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Update on Femoston Conti Shortage

The supplier of Femoston Conti has advised that the recent supply shortage of Femoston Conti has been restored.

Pharmacies across Australia are currently being restocked. No other Femoston product has been affected by the shortage. 

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About vaginal dryness

SWAN data demonstrate lack of communication when it comes to vaginal itching and burning that occurs during the menopause transition, but few women are taking action to correct the problem

It's a common problem that only gets worse during the menopause transition; yet, no one wants to talk about it, and even fewer women are doing anything to correct it. A study identifies those factors that contribute to the taboo problem of vaginal dryness. 

Many women experience vaginal dryness during menopause, which often manifests as burning, itching, or lack of lubrication during sexual activity, and they have a lot of company. Data from the Study of Women Across the Nation (SWAN) tracked more than 2,400 women over a 17-year-period showed that, at baseline, 19.4% of women (aged 42-53 y) reported vaginal dryness. By the time the women in the study were aged 57 to 69 years, 34% of them complained of symptoms.

More surprising, however, is the fact that more than 50% of women don't report vaginal dryness to their healthcare providers, and less than 4% of affected women are actively using any of the many proven therapies that include vaginal estrogen tablets, creams, and rings, according to "Factors associated with developing vaginal dryness symptoms in women transitioning through menopause: a longitudinal study," the Menopause article detailing the study results.

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Hormone therapy may lead to improved cognitive function

Study demonstrates cognitive benefits of transdermal estradiol in combination with an oral progesterone for postmenopausal women

Hormones affect just about everything that goes on in a woman's body, from reproductive function and sexual libido to weight gain and overall mood. A new study shows how, in the right dosage and combination, hormones also may slow cognitive decline in postmenopausal women as they age. 

It comes as no surprise that cognitive function declines as we age. We recognize memory decline in a number of ways, such as not being able to remember a grocery list as easily as we once did. Mild cognitive impairment (MCI) is defined as that intermediate stage between normal aging and dementia. Persons with MCI have an increased risk of progressing to Alzheimer disease or other dementia, with roughly 20% of this population crossing over from MCI to a more severe level each year. To date, no pharmacologic treatment has proven effective in managing MCI.

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Climara 50mcg Patch Shortage

The Therapeutic Goods Administration (TGA) have reported an anticipated shortage of CLIMARA 50 mcg transdermal patches with supply due to return on 31 July 2018.

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iPrevent: an evidence-based tool to assess and manage breast cancer risk

iPreventA new web-based tool is available at https://www.petermac.org/iprevent to help women understand their personal breast cancer risk and then act on it. It is designed to be used collaboratively by women and their doctors. Women can use it at home, print the output, and bring it to a consultation for discussion.

AMS has been given permision to link to the tool from our Self Assessment Tools  Are you at risk of cancer? page on breast cancer.

How Does iPrevent Work?

iPrevent asks women to first enter their family cancer history, lifestyle and reproductive risk factor information. Using that information, it then provides 10 year and residual life-time risk estimates; there are options to view these as pictograms or graphs. It then provides tailored estimates of the absolute risk reductions for relevant breast cancer prevention strategies, personalised lifestyle change suggestions, and tailored advice on breast cancer screening. Women can print out a summary to take to a medical consultation for discussion, and so the doctor can incorporate it into the woman’s medical record.

What is the Evidence Base for iPrevent?

iPrevent uses the well-validated IBIS and BOADICEA algorithms to estimate each woman’s personal risk of breast cancer. An international prospective validation study, conducted using data on over 16,000 women, has confirmed the accuracy of the risk estimates provided. It uses Cancer Australia guidelines to determine which risk management options women are advised about, based on their risk level. An Australian pilot study of women and clinicians has also demonstrated that iPrevent has high usability and acceptability, and suggested that it improves knowledge without increasing anxiety. More detail on iPrevent peer-reviewed publications can be found by clicking the “Information For Clinicians” button on the iPrevent front page.

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Stem cell therapy may help reverse effects of premature menopause, restore fertility

Young women with premature ovarian insufficiency (POI) may be able to use their own bone marrow stem cells to rejuvenate their ovaries and avoid the effects of premature menopause, new research suggests. The preliminary results from the ongoing ROSE clinical trial were presented at ENDO 2018, the 100th annual meeting of the Endocrine Society, in Chicago, USA.

"In the two participants who have completed the treatment to date, serum estrogen levels have increased as soon as 3 months after the injection of stem cells, and the effect has lasted for at least one year. Their menopausal symptoms have been alleviated, and six months after the injection of the stem cells into the ovaries, they have resumed menses," said senior author Ayman Al-Hendy, M.D., Ph.D., Professor of Gynecology and Director of Translational Research at the University of Illinois at Chicago.

The researchers plan to enroll 33 participants in their clinical trial. For the two patients who have undergone the procedure so far, they collected each woman's own mesenchymal stem cells from her posterior iliac crest bone marrow and used minimally invasive laparoscopy to inject the cells into one ovary, keeping the second, untreated, ovary as a control. The authors followed the patients closely with frequent blood work, imaging of the ovaries, menopausal symptom questionnaires, and safety studies.

Now that both women's estrogen levels have increased significantly and they have begun to menstruate, the research team looks forward to the possibility that they may again become fertile.

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Heavy Menstrual Bleeding Clinical Care Standard launched

7 December 2017

Women to benefit from first national treatment standard for heavy periods 

Heavy Menstrual Bleeding Clinical Care Standard

The first nationally agreed standard of care for women experiencing heavy menstrual bleeding says women should be offered less invasive treatments before considering a hysterectomy – a major operation best done only when other treatments are not suitable.

Heavy menstrual bleeding affects an estimated 1 in 4 women of reproductive age. Despite being common, it is also under-recognised, and can significantly reduce a woman’s social, emotional and physical quality of life. It causes considerable disruption to women’s lives lasting several days each month, with some women experiencing associated pain. Sometimes the cause of the bleeding, such as fibroids, can be identified, but for about 50% of women it cannot.

Figures strongly suggest many Australian women are having hysterectomies for heavy menstrual bleeding rather than less invasive treatments. These include a hormone-releasing intra-uterine device (IUD), or a surgical technique called endometrial ablation, which reduces the bleeding by removing the lining of the uterus.

The new Heavy Menstrual Bleeding Clinical Care Standard, from the Australian Commission on Safety and Quality in Health Care, says most women with heavy menstrual bleeding can be effectively cared for by their GP. Referral to a specialist may be warranted in some situations – such as if the woman has uterine fibroids or polyps, or in less common situations where cancer is suspected, if symptoms do not resolve with initial treatments, or if the woman would prefer surgery.

The new clinical care standard offers guidance to clinicians about appropriate care, such as by clarifying on which days during a woman’s cycle an ultrasound scan will be most useful. It also informs patients about the care they can expect to receive.

Commission Senior Medical Advisor Professor Anne Duggan, said Australia had high rates of hysterectomy relative to the UK and New Zealand – and there was also strong variation within Australia, with stark differences between regional and metropolitan areas.

“This clinical care standard was developed after the Commission’s Australian Atlas of Healthcare Variation found the rate of hospital admissions for hysterectomy and endometrial ablation combined in 2012–13 was 5.2 times as high in the local area with the highest rate compared to the area with the lowest rate,” Professor Duggan said.

“The Commission’s second Atlas, released in June this year, found the gap was even wider – 6.6 times as high between different local areas – for hysterectomy admissions alone in 2014–15. Admissions for endometrial ablation were nearly 21 times as high between different local areas.

“Hysterectomy used to be one of the few options for women with heavy menstrual bleeding, but there are now several less invasive treatment options. These differences in admission rates for hysterectomy suggest that the full range of options is not being used across the country – and may indicate women are not being informed about all the options.”

University project officer and mother-of-one Hayley Harrison, 38, from Perth, has experienced heavy menstrual bleeding all her life and says a period lasting eight days is “a good month”, while 10 days is more usual. She estimates she has had 10–20 pelvic ultrasounds and spends $40 on sanitary products for every period.

“I presented to doctors because of the pain associated with heavy menstrual bleeding,” she said. “None of them really asked how heavy my period was. I didn’t know that changing a tampon every hour for at least three to four days was abnormal.

“It wasn’t until I went to see a different doctor – she asked these questions that I’d never been asked by a doctor before. She said ‘You really do have very, very heavy periods – this is really not normal’.”

Clinical Associate Professor Deborah Bateson, Medical Director of Family Planning NSW, said family planning doctors “often see women who have been putting up with heavy menstrual bleeding for years”.

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Oestrogen patch update - supply returned

30 November 2017

Novartis has advised that the company has both received and released stock for supply locally of the following lines;

  • ESTALIS CONT 50+140MCG 
  • ESTALIS SEQ 50MCG/50+ 140MCG 
  • ESTALIS SEQ 50MCG/50+ 250MCG

As a result the only remaining HRT line now still unavailable is ESTALIS CONT 50+250MCG

This line is confirmed for arrival into Sydney early next week - 4 December 2017.

Novartis is in the process of re-stocking wholesalers for all products and the products should be in pharmacies sometime next week.

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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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