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Author: Henry G Burger (53)


Sep
2016

Part 1 of this position statement dealt with the assessment of male hypogonadism, including the indications for testosterone therapy. This article, Part 2, focuses on treatment and therapeutic considerations for male hypogonadism and identifies key questions for future research.
Key points and recommendations are:Excess cardiovascular events have been reported in some but not all studies of older men without pathological hypogonadism who were given testosterone treatment.

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Aug
2016

This article, Part 1 of the Endocrine Society of Australia's position statement on male hypogonadism, focuses on assessment of male hypogonadism, including the indications for testosterone therapy. (Part 2 will deal with treatment and therapeutic considerations.)
Key points and recommendations are:Pathological hypogonadism arises due to diseases of the hypothalamus or pituitary gland (hypogonadotropic hypogonadism) or testes (hypergonadotropic hypogonadism).

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Apr
2014

After publication of the Women's Health Initiative study in 2002, use of menopausal hormone therapy (HT) has declined by nearly 80% worldwide and internists now play only a limited role in menopause management. Over the past decade, new data have increased our knowledge of the multiple effects and mechanisms of HT.
Existing literature was reviewed.

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Jul
2014

The perimenopausal woman: endocrinology and management.

J Steroid Biochem Mol Biol 2014 Jul 14;142:121-31. Epub 2013 Oct 14.
Georgina E Hale, David M Robertson, Henry G Burger
This review focuses on the endocrine and physiological features of the transition to menopause, known as the menopausal transition or the perimenopause. The updated 2011 Stages of Reproductive Aging workshop (STRAW) system is presented with a discussion of the new subdivisions within stages -3 (late reproductive age) and +1 (postmenopause) and incorporation of FSH and other biomarkers in the supportive criteria. Ovarian follicle reserve and ovarian follicle dynamics are also discussed in terms of the changes that occur with reproductive aging, and the dramatic effect these changes have on the hypothalamic-pituitary-gonadal feedback system.

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Apr
2013

Based principally on findings in three studies, the Collaborative Reanalysis (CR), the Women's Health Initiative (WHI), and the Million Women Study, it is claimed that hormone replacement therapy (HRT) is an established cause of breast cancer. The authors have previously reviewed those studies (Parts 1-4). The WHI findings were first published in 2002, following which the use of HRT rapidly declined.

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May
2013

Vitex agnus-castus L. (chaste tree; chasteberry) is a popular herbal treatment, predominantly used for a range of female reproductive conditions in Anglo-American and European practice. The objective of this systematic review was to evaluate the evidence for the efficacy and safety of Vitex extracts from randomised, controlled trials investigating women's health.

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Apr
2012

Based principally on findings in three studies, the collaborative reanalysis (CR), the Women's Health Initiative (WHI) and the Million Women Study (MWS), it is claimed that hormone replacement therapy (HRT) with estrogen plus progestogen (E+P) is now an established cause of breast cancer; the CR and MWS investigators claim that unopposed estrogen therapy (ET) also increases the risk, but to a lesser degree than does E+P. The authors have previously reviewed the findings in the CR and WHI (Parts 1-3).
To evaluate the evidence for causality in the MWS.

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Dec
2011

The approach to menopause can be divided into the early (E) and late (L) menopausal transitions (MT) on the basis of menstrual irregularity (EMT) and subsequent observation of at least one episode of 60 or more days amenorrhoea (LMT). In total, 40-60% of cycles in the LMT are anovulatory, often with low oestradiol (E2) and high follicle-stimulating hormone concentrations. The ovulatory cycles have variable endocrine characteristics, none of which is specific to EMT or LMT.

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Dec
2011

Mifepristone alone or in combination with ethinyl estradiol (EE) can effectively stop an episode of uterine bleeding in women using the etonogestrel-releasing contraceptive implant, Implanon® but could impair contraceptive efficacy.
To examine the effects of administration of mifepristone alone or with EE on ovarian function and cervical mucus consistency in women using Implanon.
Women using Implanon were randomized to mifepristone 25 mg twice daily on day 1 plus placebo 1 daily for 4 days or plus EE 20 mcg daily for days 2-5.

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May
2011

The aim of this study was to assess the pattern of serum antimüllerian hormone (AMH) across the normal ovulatory menstrual cycle in women in late reproductive age when ovarian follicle reserve and, hence, serum AMH levels are reduced.
Serum AMH levels were determined by enzyme-linked immunosorbent assay across the ovulatory menstrual cycle from women in mid (n = 18) and late (n = 43) reproductive life, including the menopausal transition.
: No intracycle variation in AMH level was observed in women in mid reproductive life nor in 33% (n = 14) of women with normal ovulatory cycles in late reproductive age.

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Jul
2010

Our objective was to provide a scholarly review of the published literature on menopausal hormonal therapy (MHT), make scientifically valid assessments of the available data, and grade the level of evidence available for each clinically important endpoint. PARTICIPANTS IN DEVELOPMENT OF SCIENTIFIC STATEMENT: The 12-member Scientific Statement Task Force of The Endocrine Society selected the leader of the statement development group (R.J.

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Sep
2009

It has been suggested that some of the symptoms typically attributed to menopause may be more related to premenstrual syndrome (PMS) than menopause, as perimenopausal women appear to be more prone to PMS-like symptoms, or at least to tolerate them less well.
The objective of this study was to evaluate the effectiveness of a phytotherapeutic intervention comprising a combination of Hypericum perforatum (St. John's wort) and Vitex agnus-castus (chaste tree/berry) in the management of PMS-like symptoms in perimenopausal women.

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Aug
2009

The origin of the current practice of administering Vitex agnus-castus in menopause-related complaints is uncertain, but appears to be relatively recent. Here we review the evidence for this application of Vitex based on evidence from pharmacological studies and clinical research.
The mechanisms of potential relevance in the context of menopause are explored with reference to the current understanding of the endocrinology and neuroendocrinology of menopause and associated symptoms.

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Aug
2009

The aim of this study was to evaluate predictors of the placebo response in a randomized, placebo-controlled, double-blind trial of a phytotherapeutic combination for the treatment of menopausal symptoms.
A post hoc analysis was conducted on data from 46 placebo participants completing the study. Variables at baseline were investigated for prediction of improvement on any of the endpoints of flushing, depression measured on the Hamilton Depression Inventory, and menopausal symptoms measured on the Greene Climacteric Scale.

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Jun
2009

Assumptions underlying placebo controlled trials include that the placebo effect impacts on all study arms equally, and that treatment effects are additional to the placebo effect. However, these assumptions have recently been challenged, and different mechanisms may potentially be operating in the placebo and treatment arms. The objective of the current study was to explore the nature of placebo versus pharmacological effects by comparing predictors of the placebo response with predictors of the treatment response in a randomised, placebo-controlled trial of a phytotherapeutic combination for the treatment of menopausal symptoms.

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Jun
2009

Across a woman's lifetime, variations in hormone levels are known to influence mood and well-being. Whether absolute or changes in hormone levels over time are associated with depression among postmenopausal women remains unclear.
The Melbourne Women's Midlife Health Project is a longitudinal population-based study of women who were followed through the menopausal transition.

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Jun
2009

The menopausal transition is characterized by irregular menstrual cycles and unpredictable hormone levels, including dramatic swings in estradiol (E2). An increasing number of studies have found variable high E2 and low luteal phase progesterone occur with progression of Stages of Reproductive Aging Workshop (STRAW)stage, but the cause remains unclear. To explore the causes of the erratic changes in E2, individual within-cycle secretion patterns of E2, progesterone, follicle-stimulating hormone, luteinizing hormone, inhibin A, and inhibin B were explored in detail.

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Jan
2009

Ovarian hormones regulate pituitary gonadotropin secretion across the menstrual cycle via negative and positive feedback mechanisms. The contribution of individual hormones is complex and is a continuing area of research.
The aim of the study was to identify relationships between LH/FSH and estradiol, progesterone, inhibin A, inhibin B, and anti-Mullerian hormone (AMH) in ovulatory menstrual cycles across reproductive age.

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Jan
2009

To evaluate the effectiveness of a phytotherapeutic intervention comprising a combination of Hypericum perforatum (St. John's wort) and Vitex agnus-castus (Chaste tree/berry) in the management of menopausal symptoms.
A double-blind, randomized, placebo-controlled, parallel trial was performed over 16 weeks in 100 eligible late-perimenopausal or postmenopausal women experiencing hot flushes and other menopausal symptoms.

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Jan
2009

To characterize menstrual cycles in women in late reproductive age and the menopause transition, based on changes in serum hormone levels.
Serum levels of estradiol, progesterone, follicle-stimulating hormone (FSH), luteinizing hormone, inhibin A, inhibin B, and antimüllerian hormone, as previously reported as mean data grouped according to the Stages of Reproductive Aging Workshop proposals, were analyzed in 55 women aged 45 to 55 and compared with those in 21 women aged 21 to 35.
The ovulatory cycles in the older women were divided into three types.

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Jan
2009

The menopausal transition is the stage in reproductive life commonly defined as commencing with the onset of menstrual irregularity. Classic studies of the endocrinology of the transition postulated the existence of inhibin in women to explain the observed increase in follicle-stimulating hormone (FSH) levels without a significant decrease in estradiol (E2). Descriptions were provided of cycle characteristics during the transition, emphasizing the unpredictability of the endocrine changes rather than the occurrence of an orderly and progressive decline in ovarian function.

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Jan
2009

Changes in FSH and estradiol (E2) across the menopausal transition are clearly not linear. The present study utilizes data from 204 women who completed the 13-year prospective Melbourne Women's Midlife Health Project. E2, FSH, symptoms, self-rated health, mood, sexual function and coronary heart disease (CHD) risk were measured longitudinally.

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Aug
2007

Female reproductive aging based on changes in menstrual cycle length and frequency progresses through a number of stages as defined by the Stages of Reproductive Aging Workshop (STRAW) staging criteria.
This paper provides a comprehensive description of the endocrine features associated with the STRAW stages.
Healthy women aged 21-35 and 45-55 yr submitted three blood samples a week over a single menstrual cycle.

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May
2007

WHI risks: any relevance to menopause management?

Maturitas 2007 May 21;57(1):6-10. Epub 2007 Mar 21.
Henry G Burger
Two randomised controlled trials of hormone therapy (HT) were conducted within the US Women's Health Initiative. Both were chronic disease prevention trials, undertaken to determine whether HT reduced cardiovascular risk and increased breast cancer risk. Because the majority of subjects in both trials were asymptomatic and many years postmenopausal, and because substantial numbers had received HT prior to recruitment to the trials, care must be taken in drawing conclusions that the observed risks are applicable to women for whom HT is conventionally prescribed.

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Oct
2006

To determine the influence of obesity on the diagnosis of age-related androgen deficiency (AD) in symptomatic men according to current Australian guidelines.
A community-based cohort of healthy ageing men with symptoms suggestive of AD was studied between May 2001 and February 2003. Men were classified as obese or non-obese according to body mass index (BMI) or waist circumference (WC).

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Oct
2006

The objective of this study was to investigate hormonal and other factors associated with mammographic density during the menopausal transition and in postmenopause.
Mammograms were obtained from 252 participants in the Melbourne Women's Midlife Health Project-a longitudinal population-based study that included annual interviews, blood collection, and physical measurements; 869 original films of the right craniocaudal view were digitized. Total area of the breast and the area of dense tissue were measured, and the percentage of mammographically dense tissue (PMD) was calculated.

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Oct
2006

There has been controversy about the relative effects on various health outcomes of hormonal, psychosocial, and lifestyle changes during the menopausal transition. In previous studies the risk factors for one particular health endpoint have been analyzed separately. Separate analyses do not provide an overall view of the relationships between all the variables or the relative importance of different factors.

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May
2006

The diagnosis of female androgen deficiency syndrome is suggested by complaints of a diminished sense of well being, persistent unexplained fatigue and decreased sexual desire, sexual receptivity and pleasure in a woman who is oestrogen-replete and in whom no other significant contributing factors can be identified. The diagnosis is supported by the finding of low circulating concentrations of free testosterone. Barriers to its recognition include the non-specificity of the symptoms and methodological problems due to insensitive testosterone assays.

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Apr
2006

Hormone therapy in the WHI era.

Aust N Z J Obstet Gynaecol 2006 Apr;46(2):84-91
Henry G Burger
The announcement in July 2002 in the media of the results of the combined continuous hormone treatment arm of the Women's Health Initiative (WHI) had a profound effect on perceptions about hormone therapy among the lay public and the medical profession. Careful scrutiny of the announcement and the subsequent publications leads to the conclusion that the widespread fear of hormone therapy that was generated was not supported by the facts. WHI was not designed to be, nor can it be, interpreted as a randomised controlled trial of menopausal hormone therapy--rather, it was a trial of chronic disease prevention, particularly aimed at the possible cardiovascular benefits of a specific combination hormone therapy in postmenopausal women.

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Dec
2005

Perimenopausal reproductive endocrinology.

Endocrinol Metab Clin North Am 2005 Dec;34(4):907-22, ix
Georgina E Hale, Henry G Burger

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Dec
2005

To investigate factors associated with the presence, severity, and frequency of hot flushes.
A 9-year prospective study of 438 Australian-born women, aged 45 to 55 years and menstruating at baseline. Annual fasting blood collection, physical measurements, and interviews including questions about bothersome hot flushes in previous 2 weeks were performed.

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Dec
2005

There is currently little longitudinal data available on the serum hormonal characteristics of the menstrual cycles observed in women as they approach their final menstrual period (FMP) or menopause. We sought to determine whether the onset of irregular menses, marking the menopause transition, signifies the occurrence of anovulatory, potentially infertile cycles.
We studied 12 subjects, initially aged 45 to 47 years, who provided daily menstrual diaries, and had blood samples collected annually, three times weekly for 4 consecutive weeks, over a period of 36 to 98 months until FMP, for measurements of serum follicle-stimulating hormone (FSH), luteinizing hormone, estradiol, and progesterone.

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Oct
2004

The inhibins are produced and secreted by several ovarian cancers. Monitoring serum levels by immunoassay may be a useful diagnostic aid in the initial assessment of this disease and in monitoring its potential recurrence following surgery. The assays are applicable to women after menopause when the majority of ovarian cancers are detected, and when the normal ovarian production of inhibin is low to negligible.

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Jun
2004

To examine the hormonal characteristics of menstrual cycles in healthy women approaching menopause, serum hormone profiles were investigated annually in this longitudinal study of 13 healthy women between 4 and 9 yr before menopause and the year of the menopause. Serum FSH, LH, estradiol, progesterone, total inhibin, inhibins A and B, and prolactin were determined in blood samples collected annually three times weekly for 4 wk beginning with the onset of menses. Menstrual bleeding diaries covering this 4- to 9-yr period were also collected allowing the prospective identification of the final menstrual period.

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Jun
2004

To investigate the association of hormone levels at menopause, lifestyle variables, and body composition with the predicted 10-year risk of a coronary event, calculated using the PROCAM scoring system, in a population-based sample of Australian-born, middle-aged women.
A 9-year prospective study of 438 Australian-born women, who at baseline were aged 45 to 55 years and had menstruated in the prior 3 months. Interviews, fasting blood, and physical measurements were taken annually.

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Nov
2004

The aim of this study was to assess the relative strength of the association of endogenous estradiol and androgens with bone loss at the lumbar spine and femoral neck during the menopausal transition.
A longitudinal study of a population-based cohort of 159 Australian-born women who at baseline had a mean age of 50.0 years (SD=2.

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Nov
2004

A multicenter, open-label, randomized efficacy and safety study was performed with combined human chorionic gonadotropin (hCG) and recombinant follicle-stimulating hormone (recFSH) (Puregon(R)) treatment to induce spermatogenesis in hypogonadotropic hypogonadal male patients. Patients were pretreated for 16 weeks with hCG to normalize testosterone levels. A total of 30 of 49 (61%) subjects had normalized testosterone levels but were still azoospermic after the hCG-alone phase.

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Jun
2003

To investigate the effect of endogenous hormone levels on central abdominal fat during the menopausal transition in a population-based cohort of Australian-born women.
Prospective observational study.
Population-based sample.

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Mar
2003

The role of androgen therapy.

Best Pract Res Clin Endocrinol Metab 2003 Mar;17(1):165-75
Susan R Davis, Henry G Burger
The concept of a female androgen insufficiency syndrome, although not new, remains somewhat controversial. Androgens are quantitatively the predominant sex steroid in women, circulating in the micromolar and nanomolar concentration range, compared with picomolar levels of oestrogens. The most significant biologically active androgen is testosterone (T), which circulates bound tightly to sex-hormone-binding globulin (SHBG) and loosely to albumin.

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Apr
2003

Testicular regulation of inhibin B may be influenced by the germ cell complement.
We examined the effects of gonadotrophin stimulation on serum inhibin B and pro-alphaC in 25 normal men at (i) control (stimulation test 1), (ii) after spermatogenic suppression induced by testosterone plus progestin treatment (stimulation test 2), and (iii) during spermatogenic recovery induced by FSH and/or hCG treatment (stimulation test 3). For each test, subjects received a single injection of 1200 IU FSH or 5000 IU hCG or both.

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Dec
2002

Risks of postmenopausal hormone replacement.

JAMA 2002 Dec;288(22):2820; author reply 2823-4
Susan R Davis, Henry G Burger

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Jul
2002

This review explores the pituitary-ovarian hormones involved with ageing and the onset of menopause. The serum patterns of pituitary-ovarian hormones throughout the menstrual cycle alter as menopause approaches. The increase in follicular phase FSH prior to menopause is attributed to an early decline in the ovarian hormone, inhibin B, which negatively regulates follicle-stimulating hormone (FSH) secretion.

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Jun
2002

The role of androgen therapy.

Best Pract Res Clin Obstet Gynaecol 2002 Jun;16(3):383-93
Henry G Burger, Susan R Davis
The concept of an androgen deficiency syndrome in women is a relatively old one, although it has gained substantially increased attention in recent years. Androgens are quantitatively the predominant sex steroid in women, circulating in the micro- and nanomolar concentration range, compared with picomolar levels of oestrogen. The most significant biologically active androgen is testosterone, which circulates bound tightly to sex hormone-binding globulin (SHBG) and loosely to albumin.

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May
2002

Granulosa cell tumours (GCT) of the ovary arise from granulosa cells of the ovary on morphological, biochemical and molecular criteria. In order to understand the molecular pathogenesis of these tumours better we have sought to define their molecular phenotype, to identify activating mutations of the FSH-signalling pathway, to characterise their estrogen receptor expression and to explore the hypothesis that GCT may be resistant to inhibin. The pattern of gene expression observed in GCT suggests a phenotype which is similar to that of late preovulatory granulosa cells which would be consistent with activation of the FSH receptor signalling pathway, however, there is no evidence for activating mutations of either the FSH receptor or the associated trimeric G-proteins.

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Dec
1969

The menopause is the permanent cessation of menstruation resulting from the loss of ovarian follicular activity. It is heralded by the menopausal transition, a period when the endocrine, biological, and clinical features of approaching menopause begin. A common initial marker is the onset of menstrual irregularity.

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Apr
2002

Androgen production in women.

Fertil Steril 2002 Apr;77 Suppl 4:S3-5
Henry G Burger
To describe the sources, production rates, circulating concentrations, and regulatory mechanisms of the major androgen precursors and androgens in women.
Review of the major published literature.
Quantitatively, women secrete greater amounts of androgen than of estrogen.

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