measures evaluating the long-term effects of the drug in a wider, more representative, ethnic minority population as well as assessing its true cost-effectiveness compared to surgery are needed. The aim of this article is to review the historical aspects with regard to the management of uterine fibroids to gain an understanding of where we are now and to evaluate the wider use of ulipristal acetate, both its benefits and limitations and postulate where to go in the future in order to allow our women to make safe and informed choices regarding their treatment options.

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Rationale and design of ASTEROID 2, a randomized, placebo- and active comparator-controlled study to assess the efficacy and safety of vilaprisan in patients with uterine fibroids

Abstract: The placebo- and active comparator-controlled trial ASTEROID 2 is the first study to evaluate systematically the efficacy and safety of different treatment regimens of PRMs in women with UFs. The findings of this study will direct the planning of future clinical trials of vilaprisan.

Cited by 27 publications

References 27 publications

Pictorial methods to assess heavy menstrual bleeding in research and clinical practice: a systematic literature review

Pictorial methods to assess heavy menstrual bleeding in research and clinical practice: a systematic literature review

The past, present, and future of selective progesterone receptor modulators in the management of uterine fibroids

Is ulipristal acetate the new drug of choice for the medical management of uterine fibroids? Res ipsa loquitur?

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