New Survey Reveals Causes that May Affect Compliance with Local Estrogen Therapy

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May 08, 2013, 08:07 ET

PRINCETON, N.J., May 8, 2013 /PRNewswire/ -- Novo Nordisk announced that a new survey of women on local estrogen therapy revealing key insights into reasons for treatment non-compliance was published in the International Journal of Women's Health. The study, "Improved Compliance and Patient Satisfaction with Estradiol Vaginal Tablets in Postmenopausal Women Previously Treated with Another Local Estrogen Therapy," offers insight into reasons that various treatment regimens for vaginal atrophy (VA) may prove unsuccessful.

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VA is a treatable chronic condition that affects the vagina and the surrounding tissues during and after menopause due to the declining levels of estrogen.¹ Symptoms of VA include vaginal dryness, pain and bleeding during intercourse, itching in and around the vagina, vaginal soreness, and painful urination.^{1, 2} Up to 75 percent of menopausal women may experience vaginal dryness, the most common symptom of VA.¹ Yet despite the high prevalence, only 25 percent of sufferers seek medical help, as many women are not aware that VA is a treatable condition.^{1, 2}

The survey was designed to identify reasons women who receive treatment for VA would switch from the estradiol (a form of estrogen) vaginal ring, estradiol vaginal cream and/or conjugated estrogens vaginal cream formulations of local estrogen therapy (LET) to the estradiol vaginal tablet.³ The study evaluates the responses of 79 post-menopausal women currently taking estradiol vaginal tablets who were previously treated with another LET.³

Of the 79 women surveyed, 85 percent had used a vaginal cream, 9 percent had used the vaginal ring, and 6 percent had used both cream and the ring before switching to the vaginal tablet.³

"The survey may help healthcare professionals identify reasons for non-compliance with certain local estrogen therapy formulations, which emphasize the role that a patient's preference may play in the adherence to her treatment for vaginal atrophy," said lead author Mary Jane Minkin, MD, FACOG, clinical professor of obstetrics and gynecology at the Yale University School of Medicine. "These insights serve as an effective argument that patient preference should be ascertained and help guide physicians' treatment selection for their patients."

Reasons for Non-compliance
The survey found that the majority of women (66 percent) who had previously used a cream reported they were "much more likely" to use the vaginal tablet compared to the cream.³ Of those who had previously used vaginal creams, many reported missing doses at least once a month.³ Reasons for non-compliance were mostly related to the formulation: messiness when filling and inserting the applicator (61 percent), general unpleasantness of the cream (53 percent), the need to wash the applicator (48 percent), and leakage of the cream following application (37 percent).³

The survey also found that 100 percent of the eight women who used the vaginal ring reported having delayed filling their prescriptions at some point during the course of their treatment due to formulation concerns such as difficulty removing the ring (50 percent) and ability of the patient or her partner to feel the ring (25 percent, each).³

The study did not evaluate non-compliance in patients using vaginal tablets because patients were currently on the medication at the time of the study.

Reasons for Switching
The survey showed that for the majority of all respondents (52 percent), the switch to estradiol vaginal tablets was recommended by the patient's healthcare professional.³Other triggers for patient switches were general patient requests to change treatments (18 percent) and patient-specific requests for the vaginal tablet (15 percent).³ The top reasons for switching from creams were messiness when filling and inserting the applicator (43 percent) and leakage (41 percent).³

"Given that randomized, controlled clinical studies have shown that available local estrogen therapy formulations are comparable in efficacy, the choice of treatment should be driven by patient preference and clinical experience," said Dr. Minkin.

About Vagifem^® (estradiol vaginal tablets)⁴

Indications and Usage:
Vagifem^® (estradiol vaginal tablets) is used after menopause to treat menopausal changes in and around the vagina.

Important Safety Information

What is the most important information I should know about VAGIFEM^® (an estrogen hormone)

Using estrogen-alone may increase your chance of getting cancer of the uterus (womb)

Report any unusual vaginal bleeding right away while you are using Vagifem^®. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find the cause.
Do not use estrogen-alone to prevent heart disease, heart attacks, strokes or dementia (decline of brain function)
Using estrogen-alone may increase your chances of getting strokes or blood clots
Using estrogen-alone may increase your chance of getting dementia, based on a study of women age 65 years or older
Do not use estrogens with progestins to prevent heart disease, heart attack, or dementia
Using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots
Using estrogens with progestin may increase your chance of getting dementia, based on a study of women 65 years and older
You and your healthcare provider should talk regularly about whether you still need treatment with Vagifem^®

Do not start using Vagifem^® if you currently have or have had certain cancers. Estrogens may increase the chances of getting certain types of cancers, including cancer of the breast or uterus. Also, do not start using Vagifem^® if you have unusual vaginal bleeding, had a stroke or heart attack, currently have or have had blood clots, currently have or have had liver problems, have been diagnosed with a bleeding disorder, are allergic to Vagifem^® or any of its ingredients, or think you may be pregnant.

Vagifem^® is only used in the vagina; however, the risks associated with oral estrogens should be taken into account.

The most commonly reported side effects of Vagifem^® included: headache, breast pain, irregular vaginal bleeding or spotting, stomach/abdominal cramps, bloating, nausea and vomiting, hair loss, fluid retention, and vaginal yeast infection.

Estrogens should be used at the lowest possible dose for your treatment only as long as needed.

Please click here for Prescribing Information and FDA-Approved Patient Labeling.

Vagifem^® is only available by prescription. For more information about Vagifem^®, please call 1-866-668-6336.

Novo Nordisk provides patient assistance for those who qualify. Please call 1-866-310-7549 to learn more about Novo Nordisk assistance programs.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Vagifem^® is a registered trademark of Novo Nordisk FemCare AG.

About the Study
"Improved Compliance and Patient Satisfaction with Estradiol Vaginal Tablets in Postmenopausal Women Previously Treated with Another Local Estrogen Therapy" describes the results of an online study sponsored by Novo Nordisk Inc.³ The study was conducted between March 6, 2012, and April 9, 2012, and evaluates the responses of 79 post-menopausal women 18 years and older who were currently taking estradiol vaginal tablets (Vagifem^® 10 mcg) and who were previously treated with either: the estradiol vaginal ring (Estring^®, reservoir of 2 mg estradiol, Wyeth Pharmaceuticals [a division of Pfizer], Philadelphia, PA); estradiol vaginal cream (Estrace^®, estradiol cream, 0.1 mg estradiol/g USP, Contract Pharmaceuticals Limited, Buffalo, NY, for Warner Chilcott, LLC); and/or conjugated estrogens vaginal cream (Premarin^®, 0.625 mg conjugated estrogens/g USP, Wyeth Pharmaceuticals [a division of Pfizer], Philadelphia, PA).³ Post-menopausal women were defined as women who had not presented with a spontaneous menstrual period for more than one year or who had a bilateral oophorectomy.³ Respondents were excluded (n=344) if they: were or had a household member who was a healthcare provider, did not meet the definition of menopausal, were not using the vaginal tablet therapy at the time of data collection, or were LET treatment naïve before starting the vaginal tablet.³

The objectives of this research were to evaluate reasons for switching to the vaginal tablet from other formulations and to evaluate factors associated with patient preference for and compliance with use of LET.³

About Vaginal Atrophy
Vaginal atrophy (VA), a chronic condition, is the thinning and inflammation of the vaginal wall which occurs when there is a reduction in levels of estrogens.¹ Estrogens, produced by the ovaries, are responsible for maintaining the structure and function of the vaginal wall, elasticity of the tissues around the vagina and production of vaginal fluid. If left untreated, vaginal atrophy can have long-term effects in some women.⁵

Local estrogen therapy (LET) is available in the United States in various formulations, including conjugated estrogens and estradiol creams, estradiol vaginal ring, and estradiol vaginal tablet.³ The North American Menopause Society (NAMS) recommends low-dose, local vaginal estrogen therapy when estrogen therapy is considered solely for the treatment of VA.¹ NAMS also recommends that the lowest effective dose of estrogen consistent with treatment goals, benefits and risks for the individual woman should be the therapeutic goal.⁶

About Novo Nordisk
Headquartered in Denmark, Novo Nordisk is a global healthcare company with 90 years of innovation and leadership in diabetes care. The company also has leading positions within hemophilia care, growth hormone therapy, and hormone replacement therapy. For more information, visit novonordisk-us.com or follow our news in the US on Twitter: @NovoNordiskUS.

¹ The North American Menopause Society. The role of local vaginal estrogen for treatment of vaginal atrophy in postmenopausal women: 2007 position statement of The North American Menopause Society. Menopause. 2007;14(3):357–369.
² Nappi RE, Kokot-Kierepa M. Vaginal health: Insights, Views and Attitudes (VIVA) – results from an international survey. Climacteric. 2012;15:36-44.
³ Minkin MJ, Maamari R, Reiter S. Improved compliance and patient satisfaction with estradiol vaginal tablets in postmenopausal women previously treated with another local estrogen therapy. Int J Womens Health. 2013;5:133-139.
⁴ Vagifem [package insert]. Princeton, NJ: Novo Nordisk; 2012.
⁵ Sturdee DW, Panay N. Recommendations for the management of postmenopausal vaginal atrophy. Climacteric. 2010;13: 509–522.
⁶ The North American Menopause Society. The 2012 Hormone Therapy Position Statement of The North American Menopause Society. Menopause. 2012; 19(3): 257-271.

SOURCE Novo Nordisk