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Hormonal Profile of Menopausal Women Receiving Journal of Endocrinological Investigation https://doi.org/10.1007/s40618-020-01192-x REVIEW Hormonal profle of menopausal women receiving androgen replacement therapy: a meta‑analysis L. Marina1 · A. S. Sojat1 · E. Maseroli2 · G. Spaggiari3,4 · S. Pandurevic1 · D. Santi3,4 Received: 14 November 2019 / Accepted: 27 January 2020 © Italian Society of Endocrinology (SIE) 2020 Abstract Purpose Ovarian and adrenal aging leads to a progressive decline in androgen levels and deleterious efects on the quality of life. Despite this, specifc replacement is not routinely recommended in the management of women with a physiological or pathological decline in their production, mainly due to the lack of long-term follow-up safety data. The purpose of this paper was to meta-analyze and summarize the existing data about hormonal profle changes in menopausal women receiving androgen replacement treatments. Full-text articles published through May 30, 2018 were found via MEDLINE and Embase and selected according to the strict inclusion criteria. Methods Randomized clinical trials and case–control studies were enrolled. Studies not reporting steroid serum levels or not providing a control group were excluded from the analysis. Studies enrolling women with genetic defects or severe chronic systemic diseases were excluded. 113 papers fulflled the inclusion criteria and 56 papers were included in the analysis. Desired data were compiled and extracted by independent observers. Results Androgen administration increases E1, E2, testosterone, DHEA and DHEAS serum levels, and reduces SHBG. However, the E1 and E2 increase is evident only when DHEA is administered. Conclusions Whatever androgen formulation we choose in postmenopausal women, the end result is a rise in testosterone serum levels. However, DHEA regimen is also associated with an increased estrogenic availability. This might be crucial when choosing the best possible treatment for each patient individually taking into consideration if potential benefts out- weigh the risks. Keywords Menopause · Androgens · DHEAS · Estradiol · Testosterone · Androgen replacement therapy Introduction In the last two centuries, an impressive progress in medicine and quality of life has been detected, contributing to a mark- edly prolonged life span. Considering that the average age * E. Maseroli of menopause is around 51 years of age, women today will [email protected] spend more than one-third of their lifetime after menopause [1, 2]. Natural menopause represents a signifcant milestone 1 Clinic for Endocrinology, Diabetes and Metabolic Diseases, Clinical Centre of Serbia, Faculty of Medicine, University in women’s life and endocrinologically wise, it means that of Belgrade, Belgrade, Serbia women will spend this period in a hormone defciency state. 2 Andrology, Women’s Endocrinology and Gender In the literature, there is a large evidence of the delete- Incongruence Unit, Department of Experimental and Clinical rious consequences of the defciency of the main female Biomedical Sciences “Mario Serio”, University of Florence, hormone, estradiol. Estrogen defciency impairs quality of Florence, Italy life, mainly through vasomotor symptoms (VMS), increases 3 Unit of Endocrinology, Department of Biomedical, the incidence of major cardiovascular events, dementia and Metabolic and Neural Sciences, University of Modena osteoporosis, and, if not treated, overall accelerates aging and Reggio Emilia, Modena, Italy [3]. 4 Unit of Endocrinology, Department of Medical Specialties, Azienda Ospedaliero-Universitaria of Modena, Modena, Italy Vol.:(0123456789)1 3 Journal of Endocrinological Investigation Decline of testosterone levels starts much earlier than Recently, a systematic review and meta-analysis on the menopause and together with adrenal aging and linear fall of safety and efcacy of testosterone treatment in women was dehydroepiandrosterone sulfate (DHEAS) leads to an over- published followed by a Global Consensus Position State- all progressive decline in androgens levels. Physiologically, ment on the use of testosterone therapy for women. The steroidogenesis occurs in both ovaries and adrenals, in which authors showed and agreed that non-oral administration of C-19 steroids, DHEA, androstenedione and testosterone are testosterone to menopausal women with low sexual desire produced [4]. C-19 steroids derive from C-21 precursors and causing distress is efective and safe with no severe side are subsequently converted to C-18 steroids, e.g., the estro- efects noted [16, 17]. Further, they pointed that all regis- gens [5]. DHEA serum levels decrease with increasing age tered testosterone formulation are for men and that there and they are reduced by 60% after menopause [6]. Similarly, was no approved testosterone formulation in any country a 55% decline in serum testosterone levels is detected at the [16, 17]. Finally, the authors highlighted the need for more age of menopause [7]. In menopausal women, about 80% research into testosterone treatment for women [17]. of the serum DHEA is of adrenal origin and approximately Surprisingly, current literature lacks a systematic inves- 20% originates from the ovaries [1]. On the other side, ova- tigation of hormonal profle changes in women receiving ries are main sources of testosterone production, increas- androgen replacement treatments. Thus, the aim of our ing from 25 to 50% from fertile to postmenopausal woman. meta-analysis was to evaluate and summarize the exist- However, the fnal testosterone levels decrease with age due ing data about hormonal profle changes in menopausal to the inability of ovaries to compensate the decrease of the women receiving androgen replacement treatments, con- adrenal production of the testosterone prohormones (DHEA sidering all available androgens formulation and regimens. and its sulfate, DHEAS) [8, 9]. As well as estrogen defciency, androgen insufciency is also demonstrated to be associated with deleterious efect on the quality of life [10]. In particular, sexual dysfunction, Materials and methods low libido, cognitive decline, low energy, vasomotor insta- bility, bone loss, decreased muscle strength, and changes This meta-analysis was performed according to the in cognition or memory are most frequently observed [11]. Cochrane Collaboration and PRISMA statement. To In the genitourinary system and pelvic foor, androgens are ensure originality and transparency of the review process, important for the maintenance of the structure and function the meta-analysis was frst registered in the International of the tissues, and the lack of androgenic activity contributes Prospective Register of Systematic Reviews (PROSPERO; to symptoms of the genitourinary syndrome of menopause registration ID CRD42018099414). (GSM), including dysuria, recurrent urinary tract infections, Literature search was performed considering the fol- vaginal dryness, poor arousal and dyspareunia [12]. lowing criteria in MEDLINE and Embase databases: Despite the crucial role of androgens, specifc replace- ((((((((menopause) OR postmenopause) OR post meno- ment is not routinely recommended in the management pause) OR menopausal) AND women) OR woman) OR of women with a physiological or pathological (i.e., due female) AND testosterone administration) OR androgen to premature ovarian insufciency, surgical menopause or administration. All studies published until May 30, 2018 hypopituitarism) decline in their production, mainly due to were considered. the lack of long-term follow-up safety data. In 2014, the Endocrine Society Guidelines recommended against making a clinical diagnosis of “androgen defciency syndrome” in Study selection and inclusion criteria healthy women, because of the lack of a well-defned syn- drome [13]. The primary indication for the prescription of The following inclusion criteria were searched: (1) all androgens in postmenopausal women remains loss of sexual androgens formulations, (2) interventional study design, desire causing signifcant distress (hypoactive sexual desire (3) comparison with a control group, and (4) evaluation disorder, HSDD). of steroid serum levels. The randomization of patients Studies of transdermal testosterone have consistently was not considered an inclusion criterion, thus both ran- shown efcacy of HSDD treatment in both naturally and domized clinical trials (RCT), and case–control studies surgically postmenopausal women, either alone or in com- were enrolled. bination with the estrogen therapy [14]. Conversely, sys- Studies not reporting steroid serum levels or not provid- tematic reviews and meta-analyses have found no statisti- ing a control group were excluded from the analysis. More- cally signifcant beneft of systemic DHEA on female sexual over, studies enrolling women with genetic defects (i.e., function; no signifcant efect of DHEA on serious adverse Turner syndrome) or severe chronic systemic diseases (i.e., efects was observed either [15]. severe heart failure) were excluded. 1 3 Journal of Endocrinological Investigation Data collection process and quality accuracy. In particular, studies using mass spectrometry were considered to be highly accurate, whereas studies Two authors (DS and GS) performed separately literature using immunoassays were considered to have low accu- search and extracted the abstracts of studies of interest. All racy. Finally, a third sensitivity analysis was performed abstracts were evaluated for inclusion criteria and the data dividing studies according to the nature of menopause: were extracted
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