On the use of sex steroids in women during the COVID-19 pandemic

The document was approved at an expanded meeting of the Ukrainian Society of Gynecological Endocrinology with the involvement of all board members and representatives of the Association of Obstetricians-Gynecologists of Ukraine, the Association of Pharmacologists of Ukraine, the Association of Anesthesiologists of Ukraine, as well during the Third Ukrainian School of Gynecological and Reproductive Endocrinology with international participation ISGE 19–20.03.21.The COVID-19 pandemic has significantly impacted medical practice, in terms of organizational and clinical practices, posing a number of complex and contradictory challenges for professionals.This document is the result of the systematization of scientific data available by March 2021 and recommendations of international medical and specialized professional societies on controversial clinical issues in gynecological practice caused by the COVID-19 pandemic, as well as certain issues of safety and ratio of using hormonal drugs. The involvement of experts from professional associations of the obstetric and gynecological field, pharmacology, anesthesiology and vascular surgery and phlebology in the working group made it possible to formulate clinically justified provisions of the position.The position includes three thematic sections: “On the use of estrogen-containing combined hormonal contraceptives (CHC) during the COVID-19 pandemic”; “On the use of menopausal hormone therapy (MHT) during the COVID-19 pandemic”; “On the issue of unregistered compounded bioidentical hormones”. At the beginning of each thematic section, the main conclusions of the consensus position of professional medical associations are presented. According to the data available by March 2021, there is no reason to limit the use of CHC or MHT in healthy women (currently not having COVID-19). The question of CHC or MHT discontinuing or switching to other forms by women with COVID-19 should be decided depending on the severity of the disease, the total set of risk factors for thromboembolic complications and other individual characteristics of the clinical situation. Further research will provide elaboration of more detailed algorithms. Physicians need to be vigilant about the safety of compounded Bioidentical Hormonal Therapy (cBHT) in any dosage form (including pellets), especially during the COVID-19 pandemic, given the unexplored systemic effects and therefore the potential risks. Preference should be given to officially licensed medicinal products with a well-studied safety profile and clinical effects, the use of which is authorized by doctor's prescription and supported by clinical protocols and guidelines.

Bioidentical Oral 17β-Estradiol and Progesterone for the Treatment of Moderate to Severe Vasomotor Symptoms of Menopause

Objective To review the efficacy, safety, and available literature regarding the novel combination bioidentical product Bijuva, or 17β-estradiol/progesterone (17β-E/P), for the treatment of moderate to severe menopausal symptoms in cisgender females with an intact uterus. Data Sources Literature searches of both PubMed (1966 to October 2020) and Google Scholar were conducted using search terms including bioidentical, estradiol, progesterone, menopause, E2/P4, TX-001HR, and Bijuva. Study Selection and Data Extraction All articles with studies conducted in cisgender human females and in the English language were considered for review; 18 publications were included. Data Synthesis In 1 phase 3 clinical study, 17β-E/P was proven to be effective at reducing the frequency and severity of vasomotor symptoms (VMS) at 12 weeks compared with placebo, and no cases of endometrial hyperplasia were observed over the 52-week safety study period. Menopausal women with an intact uterus were included in the study population. Relevance to Patient Care and Practice Concerns over content and safety of compounded bioidentical hormones have been raised by several professional societies. As women experience VMS of menopause, a desire for a Food and Drug Administration–regulated bioidentical combination product for the treatment of moderate to severe menopausal symptoms may be desirable. Given as a once-daily oral capsule at the dose of 1 mg estradiol/100 mg progesterone, 17β-E/P is approved for the treatment of VMS associated with menopause. Conclusions 17β-E/P is a novel bioidentical product that is the first of its kind in the treatment of moderate to severe menopausal symptoms.

Understanding bioidentical hormones and their effect on quality of life

It is important to understand the functions of the body's hormones and the options available to make the right choices for use in treating the symptoms of menopause. Bioidentical hormones are compounds that have exactly the same chemical and molecular structure as endogenous human hormones. In contrast, non-bioidentical—or synthetic—hormones are structurally dissimilar from endogenous hormones. Although it has been available for years, bioidentical compounded hormone therapy has gained popularity only recently. This article highlights the main functions of these hormones and how hormone imbalances can affect a patient's quality of life, the importance of lifestyle and diet and what bioidentical hormones are, how they are prescribed, as well as the differences in treatment in different countries and the meaning of compounding.

Understanding bioidentical hormones and their effect on quality of life

It is important to understand the functions of the body's hormones and the options available to make the right choices for use in treating the symptoms of menopause. Bioidentical hormones are compounds that have exactly the same chemical and molecular structure as endogenous human hormones. In contrast, non-bioidentical—or synthetic—hormones are structurally dissimilar from endogenous hormones. Although it has been available for years, bioidentical compounded hormone therapy has gained popularity only recently. This article highlights the main functions of these hormones and how hormone imbalances can affect a patient's quality of life, the importance of lifestyle and diet and what bioidentical hormones are, as well as the differences in treatment in different countries and the meaning of compounding.