One in two postmenopausal women with Vaginal Atrophy (VA) suffers from the condition for over three years, despite the availability of effective treatments that can improve vaginal health.1 That's according to new results from the VIVA (Vaginal Health: Insights, Views & Attitudes) Survey. VA, which is characterised by symptoms including vaginal dryness, itching, burning and painful intercourse, can have a significant impact on quality of life and, if left untreated, can lead to serious long-term urogenital problems, including incontinence.2 The survey results and clinical data from ultra-low dose Vagifem® 10μg (estradiol vaginal tablets), were presented by experts in women's health at the 6th Amsterdam Menopause and Women's Health Symposium (AMS) in The Netherlands.

The VIVA Survey shows that up to 40% of postmenopausal women3 are living with VA, which is when the vaginal walls become thin, fragile and inflamed due to a reduction of oestrogen in the body. The VIVA Survey shows that while this condition has an impact on sexual intimacy, it also has negative consequences for a woman's marriage, relationships and her self-esteem.

96% of postmenopausal women are incorrectly attributing VA symptoms1 to other conditions such as thrush or bladder infections, and six in 10 women do not understand that VA is a chronic condition that requires ongoing treatment of the underlying cause.1 In addition, whilst two-thirds of postmenopausal women with VA report their symptoms as moderate-to-severe, with vaginal dryness reported as the most common symptom, the VIVA Survey reveals that one in three women does not seek medical advice.

Together, these data suggest that, due to poor understanding of VA as a chronic condition, women are resorting to short-term symptom relief afforded by treatments such as lubricants and moisturisers. However, treatments from doctors are available that address the underlying cause of VA, rather than just relieving the symptoms.

Ultra-low dose local oestrogen therapy for Vaginal Atrophy

Clinical data presented today at the AMS Congress, demonstrates that treatment with Vagifem® 10μg leads to significantly improved vaginal health.4

Vagifem® 10μg is the lowest dose of local oestrogen commercially available. It provides effective relief from the most bothersome symptoms of VA, while ensuring that systemic oestrogen levels remain within the normal postmenopausal range.5 It is the only vaginal oestrogen tablet that gives patients the convenience of a clean and precise dose delivered directly into the vagina using a pre-loaded, single-use applicator. One tablet is administered daily for the first two weeks of treatment, after which one tablet is taken twice weekly.

Dr James Simon, Clinical Professor of Obstetrics and Gynaecology at George Washington University, Washington D.C, commented, "The launch of Vagifem® 10μg in Europe represents a major step towards effectively and safely relieving the symptoms of Vaginal Atrophy in postmenopausal women. Vagifem® 10μg is the only ultra-low dose treatment option that works effectively at the location of a woman's discomfort, while limiting the administered dose of oestrogen to just 1.14mg per year."

The International Menopause Society (IMS), North American Menopause Society (NAMS) and the European Menopause and Andropause Society (EMAS) all recommend local, low-dose oestrogen therapy for the treatment of VA.

VA: The last taboo of the menopause

The VIVA Survey also found that half of women would not discuss VA symptoms with their physician. In addition, only two in five women would talk to their spouse or partner about VA and two-thirds reported that their mother never spoke to them about menopause, suggesting that VA is still very much a taboo subject.

Dr Rossella Nappi, Associate Professor of Obstetrics and Gynecology, Research Center for Reproductive Medicine and Director of the Gynecological Endocrinology & Menopause Unit, University of Pavia (Italy), said," While it is sad to see that women are reluctant to talk about their vaginal health, what is perhaps more worrying is that the VIVA survey shows that just half of doctors are raising the topic of vaginal health with their postmenopausal patients. This, and the fact that so many women are living with VA for so long, is unacceptable."

"In response to this, we, as experts in women's health, are calling on medical professionals to routinely raise the topic of vaginal health with their postmenopausal patients and to discuss appropriate treatment options with them. It is vital that we proactively address the Vaginal Atrophy taboo head-on to ensure that women have access to effective treatment and rapid relief from the distressing symptoms of VA."

Notes About the VIVA (Vaginal Health: Insights, Views & Attitudes) Survey

The VIVA survey was commissioned by Novo Nordisk and conducted by Strategy One. The survey was conducted online in August 2010, with results received from 3,520 female respondents aged 55-65 years old from Great Britain, Sweden, Denmark, Finland, Norway, Canada, and the United States of America. The aim of the survey was to evaluate the attitudes of postmenopausal women on the impact of Vaginal Atrophy (VA) and menopause on different aspects of their lives and understand the barriers and challenges to seeking advice and treatment.

About Vagifem® 10μg

Vagifem® 10μg is an ultra-low dose vaginal oestrogen tablet, which is delivered locally into the vagina for the treatment of vaginal atrophy (VA) due to oestrogen deficiency in postmenopausal women. Vagifem® tablets adhere to the vaginal mucosa to deliver a gradual and controlled release of oestrogen. Estradiol, the oestrogen used in Vagifem®, is chemically identical to the oestrogen made by the body. Because Vagifem® is inserted into the vagina, the estradiol is delivered directly to irritated vaginal tissues where it is needed, with minimal systemic absorption.5

The approval of Vagifem® 10μg to treat VA was based upon important clinical data from a randomised, placebo-controlled 52-week multicentre trial,4 which found statistically significant improvements in VA symptoms with Vagifem® 10μg versus placebo, including:

- Vaginal Maturation Index and Value, starting from week 2 (p<0.001)
- Vaginal pH, starting from week 2 (p<0.001)
- Decrease in the mean Most Bothersome Symptom score (p=0.003), apparent from week 4, statistically significant at week 8
- Vaginal Health Score (p<0.001), starting from week 2
- All improvements continued to be significantly greater than with placebo treatment at week 52
- One year of treatment with Vagifem® 10μg tablets was well tolerated by patients without any endometrial stimulation in these studies.4,6,7

Important Safety Information

Vagifem® 10μg Vaginal Tablets. Refer to the Summary of Product Characteristics before prescribing.


1. Strategy One. VIVA (Vaginal Health: Insights, Views & Attitudes) Survey. Sept 2010

2. Hextal A. Oestrogens and lower urinary tract function. Maturitas 2000; 36: 83-92.

3. North American Menopause Society. The role of local vaginal estrogen for treatment of vaginal atrophy. Menopause 2007; 14: 357-369.

4. Simon J et al. Effective Treatment of Vaginal Atrophy With an Ultra-Low-Dose Estradiol Vaginal Tablet. Obstetrics & Gynecology 2008; 112 (5): 1053-1060

5. Eugster-Hausmann M et al. Minimized estradiol absorption with ultra-low-dose 10 μg 17ß-estradiol vaginal tablets. Climacteric 2010; 13 (3): 219-227.

6. Ulrich LSG et al. Endometrial safety of ultra-low-dose Vagifem 10 μg in postmenopausal women with vaginal atrophy. Climacteric 2010; 13 (3): 228-237.

7. Simon J et al. Endometrial Safety of Ultra-Low-Dose Estradiol Vaginal Tablets. Obstetrics & Gynecology 2010; (in press)

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