olycystic Ovarian Syndrome (PCOS) affects millions ofwomen globally, and, depending on the diagnostic criteriaused, PCOS has an estimated prevalence of between 7% to17% of reproductive-aged women causing a range of symp-toms such as irregular menstrual cycles, excessive hairgrowth, weight gain, and infertility [1].PCOS is characterized by a complex interplay of hormo-nal, metabolic, and reproductive disturbances. The syn-drome’s underlying changes impact multiple systems,leading to several and complex clinical manifestations. Oneof the hallmark features of PCOS is hyperandrogenismwhich brings on symptoms like excessive hair growth,acne and alopecia. Anovulation and irregular menstrualcycles stem from the imbalance in follicle-stimulating hor-mone (FSH) and luteinizing hormone (LH) triggered byandrogen fluctuations. PCOS often involves both hyperan-drogenism and insulin resistance, due to reduced sensitivityof target cells. These metabolic conditions over time lead toincreased risk of type 2 diabetes, obesity, and dyslipidemiadevelopment. The interplay between insulin resistance andhyperandrogenism intensifies the syndrome’s clinical symp-toms. Abnormal gonadotropin-releasing hormone (GnRH)secretion has consequences of ovarian anovulation andcyst formation, resulting in unbalanced FSH and LHproduction.The current pharmacological approaches for PCOS man-agement primarily include hormonal contraceptives, anti-androgens, and insulin-sensitizing agents such as metformin.These pharmacological agents play a central role in managingPCOS. Despite targeting specific symptoms, these treatmentsoften fail to tackle the underlying hormone imbalances holi-stically [2,3]. The urgent requirement for novel advanceddrugs stems from the limitations in managing PCOS and thequest for a more comprehensive, personalized treatment strat-egy. To achieve optimal outcomes, medications should aim torectify the delicate hormonal, insulin resistance, and ovulatoryimbalances, alleviating symptoms while restoring ovulationand improving metabolic health.Several promising medications are presently undergoingphase II clinical studies, providing hope for more successfulmanagement of PCOS. This article focuses on three chosenphase II clinical studies that have produced notable outcomesout of many phase II clinical trials undertaken on the therapyof PCOS. These studies were prudently selected for the inno-vative contribution that they could bring to therapeuticoptions in the treatment of PCOS. Moreover, these studieshave explored innovative pathways that could lead toa deeper understanding of the underlying pathologicalmechanisms of PCOS. Consequently, studies that did notachieve statistical significance for any endpoint or did notpresent published results were excluded.These studies were selected from a total of 10 phase IIcompleted trials (Table 1).This article explores these novel medications, their mechan-ism of action, and their possible effects on PCOS-affectedwomen’s lives, in order to gain a deeper understanding ofthe ongoing efforts to develop improved management strate-gies for PCOS.
What’s new on the horizon for polycystic ovarian syndrome? Exploring emerging drugs in phase II / D'Angelo, Giuseppe; Ascione, Mario; Morra, Ilaria; Verrazzo, Paolo; Bifulco, Giuseppe; Giampaolino, Pierluigi; Della Corte, Luigi. - In: EXPERT OPINION ON EMERGING DRUGS. - ISSN 1472-8214. - 28:3(2023), pp. 149-152. [10.1080/14728214.2023.2260746]
What’s new on the horizon for polycystic ovarian syndrome? Exploring emerging drugs in phase II
D'Angelo, GiuseppePrimo
;Ascione, MarioSecondo
;Morra, Ilaria;Verrazzo, Paolo;Bifulco, Giuseppe;Giampaolino, Pierluigi;Della Corte, Luigi
2023
Abstract
olycystic Ovarian Syndrome (PCOS) affects millions ofwomen globally, and, depending on the diagnostic criteriaused, PCOS has an estimated prevalence of between 7% to17% of reproductive-aged women causing a range of symp-toms such as irregular menstrual cycles, excessive hairgrowth, weight gain, and infertility [1].PCOS is characterized by a complex interplay of hormo-nal, metabolic, and reproductive disturbances. The syn-drome’s underlying changes impact multiple systems,leading to several and complex clinical manifestations. Oneof the hallmark features of PCOS is hyperandrogenismwhich brings on symptoms like excessive hair growth,acne and alopecia. Anovulation and irregular menstrualcycles stem from the imbalance in follicle-stimulating hor-mone (FSH) and luteinizing hormone (LH) triggered byandrogen fluctuations. PCOS often involves both hyperan-drogenism and insulin resistance, due to reduced sensitivityof target cells. These metabolic conditions over time lead toincreased risk of type 2 diabetes, obesity, and dyslipidemiadevelopment. The interplay between insulin resistance andhyperandrogenism intensifies the syndrome’s clinical symp-toms. Abnormal gonadotropin-releasing hormone (GnRH)secretion has consequences of ovarian anovulation andcyst formation, resulting in unbalanced FSH and LHproduction.The current pharmacological approaches for PCOS man-agement primarily include hormonal contraceptives, anti-androgens, and insulin-sensitizing agents such as metformin.These pharmacological agents play a central role in managingPCOS. Despite targeting specific symptoms, these treatmentsoften fail to tackle the underlying hormone imbalances holi-stically [2,3]. The urgent requirement for novel advanceddrugs stems from the limitations in managing PCOS and thequest for a more comprehensive, personalized treatment strat-egy. To achieve optimal outcomes, medications should aim torectify the delicate hormonal, insulin resistance, and ovulatoryimbalances, alleviating symptoms while restoring ovulationand improving metabolic health.Several promising medications are presently undergoingphase II clinical studies, providing hope for more successfulmanagement of PCOS. This article focuses on three chosenphase II clinical studies that have produced notable outcomesout of many phase II clinical trials undertaken on the therapyof PCOS. These studies were prudently selected for the inno-vative contribution that they could bring to therapeuticoptions in the treatment of PCOS. Moreover, these studieshave explored innovative pathways that could lead toa deeper understanding of the underlying pathologicalmechanisms of PCOS. Consequently, studies that did notachieve statistical significance for any endpoint or did notpresent published results were excluded.These studies were selected from a total of 10 phase IIcompleted trials (Table 1).This article explores these novel medications, their mechan-ism of action, and their possible effects on PCOS-affectedwomen’s lives, in order to gain a deeper understanding ofthe ongoing efforts to develop improved management strate-gies for PCOS.File | Dimensione | Formato | |
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