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Prasterone (Intrarosa) for Dyspareunia

From the Medical Letter

The FDA has approved the steroid prasterone (Intrarosa – Endoceutics) for intravaginal treatment of postmenopausal women with moderate-to-severe dyspareunia due to vulvovaginal atrophy (VVA) (Table 1). Also called dehydroepiandrosterone (DHEA), prasterone is produced in the adrenal glands, gonads, and brain and converted intracellularly into active metabolites of estrogens and androgens. DHEA has been available over the counter for years as an oral dietary supplement claimed to benefit sexual, cardiovascular, and neuropsychiatric dysfunction.1- 3

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Bioidentical Hormones - risks revisited

The October issue of Endocrine news (1) carries an article that once again tackles the complexity of bioidentical hormones.

The freelance US writer highlights the confusion surrounding "bioidentical hormones" and more specifically the compounded formulations that are promoted as "natural".

The 2015 study by Santoro and Pinkerton (2) estimated that 1 million to 2.5 million U.S. women aged 40 years or older are using compounded hormone therapy. This may mean that custom-compounded products represent a quarter to a third of the market for hormone therapy products. Custom-compounded products lack protections of purity, controlled manufacturing processes, and evidence from clinical trials that products from less-regulated compounding pharmacies do not.

Santoro is quoted as recognising “Maybe 1% of people will have a reaction to all forms of hormone therapy and might do better with compounding” but emphasises the availability of "government-approved bioidentical hormone therapy".

The “Compounded Bioidentical Hormones in Endocrinology Practice: An Endocrine Society Scientific Statement” published in The Journal of Clinical Endocrinology & Metabolism in April 2016 (3) is worth a read or review along with Bioidentical Hormones for Menopausal Symptoms and Bioidentical Hormone Preparations - History of Development

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Oestrogen patch shortage information

20 April 2017

Fairfax through The Sydney Morning Herald and The Age, has published a story about the current shortage of oestrogen patches, a hormone replacement treatment used to manage menopausal symptoms.

With so many questions being raised about the shortage, Jean Hailes Medical Director Dr Elizabeth Farrell AO and Jean Hailes endocrinologist Dr Sonia Davison, were asked for some further advice.

With Jean Hailes for Women's kind permission, the advice is as follows:

If I use oestrogen patches such as Estradot (oestrogen only) and Estalis (combined oestrogen and progestogen), what does the shortage mean for me?

While these products are unavailable you might need to consider alternative HRT products.

How do I decide what alternative HRT I should use?

There are different options available, including a topical gel or substituting with another patch, but it's best to make an appointment and talk to your health professional to work out what's appropriate for you.

When are supplies expected to return to normal?

According to an official statement on the website of Novartis, a pharmaceutical company that supplies some oestrogen patches: "Novartis is currently undergoing a disruption in supply of Estradot, Estalis Continuous and Estalis Sequi in Australia. We apologise for the inconvenience this has caused and are working to resolve the fluctuations in supply. We anticipate a return to stable supply in Australia by mid-2017."

I'm a health practitioner, where can I find reliable information on HRT products? 

The Australasian Menopause Society has an excellent guide to MHT/HRT equivalent-dose products (Aus) and MHT/HRT equivalent-dose products (NZ) and should be consulted for further guidance as to other products that may be used. 

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Are natural alternatives to estrogen replacement therapy safe?

Although individuals often consume natural products because of their potential health benefits, a review indicates that it is not clear whether the benefits of plant-derived compounds that mimic estrogen outweigh the possible health risks. 

Phytoestrogens are compounds from plants that are similar in structure to estrogen and are found in a variety of foods, especially soy. Some women may consume phytoestrogens promoted as natural alternatives to hormone replacement therapy to help ease menopausal symptoms such as hot flushes or to protect against bone loss.

When Ivonne Rietjens, PhD, of Wageningen University in The Netherlands, and her colleagues analyzed the published medical literature, they found that several potential health benefits of phytoestrogens have been reported, including lowered risks of cardiovascular disease, obesity, metabolic syndrome and type 2 diabetes, brain function disorders, and various types of cancer, in addition to reduced menopausal symptoms. Phytoestrogens are considered endocrine disruptors, however, which indicates that they have the potential to cause negative health effects, including infertility and increased risks of cancer in estrogen-sensitive organs such as the breast and uterus.

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Sex after menopause - survey

New survey shows women still don't understand why sex hurts after menopause

Women's EMPOWER survey confirms reluctance to discuss sex problems and seek treatment despite major educational efforts

The Women's EMPOWER survey, an internet-based survey of 1,858 US postmenopausal women with symptoms of vulvovaginal atrophy (VVA). VVA, was specifically designed to assess women's awareness of VVA and their behaviors and attitudes associated with the treatment of symptoms. The findings came as little surprise to insiders in the medical industry, because they were consistent with six other past VVA surveys that also confirmed that postmenopausal women generally failed to recognize VVA and its chronic progressive course (including urinary problems) and were reluctant to discuss vaginal or sexual symptoms with their healthcare providers.

In the Women's EMPOWER survey, 81% of women were not aware that VVA is a medical condition. More than two-thirds of respondents were not familiar or only somewhat familiar with most of the prescription VVA products.

"The results of the Women's EMPOWER survey demonstrate and reinforce that, even with multimedia marketing and educational strategies in the years after other major VVA surveys, minimal progress has been made toward increasing women's awareness and understanding of VVA," says Michael Krychman, MD, of the Southern California Center for Sexual Health and Survivorship Medicine and a lead author of the Women's EMPOWER survey. "Women remain naive to the safe and effective treatment options that are currently available and are still, for the most part, underinformed and undertreated."

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Memory and hormone therapy after menopause

Contrary to popular belief, taking estrogen after menopause may not affect the memory and thinking abilities of healthy women no matter when the treatment is started. The study is among the first large, long-term clinical trial to examine the cognitive effects of estradiol, a type of estrogen, on women both close to and long after menopause.

Millions of women take estrogen to treat hot flushes, night sweats and other symptoms caused by menopause. Estradiol is the main type of estrogen produced by women in their reproductive years. Previously, researchers thought estradiol benefitted memory and thinking in women soon after menopause but not later, called the "timing hypothesis". Prior studies testing the theory have not found consistent results.

"This study fails to confirm the timing hypothesis," said study author Dr Victor W. Henderson of Stanford University School of Medicine in California and a Fellow of the American Academy of Neurology. "Our results suggest that healthy women at all stages after menopause should not take estrogen to improve memory. At the same time, women need not particularly be concerned about negative effects of postmenopausal estrogen supplements on memory when used for less than five years."

For the study, 567 healthy women between the ages of 41 and 84 were classified into early and late groups. The early group was within six years of menopause and the late group was at least 10 years postmenopausal. Participants took beta-estradiol every day or a placebo pill. The women also used a progesterone vaginal gel or placebo gel, unless they had a hysterectomy. The average treatment duration was nearly five years. Cognitive tests were performed at the beginning of the trial, 2.5 years and five years to measure thinking skills including verbal memory.

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Young Researchers: Sambrook award - applications close 15th July

The Philip Sambrook travel award is open for applications until 15th July.

Osteoporosis Australia is aiming this year to encourage interest from researchers who have received their research qualification within the last 5 years.

The award is open to both clinical and lab-based researchers, and up to $10,000 is offered to cover registration, travel and expenses for an overseas meeting.

If you know of anyone who is eligible/interested, please pass on this information.

pdfSambrook_award_flyer_2016611.05 KB

 

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Are women suffering in silence? - UK survey

New survey puts spotlight on significant impact of menopause despite recent guideline

Findings presented at the British Menopause Society’s annual conference show only half of women surveyed in Great Britain (who are currently experiencing or who have experienced menopausal symptoms within the past ten years) consult a healthcare professional for any of their menopause symptoms

A new survey conducted by Ipsos MORI on behalf of the British Menopause Society (BMS) has revealed that one in two women in Great Britain (aged 45-65 who are currently experiencing or who have experienced menopausal symptoms within the past ten years) go through the menopause without consulting a healthcare professional.1 This is despite women surveyed reporting on average seven different symptoms and 42% saying their symptoms were worse or much worse than expected.[1]

More than 200 leading women’s health experts from around the world gathered at the BMS’s annual conference to discuss recent advances in menopause research, and the impact of the National Institute of Health and Care Excellence (NICE) guideline on addressing the often overlooked needs of women experiencing the menopause.

It was hoped that the recently published NICE guideline on the diagnosis and management of the menopause would encourage more women to seek help and access to safe and effective treatments. Worryingly however, only 3% of those surveyed had heard of the guideline.[1]

The online survey found that:

  • Among those who have not consulted a healthcare professional for their menopause symptoms, more than a third (35%) believe it is something they should have to put up with [1]
  • The majority of women surveyed experienced hot flushes (79%) or night sweats (70%), but many experienced symptoms they did not expect1
    • 22% of women surveyed experienced unexpected sleeping problems / insomnia, 20% difficulty with memory / concentration and 18% joint aches1
    • It is also interesting to note that 35% said they experienced vaginal dryness, with 18% of those experiencing this symptom saying it was unexpected1
  • *For a full list of symptoms experienced, please see footnote below.
  • The impact of these symptoms has been widespread with half of women surveyed saying their menopause symptoms have affected their home life, their social life (36%), and work life (36%) [1]
    • 50% of women surveyed also reported that their sex life was affected, experiencing reduced libido (32%), reduced sex life (22%), painful or uncomfortable sex (16%) and 10% stopped having sex altogether. [1]

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Endocrine Society encourages clinicians to avoid prescribing compounded hormones

A new Scientific Statement issued by the Endocrine Society advises clinicians to avoid using compounded hormone medications to treat menopausal symptoms, female sexual dysfunction and other hormone conditions.

Sometimes called bioidentical compounded hormones, these products are typically a mixture of hormones. Compounded hormone medications are prepared by licensed professionals or facilities specifically for an individual's use. Compounded medications are meant to be an alternative when an individual does not have access to or has an adverse reaction to a medication approved by the U.S. Food & Drug Administration.

See comment from Australasian Menopause Society here

Compounded hormone medications can be unsafe when inappropriate practices are used. More than 60 people died from cases of fungal meningitis attributed to compounded medications in a 2010 case.

"In extreme cases, advertisers have marketed compounded products as being able to prevent the ravages of aging and implied they are risk free," said Nanette Santoro, MD, and the chair of the Society task force that developed the statement. "Few, if any, of these claims are supported by science."

Widely available hormone treatments that are 100 percent chemically identical to the native hormones found in the body and that are approved by the U.S. Food & Drug Administration (FDA) offer effective and safe options for people with hormone disorders, and those approved treatments should be prescribed whenever possible, Santoro said.

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FDA Approval of Flibanserin - Treating Hypoactive Sexual Desire Disorder

In a Perspective article in the New England Journal of Medicine the US Food and Drug Administration (FDA) offer an explanation regarding the approval Flibanserin. It opens as follows:

Was the Food and Drug Administration (FDA) approval of flibanserin (Addyi) for treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women long overdue? Or was it an error? In the face of divergent views, we at the FDA think it's important to clarify why flibanserin was approved after being rejected twice.

Read the full article here: http://www.nejm.org/doi/full/10.1056/NEJMp1513686#t=article

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