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Latest articles

Original Article

Combined oral hormonal contraception – an update

Anna Jelena Britschgi et al.

Pre-print

Abstract

Combined oral contraceptives (COCs) have been available for decades. While there is a wide knowledge of certain risk factors or precautions to be taken during their use, thanks to scientific progress, new insights continue to emerge that significantly influence the use of COCs. In this publication, we provide a summary of the most important and most recent key points that need to be considered when counselling women regarding COC use. One of the primary side effects of CHC use is the increased risk of venous thromboembolism, which is greatly influenced by personal and family medical history. However, the composition of COCs also plays a crucial role, with the lowest increased risk expected in combinations of ethinylestradiol and second-generation progestins, such as levonorgestrel, as well as a combination of estradiol and nomegestrol. Estetrol has recently become available as a new estrogen component in COCs, showing fewer effects on endocrine and metabolic parameters. Whether this transfers to a lower increase in the for thromboembolism remains to be seen. Caution should be taken when counselling specific patient populations. For instance, patients with BRCA1/BRCA2 mutations experience a significant further increase in their high risk for breast cancer when using COCs, and this risk increases further with duration of use. When counselling patients with migraines, it is essential to consider the significant increase in the risk for strokes associated with COC use, particularly in patients experiencing migraine with aura. Progestin-only pills containing desogestrel have shown to reduce the frequency of migraine attacks and do not elevate the risk of stroke. For patients seeking advice after using emergency contraception, timing of the initiation of COC intake should be taken into account. Due to the risk of interactions between both methods the administration of COC should start no earlier than 5 days after ulipristal acetate intake.

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Original Article

Impact of low and ultra-low dose estradiol and dydrogesterone on health-related quality of life of postmenopausal women: outcomes from two Phase 3 studies

Tommaso Simoncini et al.

Pre-print

Abstract

Background and purpose: Oral low and ultra-low dose continuous combined estradiol (E) plus dydrogesterone (D) reduce vasomotor symptoms in postmenopausal women; this pooled analysis evaluated their impact on patient-reported health-related quality of life.
Methods: In two Phase 3, double-blind studies, postmenopausal women were randomized 2:1:2 to receive E 0.5 mg/D 2.5 mg, E 1 mg/D 5 mg, or placebo for 13 weeks (European study) or 1:1 to receive E 0.5 mg/D 2.5 mg or placebo for 12 weeks (Chinese study). This post hoc analysis assessed changes in the scores of the Menopause Rating Scale (MRS) from baseline to week 4 and end of treatment (EOT) in the total pooled population and for subgroups stratified by body mass index (BMI; <25 and ≥25) or ethnicity (European and Chinese).
Results: The analysis included 640 women (E 0.5 mg/D 2.5 mg, n=288; E1 mg/D 5 mg, n=61; placebo, n=291). At EOT, mean MRS scores for hot flushes/sweating, heart discomfort, sleep problems, anxiety and dryness of vagina were significantly improved with E 0.5 mg/D 2.5 mg versus placebo in the total population, as were total MRS scores and its somato-vegetative, psychological, and urogenital subscale scores. These scores were all significantly improved by week 4, except for sleep problems and vaginal dryness and the urogenital subscale score. For E1 mg/D 5 mg versus placebo in the total population, there were significant improvements in mean MRS scores for hot flushes/sweating, sleep problems, depressive mood, anxiety, and joint and muscular discomfort as well as MRS total and somato-vegetative and psychological subscale scores. These scores were all significantly improved by week 4, except for sleep problems and anxiety, and the psychological subscale score. The mean domain score for hot flushes/sweating was also significantly improved with E 0.5 mg/D 2.5 mg versus placebo in all BMI and ethnicity subgroups. Conclusions: In this pooled analysis, E 0.5 mg/D 2.5 mg and E 1 mg/D 5 mg improved in postmenopausal women health-related quality of life across several clinically relevant domains compared to placebo.

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Systematic Review

A comparison between the anti-Mullerian hormone and ovarian ultrasound for diagnosing polycystic ovary syndrome: A systematic review

Nasreen A. Osman

Pre-print

Abstract

Background: The diagnosis of the polycystic ovary syndrome (PCOS) is challenging, with many concerns regarding the ultrasound criteria used to diagnose the syndrome. High anti-Mullerian hormone (AMH) concentrations are observed in PCOS patients. Until now, the recommendations are still against using AMH as a diagnostic test for PCOS.
Aim and methods: A systematic literature review was performed to assess AMH's accuracy in diagnosing PCOS compared to the already known ultrasound criteria. Published literature on the subject was searched in PubMed and Google Scholar from ten years back to date. The investigation was limited to studies done on humans and those published in English. All types of articles were included. A total of 1,060 articles were retrieved. The papers were then checked for eligibility; six were selected for analysis. The quality of the included studies was assessed by the QUADAS2 tool (quality assessment for studies of diagnostic accuracy). Finally, data regarding the sensitivity and specificity of AMH for diagnosing PCOS were extracted.
Results: A total of 2,314 participants were included in the six studies selected in this review. The selected studies were heterogeneous due to the different cohorts for the study, ultrasound criteria used for diagnosing PCOS, different approaches for ultrasound and other types of AMH assay.
Conclusions: AMH is a promising diagnostic tool. Adhering to the guidelines related to the ultrasound criteria and standardization of AMH assays are needed to have valid results.

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Short Review

Menopausal hormone therapy and breast cancer risk: 21 years from the WHI clinical studies

Carlos Rencoret et al.

Pre-print

Abstract

This article analyzes relevant studies that associate the relative risk of suffering from breast cancer with the use of menopausal hormone therapy, which have appeared since the publication of the Women’s Health Initiative (WHI) study in 2002 and have been in permanent discussion. Based on both the WHI study updated 20 years after its first publication, and the 2019 meta-analysis published by the Collaborative Group on Hormonal Factors in Breast Cancer in The Lancet, the authors conclude that up-to-date information shows that exogenous estrogens reduce the risk of breast cancer and that today’s combined menopausal hormone therapy (which excludes medroxyprogesterone acetate) does not increase the relative risk of breast cancer. Contemporary knowledge has revealed that not all progestins are the same, and that natural progesterone and tibolone do not report a significant increase in the relative risk of breast cancer. The relative risk of breast cancer is a partial aspect of the problem, with no real impact (absolute risk), and it is clinically not the most important issue for climacteric women who are on menopausal hormone therapy. Cardiovascular disease is the real cause of death among climacteric women, and the protection against it (excluding strokes) provided by menopausal hormone therapy when used during the window of opportunity is unquestionable. This therapy has proven to maintain and improve the quality of life of the symptomatic women.

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Short Review

Hormonal contraception and menopausal transition: a short review

Tiziana Fidecicchi et al.

Pre-print

Abstract

Background and purpose: As women enter perimenopause, their contraceptive needs evolve in line with hormonal changes. Clinicians should consider not only the prevention of unintended pregnancies, but also the potential relief of perimenopausal symptoms. This short review will summarize current knowledge regarding the different contraceptive options that should be considered when approaching a perimenopausal woman, with the goal of guiding the choice of treatment tailored to the woman's needs and the benefits and risks of each method.
Methods: A comprehensive literature search was conducted across multiple databases to identify relevant studies for this narrative review, with a focus on recent advancements and key themes in the field.
Discussion: Depending on the symptoms, combined hormonal contraceptives (CHCs) are usually preferred, as they offer the possibility of controlling abnormal bleeding, vasomotor symptoms, preventing endometrial hyperplasia, osteoporosis, and protecting against certain tumors. Natural estrogens offer even more possibilities in this group of women. If CHCs are contraindicated, progestin-only contraceptives can be used. However, although they retain contraceptive function and the ability to treat abnormal uterine bleeding, they are not useful for vasomotor symptoms and bone protection. Perimenopausal transition can also occur very early in women with premature ovarian insufficiency (POI), exposing them to a prolonged period of estrogen deprivation and potentially more serious long-term consequences; with appropriate contraceptive therapy, they can be followed up to the age of physiologic onset of menopause. Estrogen supplementation should always be considered in women with POI.
Conclusion: Contraception during the perimenopause should be tailored according to the symptoms that women present. Counseling is essential both before prescription of the contraceptive and for the decision of discontinuation, to correctly address women to postmenopausal hormone therapy.

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Position Statement

Position statement of the Latin American Federation of Climacteric and Menopause Societies (FLASCYM) regarding the use of Bioidentical Hormonal Compounds during female mid-life

Cuauhtémoc Celis-Gonzales et al.

Pre-print

Abstract

To date, menopausal hormone therapy (MHT) is the best option for the management of menopausal symptoms, especially vasomotor, genitourinary and also for the prevention of bone loss. Preliminary data of the WHI, regarding one type of regimen, reported a greater risk of breast cancer, cardiovascular disease, cerebrovascular events and thrombosis. Despite this, as years have passed other arms have provide different results. Nevertheless, the use of MHT has never recuperated as before the WHI. In parallel women and physicians have been exploring alternatives. One is bioidentical hormonal compounds. Bioidentical hormonal compounds (BHC) are not approved by the FDA and formulated as galenic preparations promoted as a safer alternative for traditional MHT. The positioning of FLASCYM is that there are inconsistencies in potency, bioequivalence and information regarding the quality of BCHs. The lack of studies regarding their use has raised concerns about the correct doses and efficacy. On the other hand, information related to the possible adverse events is very limited and long-term consequences of the use of BHC are unknown. Therefore, FLASCYM does not recommend the use of BHC.

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